Trials (Fundación Instituto Valenciano de Oncología IVO)

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NCTID: NCT05947903

Title: Validation of the European Oncology Quality of Life Toolkit 
Study Summary: The improvement or preservation of quality of life (QoL) is one of the three pillars of the European Union (EU) Mission on Cancer, which underpins the needs of patients from cancer diagnosis throughout treatment, survivorship, and advanced terminal stages. Clinical studies and real-world data show that the use of Patient Reported Outcome Measures (PROMs) for QoL assessment in routine oncology practice has positive effects on patient wellbeing and healthcare resource utilization. However, full implementation of PROMs is not yet part of standard of care and is not adequately considered in cancer policies and programs.  A comprehensive tool incorporating the perspective of patients at different stages of the disease trajectory and widely applicable across Europe is still lacking.  The European Oncology Quality of Life Toolkit (EUonQoL-Kit) is a unified patient-centred tool for the assessment of QoL, developed from preferences and priorities of people with past or current cancer experience. The EUonQoL-Kit includes three electronic questionnaires, specifically designed for different disease phases (patients in active treatment, survivors, and patients in palliative care), available in both static and dynamic (Computer Adaptive Testing, CAT) versions and in several European languages.  This is a multicentre observational study, with the following aims:  * The primary aim is to perform the psychometric validation of the EUonQoL-Kit. * Secondary aims are to assess its acceptability, to validate the CAT version, and to provide estimates of QoL across different European countries.  The EUonQoL-Kit will be administered to a sample of cancer patients and survivors from 46 European cancer centres. The sample will include patients in active treatment (group A), survivors (group B), and patients in Palliative Care (group C).  Each centre will recruit 100 patients (40 from group A, 30 from group B, 30 from group C), for an overall sample size of 4,600 patients (at least 4,000 patients are assumed to be enrolled, due to an expected lower recruitment rate of 10-15%). Three sub-samples of patients (each corresponding to 10% of the total sample for each centre) will fill in an additional questionnaire:  * EORTC QLQ-C30, to test concurrent validity. * Live-CAT version, to test the feasibility of such implementation. * EUonQoL-Kit, 2-7 days after the first completion, to assess test-retest reliability. 
Sponsor: Fondazione IRCCS Istituto Nazionale dei Tumori, Milano 
Intervention: Administration of the EUonQoL-Kit - Active Treatment questionnaire 
Start Date: 2024-04-01 
Last Updated: 2023-07-19 
Number of Patients: 4000 
Recruitment Status: NOT_YET_RECRUITING 
Condition: Cancer 

NCTID: NCT04987203

Title: Study to Compare Tivozanib in Combination With Nivolumab to Tivozanib Monotherapy in Subjects With Renal Cell Carcinoma 
Study Summary: This study will be comparing tivozanib in combination with nivolumab to tivozanib alone in subjects with advanced Renal Cell Carcinoma (RCC) who have had 1 or 2 prior lines of therapy, one of which was an Immune Checkpoint Inhibitor (ICI). 
Sponsor: AVEO Pharmaceuticals, Inc. 
Intervention: Tivozanib 
Start Date: 2021-09-09 
Last Updated: 2023-11-28 
Number of Patients: 326 
Recruitment Status: ACTIVE_NOT_RECRUITING 
Condition: Renal Cell Carcinoma 

NCTID: NCT03498716

Title: A Study Comparing Atezolizumab (Anti PD-L1 Antibody) In Combination With Adjuvant Anthracycline/Taxane-Based Chemotherapy Versus Chemotherapy Alone In Patients With Operable Triple-Negative Breast Cancer 
Study Summary: This study will evaluate the efficacy, safety, and pharmacokinetics of adjuvant atezolizumab in combination with paclitaxel, followed by atezolizumab, dose-dense doxorubicin or epirubicin (investigator’s choice), and cyclophosphamide, compared with paclitaxel followed by dose-dense doxorubicin or epirubicin (investigator’s choice) and cyclophosphamide alone in patients with Stage II-III TNBC (Triple Negative Breast Cancer) 
Sponsor: Hoffmann-La Roche 
Intervention: Atezolizumab 
Start Date: 2018-08-02 
Last Updated: 2023-09-15 
Number of Patients: 2203 
Recruitment Status: COMPLETED 
Condition: Triple Negative Breast Cancer 

NCTID: NCT04622319

Title: A Study of Trastuzumab Deruxtecan (T-DXd) Versus Trastuzumab Emtansine (T-DM1) in High-risk HER2-positive Participants With Residual Invasive Breast Cancer Following Neoadjuvant Therapy (DESTINY-Breast05) 
Study Summary: Patients with HER2-positive primary breast cancer (BC) who do not achieve complete response after appropriate neoadjuvant therapy are at higher risk of disease recurrence. More effective treatment options are needed for this patient population. This study will examine the efficacy and safety of trastuzumab deruxtecan (T-DXd) compared with trastuzumab emtansine (T-DM1) in high-risk patients with residual invasive breast cancer following neoadjuvant therapy. 
Sponsor: Daiichi Sankyo, Inc. 
Intervention: DS-8201a 
Start Date: 2020-12-04 
Last Updated: 2023-11-07 
Number of Patients: 1600 
Recruitment Status: RECRUITING 
Condition: HER2-Positive Primary Breast Cancer 

NCTID: NCT00129922

Title: Fluorouracil, Epirubicin, and Cyclophosphamide Alone or Followed by Paclitaxel for Early Breast Cancer 
Study Summary: The efficacy of adjuvant chemotherapy is limited in patients with a high risk of recurrence.  Also, for axillary positive node patients, optimum chemotherapy regimens are still under discussion. Some previous studies suggest that, in the subset of node-positive patients, treatments based on sequential administration of anthracyclines and taxanes are more efficient. Paclitaxel dose-dense (weekly) administration renders an improved therapeutic index (activity/toxicity).  The study is designed to compare 6 courses of FEC scheme (600/90/600), a combination of proven efficacy in node positive breast cancer patients, versus 4 FEC courses followed by 8 weekly paclitaxel administrations (100mg/m2).  The study hypothesis is that 5-year disease-free survival in the control arm will be 60%. The investigators expect to increase this by 8% with the experimental treatment. With an alpha error of 0.05, 80% power, and a post-randomization estimated drop-out rate of 10%, 1250 patients are needed, 625 per arm. 
Sponsor: Spanish Breast Cancer Research Group 
Intervention: paclitaxel 
Start Date: 1999-11 
Last Updated: 2023-03-06 
Number of Patients: 1289 
Recruitment Status: COMPLETED 
Condition: Breast Cancer 

NCTID: NCT00130533

Title: Maintenance Treatment With Capecitabine Versus Observation in Breast Cancer Patients 
Study Summary: This is a prospective, open-label, randomized phase III study assessing adjuvant capecitabine after standard chemotherapy for patients with early triple negative breast cancer. 
Sponsor: Spanish Breast Cancer Research Group 
Intervention: Capecitabine 
Start Date: 2006-01 
Last Updated: 2023-03-31 
Number of Patients: 876 
Recruitment Status: COMPLETED 
Condition: Breast Cancer 

NCTID: NCT04821622

Title: Study of Talazoparib With Enzalutamide in Men With DDR Gene Mutated mCSPC 
Study Summary: The purpose of the study is to evaluate the safety and efficacy of talazoparib in combination with enzalutamide compared with placebo in combination with enzalutamide in participants with DDR-deficient mCSPC. 
Sponsor: Pfizer 
Intervention: talazoparib plus enzalutamide 
Start Date: 2021-05-12 
Last Updated: 2023-11-22 
Number of Patients: 599 
Recruitment Status: ACTIVE_NOT_RECRUITING 
Condition: Prostate Cancer 

NCTID: NCT04895722

Title: Evaluation of Co-formulated Pembrolizumab/Quavonlimab (MK-1308A) Versus Other Treatments in Participants With Microsatellite Instability-High (MSI-H) or Mismatch Repair Deficient (dMMR) Stage IV Colorectal Cancer (CRC) (MK-1308A-008/KEYSTEP-008) 
Study Summary: The purpose of this study is to assess the efficacy and safety of co-formulated pembrolizumab/quavonlimab versus other treatments in participants with MSI-H or dMMR Metastatic Stage IV Colorectal Cancer. 
Sponsor: Merck Sharp & Dohme LLC 
Intervention: Pembrolizumab 
Start Date: 2021-06-25 
Last Updated: 2023-11-24 
Number of Patients: 320 
Recruitment Status: RECRUITING 
Condition: Colorectal Cancer 

NCTID: NCT00461747

Title: GEM05 for Patients With Multiple Myeloma Under 65 Years 
Study Summary: The primary objective is to compare safety and efficacy of three induction treatments: VBMCP-VBAD / Velcade versus Thalidomide / Dexamethasone versus Velcade / Thalidomide / Dexamethasone. The second one is to evaluate the ability of stem cell mobilization after the treatments in order to do an autologous transplant. Otherwise this study wants to compare the safety and efficacy of the maintenance treatments: Interferón a-2b versus Thalidomide versus Thalidomide/Velcade. 
Sponsor: PETHEMA Foundation 
Intervention: VBMCP/VBAD/Velcade 
Start Date: 2006-03 
Last Updated: 2009-09-18 
Number of Patients: 390 
Recruitment Status: COMPLETED 
Condition: Multiple Myeloma 

NCTID: NCT05173987

Title: Study of Pembrolizumab (MK-3475) Versus Chemotherapy in Mismatch Repair Deficient (dMMR) Advanced or Recurrent Endometrial Carcinoma (MK-3475-C93/KEYNOTE-C93/GOG-3064/ENGOT-en15) 
Study Summary: The purpose of this study is to assess the safety and efficacy of treatment with pembrolizumab (MK-3475) compared to a combination of carboplatin and paclitaxel in women with mismatch repair deficient (dMMR) advanced or recurrent endometrial carcinoma who have not previously been treated with prior systemic chemotherapy.  The primary study hypotheses are that pembrolizumab is superior to the combination of carboplatin and paclitaxel with respect to Progression Free Survival (PFS) per Response Evaluation Criteria in Solid Tumors Version 1.1 (RECIST 1.1) as assessed by Blinded Independent Central Review (BICR) and Overall Survival (OS). 
Sponsor: Merck Sharp & Dohme LLC 
Intervention: pembrolizumab 
Start Date: 2022-02-03 
Last Updated: 2023-11-09 
Number of Patients: 280 
Recruitment Status: ACTIVE_NOT_RECRUITING 
Condition: Endometrial Neoplasms 

NCTID: NCT02310503

Title: Spanish Registry of Mohs Surgery 
Study Summary: REGESMOHS (Registro Español de cirugía de Mohs) aims at describing effectiveness of Mohs surgery, and patient, tumor and technique factors related to adverse events and tumor recurrence.  REGESMOHS is a prospective cohort, including all patients considered for Mohs surgery in participating centers. All consecutive patients are included. The only exclusion criteria are being under 18-years-old or legally incompetent. Pre-planned follow-up is as required by common clinical practice, but at least once a year for the study period. 
Sponsor: Fundación Academia Española de Dermatología 
Intervention: Mohs surgery 
Start Date: 2013-07-01 
Last Updated: 2020-05-05 
Number of Patients: 6000 
Recruitment Status: COMPLETED 
Condition: Skin Neoplasms 

