Trials (The Maastricht UMC+ Comprehensive Cancer Center)
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NCTID: NCT02968303
Title: Induction Therapy With Vemurafenib and Cobimetinib to Optimize Nivolumab and Ipilimumab Therapy Study Summary: Rationale: The combination of ipilimumab and nivolumab induces relatively high response rates and promising response depth in late stage melanoma. Nevertheless, it takes time till responses occur and still a significant number of patients do not benefit from treatment, due to rapid progressive disease or resistance to therapy. In contrast to immunotherapies targeted therapies (BRAF or MEK inhibitors), can induce faster and higher response rates, but often of shorter duration, even when combined. Initial attempts of combining vemurafenib or dabrafenib + trametinib with ipilimumab failed due to toxicity. Patients with elevated levels of serum LDH are less likely to respond to immunotherapy compared to patients with normal LDH levels. This does not mean that such patients do not benefit at all from immunotherapy. This raises the question, whether response rates upon immunotherapy can be improved by upfront reduction of tumor burden and normalization of LDH. The investigators postulate that induction therapy with combined BRAF+MEK inhibition, and subsequent LDH normalization, can improve response rates to the rates seen in LDH normal patients. To address this question the investigators have setup a randomized phase 2 trial in metastatic melanoma patients with elevated serum LDH comparing the response rates upon ipilimumab + nivolumab versus ipilimumab + nivolumab preceded by 6 weeks of vemurafenib + cobimetinib induction. Furthermore, less than half of the patients treated with the combination of ipilimumab and nivolumab received maintenance nivolumab, and approximately 40% of all patients discontinued treatment for toxicity. In 70% of patients responses were ongoing despite discontinuation of treatment due to toxicity. This raises the question, to what extent does maintenance therapy add clinical benefit to an ongoing immune response. Preclinical data indicate even that continuous restimulation of T cells can result in activation induced non-responsiveness (anergy). Therefore, a secondary objective of this trial will be, to test a response-driven nivolumab scheme Objectives: Primary Objective • To compare efficacy of induction vemurafenib + cobimetinib followed by ipilimumab + nivolumab (Arm A) versus upfront ipilimumab + nivolumab treatment (Arm B). Secondary Objectives * To describe duration of response and overall survival induced by vemurafenib + cobimetinib followed by the combination of ipilimumab + nivolumab (Arm A) as compared to ipilimumab + nivolumab (Arm B) * To describe the rate and quality of toxicity observed in the two study arms * To describe the rate of ongoing responses upon response-driven flat dose (240mg q2w or 480mg q4w) nivolumab maintenance * To determine the immune-activating capacity of induction therapy with vemurafenib + cobimetinib followed by the combination of ipilimumab + nivolumab. * To evaluate the changes in systemic immune competence Study design: This is a two-arm phase 2 study consisting of 200 BRAFV600E/K mutation-positive late-stage melanoma patients with an elevated baseline LDH level (> ULN, < 3xULN) randomized 1:1 (stratified according to LDH) to receive either vemurafenib + cobimetinib directly followed by ipilimumab + nivolumab (Arm A) or standard first line ipilimumab + nivolumab (Arm B). Subsequently, patients in both arms will receive flat dose (240mg q2w or 480mg q4w) nivolumab maintenance in a response-driven manner. Study population: Stage IV, or unresectable stage III, BRAFV600E/K mutation positive melanoma patients, naïve for BRAF/MEK, PD-1/PD-L1 or CTLA-4 targeting therapy, 18 years and older. Intervention: Patients will be randomized 1:1 to receive either 6 weeks vemurafenib 960 mg bid + cobimetinib 60 mg QD 21-day on, 7-day off (21/7) schedule, directly followed by 4 courses of ipilimumab 3mg/kg q3wk + nivolumab 1mg/kg q3wk (Arm A) or first line standard 4 courses of ipilimumab 3mg/kg q3wk + nivolumab 1mg/kg q3wk (Arm B). Subsequently, patients in both arms will receive nivolumab maintenance flat dose (240mg q2w or 480mg q4w) in a response-driven manner according to their response at week 18. Main study parameters/endpoints: Primary Endpoints • Compare the best overall response rate (BORR) according to RECIST 1.1 of both arms at week 18 from start of treatment. Secondary Endpoints * Progression-free survival (PFS) according to RECIST 1.1 * Overall survival (OS) * Percentage of grade 3/4 toxicities according to CTCv4.03 * Percentage of ongoing response, percentage of patients requiring re-induction, response percentage upon re-induction * Changes in tumor-specific T cell responses Sponsor: Radboud University Medical Center Intervention: Vemurafenib and Cobimetinib Start Date: 2017-01-27 Last Updated: 2020-06-05 Number of Patients: 200 Recruitment Status: UNKNOWN Condition: Melanoma, Malignant, of Soft Parts
NCTID: NCT05709197
