Trials (Tartu University Hospital)
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NCTID: NCT04241185
Title: Efficacy and Safety of Pembrolizumab (MK-3475) in Combination With Chemoradiotherapy (CRT) Versus CRT Alone in Muscle-invasive Bladder Cancer (MIBC) (MK-3475-992/KEYNOTE-992) Study Summary: This study is designed to assess the antitumor efficacy and safety of pembrolizumab in combination with chemoradiotherapy (CRT) versus CRT alone in participants with muscle-invasive bladder cancer (MIBC). The primary hypothesis is that pembrolizumab + chemoradiotherapy is superior to placebo + chemoradiotherapy with respect to bladder intact event-free survival. Sponsor: Merck Sharp & Dohme LLC Intervention: Pembrolizumab Start Date: 2020-05-19 Last Updated: 2023-11-18 Number of Patients: 636 Recruitment Status: RECRUITING Condition: Urinary Bladder Neoplasms
NCTID: NCT05243550
Title: A Phase 3 Single-Arm Study of UGN-102 for Treatment of Low Grade Intermediate Risk Non-Muscle-Invasive Bladder Cancer Study Summary: This Phase 3, multinational, single-arm, multicenter study will evaluate the efficacy and safety of UGN-102 as primary chemoablative therapy in patients with low grade intermediate risk non-muscle-invasive bladder cancer (LG IR NMIBC). Sponsor: UroGen Pharma Ltd. Intervention: UGN-102 Start Date: 2022-03-01 Last Updated: 2023-09-29 Number of Patients: 220 Recruitment Status: ACTIVE_NOT_RECRUITING Condition: Bladder Cancer
NCTID: NCT02163759
Title: A Study Comparing the Efficacy and Safety of Etrolizumab With Adalimumab and Placebo in Participants With Moderate to Severe Ulcerative Colitis (UC) in Participants Naive to Tumor Necrosis Factor (TNF) Inhibitors Study Summary: This Phase III, double-blind, placebo and active-comparator controlled, multicenter study will investigate the efficacy and safety of etrolizumab in induction of remission in participants with moderately to severely active ulcerative colitis (UC) who are naÏve to tumor necrosis factor (TNF) inhibitors and refractory to or intolerant of prior immunosuppressant and/or corticosteroid treatment. In addition to this study, a second Phase III trial with identical study design (GA28949; NCT02171429) was independently conducted. Sponsor: Hoffmann-La Roche Intervention: Adalimumab Start Date: 2014-11-04 Last Updated: 2021-07-23 Number of Patients: 358 Recruitment Status: COMPLETED Condition: Ulcerative Colitis
NCTID: NCT04607850
Title: Prime-boost Vaccine Study in Women With Low-grade Cervical HPV Lesions Study Summary: A Phase 1b/2 multi-centre study evaluating the safety, efficacy and immunogenicity of prime-boost vaccines ChAdOx1-HPV and MVA-HPV in women with HPV related low grade cervical lesions. Sponsor: Vaccitech (UK) Limited Intervention: ChAdOx1-HPV Start Date: 2021-03-16 Last Updated: 2023-03-29 Number of Patients: 99 Recruitment Status: ACTIVE_NOT_RECRUITING Condition: HPV Infection
NCTID: NCT05609968
Title: Study of Pembrolizumab (MK-3475) Monotherapy Versus Sacituzumab Govitecan in Combination With Pembrolizumab for Participants With Metastatic Non-small Cell Lung Cancer (NSCLC) With Programmed Cell Death Ligand 1 (PD-L1) Tumor Proportion Score (TPS) ≥50% (MK-3475-D46) Study Summary: The purpose of this study is to compare pembrolizumab (MK-3475) in combination with sacituzumab govitecan with pembrolizumab alone with respect to progression-free survival (PFS) and overall survival (OS) per Response Evaluation Criteria in Solid Tumors Version 1.1 (RECIST 1.1) as assessed by blinded independent central review (BICR) among adults with metastatic non-small cell lung cancer (NSCLC) with programmed cell death ligand 1 (PD-L1) tumor proportion score (TPS) ≥50%). Sponsor: Merck Sharp & Dohme LLC Intervention: Sacituzumab Govitecan Start Date: 2023-02-06 Last Updated: 2023-11-18 Number of Patients: 614 Recruitment Status: RECRUITING Condition: Carcinoma, Non-Small-Cell Lung