NCTID: NCT00494897

Title: PETHEMA LAL-RI/96: Treatment for Patients With Standard Risk Acute Lymphoblastic Leukemia 
Study Summary: The objective of current protocol is try improve the results of chemotherapy treatment in patients with ALL wich is not indicated the peripheral stem cell transplant in first remission, with an intensive consolidation follow by re-inductions. 
Sponsor: PETHEMA Foundation 
Intervention: Asparaginase 
Start Date: 1996-06 
Last Updated: 2009-05-19 
Number of Patients: 374 
Recruitment Status: COMPLETED 
Condition: Acute Lymphoblastic Leukemia 

NCTID: NCT01518283

Title: Study of Weekly Cabazitaxel for Advanced Prostate Cancer 
Study Summary: This is a multicenter open label non randomized phase II clinical trial of Weekly Cabazitaxel for Advanced Prostate Cancer in Hormone-Refractory Patients Previously Treated with Docetaxel.  The purpose of this study is to evaluate the activity of the weekly administration of cabazitaxel as time to progression by PSA at week 12. 
Sponsor: Spanish Oncology Genito-Urinary Group 
Intervention: Cabazitaxel 10 mg/m2 
Start Date: 2012-05 
Last Updated: 2017-07-02 
Number of Patients: 74 
Recruitment Status: COMPLETED 
Condition: Hormone Refractory Prostate Cancer 

NCTID: NCT00129389

Title: FAC Versus FAC Plus Weekly Paclitaxel as Adjuvant Treatment of Node Negative High Risk Breast Cancer Patients 
Study Summary: This is a prospective, open-label, randomized, phase III trial. Patients will be stratified after breast surgery, as per investigational site; menopausal status; node negative diagnosis, as per sentinel-node technique versus lymphadenectomy; hormone receptor status (positive versus negative). 
Sponsor: Spanish Breast Cancer Research Group 
Intervention: Fluorouracil 
Start Date: 2003-09-19 
Last Updated: 2023-03-07 
Number of Patients: 1925 
Recruitment Status: COMPLETED 
Condition: Breast Cancer 

NCTID: NCT01026142

Title: A Study of a Combination of Trastuzumab and Capecitabine With or Without Pertuzumab in Patients With HER2-positive Metastatic Breast Cancer (PHEREXA) 
Study Summary: This randomized, two-arm study evaluated the efficacy and safety of a combination of trastuzumab and capecitabine with or without pertuzumab in patients with human epidermal growth factor receptor 2 (HER2)-positive metastatic breast cancer. The study population consisted of female patients, whose disease had progressed during or following previous trastuzumab therapy for metastatic disease. All patients in Arm A and Arm B received trastuzumab (8 mg/kg iv as loading dose and then 6 mg/kg iv every 3 weeks thereafter) and capecitabine oral twice daily for 14 days every 3 weeks (1250 mg/m2 twice daily in Arm A and 1000 mg/m2 twice daily in Arm B). In addition, patients in Arm B received pertuzumab (840 mg iv as loading dose and then 420 mg iv thereafter) every 3 weeks. Study treatment continued until disease progression or unacceptable toxicity. 
Sponsor: Hoffmann-La Roche 
Intervention: Capecitabine 
Start Date: 2010-01-26 
Last Updated: 2018-08-14 
Number of Patients: 452 
Recruitment Status: COMPLETED 
Condition: Breast Cancer 

NCTID: NCT01374087

Title: Study to Assess the Efficacy of Brachytherapy With or Without Hormone Therapy, Using Triptorelin 22.5mg in Patients With Recurrence of Prostate Cancer 
Study Summary: The primary objective of the study was to compare the efficacy of brachytherapy versus brachytherapy + triptorelin 22.5 mg (single injection) in subjects with recurrence of prostate cancer previously treated with radiotherapy. Efficacy was to be assessed by biochemical failure-free survival (BFFS) curves from treatment initiation up to 5 years.  Secondary objectives included comparing the following: the differences in time to progression of subjects receiving brachytherapy + triptorelin 22.5 mg versus subjects receiving brachytherapy only, the BFFS percentages between both treatment groups at 5 years from treatment initiation, overall survival between both treatment groups, total testosterone changes (from baseline visit up to 12 months) and Prostate Specific Antigen (PSA) levels (from baseline visit up to 60 months of treatment) between both treatment groups, quality of life (QoL) modifications (Spanish version of the Expanded Prostate Cancer Index Composite (EPIC) questionnaire) between the baseline score and the rest of measurements, and to compare safety between both treatment groups. 
Sponsor: Ipsen 
Intervention: Triptorelin 22.5 mg 
Start Date: 2011-11 
Last Updated: 2019-09-18 
Number of Patients: 32 
Recruitment Status: TERMINATED 
Condition: Prostate Cancer 

NCTID: NCT03879122

Title: A Trial of Immunotherapy Strategies in Metastatic Hormone-sensitive Prostate Cancer 
Study Summary: Metastatic prostate cancer is an incurable disease that typically spreads beyond the prostate. The standard of care is to systemically treat the disease with androgen deprivation therapy (ADT). However, the disease progresses in virtually all patients to the state of castration resistant prostate cancer (CRPC), with a median time to progression of 24 months. Patients with high volume disease (with either visceral metastasis and/or bone metastasis) exhibit a worse prognosis, with a median clinical progression of 14 months.  Recently, the CHAARTED and STAMPEDE studies demonstrated that the combination of Docetaxel (chemotherapy) and ADT delayed the clinical progression and improved the survival a median of 14 months (17 for high volume patients). Nevertheless, the prognosis of patients with high volume metastatic disease continues to be poor.  Meanwhile the immunotherapy, the use of antibodies that recognize tumoral cells and promote the immune system activity against the cancer, has emerged as a very useful option in many cancers. Among others, the antibodies Nivolumab and Ipilimumab have been approved for the treatment of multiple types of cancer.  In this context, SOGUG (Spanish Oncology Genitourinary Group) has designed this new study “PROSTRATEGY” with the objective of evaluating whether the addition of immunotherapy to chemotherapy and ADT improves the prognosis and survival of patients with high volume metastatic hormone-sensitive prostate cancer. 
Sponsor: Spanish Oncology Genito-Urinary Group 
Intervention: Ipilimumab 5 MG/ML 
Start Date: 2019-02-11 
Last Updated: 2022-10-26 
Number of Patients: 135 
Recruitment Status: ACTIVE_NOT_RECRUITING 
Condition: Metastatic Hormone-sensitive Prostate Cancer 

NCTID: NCT03132493

Title: Nivolumab in the Real World: Analysis of the Expanded Use in Spanish Patient 
Study Summary: The investigators will be retrospectively review the case note of patients registered in the EAP of Nivolumab.  A standard anonymous data collection form will be used to collect data and to analyze it.  Patients with advanced Non-Small Cell Lung Cancer previously treated and included in the SPANISH expanded access programme of nivolumab. 
Sponsor: Spanish Lung Cancer Group 
Intervention: Nivolumab 10 MG/ML 
Start Date: 2017-06-01 
Last Updated: 2018-11-14 
Number of Patients: 676 
Recruitment Status: COMPLETED 
Condition: Non Small Cell Lung Cancer 

NCTID: NCT03242382

Title: Trial of Palbociclib in Second Line of Advanced Sarcomas With CDK4 Overexpression. 
Study Summary: Non-randomized, open, two-cohort, phase II, multicenter national clinical trial. 20 sites in Spain.  Cohort 1 includes soft-tissue sarcoma and osteosarcoma (21 patients), while Cohort 2 includes chordoma patients only (19 patients).  Palbociclib will be administered orally at a dose of 125 mg once a day for 21 consecutive days followed by 7 rest days to comprise a complete cycle of 28 days. Treatment will continue until disease progression, development of unacceptable toxicity, non-compliance, withdrawal of consent by the patient or investigator decision.  The main goal is to determine progression-free survival rate (PFSR) according to RECIST 1.1 at 6 months. 
Sponsor: Grupo Espanol de Investigacion en Sarcomas 
Intervention: Palbociclib 
Start Date: 2017-03-31 
Last Updated: 2022-06-01 
Number of Patients: 40 
Recruitment Status: RECRUITING 
Condition: Soft-tissue Sarcoma 

NCTID: NCT02819882

Title: A Prospective Registry Study in Patients With Unresectable Locally Advanced or Metastatic Breast Cancer (MBC) 
Study Summary: This study is a prospective, multicenter non-interventional cohort study designed to develop a registry in unresectable locally advanced or metastatic disease. 
Sponsor: Spanish Breast Cancer Research Group 
Intervention: No intervention 
Start Date: 2016-08 
Last Updated: 2023-01-23 
Number of Patients: 1400 
Recruitment Status: RECRUITING 
Condition: Breast Neoplasms 

NCTID: NCT03305952

Title: Cognitively-Based Compassion Training for Breast Cancer Survivors 
Study Summary: There is a growing number of evidence of how mindfulness training enhances psychological and physical well-being and coping strategies in patients with oncological illnesses. However, there are very few studies analyzing the efficacy of Compassion-Based Interventions on breast cancer survivors.  The goal of this study is to analyze enrollment, participant satisfaction and adherence to program and differences in psychological well-being, health related quality of life, fear of illness recurrence, compassion and self-compassion variables after a Compassion-Based Intervention in a Spanish breast cancer survivor sample.  This study is a randomized clinical trial of a secularized intervention called Cognitively-Based Compassion Training (CBCT). Subjects (n = 58) were randomly assigned to CBCT (n = 28) or a treatment as usual control group (TAU) (n = 28). Participants in the CBCT intervention condition were asked to meet weekly for a two (2) hour long session during two months. Pre-post-intervention and six month follow-up measures took place to evaluate: psychological well-being (somatic, depressive, and anxious symptomatology), health related quality of life (physical, social, emotional, and functional); psychological stress, coping strategies and triggering cognitions linked to cancer recurrence fear, self-compassion, compassion and mindfulness and awareness in both intervention and wait list groups.  CBCT is a promising and potentially useful intervention to enhance physical and emotional well-being in breast cancer survivors. Nevertheless, future randomized trials are needed and a process of cultural adaptation required. 
Sponsor: University of Valencia 
Intervention: CBCT 
Start Date: 2016-01-11 
Last Updated: 2017-10-10 
Number of Patients: 72 
Recruitment Status: UNKNOWN 
Condition: Compassion 

NCTID: NCT03470805

Title: Olaparib After Response to Trabectedin-pegylated Liposomal Doxorubicin in Recurrent Ovarian Carcinoma 
Study Summary: Epithelial ovarian cancer harbours 20% Breast Cancer gene (BRCA)1/2 mutations independently of family history. Poly ADP ribose polymerase (PARP) inhibitors (PARPi) have shown clinical activity among patients with homologous recombination deficiency (HRD) and specifically among BRCA1/2 mutation carriers.  The European Medicines Agency (EMA) approved the use of olaparib as maintenance therapy “as monotherapy for the maintenance treatment of adult patients with platinum sensitive relapsed BRCA mutated (germline and/or somatic) high-grade serous epithelial ovarian, fallopian tube, or primary peritoneal cancer who are in response (complete response or partial response) to platinum-based chemotherapy”.  Trabectedin and Pegylated liposomal doxorubicin (PLD) have shown relevant activity in relapsed epithelial ovarian cancer. In the relapse with Treatment-free interval of last platinum (TFIp) between 6 and 12 months this efficacy translated into an increase in Overall survival (OS) and Progression free survival (PFS).  There is an increase of hypersensitivity reactions (HSR) among platinum sensitive patients, that reaches 44% in third line and does not always allow for platinum use despite desensitization protocols. In relapse with TFIp between 6-12 months the use of Trabectedin+PLD is accepted in guidelines and consensus.  Following clinical BRCAness criteria a group of patients that harbours up to 50% of BRCA1/2 mutations can be selected. Olaparib has been licensed according to EMA for maintenance in BRCA mutated patients after response to platinum following Study 19 phase II trial and further confirmed with phase III SOLO-2 data. However there is no evidence of the benefit of adding olaparib after Trabectedin+PLD response among BRCA1/2 carriers.  The combination of Trabectedin+PLD, as well as both single drugs, have shown higher activity among BRCA1/2 carriers. 
Sponsor: Grupo Español de Investigación en Cáncer de Ovario 
Intervention: Olaparib 
Start Date: 2018-06-21 
Last Updated: 2022-09-23 
Number of Patients: 9 
Recruitment Status: COMPLETED 
Condition: Ovarian Cancer 