Title: The Effectiveness of Adding Braun Anastomosis to Standard Child Reconstruction After Pancreatoduodenectomy Study Summary: The goal of this clinical trial (REMBRANDT) is to evaluate the effectiveness of adding an extra connection (i.e. ‘Braun anastomosis’) after standard reconstruction in pancreatic head resection in reducing the incidence of delayed gastric emptying. Sponsor: Radboud University Medical Center Intervention: Braun anastomosis Start Date: 2023-04-17 Last Updated: 2023-04-27 Number of Patients: 256 Recruitment Status: RECRUITING Condition: Pancreatic Disease
NCTID: NCT02798003
Title: Food Reward in Cachexia Induced by Acute or Chronic Disease Study Summary: To study activity in the reward-circuitry of the brain in patients suffering from cachexia induced by cancer or chronic disease. Sponsor: Maastricht University Medical Center Intervention: Functional magnetic resonance imaging (fMRI) Start Date: 2016-11 Last Updated: 2016-12-23 Number of Patients: 44 Recruitment Status: UNKNOWN Condition: Cachexia
NCTID: NCT05514054
Title: A Study of Imlunestrant Versus Standard Endocrine Therapy in Participants With Early Breast Cancer Study Summary: The main purpose of this study is to measure how well imlunestrant works compared to standard hormone therapy in participants with early breast cancer that is estrogen receptor positive (ER+) and human epidermal receptor 2 negative (HER2-). Participants must have already taken endocrine therapy for two to five years and must have a higher-than-average risk for their cancer to return. Study participation could last up to 10 years. Sponsor: Eli Lilly and Company Intervention: Imlunestrant Start Date: 2022-10-04 Last Updated: 2023-10-24 Number of Patients: 6000 Recruitment Status: RECRUITING Condition: Breast Neoplasms
NCTID: NCT05063786
Title: Trastuzumab + Alpelisib +/- Fulvestrant vs Trastuzumab + CT in Patients With PIK3CA Mutated Previously Treated HER2+ Advanced BrEasT Cancer (ALPHABET) Study Summary: Randomized phase III trial of trastuzumab + Alpelisib +/- fulvestrant versus trastuzumab + chemotherapy in patients with PIK3CA mutated previously treated HER2+ Advanced Breast cancer. Sponsor: Spanish Breast Cancer Research Group Intervention: Trastuzumab Start Date: 2021-09-14 Last Updated: 2023-03-24 Number of Patients: 300 Recruitment Status: RECRUITING Condition: Advanced Breast Cancer
NCTID: NCT04211337
Title: A Study of Selpercatinib (LY3527723) in Participants With RET-Mutant Medullary Thyroid Cancer Study Summary: The reason for this study is to see if the study drug selpercatinib is safe and more effective compared to a standard treatment in participants with rearranged during transfection (RET)-mutant medullary thyroid cancer (MTC) that cannot be removed by surgery or has spread to other parts of the body. Participants who are assigned to the standard treatment and discontinue due to progressive disease have the option to potentially crossover to selpercatinib. Sponsor: Loxo Oncology, Inc. Intervention: Selpercatinib Start Date: 2020-02-11 Last Updated: 2023-10-30 Number of Patients: 291 Recruitment Status: ACTIVE_NOT_RECRUITING Condition: Medullary Thyroid Cancer
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: NCT05050942
Title: A Trial to Assess Efficacy and Safety of Octreotide Subcutaneous Depot in Patients With GEP-NET Study Summary: The purpose of this study is to compare the effectiveness and safety of CAM2029 to octreotide LAR or lanreotide ATG in patients with advanced, well-differentiated GEP-NET. Patients who experience progressive disease in the randomized part of the study may proceed to an open-label extension part with intensified treatment with CAM2029. Sponsor: Camurus AB Intervention: CAM2029 Start Date: 2021-10-22 Last Updated: 2023-10-06 Number of Patients: 300 Recruitment Status: RECRUITING Condition: Gastro-enteropancreatic Neuroendocrine Tumor
NCTID: NCT02281682
Title: IM Versus 5-FU Versus IMI Versus MAL-PDT in Treatment of Actinic Keratosis Study Summary: A multi-centre randomised controled single blind clinical phase IV trial with the aim to determine the most effective treatment in terms of lesion reduction, costs and patient satisfaction in treatment of actinic keratosis (AK), when comparing topical treatment with photodynamic therapy (PDT), 5% 5-fluorouracil (5-FU) cream, 5% Imiquimod (IMI) cream and ingenol mebutate (IM) gel. Sponsor: Maastricht University Medical Center Intervention: Imiquimod Start Date: 2014-11 Last Updated: 2017-10-30 Number of Patients: 624 Recruitment Status: UNKNOWN Condition: Keratosis, Actinic
NCTID: NCT02162563
Title: Treatment Strategies in Colorectal Cancer Patients With Initially Unresectable Liver-only Metastases Study Summary: Colorectal cancer patients with initially unresectable liver-only metastases may be cured after downsizing of metastases by neoadjuvant systemic therapy. However, the optimal neoadjuvant induction regimen has not been defined, and no consensus exist on criteria for resectability. In this study colorectal cancer patients with initially unresectable liver-only metastases, as prospectively confirmed by an expert panel according to predefined criteria, will be tested for RAS and BRAF tumor mutation status and selected by location of primary tumor. Patients with RAS or BRAF mutant and/or right sided tumors will be randomised between doublet chemotherapy (FOLFOX or FOLFIRI) plus bevacizumab (schedule 1), and triple chemotherapy (FOLFOXIRI) plus bevacizumab (schedule 2). Patients with RAS AND BRAF wildtype AND left-sided primary tumors will be randomized between doublet chemotherapy (FOLFOX or FOLFIRI) plus either bevacizumab (schedule 1) or panitumumab (schedule 3). Patient imaging will be reviewed for resectability by a central panel, consisting of at least one radiologist and three surgeons every assessment. Central panel review will be performed prior to randomization as well as during treatment, as described in the protocol. Sponsor: Dutch Colorectal Cancer Group Intervention: FOLFOX/ FOLFIRI with bevacizumab Start Date: 2014-07 Last Updated: 2022-03-25 Number of Patients: 564 Recruitment Status: RECRUITING Condition: Colorectal Cancer