NCTID: NCT03267316
Title: A First-in-Human Study of CAN04 in Patients With Solid Malignant Tumors Study Summary: This study will evaluate the safety, tolerability, and preliminary antitumor activity of CAN04 both as a monotherapy and in combination with standard of care treatment in subjects with solid cancer tumors. Following completion of the first part, the dose escalation cohorts, and determination of maximum tolerated dose or recommended phase 2 dose (MTD/RP2D), safety and tolerability will be further evaluated in an expanded cohort of subjects with pancreatic or lung cancer, as monotherapy or in combination with the standard of care treatment and to identify the RP2D of CAN04 in combination with standard of care. In addition, early signs of efficacy during treatment with CAN04 will be investigated. Sponsor: Cantargia AB Intervention: CAN04 Start Date: 2017-09-19 Last Updated: 2023-10-18 Number of Patients: 167 Recruitment Status: ACTIVE_NOT_RECRUITING Condition: Non Small Cell Lung Cancer
NCTID: NCT02178956
Title: A Study of BBI608 Plus Weekly Paclitaxel to Treat Gastric and Gastro-Esophageal Junction Cancer Study Summary: The purpose of this study is to find out whether it is better to receive a new drug, BBI608, in addition to paclitaxel chemotherapy or better to receive paclitaxel chemotherapy alone as second line treatment for gastric and gastroesophageal junction cancer after prior first line platinum and fluoropyrimidine based chemotherapy. Sponsor: Sumitomo Pharma America, Inc. Intervention: BBI608 Start Date: 2014-10 Last Updated: 2023-11-15 Number of Patients: 714 Recruitment Status: COMPLETED Condition: Gastric Cancer
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: NCT02077868
Title: Evaluation of MGN1703 Maintenance Treatment in Patients With mCRC With Tumor Reduction During Induction Treatment Study Summary: The purpose of this this trial is to prove the efficacy and safety of MGN1703 as a maintenance therapy after first-line chemotherapeutic treatment of metastatic colorectal cancer. Sponsor: Mologen AG Intervention: Usual Maintenance Start Date: 2014-09 Last Updated: 2019-09-10 Number of Patients: 540 Recruitment Status: UNKNOWN Condition: Metastatic Colorectal Cancer
NCTID: NCT01322490
Title: A Randomized, Double-blind, Phase 3 Efficacy Trial of PROSTVAC-V/F +/- GM-CSF in Men With Asymptomatic or Minimally Symptomatic Metastatic Castrate-Resistant Prostate Cancer Study Summary: The purpose of this study is to determine whether PROSTVAC alone or in combination with GM-CSF is effective in prolonging overall survival in men with few or no symptoms from metastatic, castrate-resistant prostate cancer. Sponsor: Bavarian Nordic Intervention: PROSTVAC-V Start Date: 2011-11-28 Last Updated: 2019-09-04 Number of Patients: 1297 Recruitment Status: COMPLETED Condition: Prostate Cancer Metastatic
NCTID: NCT01667419
Title: A Study of Vemurafenib Adjuvant Therapy in Participants With Surgically Resected Cutaneous BRAF-Mutant Melanoma Study Summary: This multicenter, randomized, double-blind, placebo-controlled study will evaluate the efficacy and safety of vemurafenib in participants with completely resected, cutaneous BRAF mutation-positive melanoma at high risk for recurrence. Participants will be enrolled in two separate cohorts: Cohort 1 will include participants with completely resected Stage IIC, IIIA (participants with one or more nodal metastasis greater than \[\>\] 1 millimeter \[mm\] in diameter), or IIIB cutaneous melanoma, as defined by the American Joint Committee on Cancer (AJCC) Classification, Version 7; Cohort 2 will include participants with Stage IIIC cutaneous melanoma, as defined by this classification scheme. Within each cohort, participants will be randomized (1:1 ratio) to receive vemurafenib or matching placebo over a 52-week period. Sponsor: Hoffmann-La Roche Intervention: Vemurafenib Start Date: 2012-09-24 Last Updated: 2019-07-23 Number of Patients: 498 Recruitment Status: COMPLETED Condition: Melanoma