NCTID: NCT00550004

Title: Phase II Study to Evaluate Efficacy and Safety of RP101 in Combination With Gemcitabine 
Study Summary: This will be a Phase II, multicenter, randomized, double blind, placebo controlled, study of six 28-day treatment cycles for patients with locally advanced, unresectable, or metastatic pancreatic cancer. The study will be conducted at approximately 55 sites in the North American, Europe, and South America. Approximately 153 subjects will be enrolled in a randomization (ratio 2:1). 
Sponsor: SciClone Pharmaceuticals 
Intervention: RP101 
Start Date: 2007-09 
Last Updated: 2011-06-08 
Number of Patients: 153 
Recruitment Status: TERMINATED 
Condition: Pancreatic Cancer 

NCTID: NCT00543127

Title: Fulvestrant (Faslodex) + Anastrozole (Arimidex) vs Anastrozole 
Study Summary: Postmenopausal women with hormone receptor positive and negative Her2 tumours.  Before randomization, the patients will be stratified according to the center, positive nodes (0 vs. 1-3 vs. ≥4), previous chemotherapy (yes vs no) and hormonal receptors status. 
Sponsor: Spanish Breast Cancer Research Group 
Intervention: Fulvestrant 
Start Date: 2007-11 
Last Updated: 2023-03-10 
Number of Patients: 870 
Recruitment Status: TERMINATED 
Condition: Breast Cancer 

NCTID: NCT01514526

Title: Clinical Trial of Dovitinib in First-line Metastatic or Locally Advanced Non-resectable Adrenocortical Carcinoma 
Study Summary: * Design: non-randomized, open label, phase II clinical trial. * Study population and disease: adult patients with metastatic or locally advanced non-resectable adrenocortical carcinoma, confirmed histologically. * Estimated number of patients: 15. * Study drug: dovitinib (TKI-258), dosed on a flat scale of 500mg/day on a 5 days on / 2 days off. * Treatment duration: study treatment period will be continued until disease progression, unacceptable toxicity, death or premature withdrawal from study. An average of 6 months treatment period is expected. * Study duration: expected recruitment period will be 18 months, and patients will be followed for 6 additional months after last patient is included in the trial.Study total expected duration is 24 months. * Sites: the study is planned to be conducted in 7 Spanish centers. 
Sponsor: Spanish Oncology Genito-Urinary Group 
Intervention: Dovitinib 
Start Date: 2012-01 
Last Updated: 2017-04-25 
Number of Patients: 17 
Recruitment Status: COMPLETED 
Condition: Adrenocortical Carcinoma 

NCTID: NCT04464226

Title: Study to Continue Treatment With Darolutamide in Patients Who Have Been Participating in Previous Darolutamide Studies Supported by Bayer 
Study Summary: The aim of this study is to provide darolutamide treatment to patients who participated in a previous study with darolutamide supported by Bayer and the treating doctor considers that the continuation of the treatment with darolutamide to be beneficial. Patients will be carried over from the previous studies and continue in this study with darolutamide treatment on the same dosage. They will also return to the study centers for doctor’s visits as often as they did in the previous study. 
Sponsor: Bayer 
Intervention: Darolutamide (Nubeqa, BAY1841788) 
Start Date: 2020-10-20 
Last Updated: 2023-11-18 
Number of Patients: 678 
Recruitment Status: RECRUITING 
Condition: Cancer 

NCTID: NCT03248427

Title: Neadjuvant Multi-agent Chemotherapy or Letrozole Plus Ribociclib in Luminal B/HER2-negative Breast Cancer. 
Study Summary: CORALLEEN is a two-arm, randomized, multicentric study in postmenopausal women with primary HR+/HER2 negative Luminal B breast cancer that will explore if the combination of ribociclib with letrozole offers clinical benefit at least comparable to that of standard chemotherapy. 
Sponsor: SOLTI Breast Cancer Research Group 
Intervention: Ribociclib 
Start Date: 2017-07-13 
Last Updated: 2021-03-17 
Number of Patients: 106 
Recruitment Status: COMPLETED 
Condition: Breast Cancer 

NCTID: NCT03994627

Title: Olaratumab (LY3012207) Patient Access for Soft Tissue Sarcoma 
Study Summary: The purpose of this study is to continue to provide olaratumab to eligible patients who are currently receiving olaratumab commercially for the treatment of soft tissue sarcoma (STS). 
Sponsor: Eli Lilly and Company 
Intervention: Olaratumab 
Start Date: NA 
Last Updated: 2023-09-29 
Number of Patients: NA 
Recruitment Status: AVAILABLE 
Condition: Soft Tissue Sarcoma 

NCTID: NCT06133517

Title: PeRioperative Immunotherapy Combined With Sacituzumab Govitecan in Muscle Invasive blAdder Cancer 
Study Summary: The main objective of this trial is to evaluate the efficacy of the combo Sacituzumab govitecan (SG) + Zimberelimab (AB 122) (ZIM) + Domvanalimab (AB 154) (DOM), measured as pathologic complete response (pCR) rates, in the perioperative setting in patients with Muscle Invasive Bladder Cancer (MIBC) who are either unfit for platinum-based chemotherapy or unwilling to receive that therapy. 
Sponsor: Fundación para el Progreso de la Oncología en Cantabria 
Intervention: Sacituzumab govitecan 
Start Date: 2024-03 
Last Updated: 2023-11-15 
Number of Patients: 70 
Recruitment Status: NOT_YET_RECRUITING 
Condition: Urothelial Bladder Carcinoma 

NCTID: NCT05207709

Title: Ribociclib vs. Palbociclib in Patients With Advanced Breast Cancer Within the HER2-Enriched Intrinsic Subtype 
Study Summary: HARMONIA is an international, multicenter, randomized, open-label and phase III study. The primary objective of this study is to demonstrate that the combination of ribociclib with endocrine therapy (letrozole or fulvestrant) is superior to palbociclib with endocrine therapy (letrozole or fulvestrant) in prolonging progression-free survival in patients with advanced HR+/HER2- and HER2-E breast cancer. The study will enroll approximately 456 patients with HER2-E disease from approximately 95 sites worldwide.  In addition, the HARMONIA trial will include an exploratory cohort of patients with HR+/HER2- and Basal-like disease treated with paclitaxel +/- Tislelizumab. This cohort does not have a predefined sample size and the objective is only exploratory, given the suggested lack of efficacy of the combinations of hormone therapy and CDK4/6 inhibitors in this subgroup of patients. Enrolment into the basal-like cohort will stop once the HER2-E disease cohort is fully enrolled. 
Sponsor: SOLTI Breast Cancer Research Group 
Intervention: Ribociclib + Letrozole OR Fulvestrant 
Start Date: 2022-03-28 
Last Updated: 2023-06-23 
Number of Patients: 456 
Recruitment Status: RECRUITING 
Condition: Metastatic Breast Cancer 

NCTID: NCT03763604

Title: Named Patient Use Program to Provide Abemaciclib (LY2835219) for the Treatment of Metastatic Breast Cancer 
Study Summary: The treating physician/investigator contacts Lilly when, based on their medical opinion, a patient meets the criteria for inclusion in the expanded access program. 
Sponsor: Eli Lilly and Company 
Intervention: Abemaciclib 
Start Date: NA 
Last Updated: 2023-10-12 
Number of Patients: NA 
Recruitment Status: AVAILABLE 
Condition: Metastatic Breast Cancer 

NCTID: NCT01669239

Title: Study of Neoadjuvant Myocet®, Paclitaxel, Pertuzumab, and Trastuzumab in HER2-positive Breast Cancer 
Study Summary: This is a prospective, multicenter, single-arm, phase II study to evaluate the safety of neoadjuvant liposomal doxorubicin plus paclitaxel, trastuzumab, and pertuzumab in patients with HER2-positive breast cancer 
Sponsor: SOLTI Breast Cancer Research Group 
Intervention: Liposomal Doxorubicin 
Start Date: 2013-06 
Last Updated: 2017-11-06 
Number of Patients: 83 
Recruitment Status: COMPLETED 
Condition: Breast Cancer 

NCTID: NCT01276379

Title: Study Evaluating Biomarkers in Patients With Colorectal Cancer and Native KRAS Treated With Chemotherapy + Cetuximab 
Study Summary: Advanced colorectal cancer (ACRC) is a heterogeneous disease and classification of patients is nowadays inefficient. Roughly twenty per cent of patients present with favorable figures (less than 4 liver nodules and less than 5 cm) and are suitable for local treatments (surgery or local-ablative therapies). Additionally, 10-15% of patients have poor performance status (PS >2) or are severe disabled due to geriatric syndromes or/and co-morbid diseases that preclude any treatment strategies than best supportive care alone. The rest of patients (fit patients not suitable for radical treatments) constitute the population of patients treated with palliative therapies. Despite of it not all these patients have the same prognosis. Patients with PS 0,1 and levels of LDH <ULN (Intermediate-risk patients) have better PFS and OS irrespective of therapy in all randomized clinical trials (de Gramont et al, JCO 2000; Douillard et al, Lancet 2000; Koopman et al, 2007).  CRYSTAL trial shows a benefit in PFS (1.5 months) in RASWT of FOLFIRI plus cetuximab compared with FOLFIRI alone. Nowadays the selection of patients for cetuximab treatment is based on mutational status of KRAS, which allow to select those patients who will not respond to therapy. Other surrogate markers of activity should be also evaluated. Our hypothesis is that the suggested biomarkers will allow the selection of the patients who will benefit the most from the biweekly cetuximab treatment. 
Sponsor: Grupo Espanol Multidisciplinario del Cancer Digestivo 
Intervention: FOLFIRI (m) 
Start Date: 2011-01 
Last Updated: 2021-07-02 
Number of Patients: 221 
Recruitment Status: COMPLETED 
Condition: Colorectal Cancer 

NCTID: NCT04293393

Title: Neoadjuvant Study Chemotherapy vs Letrozole + Abemaciclib in HR+/HER2- High/Intermediate Risk Breast Cancer Patients 
Study Summary: Phase II, randomized, open-label, international, multicenter study to compare efficacy of standard chemotherapy vs. letrozole plus abemaciclib as neoadjuvant therapy in HR-positive/HER2-negative high/intermediate risk breast cancer patients 
Sponsor: Spanish Breast Cancer Research Group 
Intervention: Doxorubicin 
Start Date: 2020-10-02 
Last Updated: 2023-07-19 
Number of Patients: 200 
Recruitment Status: ACTIVE_NOT_RECRUITING 
Condition: Early Breast Cancer 