NCTID: NCT02753127
Title: A Study of Napabucasin (BBI-608) in Combination With FOLFIRI in Adult Patients With Previously Treated Metastatic Colorectal Cancer Study Summary: This is an international multi-center, prospective, open-label, randomized, adaptive design phase 3 trial of the cancer stem cell pathway inhibitor napabucasin plus standard bi-weekly FOLFIRI versus standard bi-weekly FOLFIRI in patients with previously treated metastatic colorectal cancer (CRC). Sponsor: Sumitomo Pharma America, Inc. Intervention: Napabucasin Start Date: 2016-06 Last Updated: 2023-11-15 Number of Patients: 1253 Recruitment Status: COMPLETED Condition: Colorectal Cancer
NCTID: NCT02500004
Title: Brown Adipose Tissue Activity and Energy Metabolism in Cachexia Study Summary: To study BAT activity and energy metabolism in patients with cachexia induced by cancer or chronic disease. Sponsor: Maastricht University Medical Center Intervention: 18F-FDG PET-MRI-imaging Start Date: 2015-06 Last Updated: 2018-08-03 Number of Patients: 16 Recruitment Status: COMPLETED Condition: Cachexia
NCTID: NCT02246127
Title: Efficacy and Safety of Everolimus and (STZ-5FU) Given One Upfront the Other Upon Progression in Advanced Pancreatic Neuroendocrine Tumor (pNET) Study Summary: The purpose of this study is to compare STZ vs everolimus as first line treatment for advanced pNET and to elucidate which sequence of streptozotocin (STZ) based chemotherapy and the mammalian Target of Rapamycin (mTOR) inhibitor, everolimus, gives better results in terms of second Progression Free Survival (PFS) in well differentiated and advanced pancreatic NETs. Sponsor: Grupo Espanol de Tumores Neuroendocrinos Intervention: Drug: Everolimus Start Date: 2014-10-27 Last Updated: 2023-02-24 Number of Patients: 141 Recruitment Status: COMPLETED Condition: Neuroendocrine Tumors
NCTID: NCT04975308
Title: A Study of Imlunestrant, Investigator’s Choice of Endocrine Therapy, and Imlunestrant Plus Abemaciclib in Participants With ER+, HER2- Advanced Breast Cancer Study Summary: The main purpose of this study is to measure how well imlunestrant works compared to standard hormone therapy, and how well imlunestrant with abemaciclib work compared to imlunestrant in participants with breast cancer that is estrogen receptor positive (ER+) and human epidermal receptor 2 negative (HER2-). Participants must have breast cancer that is advanced or has spread to another part of the body. Study participation could last up to 5 years. Sponsor: Eli Lilly and Company Intervention: Imlunestrant Start Date: 2021-10-04 Last Updated: 2023-10-19 Number of Patients: 860 Recruitment Status: RECRUITING Condition: Breast Neoplasms
NCTID: NCT05375526
Title: Magtrial: Magtrace® as Tracer for Sentinel Lymph Node Detection in Early Stage Epithelial Ovarian Cancer Study Summary: Epithelial ovarian cancer (EOC) remains the tumour with the most unfavourable prognosis within the field of gynaecological oncology. The incidence of ovarian cancer in the Netherlands in 2008 was 14.5 per 100.000, with 12.3 deaths per 100.000. In the US in 2007 the incidence was 13.0 per 100.000 and there were 8.2 deaths per 100.000. The high mortality rate is partially due to the fact that approximately 75% of patients is diagnosed with advanced stage EOC. The remaining 25% of patients are diagnosed in an early stage, which require a complete surgical staging procedure including pelvic and para-aortic lymphadenectomy. Although this lymphadenectomy is standard-of-care, it leads to significant morbidity in these patients. Mainly direct postoperative complications such as infection, repeat surgery and early death have been reported. Also, long-term complications such as lymph cysts or lymphedema have been described. A potential method to reduce this morbidity and mortality, as already been described in other cancers such as breast cancer and vulvar cancer, is utilizing a sentinel lymph node (SLN) technique. By identifying and resecting the SLN, the patient is potentially spared form lymphadenectomy. Sponsor: Maastricht University Medical Center Intervention: Magtrace Start Date: 2022-06-01 Last Updated: 2022-05-16 Number of Patients: 10 Recruitment Status: NOT_YET_RECRUITING Condition: Ovarian Cancer
NCTID: NCT03901339
Title: Study of Sacituzumab Govitecan-hziy Versus Treatment of Physician’s Choice in Participants With HR+/HER2- Metastatic Breast Cancer Study Summary: The primary objective of this study is to assess and compare the efficacy and safety of sacituzumab govitecan-hzi versus treatment of physician’s choice (TPC) in participants with hormonal receptor-positive (HR+) human epidermal growth factor receptor 2 (HER2-) negative metastatic breast cancer (MBC). Sponsor: Gilead Sciences Intervention: Sacituzumab Govitecan-hziy Start Date: 2019-05-08 Last Updated: 2023-11-18 Number of Patients: 543 Recruitment Status: COMPLETED Condition: Metastatic Breast Cancer