NCTID: NCT01905943
Title: A Safety and Efficacy Study of Obinutuzumab Alone or in Combination With Chemotherapy in Participants With Chronic Lymphocytic Leukemia Study Summary: This multicenter, open-label, single-arm study will evaluate the safety and efficacy of obinutuzumab alone or in combination with chemotherapy in participants with previously untreated or relapsed/refractory chronic lymphocytic leukemia (CLL). This is a Post-Authorization Safety Study. Participants will receive 6 cycles of single-agent obinutuzumab or obinutuzumab in combination with chemotherapy at the investigator's discretion. Each participant will be followed until 30 months after the last participant has been enrolled. Total length of the study is anticipated to be approximately 5 years. Sponsor: Hoffmann-La Roche Intervention: Bendamustine Start Date: 2013-11-04 Last Updated: 2019-10-28 Number of Patients: 979 Recruitment Status: COMPLETED Condition: Chronic Lymphocytic Leukemia
NCTID: NCT02562443
Title: Controlled Study of Rigosertib Versus Physician's Choice of Treatment in MDS Patients After Failure of an HMA Study Summary: The study's primary objective \[in a population of patients with MDS after failure of treatment with azacitidine (AZA) or decitabine (DAC)\], is to compare the overall survival (OS) of patients in the rigosertib group vs the Physician's Choice group, in all patients and in a subgroup of patients with IPSS-R very high risk. Sponsor: Onconova Therapeutics, Inc. Intervention: rigosertib Start Date: 2015-12-02 Last Updated: 2022-09-26 Number of Patients: 372 Recruitment Status: TERMINATED Condition: Myelodysplastic Syndrome
NCTID: NCT04210115
Title: Study of Pembrolizumab (MK-3475) Versus Placebo in Participants With Esophageal Carcinoma Who Are Receiving Chemotherapy and Radiation Therapy (MK-3475-975/KEYNOTE-975) Study Summary: The purpose of this study is to assess the efficacy and safety of treatment with definitive chemoradiotherapy (dCRT) + pembrolizumab (MK-3475) compared to treatment with dCRT + placebo with respect to Event-free Survival (EFS) and Overall Survival (OS) in: * participants whose tumors express Programmed Death-Ligand 1 (PD-L1) Combined Positive Score (CPS) ≥10 * participants whose tumors express PD-L1 CPS ≥1 * all participants The primary study hypotheses are that dCRT+ pembrolizumab is better than dCRT + placebo with respect to: * EFS in participants whose tumors express PD-L1 CPS ≥10 * EFS in participants whose tumors express PD-L1 CPS ≥1 * EFS in all participants * OS in participants whose tumors express PD-L1 CPS ≥10 * OS in participants whose tumors express PD-L1 CPS ≥1 * OS in all participants Sponsor: Merck Sharp & Dohme LLC Intervention: pembrolizumab Start Date: 2020-02-28 Last Updated: 2023-11-18 Number of Patients: 700 Recruitment Status: RECRUITING Condition: Esophageal Squamous Cell Carcinoma (ESCC)
NCTID: NCT01860638
Title: A Comparison of Continuous Bevacizumab (Avastin) Treatment or Placebo in Addition to Lomustine Followed by Standard of Care After Disease Progression in Participants With Glioblastoma Study Summary: This multicenter, double-blind, placebo-controlled, randomized study will evaluate the efficacy and safety of the addition of bevacizumab treatment to lomustine (in 2nd-line \[2L\] treatment) and SOC (in 3rd-line \[3L\] and subsequent lines of treatment) following first-line disease progression (PD1) in participants with newly diagnosed glioblastoma. All enrolled participants will receive 1L treatment with