NCTID: NCT00849667

Title: Efficacy and Safety of Farletuzumab (MORAb-003) in Combination With Carboplatin and Taxane in Participants With Platinum-sensitive Ovarian Cancer in First Relapse 
Study Summary: This research is being done to find out if Carboplatin and Taxane works better alone or when given with an experimental drug called MORAb-003(farletuzumab) in subjects with first platinum sensitive relapsed ovarian cancer. 
Sponsor: Morphotek 
Intervention: Farletuzumab 
Start Date: 2009-04-16 
Last Updated: 2022-12-30 
Number of Patients: 1100 
Recruitment Status: TERMINATED 
Condition: Ovarian Cancer 

NCTID: NCT01307397

Title: A Study of Vemurafenib in Participants With Metastatic Melanoma 
Study Summary: This multi-center study evaluates the safety and efficacy of vemurafenib in participants with BRAF V600 mutation-positive, surgically incurable, and unresectable Stage IIIC or IV (American Joint Committee on Cancer <math display="block">AJCC</math>) metastatic melanoma. 
Sponsor: Hoffmann-La Roche 
Intervention: Vemurafenib 
Start Date: 2011-03-01 
Last Updated: 2017-12-18 
Number of Patients: 3219 
Recruitment Status: COMPLETED 
Condition: Malignant Melanoma 

NCTID: NCT04188548

Title: A Study of LY3484356 in Participants With Advanced or Metastatic Breast Cancer or Endometrial Cancer 
Study Summary: The reason for this study is to see if the study drug LY3484356 alone or in combination with other anticancer therapies is safe and effective in participants with advanced or metastatic breast cancer or endometrial cancer. 
Sponsor: Eli Lilly and Company 
Intervention: LY3484356 
Start Date: 2019-12-10 
Last Updated: 2023-04-13 
Number of Patients: 500 
Recruitment Status: ACTIVE_NOT_RECRUITING 
Condition: Breast Cancer 

NCTID: NCT05288166

Title: A Study of Abemaciclib (LY2835219) With Abiraterone in Men With Prostate Cancer That Has Spread to Other Parts of the Body and is Expected to Respond to Hormonal Treatment (Metastatic Hormone-Sensitive Prostate Cancer) 
Study Summary: The purpose of this study is to learn whether adding abemaciclib to abiraterone plus prednisone prolongs the time before prostate cancer gets worse. Participation may last approximately 60 months. 
Sponsor: Eli Lilly and Company 
Intervention: Abemaciclib 
Start Date: 2022-04-14 
Last Updated: 2023-10-19 
Number of Patients: 900 
Recruitment Status: RECRUITING 
Condition: Prostatic Neoplasms 

NCTID: NCT04704219

Title: Pembrolizumab Plus Lenvatinib for First-line Advanced/Metastatic Non-clear Cell Renal Cell Carcinoma (1L nccRCC) (MK-3475-B61) 
Study Summary: This study is being performed as a single-arm open-label study in order to rapidly provide information on the potential benefits of the combination of pembrolizumab and lenvatinib in participants with previously untreated advanced/metastatic non-clear cell renal cell carcinoma. 
Sponsor: Merck Sharp & Dohme LLC 
Intervention: Pembrolizumab 
Start Date: 2021-02-23 
Last Updated: 2023-08-29 
Number of Patients: 152 
Recruitment Status: ACTIVE_NOT_RECRUITING 
Condition: Renal Cell Carcinoma 

NCTID: NCT05250648

Title: Clinical Trial on HIPEC With Mitomycin C in Colon Cancer Peritoneal Metastases (GECOP-MMC) 
Study Summary: The aim of this study is to assess whether there are differences in PERITONEAL RECURRENCE in patients with Colon Cancer Peritoneal Metastases treated with complete surgical resection and systemic chemotherapy, with (Group 1) or without (Group 2) HIPEC with Mitomycin-C. 
Sponsor: Hospital Universitario de Fuenlabrada 
Intervention: complete cytoreductive surgery plus HIPEC with Mytomicin C for 90 minutes 
Start Date: 2022-03-02 
Last Updated: 2023-09-25 
Number of Patients: 216 
Recruitment Status: RECRUITING 
Condition: Peritoneal Carcinomatosis 

NCTID: NCT04595565

Title: Sacituzumab Govitecan in Primary HER2-negative Breast Cancer 
Study Summary: Phase III, prospective, multi-center, randomized, open label, parallel group, study in patients with HER2-negative breast cancer with residual disease after neoadjuvant chemotherapy with 1:1 allocation to:  * Arm A: Sacituzumab govitecan (days 1, 8 q3w for eight cycles); * Arm B: treatment of physician´s choice (TPC, defined as capecitabine or platinum-based chemotherapy for eight cycles or observation.  Treatment in either arm will be given for eight cycles.  In patients with HR-positive breast cancer, endocrine-based therapy, which includes the use of CDK4/6 inhibitors, will be administered according to local guidelines. The start of endocrine therapy will be at the discretion of the investigator; however, it will be encouraged to start after surgery/radiotherapy in patients without additional cytotoxic agents.  Adjuvant pembrolizumab can be given until the completion of radiotherapy before randomization. Within the study the use of pembrolizumab in patients with TNBC who received pembrolizumab as neoadjuvant therapy is allowed as monotherapy in the TPC arm, according to the approval of pembrolizumab in this setting. 
Sponsor: German Breast Group 
Intervention: Capecitabine 
Start Date: 2020-10-28 
Last Updated: 2023-03-02 
Number of Patients: 1332 
Recruitment Status: RECRUITING 
Condition: HER2-negative Breast Cancer 

NCTID: NCT05009030

Title: Anti-SARS-COV2 Vaccination Study in Lung Cancer Patients 
Study Summary: Observational and multicenter retrospective study of data collection in hospital centers throughout the Spanish geography.  This study aims to be nationwide in order to study general common variables of the patients, as well as the correlation with the cancer treatments received. 
Sponsor: Fundación GECP 
Intervention: COVID-19 vaccine 
Start Date: 2021-05-06 
Last Updated: 2022-07-29 
Number of Patients: 794 
Recruitment Status: COMPLETED 
Condition: Lung Cancer 

NCTID: NCT04337931

Title: A Study to Evaluate Sotigalimab (APX005M) in Subjects With Unresectable or Metastatic Melanoma 
Study Summary: This is a multicenter, open label, Phase 2 study, with 3 parallel cohorts. The aim of the study is to evaluate the efficacy of APX005M administered at 2 different schedules to adult subjects with unresectable or metastatic melanoma. Subjects who have not received prior immunotherapy will be alternately assigned to 1 of 2 cohorts (2 different APX005M administration schedules) as long as both are open. Subjects who have failed approved immunotherapy regimens will be assigned to a 3rd cohort of APX005M in combination with radiation therapy. 
Sponsor: Apexigen America, Inc. 
Intervention: APX005M 
Start Date: 2019-12-16 
Last Updated: 2023-09-01 
Number of Patients: 44 
Recruitment Status: COMPLETED 
Condition: Unresectable Melanoma 

NCTID: NCT01454089

Title: A Phase 2 Study Comparing Chemotherapy in Combination With OGX-427 or Placebo in Patients With Bladder Cancer 
Study Summary: The primary objective of this study is to ascertain whether there is evidence of longer survival relative to the control arm for three comparisons: 600 mg OGX-427 Arm to control Arm; 1000 mg OGX-427 Arm to control Arm; and pooled 600 mg and 1000 mg OGX-427 Arms to control Arm. 
Sponsor: Achieve Life Sciences 
Intervention: OGX-427 600 mg 
Start Date: 2011-10 
Last Updated: 2016-10-07 
Number of Patients: 183 
Recruitment Status: COMPLETED 
Condition: Urologic Neoplasms 

NCTID: NCT02802748

Title: Phase 0 Study of Metronomic Oral Vinorelbine and Letrozole in HR+/HER2-negative Early Breast Cancer Patients (VENTANA) 
Study Summary: VENTANA is a “window-of-opportunity” trial that will explore whether, similar to CDK4/6 inhibitors, Oral Metronomic Vinorelbine in combination with Letrozole induces a superior anti-proliferative effect than Letrozole alone. 
Sponsor: SOLTI Breast Cancer Research Group 
Intervention: Oral Vinorelbine 
Start Date: 2016-07 
Last Updated: 2018-09-20 
Number of Patients: 60 
Recruitment Status: COMPLETED 
Condition: Breast Cancer 

NCTID: NCT02847429

Title: Randomized Trial of Crenolanib in Subjects With D842V Mutated GIST 
Study Summary: This is a multicenter, randomized, double-blinded, placebo-controlled, trial of oral crenolanib versus oral placebo in combination with best supportive care in subjects with advanced or metastatic GIST with a D842V mutation in the PDGFRA gene. Approximately 120 subjects will be randomized in a 2:1 ratio to receive either crenolanib 100 mg or matching placebo orally (PO) 3 times daily (TID) in combination with best supportive care. 
Sponsor: Arog Pharmaceuticals, Inc. 
Intervention: Crenolanib 
Start Date: 2016-08 
Last Updated: 2021-01-22 
Number of Patients: 120 
Recruitment Status: UNKNOWN 
Condition: GIST With D842V Mutated PDGFRA Gene 

NCTID: NCT05296746

Title: Neoadjuvant and Adjuvant Ribociclib and ET for Clinically High-risk ER+ and HER2- Breast Cancer 
Study Summary: This is an open-label, multicenter international trial in men and women with primary operable HR+/HER2-, ki67≥20%, grade 2 or 3 and stage II breast cancer to evaluate safety and long-term efficacy of a non-chemo treatment in patients biologically responders to neoadjuvant ribociclib and letrozole.  This study aims to evaluate whether chemotherapy could be avoided for initial high-risk clinicopathological breast cancer patients that are converted to low genomic risk assessed by Risk of Recurrence-low (ROR-low) at 6 months of letrozole - ribociclib neoadjuvant treatment by continuing with this treatment in adjuvant setting. 
Sponsor: SOLTI Breast Cancer Research Group 
Intervention: Ribociclib (neoadjuvant) 
Start Date: 2022-05-03 
Last Updated: 2023-10-10 
Number of Patients: 1100 
Recruitment Status: RECRUITING 
Condition: Breast Cancer Stage II 

NCTID: NCT00545077

Title: Bevacizumab + Endocrine Treatment vs Endocrine Treatment as First Line in Postmenopausal Women 
Study Summary: Locally advanced or metastatic breast cancer in postmenopausal women with negative Human Epidermal Growth Factor Receptor 2 (HER2), who are candidates for hormone treatment and who have not received previous chemotherapy or hormonotherapy for the metastatic disease. 
Sponsor: Spanish Breast Cancer Research Group 
Intervention: Letrozole 
Start Date: 2007-11-06 
Last Updated: 2023-03-31 
Number of Patients: 380 
Recruitment Status: COMPLETED 
Condition: Breast Cancer 

NCTID: NCT04253561

Title: Ipatasertib + Pertuzumab +Trastuzumab in Advanced HER2+ PI3KCA-mutant Breast Cancer Patients 
Study Summary: This is an open label, single arm, multicenter, phase Ib study to evaluate the safety and clinical activity of the combination of ipatasertib, trastuzumab and pertuzumab in patients with unresectable locally advanced or metastatic HER2-positive breast cancer with tumors harboring PIK3CA mutations, candidates to receive maintenance HP after first line treatment for metastatic disease with a taxane plus HP 
Sponsor: SOLTI Breast Cancer Research Group 
Intervention: Ipatasertib 
Start Date: 2020-02-25 
Last Updated: 2023-04-18 
Number of Patients: 15 
Recruitment Status: RECRUITING 
Condition: Metastatic Breast Cancer 