NCTID: NCT03102320
Title: Phase 1b Multi-indication Study of Anetumab Ravtansine in Mesothelin Expressing Advanced Solid Tumors Study Summary: The key purpose of the main part of the study is to assess efficacy and safety of anetumab ravtansine as monotherapy or combination therapy for mesothelin expressing advanced solid tumors. The main purpose of the safety lead-in (dose-finding) part of the study is to determine the safety and tolerability of anetumab ravtansine in combination with cisplatin and in combination with gemcitabine, and to determine the MTD of anetumab ravtansine in combination with cisplatin for mesothelin expressing advanced cholangiocarcinoma and in combination with gemcitabine for mesothelin expressing advanced adenocarcinoma of the pancreas. Patients will receive anetumab ravtansine every three weeks in monotherapy for most indications. In cholangiocarinoma and adenocarinoma of the pancreas, 3-weekly anetumab ravtansine is administered in combination with cisplatin or gemcitabine respectively (both administered in a 2 week on / 1 week off schedule). Treatment will continue until disease progression or until another criterion for withdrawal is met. .Efficacy will be measured by evaluating the tumor’s objective response rate. Radiological tumor assessments will be performed at defined time points until the patient’s disease progresses. Blood samples will be collected for safety, pharmacokinetic and biomarker analysis. Archival or fresh biopsy tissue will also be collected for mesothelin expression testing and biomarker analyses. Sponsor: Bayer Intervention: Cisplatin Start Date: 2017-05-26 Last Updated: 2022-06-30 Number of Patients: 173 Recruitment Status: COMPLETED Condition: Neoplasms
NCTID: NCT04868396
Title: Patient-derived Glioma Stem Cell Organoids Study Summary: Rationale: Glioblastoma (GM) is the most frequent incurable adult brain tumor with median survival of 15 months after diagnosis, despite extensive treatment with surgery, radiation therapy and chemotherapy. Tumor recurrence is inevitable after which life prolonging therapies are no longer available. The development of new treatments for GM is being hampered by inter-and intratumoral heterogeneity of tumors and their microenvironment, which currently cannot be predicted accurately with current diagnostics. Objective: To establish primary patient derived organoid cultures from GM to study mechanisms that contribute to aggressive tumor growth and treatment resistance in primary and recurrent GM. Study design: Preclinical study, using patient derived glioblastoma tissue. Study population: Patients 18 years or older, with newly diagnosed glioblastoma. Main study parameters/endpoints: Intra-and inter organoid genetic and epigenetic heterogeneity that is representative for GM. Nature and extent of the burden and risks associated with participation, benefit and group relatedness: Minimal burden, since the biopsies are part of a regular neurosurgical procedure (debulking); which intends to eradicate the macroscopical tumorload in order to optimize survival benefit. The tissue (biopsy) that will be used for this trial is part of the tumor tissue that is resected during the standard debulking. Benefit: no benefit for the patient. Sponsor: Maastricht Radiation Oncology Intervention: Tumor biopsy Start Date: 2021-04-10 Last Updated: 2023-08-23 Number of Patients: 60 Recruitment Status: ACTIVE_NOT_RECRUITING Condition: Glioblastoma
NCTID: NCT05845814
Title: A Study of Efficacy and Safety of Pembrolizumab Plus Enfortumab Vedotin (EV) +/- Investigational Agents in First-Line Metastatic Urothelial Carcinoma (mUC) (MK-3475-04B/KEYMAKER-U04) Study Summary: This study is a substudy being conducted under one pembrolizumab umbrella master study KEYMAKER-U04. The substudy will consist of 2 parts. Part 1 will evaluate the efficacy and safety of coformulated favezelimab/pembrolizumab plus EV and coformulated vibostolimab/pembrolizumab plus EV relative to pembrolizumab plus EV. There will be no comparison of coformulated favezelimab/pembrolizumab plus EV versus coformulated vibostolimab/pembrolizumab plus EV. If ORR and/or DRR are substantially better on coformulated favezelimab/pembrolizumab plus EV and/or coformulated vibostolimab/pembrolizumab plus EV compared with pembrolizumab plus EV, after evaluation of the totality of data, the sponsor might consider Part 2 (expansion) to further characterize the efficacy and safety of the treatment arms under study. Sponsor: Merck Sharp & Dohme LLC Intervention: Coformulated favezelimab/pembrolizumab Start Date: 2023-06-23 Last Updated: 2023-11-18 Number of Patients: 390 Recruitment Status: RECRUITING Condition: Metastatic Urothelial Carcinoma
NCTID: NCT02540551