radiotherapy, temozolomide, and bevacizumab. At PD1, eligible participants will be randomized (1:1) to receive 2L treatment with either bevacizumab plus lomustine or placebo plus lomustine. After second-line disease progression (PD2), participants will receive 3L treatment and will continue blinded bevacizumab or placebo with the addition of an SOC agent. Following third-line disease progression (PD3), participants will receive subsequent lines of treatment and will either continue blinded bevacizumab or placebo (at the discretion of the investigator), or switch to open-label bevacizumab (at the choice of the participant). Sponsor: Hoffmann-La Roche Intervention: Bevacizumab Start Date: 2013-08-19 Last Updated: 2018-04-30 Number of Patients: 296 Recruitment Status: COMPLETED Condition: Glioblastoma
NCTID: NCT05797831
Title: Study of Navtemadlin as Maintenance Therapy in TP53WT Advanced or Recurrent Endometrial Cancer Study Summary: This study evaluates navtemadlin as maintenance treatment for patients with advanced or recurrent endometrial cancer (EC) who have achieved complete response or partial response on chemotherapy. The study will be conducted in 2 parts. Part 1 will evaluate safety and efficacy of two different doses of navtemadlin alongside an observational control arm to determine the Phase 3 navtemadlin dose. Part 2 will evaluate the efficacy and safety of navtemadlin Phase 3 dose compared to placebo. Sponsor: Kartos Therapeutics, Inc. Intervention: Navtemadlin Start Date: 2023-07-17 Last Updated: 2023-11-01 Number of Patients: 268 Recruitment Status: RECRUITING Condition: Endometrial Cancer
NCTID: NCT03267030
Title: Asparaginase Encapsulated in Erythrocytes for Patients With ALL and Hypersensitivity to PEG-asparaginase Study Summary: Pegylated-asparaginase (PEG-ASP) is an important part of the treatment of childhood acute lymphoblastic leukaemia (ALL). Unfortunately 13% of patients develops allergy and further treatment is impossible. Furthermore, 6% of patients have developed antibodies (silent inactivation) and have no effect of the PEG-ASP treatment. Truncated asparaginase therapy is associated with inferior event-free survival outcomes, in particular relapse in central nervous system (CNS). Eryaspase is a new formulation of asparaginase encapsulated in erythrocytes. The erythrocyte membrane protects asparaginase against fast degradation and elimination processes. The encapsulation eliminates the direct somatic contact, and it is hypothesized that this provides the potential to prolong the activity of the enzyme and reduce toxicities. Sponsor: Birgitte Klug Albertsen Intervention: GRASPA Start Date: 2017-08-23 Last Updated: 2021-01-25 Number of Patients: 55 Recruitment Status: COMPLETED Condition: Acute Lymphoblastic Leukemia
NCTID: NCT03869892
Title: Phase III Study in First-line Treatment of Patients With Metastatic Colorectal Cancer Who Are Not Candidate for Intensive Therapy. Study Summary: The main purpose of this study is to demonstrate the superiority of S 95005 in combination with bevacizumab over capecitabine in combination with bevacizumab. Sponsor: Institut de Recherches Internationales Servier Intervention: Trifluridine/tipiracil hydrochloride (S95005) Start Date: 2019-03-21 Last Updated: 2023-11-18 Number of Patients: 856 Recruitment Status: ACTIVE_NOT_RECRUITING Condition: Metastatic Colorectal Cancer
NCTID: NCT02242942
Title: Comparison of the Treatments of Obinutuzumab + Venetoclax Versus Obinutuzumab + Chlorambucil in Patients With Chronic Lymphocytic Leukemia Study Summary: This open-label, multicenter, randomized Phase III study is designed to compare the efficacy and safety of a combined regimen of obinutuzumab and venetoclax versus obinutuzumab + chlorambucil in participants with chronic lymphocytic leukemia (CLL) and coexisting medical conditions. The time on study treatment was approximately one year and the follow-up period will be up to 9 years. Sponsor: Hoffmann-La Roche Intervention: Chlorambucil Start Date: 2014-12-31 Last Updated: 2023-09-21 Number of Patients: 445 Recruitment Status: ACTIVE_NOT_RECRUITING Condition: Lymphocytic Leukemia, Chronic