NCTID: NCT00504764

Title: Treatment of Relapsed Promyelocytic Leukemia With Arsenic Trioxide (ATO) 
Study Summary: Summary Acute promyelocytic leukemia is defined by a characteristic morphology (AML FAB M3/M3v), by the specific translocation t(15;17) and its molecular correlates (PML/RARa and RARa/PML). Thereby it can be separated from all other forms of acute leukemia.  By all-trans retinoic acid in combination with chemotherapy cure rates of 70 to 80% can be reached. On average, about 10% of patients still die in the early phase of the treatment and about 20 to 30% relapse. Molecular monitoring of the minimal residual disease (MRD) by qualitative nested RT-PCR and quantitative REAL-time PCR of PML/RARa allows to follow the individual kinetics of MRD and to identify patients with an imminent hematological relapse.  A standardized treatment for patients with relapsed APL has not yet been established. With arsenic trioxide (ATO) monotherapy remission rates over 80% were achieved and long-lasting molecular remissions are described. The drug was mostly well tolerated. ATO exerts a dose dependent dual effect on APL blasts, apoptosis in higher and partial differentiation in lower concentrations. ATO was also successfully administered before allogeneic and autologous transplantation. ATO is approved for the treatment of relapsed and refractory APL in Europe and in the USA.  After remission induction, there are several options for postremission therapy Previous studies shows that risk of relapse is higher in patients treated with ATO postremission in monotherapy , than in other that receive ATO plus chemotherapy or transplantation (TPH). Also, compared with chemotherapy, ATO induction and consolidation has a favorable impact in posterior response to transplantation. It is due to a low toxicity or a best quality of remission to TPH. It seems better, for these reasons, the intensification with TPH (autologous or allogenic) in patients with relapsed APL treated with ATO. For another hand, patients no candidates to TPH can be treated with ATO combined with other active agents in APL, as ATRA, anthracyclines o Mylotarg 
Sponsor: PETHEMA Foundation 
Intervention: Arsenic Trioxide 
Start Date: 2007-07 
Last Updated: 2014-10-28 
Number of Patients: 60 
Recruitment Status: COMPLETED 
Condition: Acute Promyelocytic Leukemia 

NCTID: NCT04142060

Title: Targeting the PAM50 Her2-Enriched Phenotype With Enzalutamide in Hormone Receptor-Positive/Her2-Negative Metastatic BC 
Study Summary: The main hypothesis of the study is that enzalutamide induces a significant proliferative arrest in HR+/HER2-negative breast cancer falling into the PAM50 HER2-E subtype. Currently, enzalutamide clinical development is ongoing in different prostate cancer indications but the breast cancer development program has been discontinued. As the role of the AR in HR-positive breast cancer and the predictive value of previously identified biomarker are still unclear, further research is needed to effectively utilize enzalutamide in this disease. 
Sponsor: SOLTI Breast Cancer Research Group 
Intervention: Enzalutamide 
Start Date: 2020-06-01 
Last Updated: 2022-10-28 
Number of Patients: 34 
Recruitment Status: TERMINATED 
Condition: Breast Cancer 

NCTID: NCT04868877

Title: A Phase 1/2 Study Evaluating MCLA-129, a Human Anti-EGFR and Anti-c-MET Bispecific Antibody, in Patients With Advanced NSCLC and Other Solid Tumors 
Study Summary: A phase 1/2 open-label multicenter study will be performed with an initial dose escalation part to determine the MTD and/or the RP2D of MCLA-129 as monotherapy in patients with NSCLC, HNSCC, GC/GEJ, ESCC, or other solid tumors and who have progressed after receiving prior therapy for advanced/metastatic disease. 
Sponsor: Merus N.V. 
Intervention: MCLA-129 
Start Date: 2021-04-28 
Last Updated: 2023-05-09 
Number of Patients: 380 
Recruitment Status: RECRUITING 
Condition: Non-Small Cell Lung Cancer Metastatic 

NCTID: NCT02036060

Title: Abiraterone Acetate in Combination With Docetaxel After Disease Progression to Abiraterone Acetate in Metastatic Castration Resistant Prostate Cancer. 
Study Summary: Prostate cancer is the most frequently diagnosed non-skin cancer, and the second leading cause of men cancer death in the United States. Hormonal therapy remains a first-line treatment for metastatic prostate cancer. Initial responses to hormonal therapy with chemical or surgical castration are quite favorable, however, most patients will progress to a castration-resistant phase of the disease. Docetaxel is the primary chemotherapeutic option for patients with mCRPC.  Abiraterone is a novel, selective, irreversible, and potent inhibitor of 17-<math display="block">alpha</math>-hydroxylase/17,20-lyase (CYP17) enzymatic activity that has recently been demonstrated to further reduce testosterone levels in the blood to undetectable range (< 1 ng/dL) and is suggested to reduce de novo intratumor androgen synthesis. Abiraterone demonstrated activity in castration resistant prostate cancer patients previously treated with docetaxel chemotherapy. Recently, results of a phase III trial comparing abiraterone plus prednisone vs placebo plus prednisone in asymptomatic and without visceral metastasis, castration-resistant metastatic prostate cancer patients, demonstrated a better radiological progression free survival for abiraterone treated patients and a trend towards a better survival was clear for abiraterone treated patients.  No clinical evidence exists about efficacy of chemotherapy and antiandrogen therapy combination. All trials have been performed in patients in which LHRH agonist treatment was continued although there is not clear evidence about efficacy of hormonal treatment. Some retrospective studies suggest that androgen deprivation treatment should be maintained in chemotherapy treated patients. Abiraterone has been proved to suppress androgen levels to negative values, and to add efficacy to castration hormonal therapy. Combination of abiraterone with docetaxel chemotherapy seems promising adding efficacy to only docetaxel chemotherapy. A randomized phase II study comparing docetaxel + prednisone + abiraterone to docetaxel + prednisone in mCRPC in patients treated previously with abiraterone, seems promising to explore addition of efficacy to taxotere after abiraterone hormonal treatment. 
Sponsor: Spanish Oncology Genito-Urinary Group 
Intervention: docetaxel 75 mg/m2 + prednisone 10 mg/d + abiraterone 1000 mg/d 
Start Date: 2014-02-07 
Last Updated: 2020-11-16 
Number of Patients: 119 
Recruitment Status: COMPLETED 
Condition: Metastatic Prostate Cancer 

NCTID: NCT02723877

Title: PQR309 and Eribulin in Metastatic HER2 Negative and Triple-negative Breast Cancer (PIQHASSO) 
Study Summary: This study is an open-label,non randomized, multi-center, phase 1/2b (dose escalation followed by expansion part) study evaluating clinical safety, efficacy and pharmacokinetics of PQR309 in combination with standard dose of eribulin in patients with locally advanced or metastatic HER2-negative (escalation part) and Triple Negative Breast Cancer (expansion part). 
Sponsor: PIQUR Therapeutics AG 
Intervention: PQR309 
Start Date: 2016-03-28 
Last Updated: 2019-03-22 
Number of Patients: 41 
Recruitment Status: COMPLETED 
Condition: Metastatic Breast Cancer 

NCTID: NCT03486873

Title: Long-term Safety and Efficacy Extension Study for Participants With Advanced Tumors Who Are Currently on Treatment or in Follow-up in a Pembrolizumab (MK-3475) Study (MK-3475-587/KEYNOTE-587) 
Study Summary: The purpose of this study is to evaluate the long-term safety and efficacy of pembrolizumab (MK-3475) in participants from previous Merck pembrolizumab-based parent studies who transition into this extension study.  This study will consist of three phases: 1) First Course Phase, 2) Survival Follow-up Phase or 3) Second Course Phase. Each participant will transition to this extension study in one of the following three phases, depending on the study phase they were in at the completion of the parent study. Participants who were in the First Course Phase of study treatment in their parent study will enter the First Course Phase of this study and complete up to 35 doses or more every 3 weeks (Q3W) or 17 doses or more every 6 weeks (Q6W) of study treatment with pembrolizumab or a pembrolizumab-based combination according to arm assignment. Participants who were in the Follow-up Phase in the parent study (post-treatment or Survival Follow-up Phase) will enter the Survival Follow-up Phase of this study. Participants who were in the Second Course Phase in their parent study will enter Second Course Phase of this study and complete up to 17 doses Q3W or 8 doses Q6W of study treatment with pembrolizumab or a pembrolizumab-based combination according to arm assignment.  Any participant originating from a parent trial where crossover to pembrolizumab was permitted upon disease progression may be may be eligible for 35 doses as Q3W or 17 doses Q6W of pembrolizumab (approximately 2 years), if they progress while on the control arm and pembrolizumab is approved for the indication in the country where the potential eligible crossover participant is being evaluated. 
Sponsor: Merck Sharp & Dohme LLC 
Intervention: Pembrolizumab 
Start Date: 2018-08-21 
Last Updated: 2023-11-27 
Number of Patients: 2300 
Recruitment Status: RECRUITING 
Condition: Solid Tumors 

NCTID: NCT05252988

Title: Trial to Evaluate Diarrhoea Discontinuations at 3 Cycles in Patients With Early-stage HER2+, HR+ Breast Cancer Treated With Neratinib Plus Loperamide Versus Neratinib Dose Escalation Plus Loperamide Administered as Needed Versus Neratinib Plus Loperamide Plus Colesevelam (DIANER) 
Study Summary: A Randomized Phase II Study to Evaluate the Incidence of Discontinuations due to Diarrhoea at 3 Cycles in patients with Early-stage HER2-positive (HER2+), Hormone Receptor-positive (HR+) Breast Cancer treated with Neratinib plus Loperamide prophylaxis versus Neratinib with Initial Dose Escalation plus PRN Loperamide prophylaxis versus Neratinib plus Loperamide plus Colesevelam prophylaxis. 
Sponsor: Spanish Breast Cancer Research Group 
Intervention: Neratinib 
Start Date: 2022-08-31 
Last Updated: 2022-12-01 
Number of Patients: 315 
Recruitment Status: RECRUITING 
Condition: Early-stage Breast Cancer 