Title: Sentinel Node Detection in Ovarian Cancer Study Summary: Recently the investigators have shown that the SN procedure performed through the injection of tracers into the ovarian ligaments is feasible and promising in patients with clinical early stage ovarian cancer (OC). Injection of radioactive tracers resulted in the identification of SNs in all 21 patients. Before a multicentre prospective trial can be initiated, still some questions have to be answered, especially if a SN procedure still is feasable in patients with OC through injection of the tracers in the ovarian ligaments, when the ovarian tumour has already been resected, either during the same surgical procedure (ovarian tumour resected for frozen section with a malignancy as result) or at a second surgical procedure to complete the staging procedure (by laparotomy or laparoscopy). Sponsor: Maastricht University Medical Center Intervention: Injection of radioactive tracer combined with Patent Blue Start Date: 2016-01-01 Last Updated: 2020-03-24 Number of Patients: 11 Recruitment Status: TERMINATED Condition: Ovarian Neoplasms
NCTID: NCT03458221
Title: Signal TrAnsduction Pathway Activity Analysis in OVarian cancER Study Summary: The purpose of this prospective, parallel-group, cohort study is to implement phenotype-guided targeted therapy based on functional signal transduction pathway (STP) activity in recurrent ovarian cancer patients using a novel mRNA-based assay. Existing targeted drugs with tolerable toxicity profiles are used to investigate the therapeutic value beyond their approved indication, which are deemed beneficial in the select group of patients with a relevant predominantly active functional STP, in order to improve survival and maintain quality of life. Sponsor: Gynaecologisch Oncologisch Centrum Zuid Intervention: Letrozole Oral Product Start Date: 2023-01-31 Last Updated: 2023-04-18 Number of Patients: 148 Recruitment Status: RECRUITING Condition: Recurrent Ovarian Cancer
NCTID: NCT04607421
Title: A Study of Encorafenib Plus Cetuximab With or Without Chemotherapy in People With Previously Untreated Metastatic Colorectal Cancer Study Summary: The purpose of this study is to evaluate two study medicines (encorafenib plus cetuximab) taken alone or together with standard chemotherapy for the potential treatment of colorectal cancer that: * has spread to other parts of the body (metastatic); * has a certain type of abnormal gene called “BRAF”; and * has not received prior treatment. Participants in this study will receive one of the following study treatments: * Encorafenib plus cetuximab: These participants will receive encorafenib by mouth at home every day and cetuximab once every two weeks by intravenous (IV) infusion (an injection into the vein) at the study clinic. * Encorafenib plus cetuximab with chemotherapy: These participants will receive encorafenib and cetuximab in the way described in the bullet above. Additionally, they will receive standard chemotherapy by IV infusion and oral treatment at home. * Chemotherapy alone: These participants will receive chemotherapy, the standard treatment for this condition, by IV infusion at the study clinics and oral treatment at home. The study team will monitor how each participant responds to the study treatment for up to about 3 years. Sponsor: Pfizer Intervention: Encorafenib Start Date: 2020-12-21 Last Updated: 2023-09-11 Number of Patients: 815 Recruitment Status: RECRUITING Condition: Neoplasms
NCTID: NCT04209855
Title: A Study of Mirvetuximab Soravtansine vs. Investigator’s Choice of Chemotherapy in Platinum-Resistant, Advanced High-Grade Epithelial Ovarian, Primary Peritoneal, or Fallopian Tube Cancers With High Folate Receptor-Alpha Expression Study Summary: This Phase 3 study is designed to compare the efficacy and safety of mirvetuximab soravtansine vs. investigator’s choice chemotherapy in patients with platinum-resistant high-grade epithelial ovarian cancer, primary peritoneal, or fallopian tube cancer, whose tumors express a high-level of FRα. Patients will be, in the opinion of the Investigator, appropriate for single-agent therapy for their next line of therapy. Folate receptor alpha (FRα) positivity will be defined by the Ventana FOLR1 (FOLR1-2.1) CDx assay. Sponsor: ImmunoGen, Inc. Intervention: Mirvetuximab Soravtansine Start Date: 2019-12-31 Last Updated: 2023-03-06 Number of Patients: 453 Recruitment Status: ACTIVE_NOT_RECRUITING Condition: Epithelial Ovarian Cancer
NCTID: NCT03172377
Title: Lengthening Adalimumab Dosing Interval in Quiescent Crohn’s Disease Patients Study Summary: Crohn’s disease is a chronic inflammatory bowel disease. This disease can be treated with, among other things, biologicals such as adalimumab. Patients use adalimumab for a long time to maintain remission and to prevent relapse of the bowel inflammation. The disadvantages of this therapy are the high price and side effects (such as the higher risk of infection). Currently, adalimumab is given every 2 weeks, by injection under the skin. The optimal time between two injections has never been investigated before. Prior research in patients with rheumatoid arthritis shows that disease remission can be maintained with longer injection-intervals. Our hypothesis is that this is the same for Crohn’s disease patients. Our aim is to show non-inferiority of extending the adalimumab dosing interval, under strict disease monitoring in Crohn’s disease patients in sustained (>9 months) clinical remission, compared to standard care. During the trial,174 patients with stable Crohn’s disease will be divided into 2 groups. One group continues adalimumab injections with the same 2-week interval. And the other group will incrementally extend the interval to 4 weeks, under strict disease monitoring. If a step-down leads to recurrence of disease activity patients will return to the preceding effective dosing interval. Thus, we will investigate whether, and for whom, it is safe to extend the adalimumab injection interval. Sponsor: Radboud University Medical Center Intervention: Lengthening adalimumab dosing interval Start Date: 2017-05-03 Last Updated: 2022-10-14 Number of Patients: 174 Recruitment Status: UNKNOWN Condition: Crohn Disease in Remission