NCTID: NCT02425891
Title: A Study of Atezolizumab in Combination With Nab-Paclitaxel Compared With Placebo With Nab-Paclitaxel for Participants With Previously Untreated Metastatic Triple-Negative Breast Cancer (IMpassion130) Study Summary: This multicenter, randomized, double-blind study evaluated the efficacy, safety, and pharmacokinetics of atezolizumab (MPDL3280A) administered with nab-paclitaxel compared with placebo in combination with nab-paclitaxel in participants with locally advanced or metastatic triple-negative breast cancer (TNBC) who have not received prior systemic therapy for metastatic breast cancer (mBC). The safety of single-agent nab-paclitaxel has been determined in previous studies of participants with mBC and the safety data to date suggest that atezolizumab can be safely combined with standard chemotherapy agents. Sponsor: Hoffmann-La Roche Intervention: Atezolizumab (MPDL3280A), an engineered anti-PDL1 antibody Start Date: 2015-06-23 Last Updated: 2022-07-19 Number of Patients: 902 Recruitment Status: COMPLETED Condition: Triple Negative Breast Cancer
NCTID: NCT02718417
Title: Avelumab in Previously Untreated Patients With Epithelial Ovarian Cancer (JAVELIN OVARIAN 100) Study Summary: This is a Phase 3, open-label, international, multi-center, efficacy, and safety study of avelumab in combination with and/or following platinum-based chemotherapy. Eligible patients must have previously untreated, histologically confirmed Stage III-IV epithelial ovarian (EOC), fallopian tube cancer (FTC), or primary peritoneal cancer (PPC) and be candidates for platinum-based chemotherapy. The primary purpose of the study is to demonstrate if avelumab given as single agent in the maintenance setting following frontline chemotherapy or in combination with carboplatin/paclitaxel is superior to platinum-based chemotherapy alone followed by observation in this population of newly diagnosed ovarian cancer patients. Sponsor: Pfizer Intervention: carboplatin Start Date: 2016-05-19 Last Updated: 2020-07-14 Number of Patients: 998 Recruitment Status: TERMINATED Condition: Ovarian Cancer
NCTID: NCT02239120
Title: Dabigatran Etexilate for Secondary Stroke Prevention in Patients With Embolic Stroke of Undetermined Source (RE-SPECT ESUS) Study Summary: This trial will enroll approximately 6,000 patients with recent embolic stroke of unknown source (ESUS). Patients will be randomized to dabigatran or acetylsalicyclic acid (ASA) (1:1 ratio) and have visits every three months. The study doctor may prescribe blinded concomitant ASA for pts with coronary artery disease but this is not mandatory. All Adverse Events (AEs), Serious Adverse Events (SAEs), outcome events will be recorded. The trial will conclude when the required number of stroke events are positively adjudicated which is estimated to take 3 years (including 2.5 years of enrollment). Sponsor: Boehringer Ingelheim Intervention: optional ASA as comedication Start Date: 2014-11-27 Last Updated: 2019-09-06 Number of Patients: 5390 Recruitment Status: COMPLETED Condition: Stroke
NCTID: NCT04624204