NCTID: NCT04510688

Title: Spanish Real-World Evidence Cabozantinib 
Study Summary: RCC (Renal Cell Carcinoma) is the most common form of kidney cancer, accounting for 2-3% of all adult malignancies and for 90% of all kidney cancers. The incidence of RCC has steadily increased over the past two decades, showing a plateau in recent years. Many patients with RCC remain asymptomatic until late disease stages and other patients have disease at diagnosis (metastatic RCC or mRCC).  Recently, the tyrosine kinase inhibitor (TKI) cabozantinib was approved as a first-line therapy for patients with advanced clear-cell RCC (ccRCC). Cabozantinib was initially approved for patients previously treated with antiangiogenic therapy based on the phase 3 METEOR study, which demonstrated a clinical benefit compared with everolimus.  Immunotherapy has been also developed in ccRCC.  The frontline treatment paradigm for ccRCC has evolved, particularly for intermediate-/poor-risk patients, with the recent addition of cabozantinib and nivolumab/ipilimumab (immunotherapy), but overall survival data are needed to understand their benefit-to-risk profiles compared with established therapies.  In October 2016, the Spanish Agency of medicines (AEMPS) granted the temporary Authorization for special use to Cabometyx® 20/40/60 mg within a Managed Access Program (MAP) for the treatment of advanced RCC in adults following prior VEGF-targeted therapy (Vascular Endothelial Growth Factor targeted therapy). The MAP allows the possibility of using a medicinal product which is not yet commercially available or approved. By the end of the MAP period, on July 2017, 136 patients had been included by 61 centers who received at least one dose of Cabometyx® for the treatment of advanced RCC.  Since then, Cabometyx® 20/40/60 mg was made commercially available for the treatment of advanced RCC in adults following prior VEGF-targeted therapy. After the commercialization of Cabometyx® in July 2017 in Spain, the inclusion of new patients in the MAP was closed but those patients that were already included continued receiving Cabometyx® free of charge until clinical decision. In July 2018, the European Commission approved a new indication for adult patients previously untreated with intermediate or poor risk.  Based on this rationale, the aim of this study is to obtain safety and effectiveness information regarding the use of cabozantinib in a non-selected RCC population, both in patients that received this agent under the MAP or under routine clinical prescription (real-world <math display="block">RW</math>). 
Sponsor: Spanish Oncology Genito-Urinary Group 
Intervention: Cabozantinib 
Start Date: 2019-10-23 
Last Updated: 2022-10-26 
Number of Patients: 275 
Recruitment Status: COMPLETED 
Condition: Renal Cell Carcinoma 

NCTID: NCT04887831

Title: Trilaciclib, a CDK 4/6 Inhibitor, in Patients With Advanced/Metastatic Bladder Cancer Receiving Chemotherapy Then Avelumab 
Study Summary: This is a Phase 2, multicenter, randomized, open-label study evaluating the safety and efficacy of trilaciclib administered with platinum-based chemotherapy followed by trilaciclib administered with avelumab maintenance therapy compared with platinum-based chemotherapy followed by avelumab maintenance therapy in patients receiving first-line treatment for advanced/metastatic bladder cancer. 
Sponsor: G1 Therapeutics, Inc. 
Intervention: Trilaciclib 
Start Date: 2021-06-04 
Last Updated: 2023-09-13 
Number of Patients: 92 
Recruitment Status: ACTIVE_NOT_RECRUITING 
Condition: Urothelial Carcinoma 

NCTID: NCT03434158

Title: Olaparib Maintenance in Patients With MCRPC After Docetaxel Treatment Reaching Partial or Stable Response (IMANOL) 
Study Summary: A number of important systemic therapies have been developed to treat mCRPC and have received regulatory approval and now comprise the current therapeutic landscape. Durable and complete response following first-line chemotherapy in patients with advanced PC are uncommon. Most patients will ultimately experience disease progression within 6-9 months after initial response. Optimal Second line therapy in mCRPC is not well established and several options are possible.  Olaparib has demonstrated anti-tumour activity in non-comparative studies in patients with germline BReast CAncer gene (gBRCA) mutated cancers including ovarian, breast, pancreas and prostate. Olaparib is indicated as monotherapy for the maintenance treatment of adult patients with platinum-sensitive relapsed Breast Cancer gene-mutated (germline and/or somatic) high grade serous epithelial ovarian, fallopian tube, or primary peritoneal cancer who are in response (complete response or partial response) to platinum-based chemotherapy.  This phase II study is developed to assess the effect of maintenance treatment with olaparib on radiologic progression free survival (rPFS) in patients with mCRPC who have received at least 6 cycles of docetaxel and achieved partial or complete response or disease stabilization according RECIST 1.1 criteria and PCWG3. 
Sponsor: Spanish Oncology Genito-Urinary Group 
Intervention: Olaparib 
Start Date: 2018-02-06 
Last Updated: 2022-11-03 
Number of Patients: 16 
Recruitment Status: COMPLETED 
Condition: Prostate Cancer Metastatic 

NCTID: NCT04251169

Title: Pembrolizumab + Paclitaxel in Hormone Receptor-positive (HR+)/Human Epidermal Growth Factor Receptor 2-negative (HER2-) Non-luminal (by PAM50) Advanced Breast Cancer After Cyclin-dependent Kinase 4/6 (CDK4/6) Inhibitors Progression 
Study Summary: This is an open-label, single arm, multicenter phase II study evaluating treatment with pembrolizumab in combination with paclitaxel in patients with locally advanced or metastatic non-luminal Hormone receptor-positive, HER2-negative (hereafter referred to as HR+/HER2-) breast cancer who had recurrence or progression while receiving previous therapy with a CDK inhibitor in the adjuvant setting or to treat advanced disease (or both). 
Sponsor: SOLTI Breast Cancer Research Group 
Intervention: Pembrolizumab 
Start Date: 2020-07-21 
Last Updated: 2023-01-25 
Number of Patients: 46 
Recruitment Status: ACTIVE_NOT_RECRUITING 
Condition: Metastatic Breast Cancer 

NCTID: NCT04961996

Title: A Study Evaluating the Efficacy and Safety of Adjuvant Giredestrant Compared With Physician’s Choice of Adjuvant Endocrine Monotherapy in Participants With Estrogen Receptor-Positive, HER2-Negative Early Breast Cancer (lidERA Breast Cancer) 
Study Summary: This is a Phase III, global, randomized, open-label, multicenter, study evaluating the efficacy and safety of adjuvant giredestrant compared with endocrine therapy of physician’s choice in participants with medium- and high-risk Stage I-III histologically confirmed estrogen receptor (ER)-positive and human epidermal growth factor receptor 2 (HER2)-negative early breast cancer.  In addition, an open-label exploratory substudy will explore the safety and efficacy of giredestrant in combination with abemaciclib in a subset of the primary study population. 
Sponsor: Hoffmann-La Roche 
Intervention: Giredestrant 
Start Date: 2021-08-27 
Last Updated: 2023-11-18 
Number of Patients: 4200 
Recruitment Status: RECRUITING 
Condition: Early Breast Cancer 

NCTID: NCT04102618

Title: A Window-of-opportunity Study of Pelareorep in Early Breast Cancer 
Study Summary: The purpose of this study is to find out if pelareorep in combination with different therapies helps to reduce the growth of breast cancer cells and increase the immune system’s response to cancer. This study will also help to understand what this treatment does to the tumor. In addition, the safety of the combination treatments with pelareorep will be evaluated. 
Sponsor: Oncolytics Biotech 
Intervention: Pelareorep 
Start Date: 2019-03-29 
Last Updated: 2022-08-15 
Number of Patients: 26 
Recruitment Status: TERMINATED 
Condition: Breast Cancer 

NCTID: NCT01772472

Title: A Study of Trastuzumab Emtansine Versus Trastuzumab as Adjuvant Therapy in Patients With HER2-Positive Breast Cancer Who Have Residual Tumor in the Breast or Axillary Lymph Nodes Following Preoperative Therapy (KATHERINE) 
Study Summary: This 2-arm, randomized, open-label study will evaluate the efficacy and safety of trastuzumab emtansine versus trastuzumab as adjuvant therapy in patients with HER2-positive breast cancer who have residual tumor present in the breast or axillary lymph nodes following preoperative therapy. Eligible patients will be randomized to receive either trastuzumab emtansine 3.6 mg/kg or trastuzumab 6 mg/kg intravenously every 3 weeks for 14 cycles. Radiotherapy and/or hormone therapy will be given in addition if indicated. 
Sponsor: Hoffmann-La Roche 
Intervention: trastuzumab 
Start Date: 2013-04-03 
Last Updated: 2023-11-13 
Number of Patients: 1487 
Recruitment Status: ACTIVE_NOT_RECRUITING 
Condition: Breast Cancer 

NCTID: NCT04895358

Title: Study of Pembrolizumab (MK-3475) Plus Chemotherapy Versus Placebo Plus Chemotherapy for HR+/HER2- Locally Recurrent Inoperable or Metastatic Breast Cancer (MK-3475-B49/KEYNOTE-B49) 
Study Summary: The safety and efficacy of pembrolizumab plus the investigator’s choice of chemotherapy will be assessed compared to placebo plus the investigator’s choice of chemotherapy in the treatment of chemotherapy-candidate hormone receptor-positive, human epidermal growth factor receptor 2-negative (HR+/HER2-) locally recurrent inoperable or metastatic breast cancer.  The primary hypotheses are that the combination of pembrolizumab and chemotherapy is superior to placebo and chemotherapy in regards to Progression-Free Survival (PFS) or overall survival (OS) in participants with programmed cell death-ligand 1 (PD-L1) combined positive score (CPS) ≥1 and ≥10. 
Sponsor: Merck Sharp & Dohme LLC 
Intervention: pembrolizumab 
Start Date: 2021-06-18 
Last Updated: 2023-11-27 
Number of Patients: 800 
Recruitment Status: RECRUITING 
Condition: Breast Neoplasms 

NCTID: NCT05743036

Title: ZN-c3 in Adult Participants With Metastatic Colorectal Cancer 
Study Summary: The purpose of this study is to evaluate the safety, tolerability, and potential clinical benefits of ZN-c3 administered in combination with encorafenib and cetuximab in adult participants with metastatic BRAF V600E mutant colorectal cancer previously treated with one or two treatment regimens. 
Sponsor: K-Group, Beta, Inc., a wholly owned subsidiary of Zentalis Pharmaceuticals, Inc 
Intervention: ZN-c3 
Start Date: 2023-02-27 
Last Updated: 2023-10-25 
Number of Patients: 82 
Recruitment Status: RECRUITING 
Condition: Metastatic Colorectal Cancer 

NCTID: NCT04889924

Title: ALND vs ART in Positive Sentinel Node After Neoadjuvant Therapy in Breast Cancer 
Study Summary: In the case of primary surgery, in patients with sentinel node involvement, it has already been shown that omitting axillary lymph node dissection (ALND), often combining axillary radiotherapy (RT), does not worsen the prognosis and does significantly reduce the appearance of lymphedema. However, patients who have received neoadjuvant systemic treatment cannot benefit from this option, even though in the majority of those who have responded well to treatment, a residual disease in the armpit is low, but there are no studies yet published that supports the possibility of not performing lymphadenectomy.  The primary endpoint is to evaluate wether axillary radiotherapy (ART) presents a lower risk of lymphedema with respect to lymphadenectomy (ALND) in patients with breast cancer who, after neoadjuvant systemic treatment (NST), present the sentinel node affected. Likewise, we will evaluate recurrences and overall survival in both groups. Finally, we will analyze the quality of life of these patients. 
Sponsor: Hospital Universitari de Bellvitge 
Intervention: Axillary Radiotherapy 
Start Date: 2021-06-01 
Last Updated: 2023-10-17 
Number of Patients: 820 
Recruitment Status: RECRUITING 
Condition: Breast Cancer 

NCTID: NCT03390595

Title: Avelumab Plus Carboplatin-gemcitabine in Urothelial Carcinoma 
Study Summary: Phase II Multicentre, randomized, open-label study to evaluate the safety and efficacy of avelumab with gemcitabine/carboplatin versus gemcitabine/carboplatin alone in patients with unresectable or metastatic urothelial carcinoma (UC) who have not received prior systemic therapy and who are ineligible to receive cisplatin-based therapy. 
Sponsor: Associació per a la Recerca Oncologica, Spain 
Intervention: avelumab 10mg/kg with carboplatin/gemcitabine 
Start Date: 2018-05-17 
Last Updated: 2023-10-18 
Number of Patients: 85 
Recruitment Status: COMPLETED 
Condition: Metastatic Urothelial Cancer 