NCTID: NCT05040646
Title: The Development of a Patient Reported Outcomes Measure Committed to the Watch-and-wait Program for Rectal Cancer Study Summary: The purpose of this study to develop an international tool that can be used to assess burden of disease in patients enrolled in the W&W program for rectal cancer Sponsor: Maastricht University Medical Center Intervention: Delphi exercise Start Date: 2021-11-01 Last Updated: 2023-03-16 Number of Patients: 80 Recruitment Status: COMPLETED Condition: Rectal Cancer
NCTID: NCT04824794
Title: GEN3014 Safety Trial in Relapsed or Refractory Hematologic Malignancies Study Summary: The drug that will be investigated in the study is an antibody, GEN3014. Since this is the first study of GEN3014 in humans, the main purpose is to evaluate safety. Besides safety, the study will determine the recommended GEN3014 dose to be tested in a larger group of participants and assess preliminary clinical activity of GEN3014. GEN3014 will be studied in relapsed or refractory multiple myeloma (also known as RRMM) and other blood cancers. The study consists of 3 parts: # The Dose Escalation will test increasing doses of GEN3014 to find a safe dose level to be tested in the other two parts. # Expansion Part A will further test the GEN3014 dose determined from the Dose Escalation Part. # Expansion Part B will compare intravenous (IV) GEN3014 with the approved multiple myeloma drug, subcutaneous (SC) daratumumab. Participants in the US will not participate Expansion Part B. Participants will receive either investigational GEN3014 or daratumumab; none will be given placebo. The study duration will be different for the individual participants. Overall, the study may be ongoing up to 5 years after the last participant’s first treatment. Sponsor: Genmab Intervention: GEN3014 Start Date: 2021-03-09 Last Updated: 2023-10-05 Number of Patients: 252 Recruitment Status: RECRUITING Condition: Multiple Myeloma (MM)
NCTID: NCT05217446
Title: A Study of Encorafenib Plus Cetuximab Taken Together With Pembrolizumab Compared to Pembrolizumab Alone in People With Previously Untreated Metastatic Colorectal Cancer Study Summary: The purpose of this study is to learn about the effects of three study medicines (encorafenib, cetuximab, and pembrolizumab) given together for the treatment of colorectal cancer that: * is metastatic (spread to other parts of the body); * has the condition of genetic hypermutability (tendency to mutation) or impaired DNA mismatch repair (MMR) * has a certain type of abnormal gene called “BRAF” and; * has not received prior treatment. All participants in this study will receive pembrolizumab at the study clinic as an intravenous (IV) infusion (given directly into a vein) at the study clinic. In addition, half of the participants will take encorafenib by mouth at home every day and cetuximab by IV infusion at the study clinic. The study team will monitor how each participant is doing with the study treatment during regular visits at the study clinic. Sponsor: Pfizer Intervention: Encorafenib Start Date: 2022-07-11 Last Updated: 2023-10-25 Number of Patients: 104 Recruitment Status: RECRUITING Condition: Metastatic Colorectal 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: NCT03772028
Title: Primary Cytoreductive Surgery With or Without Hyperthermic Intraperitoneal Chemotherapy (HIPEC) Study Summary: stage III epithelial ovarian cancer randomizing between primary cytoreductive surgery with or without hyperthermic intraperitoneal chemotherapy Sponsor: The Netherlands Cancer Institute Intervention: cisplatin Start Date: 2020-01-01 Last Updated: 2023-09-08 Number of Patients: 538 Recruitment Status: RECRUITING Condition: Ovarian Cancer
NCTID: NCT05701241
Title: Continuing Somatostatin Analogues Upon Progression in Neuroendocrine Tumour pAtients Study Summary: The SAUNA trial is a multi-national, multi-centre, open-label, randomised, controlled, pragmatic clinical trial in patients with advanced, non-functional gastroenteropancreatic (GEP) neuroendocrine tumours (NET) with progressive disease on first-line therapy with somatostatine analogues (SSA). Eligible patients will be divided into two substudies according to the second-line therapy of choice (peptide receptor radionuclide therapy (PRRT) or targeted therapy, at the discretion of the local investigator). Patients within each substudy will be randomised 1:1 between continuation or withdrawal from SSA at the start of second-line systemic therapy. Stratification will occur according to study site and according to the Ki67 value (below 10% (grade 1 and low grade 2) and equal to or above 10% (high grade 2)). Sponsor: University Hospital, Antwerp Intervention: Somatostatin analog Start Date: 2023-06-28 Last Updated: 2023-07-12 Number of Patients: 270 Recruitment Status: RECRUITING Condition: Gastroenteropancreatic Neuroendocrine Tumor