Title: Placebo-controlled, Study of Concurrent Chemoradiation Therapy With Pembrolizumab Followed by Pembrolizumab and Olaparib in Newly Diagnosed Treatment-Naïve Limited-Stage Small Cell Lung Cancer (LS-SCLC) (MK 7339-013/KEYLYNK-013) Study Summary: The purpose of this study is to compare overall survival (OS) and 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). Hypothesis (H1): Concurrent chemoradiation therapy with pembrolizumab followed by pembrolizumab plus olaparib is superior to concurrent chemoradiation therapy alone with respect to PFS per RECIST 1.1 by BICR. Hypothesis (H2): Concurrent chemoradiation therapy with pembrolizumab followed by pembrolizumab is superior to concurrent chemoradiation therapy alone with respect to PFS per RECIST 1.1 by BICR. Hypothesis (H3): Concurrent chemoradiation therapy with pembrolizumab followed by pembrolizumab plus olaparib is superior to concurrent chemoradiation therapy alone with respect to OS. Hypothesis (H4): Concurrent chemoradiation therapy with pembrolizumab followed by pembrolizumab is superior to concurrent chemoradiation therapy alone with respect to OS. Sponsor: Merck Sharp & Dohme LLC Intervention: Pembrolizumab 200 mg Start Date: 2020-12-08 Last Updated: 2023-11-18 Number of Patients: 672 Recruitment Status: RECRUITING Condition: Small Cell Lung Cancer
NCTID: NCT00003991
Title: Interleukin-2 Plus Histamine Dihydrochloride in Treating Patients With Acute Myeloid Leukemia Study Summary: RATIONALE: Interleukin-2 may stimulate a person's white blood cells to kill acute myeloid leukemia cells. Histamine dihydrochloride may prolong remission and reduce the risk of relapse in patients with acute myeloid leukemia in remission. PURPOSE: Randomized phase III trial to determine the effectiveness of interleukin-2 plus histamine dihydrochloride in treating patients who have acute myeloid leukemia that is in remission following previous therapy. Sponsor: Maxim Pharmaceuticals Intervention: aldesleukin Start Date: 1998-07 Last Updated: 2013-11-06 Number of Patients: 360 Recruitment Status: COMPLETED Condition: Leukemia
NCTID: NCT04322539
Title: A Study of Efficacy and Safety of Fruquintinib (HMPL-013) in Participants With Metastatic Colorectal Cancer Study Summary: This is a global, randomized, double-blind, placebo-controlled, multicenter phase 3 clinical trial to compare the efficacy and safety of fruquintinib plus best supportive care (BSC) versus placebo plus BSC in participants with refractory metastatic colorectal cancer (mCRC). 691 participants were randomized to one of the following treatment arms in a 2:1 ratio, fruquintinib plus BSC or placebo plus BSC. Sponsor: Hutchison Medipharma Limited Intervention: Fruquintinib Start Date: 2020-08-12 Last Updated: 2023-09-14 Number of Patients: 691 Recruitment Status: ACTIVE_NOT_RECRUITING Condition: Metastatic Colorectal Cancer
NCTID: NCT05073315
Title: A Comparative Study Between ABP 501 and Humira® in Participants With Moderate to Severe Plaque Psoriasis Study Summary: Study to evaluate pharmacokinetics, efficacy, safety and immunogenicity of multiple switches between Humira® and ABP 501 (new high concentration formulation) compared with continued use of Humira® in participants with moderate to severe plaque psoriasis. This multi-center study is composed of two periods: A lead-in period of treatment with Humira® followed by a randomized two parallel arm period. Sponsor: Amgen Intervention: Adalimumab Start Date: 2021-10-04 Last Updated: 2023-01-05 Number of Patients: 425 Recruitment Status: COMPLETED Condition: Plaque Psoriasis
NCTID: NCT00057616
Title: Study to Compare the Efficacy and Safety of CC-5013 vs. Placebo in Subjects With Metastatic Malignant Melanoma. Study Summary: Subjects are randomized to one of two treatment arms. All subjects are screened for eligibility within 28 days prior to randomization. The study consists of a treatment phase and a follow-up phase. Subjects are treated in repeating 4 week cycles. Sponsor: Celgene Intervention: CC-5013 Start Date: 2002-10-01 Last Updated: 2019-11-08 Number of Patients: 274 Recruitment Status: COMPLETED Condition: Melanoma
NCTID: NCT01572038