NCTID: NCT01285778

Title: Vectibix for the Treatment of Anal Cancer 
Study Summary: Chemoradiation with 5-FU and Mitomycin C is the standard treatment in anal canal SCC. Panitumumab has shown efficacy in other tumors and anti-EGFR treatment has shown clinical activity in a single report of a refractory anal canal SCC patient. Based on this background, we propose to conduct a phase II study to investigate the efficacy and toxicity of radiotherapy with the association:  * 5-FU 1000mg/m2 on days 1-4 and 29-32 * Mitomycin C 10mg/m2 on days 1 and 29 * Panitumumab 6 mg/kg on day 1, then every 2 weeks for 8 weeks 
Sponsor: Grupo Espanol Multidisciplinario del Cancer Digestivo 
Intervention: panitumumab, mytomicin C, 5-FU, radiation 
Start Date: 2010-10 
Last Updated: 2018-05-16 
Number of Patients: 58 
Recruitment Status: COMPLETED 
Condition: Anal Squamous Cell Carcinoma 

NCTID: NCT05181462

Title: Nadunolimab in Combination With Gemcitabine Plus Carboplatin in Patients With Advanced Triple Negative Breast Cancer. 
Study Summary: Triple negative breast cancer (TNBC) represents approximately 15% of all breast cancers (BC) worldwide. The term triple negative means that tumor growth is not stimulated by the hormones estrogen and progesterone, nor by the HER2 protein, so unlike other types of BC, TNBC, which is an aggressive form of BC, does not have specific effective therapies available being the least common form of BC and the most difficult to treat.  Advanced or metastatic TNBC is treated with combinations of platinum-based chemotherapy with taxanes or gemcitabine with a 5-year survival rate of 12%. Recent studies have shown that TNBC expresses Interleukin 1 Receptor Accessory Protein (IL1RAP) at higher levels than other forms of BC.  Nadunolimab is a fully humanized monoclonal antibody that blocks the signals that occur within the cell produced by IL1RAP protein, thereby impairing the cancer cells’ ability to secrete tumor stimulating substances, in turn reducing the tumor, inflammation and tumor progression. On the other hand, it is an antibody designed to activate the immune system to fight cancer cells.  This clinical trial is divided into two phases, phase Ib in which it is expected to include up to 18 patients and phase II in which it is expected to include 98 patients. The main purpose of phase Ib is to ensure that the combination of nadunolimab plus chemotherapy (gemcitabine plus carboplatin) is safe and determine the highest dose of nadunolimab that can be given safely without causing serious side effects. If the pre-specified objectives in this part are achieved, the trial will be expanded to a randomized phase II, to evaluate the efficacy of the combination of nadunolimab plus gemcitabine plus carboplatin, compared to a control group that will receive gemcitabine plus carboplatin only. 
Sponsor: Cantargia AB 
Intervention: Carboplatin 
Start Date: 2022-01-11 
Last Updated: 2023-09-07 
Number of Patients: 116 
Recruitment Status: RECRUITING 
Condition: Triple Negative Breast Cancer 

NCTID: NCT05239728

Title: A Study of Belzutifan (MK-6482) Plus Pembrolizumab (MK-3475) Versus Placebo Plus Pembrolizumab in Participants With Clear Cell Renal Cell Carcinoma Post Nephrectomy (MK-6482-022) 
Study Summary: The purpose of this study is to assess the efficacy and safety of oral belzutifan (MK-6482) plus intravenous (IV) pembrolizumab (MK-3475) compared to placebo plus pembrolizumab, in the adjuvant treatment of Clear Cell Renal Cell Carcinoma (ccRCC) post nephrectomy.  The primary study hypothesis is that belzutifan plus pembrolizumab is superior to placebo plus pembrolizumab with respect to disease-free survival (DFS). 
Sponsor: Merck Sharp & Dohme LLC 
Intervention: Belzutifan 
Start Date: 2022-03-15 
Last Updated: 2023-11-28 
Number of Patients: 1800 
Recruitment Status: RECRUITING 
Condition: Carcinoma, Renal Cell 

NCTID: NCT02925702

Title: PRORADIUM: Prospective Multi-centre Study of Prognostic Factors in mCRPC Patients Treated With Radium-223. 
Study Summary: PRORADIUM is a prospective multicentre observational study in metastatic Castration-Resistant Prostate Cancer (mCRPC), designed to explore prognostic biomarkers in patients undergoing treatment with radium-223. 
Sponsor: Centro Nacional de Investigaciones Oncologicas CARLOS III 
Intervention: Radium 223 55mBq/Kg every 4 weeks intravenously 
Start Date: 2016-02 
Last Updated: 2020-01-27 
Number of Patients: 161 
Recruitment Status: UNKNOWN 
Condition: Advanced Prostate Cancer 

NCTID: NCT02684318

Title: Study to Evaluate PM01183 in Combination With Olaparib in Advanced Solid Tumors 
Study Summary: Phase Ib/II study to evaluate the efficacy and tolerability of PM01183 in combination with olaparib in patients with advanced solid tumors. 
Sponsor: Poveda, Andrés, M.D. 
Intervention: PM01183 + olaparib 
Start Date: 2015-07 
Last Updated: 2017-06-22 
Number of Patients: 100 
Recruitment Status: UNKNOWN 
Condition: Advanced Cancer 

NCTID: NCT02603432

Title: A Study Of Avelumab In Patients With Locally Advanced Or Metastatic Urothelial Cancer (JAVELIN Bladder 100) 
Study Summary: The main purpose of this study is to compare maintenance treatment with avelumab plus best supportive care (BSC) with BSC alone, to determine if avelumab has an effect on survival in patients with locally advanced or metastatic urothelial cancer that did not worsen during or following completion of first-line chemotherapy. 
Sponsor: Pfizer 
Intervention: Avelumab 
Start Date: 2016-04-25 
Last Updated: 2023-06-06 
Number of Patients: 700 
Recruitment Status: COMPLETED 
Condition: Urothelial Cancer 

NCTID: NCT01246440

Title: Catumaxomab as a Consolidation Therapy in Patients With Ovarian Cancer in Second or Third Clinical Disease Remission 
Study Summary: The purpose of this study is to evaluate the efficacy and safety of catumaxomab as consolidation treatment in patients with epithelial ovarian cancer in second or third complete remission. 
Sponsor: Grupo Español de Investigación en Cáncer de Ovario 
Intervention: Catumaxomab 
Start Date: 2010-06 
Last Updated: 2016-08-11 
Number of Patients: 39 
Recruitment Status: COMPLETED 
Condition: Ovarian Cancer 

NCTID: NCT05700344

Title: SOGUG-AVELUMAB_RWD 
Study Summary: The study goal is to evaluate the effectiveness in clinical practice of Avelumab as first line maintenance therapy in patients with locally advanced or metastatic Urothelial Carcinoma, who have not progressed after first line platinum-based treatment.  Study is performed at national hospitals from approximately 22 different sites and expecting to recruit 120 patients.  Patients understanding the nature of the study by providing their informed consent prior to participation.  * Patients of both sexes diagnosed with locally advanced or metastatic Urothelial Carcinoma, stage IV disease before first line with carboplatin/cisplatin-based chemotherapy. No disease progression after four-six cycles of ChT according to the Response Evaluation Criteria in Solid Tumor with a treatment free interval of 4-10 weeks before Avelumab initiation date. * Patients who started Avelumab as maintenance therapy in first line after 21/Jan./2021 and before 27/Apr./2022 (both dates included). 
Sponsor: Spanish Oncology Genito-Urinary Group 
Intervention: Avelumab 
Start Date: 2022-09-05 
Last Updated: 2023-11-28 
Number of Patients: 125 
Recruitment Status: COMPLETED 
Condition: Metastatic Urothelial Carcinoma 

NCTID: NCT00443235

Title: GEM05 for Patients With Multiple Myeloma More Than 65 Years Old 
Study Summary: The primary objective is to analyze and compare the efficacy, the response rate, the CR and the response rate duration of both induction treatments and both maintenance treatments 
Sponsor: PETHEMA Foundation 
Intervention: Melphalan/Prednisone/Velcade 
Start Date: 2005-03 
Last Updated: 2011-09-19 
Number of Patients: 260 
Recruitment Status: COMPLETED 
Condition: Multiple Myeloma 

NCTID: NCT04802876

Title: Efficacy of Tislelizumab and Spartalizumab Across Multiple Cancer-types in Patients With PD1-high mRNA Expressing Tumors 
Study Summary: This is an open-label, parallel group, non-randomized, multicenter phase II study to evaluate the efficacy of spartalizumab (cohorts 1 and 2) and tislelizumab (cohort 3) in monotherapy in patients with PD1-high-expressing tumors. 
Sponsor: SOLTI Breast Cancer Research Group 
Intervention: Spartalizumab 
Start Date: 2021-04-12 
Last Updated: 2023-07-07 
Number of Patients: 184 
Recruitment Status: RECRUITING 
Condition: MSI-H Colorectal Cancer 

NCTID: NCT03000374

Title: Induction Therapy With Panitumumab + mFOLFOX-6 in Rectal Cancer and Quadruple Wild-type Mutation Before Surgery 
Study Summary: Patients with rectal adenocarcinoma of intermediate risk (defined by magnetic resonance imaging <math display="block">MRI</math>), without mutations in KRAS, BRAF, NRAS and PI3KCA, who are candidates for preoperative treatment, will receive a preoperative Induction therapy with 12 weeks of panitumumab with mFOLFOX-6 to evaluate the efficacy in terms of pathologic complete response (pCR) 
Sponsor: Grupo Espanol Multidisciplinario del Cancer Digestivo 
Intervention: Panitumumab 
Start Date: 2017-05-30 
Last Updated: 2022-03-17 
Number of Patients: 34 
Recruitment Status: COMPLETED 
Condition: Rectal Cancer 

NCTID: NCT05546476

Title: Study of the Efficacy and Safety of Ponsegromab in Patients With Cancer, Cachexia and Elevated GDF-15 
Study Summary: Study to evaluate the efficacy, safety and tolerability of ponsegromab compared to placebo in patients with cancer, cachexia, and elevated GDF 15. 
Sponsor: Pfizer 
Intervention: ponsegromab 
Start Date: 2022-11-21 
Last Updated: 2023-11-28 
Number of Patients: 168 
Recruitment Status: ACTIVE_NOT_RECRUITING 
Condition: Non-small Cell Lung Cancer 

NCTID: NCT03751176

Title: Second-line FOLFIRI + Panitumumab in Subjects With Wild Type RAS Metastatic Colorectal 
Study Summary: To estimate progression-free-survival at 6 months in subjects treated in first-line with panitumumab and FOLFOX and with wild type RAS mCRC (metastatic colorectal cancer) confirmed in liquid biopsies before starting second line treatment will be screened for this trial and who have interrupted panitumumab for <3 months (panitumumab continuation). Control arm of subjects treated with FOLFIRI alone will be included.  The combinations of 5-fluorouracil (5-FU) with oxaliplatin (FOLFOX)are considered the backbone chemotherapy for mCRC. Clinical trials have shown the benefit of adding monoclonal antibodies to subjects without mutations in RAS, directed against the epidermal growth factor receptor (EGFR) (cetuximab and panitumumab) to conventional chemotherapy as first-line treatment of mCRC. This trial purposes to study the treatment beyond progression with panitumumab in subjects treated in first-line with an anti-EGFR monoclonal antibody, or rather,the re-introduction of the same targeted therapy after progression to first line.  The clinical hypothesis of this study is that the second-line regimen FOLFIRI + panitumumab, is sufficiently active (defined as a 6-months PFS higher than 30% <math display="block">based on prior results with second-line FOLFIRI alone</math> and of at least 50%), justifying further study in this population. 
Sponsor: Grupo Espanol Multidisciplinario del Cancer Digestivo 
Intervention: Panitumumab 
Start Date: 2018-11-08 
Last Updated: 2021-06-30 
Number of Patients: 31 
Recruitment Status: UNKNOWN 
Condition: Colorectal Cancer Metastatic 