NCTID: NCT01865110
Title: R-CHOP + R-HAD vs R-CHOP Followed by Maintenance Lenalidomide + Rituximab vs Rituximab for Older Patients With MCL Study Summary: This study aims to evaluate whether the addition of lenalidomide to rituximab-maintenance improves progression free survival (PFS) compared to standard rituximab maintenance after induction treatment consisting of R-CHOP + R-HAD vs R-CHOP alone in older patients (≥ 60 year old) with mantle cell lymphoma. The treatments consist of two phases: induction treatment (3 R-CHOP21 + 3 cycles of R-HAD28 alternating) vs 8 cycles of R-CHOP21) followed by maintenance treatment (13 cycles of rituximab + 26 cycles of lenalidomide vs 13 cycles of rituximab). Sponsor: The Lymphoma Academic Research Organisation Intervention: R-CHOP Start Date: 2013-11 Last Updated: 2023-09-26 Number of Patients: 623 Recruitment Status: ACTIVE_NOT_RECRUITING Condition: Mantle Cell Lymphoma
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: NCT03848078
Title: (Cost)-Effectiveness of Optical Coherence Tomography (OCT) in Basal Cell Carcinoma (BCC) Study Summary: A multi-centre randomized non-inferiority trial investigating the (cost-)effectiveness of Optical Coherence Tomography (OCT) versus regular punch biopsy in the diagnosis and subtyping of Basal Cell Carcinoma (BCC). Sponsor: Maastricht University Medical Center Intervention: Optical Coherence Tomography Start Date: 2019-02-26 Last Updated: 2021-02-25 Number of Patients: 598 Recruitment Status: UNKNOWN Condition: Basal Cell Carcinoma
NCTID: NCT05480735
Title: EffectiveNess of a Multimodal preHAbilitation Program in patieNts With Bladder canCEr Undergoing Cystectomy Study Summary: Currently, the potential value of a multimodal prehabilitation program in bladder cancer has not been extensively studied. The investigators designed the ENHANCE study to assess the effect of a structured multimodal prehabilitation program in 154 patients with bladder cancer on the number (primary endpoint) and severity of complications within 90 days, length of hospital stay, readmissions, physical fitness, muscle strength, physical functioning, nutritional status, smoking behaviour, anxiety and depression, fatigue, quality of life, physical activity, tumor tissue characteristics, and healthcare costs. Sponsor: The Netherlands Cancer Institute Intervention: Prehabilitation Start Date: 2022-08-11 Last Updated: 2022-10-31 Number of Patients: 154 Recruitment Status: RECRUITING Condition: Bladder Carcinoma
NCTID: NCT03400280
Title: POstopeRative Standardization of Care: THe Implementation of Best Practice After Pancreatic Resection Study Summary: This Nationwide stepped-wedge cluster randomized trial is designed to evaluate if the implementation of a best practice algorithm for postoperative care results in a decrease in incidence of major complications and death after pancreatic resection as compared to current practice. Sponsor: St. Antonius Hospital Intervention: Best practice algorithm for postoperative care Start Date: 2018-01-08 Last Updated: 2019-06-14 Number of Patients: 1600 Recruitment Status: UNKNOWN Condition: Pancreatic Diseases
NCTID: NCT04976634
Title: Pembrolizumab Plus Lenvatinib in Combination With Belzutifan in Solid Tumors (MK-6482-016) Study Summary: The purpose of this study is to determine the safety and efficacy of belzutifan in combination with pembrolizumab and lenvatinib in multiple solid tumors including hepatocellular carcinoma (HCC), colorectal cancer (CRC), pancreatic ductal adenocarcinoma (PDAC), biliary tract cancer (BTC), endometrial cancer (EC),and esophageal squamous cell carcinoma (ESCC). There is no formal hypothesis testing in this study. Sponsor: Merck Sharp & Dohme LLC Intervention: Pembrolizumab Start Date: 2021-08-18 Last Updated: 2023-11-18 Number of Patients: 730 Recruitment Status: RECRUITING Condition: Carcinoma, Hepatocellular
NCTID: NCT04927780
Title: Perioperative or Adjuvant mFOLFIRINOX for Resectable Pancreatic Cancer Study Summary: The PREOPANC-3 study is a randomized, multicenter, phase 3 trial. Patients with resectable pancreatic cancer will be randomly assigned (1:1) to 8 cycles of neoadjuvant mFOLFIRINOX followed by surgery and 4 cycles of adjuvant mFOLFIRINOX (arm 1) or to upfront surgery followed by 12 cycles of adjuvant mFOLFIRINOX (arm 2). The primary objective of the trial is to determine whether perioperative mFOLFIRINOX improves overall survival compared with adjuvant mFOLFIRINOX in patients with resectable pancreatic cancer. Sponsor: Erasmus Medical Center Intervention: Leucovorin Calcium Start Date: 2021-09-07 Last Updated: 2023-08-15 Number of Patients: 378 Recruitment Status: RECRUITING Condition: Pancreatic Cancer
NCTID: NCT03727724
Title: Afatinib and Cetuximab in Epidermal Growth Factor Receptor (EGFR) Exon 20 Insertion Positive Non-small-cell Lung Cancer Study Summary: This is a single arm open-label multi-center phase II study, investigating disease control rate after 18 weeks of treatment with afatinib/cetuximab combination therapy in patients with advanced non-small cell lung cancer (NSCLC) harboring an EGFR exon 20 insertion. Sponsor: The Netherlands Cancer Institute Intervention: Afatinib Start Date: 2018-12-04 Last Updated: 2023-10-18 Number of Patients: 37 Recruitment Status: COMPLETED Condition: Carcinoma, Non-Small-Cell Lung