Title: A Study of Pertuzumab in Combination With Trastuzumab (Herceptin) and a Taxane in First-Line Treatment in Participants With Human Epidermal Growth Factor 2 (HER2)-Positive Advanced Breast Cancer Study Summary: This multicenter, open-label, single-arm, Phase IIIb study will evaluate the safety and tolerability of pertuzumab in combination with trastuzumab (Herceptin) and a taxane (docetaxel, paclitaxel or nab-paclitaxel) in first-line treatment in participants with metastatic or locally recurrent HER2-positive breast cancer. Participants will receive pertuzumab intravenously (IV) and trastuzumab (Herceptin) IV plus a taxane in cycles of 3 weeks each until predefined study end, unacceptable toxicity, withdrawal of consent, disease progression, or death, whichever occurs first. Sponsor: Hoffmann-La Roche Intervention: Docetaxel Start Date: 2012-06-01 Last Updated: 2020-09-25 Number of Patients: 1436 Recruitment Status: COMPLETED Condition: Breast Neoplasms
NCTID: NCT01712789
Title: Evaluation of Safety of Pomalidomide in Combination With Dexamethasone (Low Dose) in Patients With Refractory or Relapsed and Refractory Multiple Myeloma Study Summary: The primary purpose of the study is to evaluate the safety and efficacy and to generate PK and biomarker data for the combination of pomalidomide and low-dose dexamethasone in patients with refractory or relapsed and refractory multiple myeloma. The study consists of a Screening phase within 28 days prior to cycle 1 day 1, a Treatment phase and a Follow-up phase which starts within 28 days of discontinuation from study treatment, every 3 months for up to 5 years. In addition, the collection of steady-state PK data from a large population will enable robust population PK and assess Pomalidomide exposure response analyses. The exploratory objectives of the study are to investigate potential markers predictive of POM response or resistance and pharmacodynamic markers. Sponsor: Celgene Intervention: Pomalidomide Start Date: 2012-11-06 Last Updated: 2022-01-10 Number of Patients: 682 Recruitment Status: COMPLETED Condition: Multiple Myeloma
NCTID: NCT00088530
Title: BBR 2778 for Relapsed, Aggressive Non-Hodgkin's Lymphoma (NHL) Study Summary: BBR 2778 is a novel aza-anthracenedione that has activity in experimental tumors and shows reduced potential for cardiotoxicity in animal models. This cytotoxic agent has structural similarities with mitoxantrone as well as general similarities with anthracyclines (such as the tricyclic central quinoid chromophore). Sponsor: CTI BioPharma Intervention: pixantrone, cyclophosphamide, vincristine, rituximab, prednisone Start Date: 2004-07 Last Updated: 2020-02-05 Number of Patients: 140 Recruitment Status: COMPLETED Condition: Lymphoma, Non-Hodgkin
NCTID: NCT04026230
Title: Impact of Atorvastatin on Prostate Cancer Progression During ADT Study Summary: This randomized double-blind placebo-controlled trial tests whether intervention with atorvastatin delays development of castration resistance compared to placebo during androgen deprivation therapy (ADT) for prostate cancer. Sponsor: Tampere University Hospital Intervention: Atorvastatin 80mg Start Date: 2019-08-15 Last Updated: 2022-10-21 Number of Patients: 400 Recruitment Status: RECRUITING Condition: Metastatic Prostate 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: NCT03782207
Title: A Study Investigating the Outcomes and Safety of Atezolizumab Under Real-World Conditions in Patients Treated in Routine Clinical Practice Study Summary: This is a non-interventional, multi-country, multi-centre, multiple cohort prospective study, with retrospective collection of prior medical/treatment history data from medical records, designed to assess the real-world outcomes and safety of atezolizumab for indications in the existing label in the real world setting of routine clinical practice. Sponsor: Hoffmann-La Roche Intervention: Atezolizumab Start Date: 2019-02-07 Last Updated: 2023-11-03 Number of Patients: 3040 Recruitment Status: ACTIVE_NOT_RECRUITING Condition: Urothelial Carcinoma