NCTID: NCT00129935

Title: EC Followed Docetaxel Versus ET Followed Capecitabine as Adjuvant Chemotherapy for Node Positive Operable Breast Cancer 
Study Summary: This is a prospective, randomised phase III trial, to compare the efficacy and safety profiles of two types of adjuvant chemotherapy regimens for human epidermal growth factor receptor 2 (HER2) negative, node positive breast cancer patients.  Control Arm: This includes 4 cycles of EC 90/600 mg/m2 day 1 every 3 weeks, followed by 4 cycles of T 100 mg/m2 day 1 every 3 weeks.  Experimental Arm: This includes 4 cycles of ET 90/75 mg/m2, day 1 every 3 weeks, followed by 4 cycles of capecitabine 1250 mg/m2, twice a day, via oral intake, for 14 days, and then a one-week rest period.  Premenopausal women with hormone receptor positive tumours must receive 5 years of tamoxifen after the end of chemotherapy.  Postmenopausal women with hormone receptor positive tumours can receive tamoxifen or aromatase inhibitors (or both) after the end of chemotherapy.  Patients may receive radiotherapy when clinically indicated. 
Sponsor: Spanish Breast Cancer Research Group 
Intervention: Docetaxel 
Start Date: 2004-02 
Last Updated: 2023-03-31 
Number of Patients: 1384 
Recruitment Status: COMPLETED 
Condition: Breast Cancer 

NCTID: NCT00478699

Title: Randomized Customized Adjuvant Chemotherapy (GECP-SCAT) 
Study Summary: Randomized Study of Customized Adjuvant Chemotherapy based on BRCA1 mRNA Levels in Completely Resected stages II-IIIA Non-Small-Cell Lung Cancer Patients. 
Sponsor: Spanish Lung Cancer Group 
Intervention: Docetaxel/Cisplatin 
Start Date: 2007-06 
Last Updated: 2015-07-07 
Number of Patients: 500 
Recruitment Status: COMPLETED 
Condition: Non-small-cell Lung Cancer 

NCTID: NCT01358201

Title: PETHEMA LAL-07FRAIL: All Treatment In Fragile Patients Ph’ Negative Over 55 Years 
Study Summary: The biological characteristics of the adult LAL, karyotypic and phenotypic particular, are fundamentally different from those of Acute Lymphoblastic Leukemia (ALL) children and, consequently, the results of treatment are substantially lower. Additionally, elderly patients tolerate the drugs considered relatively low-key in the management of the LAL and suffer more toxicity. Although the LAL is much more common in patients over 60 years of age than in younger adults, older adults with ALL are clearly underrepresented in prospective controlled studies. A good portion of elderly patients are not able to tolerate the intensity of the standard treatment applied to children or young adults and a significant portion of them receive only palliative or supportive treatment. The data in the literature relating specifically to the elderly population are scarce and most of them have obtained a stratification by age of study designed for young people (CALGB, GMALL, PETHEMA). To date, the group’s recommendation was to treat PETHEMA the LAL-96RI protocol for elderly patients because this protocol less aggressive than those used in high-risk ALL. However, the development of inhibitors of tyrosine kinases LAL effective in Bcr / abl positive, a relatively common type of LAL in the older patient, requires a differentiated treat these patients. Moreover, analysis of data from patients treated so far with the LAL-96RI protocol has shown mediocre results even for LAL Bcr / abl negative. This analysis also showed a significant benefit in survival related to the reduction of treatment (removal of the L-asparaginase during induction and cyclophosphamide at the end of induction) attributed to a reduction in toxicity 
Sponsor: PETHEMA Foundation 
Intervention: vINCRISTINE 
Start Date: 2010-05 
Last Updated: 2022-01-19 
Number of Patients: 100 
Recruitment Status: RECRUITING 
Condition: Acute Lymphoblastic Leukemia 

NCTID: NCT02335957

Title: OPTimizing Irradiation Through Molecular Assessment of Lymph Node (OPTIMAL) 
Study Summary: The main purpose of this study is to show the non-inferiority of the incidental irradiation, as compared to intentional irradiation of the axillary nodes, in terms of 5-years disease-free survival (DFS) of early stage breast cancer patients with limited affectation of sentinel node assessed by OSNA (250 to 15,000 copies/uL), treated with breast-conservative surgery without axillary lymphadenectomy. 
Sponsor: Grupo de Investigación Clínica en Oncología Radioterapia 
Intervention: Irradiation 
Start Date: 2015-04 
Last Updated: 2022-04-01 
Number of Patients: 489 
Recruitment Status: COMPLETED 
Condition: Breast Cancer 

NCTID: NCT02614534

Title: Clinical Trial to Evaluate Safety and Efficacy of Hyperthermic Intra-peritoneal Chemotherapy (HIPEC) With Mitomycin C Used During Surgery for Treatment of Locally Advanced Colorectal Carcinoma 
Study Summary: The purpose of this study is to determine whether Hyperthermic Intra-peritoneal Chemotherapy (HIPEC) with Mitomycin C used during surgery for treatment of locally advanced colorectal carcinoma is effective in the treatment of locally advanced colorectal carcinoma. 
Sponsor: Maimónides Biomedical Research Institute of Córdoba 
Intervention: MITOMYCIN-C 30 mg 
Start Date: 2015-11-16 
Last Updated: 2023-09-28 
Number of Patients: 200 
Recruitment Status: ACTIVE_NOT_RECRUITING 
Condition: Colorectal Cancer 

NCTID: NCT01970540

Title: Study Escalating Doses of PM01183 in Combination With Fixed Doxorubicin in Patients With Specific Advanced Unresectable Solid Tumors 
Study Summary: Phase I Multicenter, Open-label, Clinical and Pharmacokinetic Study of PM01183 in Combination with Fixed Doxorubicin in Non- Heavily Pretreated Patients with Selected Advanced Solid Tumors to determine the maximum tolerated dose (MTD) and the recommended dose (RD) of PM01183 in combination with doxorubicin, to characterize the safety profile and feasibility of this combination, to characterize the pharmacokinetics (PK) of this combination, to obtain preliminary information on the clinical antitumor activity,to explore the feasibility, safety and efficacy of a potential improvable dose of this combination in selected tumor types <math display="block">i.e. small cell lung cancer (SCLC) and endometrial cáncer</math> and to evaluate the pharmacogenomics (PGx) in tumor samples of patients exposed to PM01183 and doxorubicin at the RD in order to assess potential markers of response and/or resistance. 
Sponsor: PharmaMar 
Intervention: lurbinectedin (PM01183) 
Start Date: 2011-05-25 
Last Updated: 2020-03-09 
Number of Patients: 122 
Recruitment Status: COMPLETED 
Condition: Endometrial Adenocarcinomas 

NCTID: NCT04420598

Title: DS-8201a for trEatment of aBc, BRain Mets, And Her2[+] Disease 
Study Summary: This is a multicenter, international, open-label, single-arm, multicohort, two-stage optimal Simon’s design, phase II clinical trial 
Sponsor: MedSIR 
Intervention: Trastuzumab deruxtecan 
Start Date: 2020-05-25 
Last Updated: 2023-09-07 
Number of Patients: 41 
Recruitment Status: COMPLETED 
Condition: Advanced Breast Cancer 

NCTID: NCT04700124

Title: Perioperative Enfortumab Vedotin (EV) Plus Pembrolizumab (MK-3475) Versus Neoadjuvant Chemotherapy for Cisplatin-eligible Muscle Invasive Bladder Cancer (MIBC) (MK-3475-B15/ KEYNOTE-B15 / EV-304) 
Study Summary: The purpose of this study is to assess the antitumor efficacy and safety of perioperative enfortumab vedotin (EV) plus pembrolizumab and radical cystectomy (RC) + pelvic lymph node dissection (PLND) compared with the current standard of care (neoadjuvant chemotherapy <math display="block">gemcitabine plus cisplatin</math> and RC + PLND) for participants with MIBC who are cisplatin-eligible. The primary hypothesis is perioperative EV and pembrolizumab and RC + PLND (Arm A) will achieve superior event free survival (EFS) compared with neoadjuvant gemcitabine + cisplatin and RC + PLND (Arm B). 
Sponsor: Merck Sharp & Dohme LLC 
Intervention: Pembrolizumab 
Start Date: 2021-04-21 
Last Updated: 2023-11-18 
Number of Patients: 784 
Recruitment Status: ACTIVE_NOT_RECRUITING 
Condition: Muscle Invasive Bladder Cancer 

NCTID: NCT04564157

Title: New Adjuvant Trial of Chemotherapy vs Chemo-immunotherapy 
Study Summary: This is an open-label, randomised, two-arm, phase III, multi-centre clinical trial.  210 stage IB-IIIA, completely resected, non-small cell lung cancer patients will be enrolled in this trial to evaluate the disease free survival between experimental arm (Adjuvant Chemotherapy-Immunotherapy + maintenance adjuvant Immunotherapy) and control arm (Adjuvant Chemotherapy) 
Sponsor: Fundación GECP 
Intervention: Carboplatin 
Start Date: 2021-01-13 
Last Updated: 2023-06-26 
Number of Patients: 210 
Recruitment Status: RECRUITING 
Condition: Non-Small Cell Lung Cancer 

NCTID: NCT02477644

Title: Platine, Avastin and OLAparib in 1st Line 
Study Summary: Randomized, Double-Blind, Phase III Trial of Olaparib vs. Placebo in Patients with Advanced FIGO Stage IIIB - IV High Grade Serous or Endometrioid Ovarian, Fallopian Tube, or Peritoneal Cancer treated with standard First-Line Treatment, Combining Platinum-Taxane Chemotherapy and Bevacizumab Concurrent with Chemotherapy and in Maintenance. 
Sponsor: Arcagy Research 
Intervention: Olaparib 
Start Date: 2015-05-06 
Last Updated: 2022-08-02 
Number of Patients: 806 
Recruitment Status: COMPLETED 
Condition: Ovarian Cancer 

NCTID: NCT02492711

Title: Margetuximab Plus Chemotherapy vs Trastuzumab Plus Chemotherapy in the Treatment of HER2+ Metastatic Breast Cancer 
Study Summary: The purpose of this study is to determine whether patients with metastatic breast cancer treated with margetuximab plus chemotherapy have longer progression free survival (PFS) and overall survival (OS) than patients treated with trastuzumab plus chemotherapy.  A non-randomized sub-study cohort of approximately 88 patients will be enrolled to evaluate the safety of a reduced margetuximab infusion rate in patients receiving margetuximab either as monotherapy or in combination with chemotherapy. 
Sponsor: MacroGenics 
Intervention: Margetuximab 
Start Date: 2015-08-24 
Last Updated: 2022-11-23 
Number of Patients: 624 
Recruitment Status: COMPLETED 
Condition: HER-2 Positive Breast Cancer