NCTID: NCT05224141
Title: Pembrolizumab/Vibostolimab (MK-7684A) or Atezolizumab in Combination With Chemotherapy in First Line Treatment of Extensive-Stage Small Cell Lung Cancer (MK-7684A-008, KEYVIBE-008) Study Summary: This study will evaluate the combination of a fixed dose pembrolizumab/vibostolimab co-formulation (MK-7684A) with etoposide/platinum chemotherapy followed by MK-7684A compared to the combination of atezolizumab with etoposide/platinum chemotherapy followed by atezolizumab in the first-line treatment of Extensive-Stage Small Cell Lung Cancer (ES-SCLC). The primary hypothesis is, with respect to overall survival, MK-7684A in combination with the background therapy of etoposide/platinum followed by MK-7684A, is superior to atezolizumab in combination with the background therapy of etoposide/platinum followed by atezolizumab. Sponsor: Merck Sharp & Dohme LLC Intervention: Pembrolizumab/Vibostolimab Co-Formulation Start Date: 2022-03-24 Last Updated: 2023-10-10 Number of Patients: 450 Recruitment Status: ACTIVE_NOT_RECRUITING Condition: Small Cell Lung Carcinoma
NCTID: NCT05741944
Title: The Value of a Risk Prediction Tool (PERSARC) for Effective Treatment Decisions of Soft-tissue Sarcomas Patients Study Summary: The goal of this clinical trial is to assess the (cost-)effectiveness of a personalised risk assessment tool (PERSARC) to increase patients’ knowledge about risks and benefits of treatment options and to reduce decisional conflict in comparison with usual care in high-grade extremity Soft-Tissue Sarcoma-patients. High-grade (2-3) extremity Soft-Tissue Sarcoma patients (>= 18 years) will either receive standard care (control group) or care with the use of PERSARC; i.e. PERSARC will be used in multidisciplinary tumour boards to guide treatment advice and in consultation in which the oncological/orthopaedic surgeon informs the patient about his/her diagnoses and discusses the benefits and harms of all relevant treatment options (intervention group) Sponsor: Leiden University Medical Center Intervention: Care with the use of PERSARC Start Date: 2021-08-24 Last Updated: 2023-02-23 Number of Patients: 120 Recruitment Status: RECRUITING Condition: Soft-tissue Sarcoma
NCTID: NCT05383170
Title: A Study to Evaluate the Safety and Efficacy of CyPep-1 in Combination With Pembrolizumab for the Treatment of Advanced or Metastatic Cancers Study Summary: This Phase 1b/2a study will assess the efficacy, safety, and pharmacodynamics of CyPep-1 when administered directly into measurable tumor lesions in combination with the anti-PD-1 antibody pembrolizumab. Additionally, the study will assess anti-tumor effects of CyPep-1 on injected lesions and non-injected target lesions identified at baseline, as well as local and systemic immunological effects of CyPep-1 in combination with pembrolizumab. Sponsor: Cytovation AS Intervention: CyPep-1 Start Date: 2023-03-21 Last Updated: 2023-11-15 Number of Patients: 90 Recruitment Status: ACTIVE_NOT_RECRUITING Condition: Advanced Head and Neck Squamous Cell Carcinoma
NCTID: NCT03784599
Title: T-DM1 and Osimertinib Combination Treatment to Target HER2 Bypass Track Resistance in EGFR Mutation Positive NSCLC Study Summary: This is a single arm open-label multi-center phase II study, investigating disease control rate after 3 months of treatment with trastuzumab-emtansine/osimertinib combination therapy in patients with advanced EGFR mutation positive non-small cell lung cancer (NSCLC) with HER2 bypass track resistance. Sponsor: The Netherlands Cancer Institute Intervention: Trastuzumab emtansine Start Date: 2018-12-18 Last Updated: 2022-11-10 Number of Patients: 28 Recruitment Status: TERMINATED Condition: Carcinoma, Non-Small-Cell Lung
NCTID: NCT01171170
Title: Paclitaxel-Carboplatin-Bevacizumab +/- Nitroglycerin in Metastatic Non-Squamous-Non-Small Cell Lung Cancer Study Summary: This study is designed to assess the effects of adding nitroglycerin (NTG) patches, delivery 25 mg NTG per 24 h, to the standard first line treatment of metastatic non-squamous non-small cell lung cancer (NSCLC), i.e. 4 cycles of carboplatin-paclitaxel-bevacizumab, followed by bevacizumab alone until disease progression. Tumor hypoxia is a common phenomenon in lung cancer; it is a known poor prognostic marker, related to treatment resistance. Pre-clinical studies have shown that nitric oxide (NO) donating drugs may decrease hypoxia related drug resistance. NTG is a NO donating drug. NTG increases tumor blood flow and thereby augments antitumor drug delivery to the tumor. A randomized phase II has shown an increase in the response rate from 42% to 72%, when NTG patches (25 mg/day, day -2 to +3) were added to vinorelbine/cisplatin in patients with advanced NSCLC. In addition, the time to progression increased from 185 to 327 days. The hypothesis of the present study is that adding NTG transdermal patches to bevacizumab containing chemotherapy improves progression free survival, response rate and overall survival in patients with metastatic non-squamous NSCLC. Sponsor: Dutch Society of Physicians for Pulmonology and Tuberculosis Intervention: carboplatin paclitaxel bevacizumab Start Date: 2011-01 Last Updated: 2020-09-28 Number of Patients: 223 Recruitment Status: COMPLETED Condition: Non Small Cell Lung Cancer