NCTID: NCT00950300
Title: A Study to Compare Subcutaneous (SC) Versus Intravenous (IV) Administration of Herceptin (Trastuzumab) in Women With Human Epidermal Growth Factor Receptor (HER) 2-Positive Early Breast Cancer Study Summary: In this open-label multicenter trial, participants with operable or locally advanced breast cancer will be randomized to pre-operative treatment with 8 cycles of chemotherapy (4 cycles of docetaxel followed by 4 cycles of 5-fluorouracil, epirubicin, and cyclophosphamide) concurrent with either SC Herceptin or IV Herceptin. After surgery, participants will receive a further 10 cycles of SC or IV Herceptin as per randomization to complete 1 year of treatment. All cycles will be 21 days in length. After the end of study treatment, participants will be followed for safety and efficacy for up to 5 years or until disease recurrence, whichever is earlier. Sponsor: Hoffmann-La Roche Intervention: 5-Fluorouracil Start Date: 2009-10-16 Last Updated: 2018-01-23 Number of Patients: 596 Recruitment Status: COMPLETED Condition: Breast Cancer
NCTID: NCT05850520
Title: A Study to Learn How Well a Higher Amount of Aflibercept Given as an Injection Into the Eye Works and How Safe it is in People With Reduced Vision Due to Swelling in the Macula, Central Part of the Retina Caused by a Blocked Vein in the Retina (Macula Edema Secondary to Retinal Vein Occlusion) Study Summary: Researchers are looking for a better way to treat people who have macular edema secondary to retinal vein occlusion (RVO). In people with RVO, a blood vessel that carries blood away from the retina (vein) becomes blocked. The retina is the very back part of the eye. The blocked vein causes fluid and blood to leak into the retina and thereby causes a swelling of the macula (the center of the retina responsible for fine vision). This swelling is called macular edema. When a vein in the retina is blocked, the levels of a protein called vascular endothelial growth factor (VEGF) rises. VEGF helps the growth of new blood vessels. This can lead to macular edema and may cause the vision to become blurry. The study treatment intravitreal (IVT) aflibercept is given as an injection into the eye. It works by blocking VEGF and this can help repair vision problems related to RVO. IVT aflibercept is already available and is prescribed by doctors as the standard of care treatment for macula edema secondary to RVO. Standard of care is a treatment that medical experts consider most appropriate for a disease. Standard of care is given every 4 weeks in people with macula edema secondary to RVO. While repeated injections of aflibercept may prevent worsening of vision, it may place a burden on the patient. However, a higher amount (8 mg) compared to the standard of care (2 mg) of IVT aflibercept is being tested in studies. This higher amount could be given less often. The amount of IVT aflibercept given is measured in milligrams, also known as mg. The main purpose of this study is to learn how well a higher amount of the study treatment aflibercept works in people with macular edema secondary to RVO. To answer this, researchers will measure changes in vision called best corrected visual acuity (BCVA) in the study participants between study start and after 36 weeks of treatment. Changes will then be compared between those participants who received the higher amount of IVT aflibercept and those that received standard of care. To learn how safe the study treatment is in the participants, the researchers will count the number of participants from study start and up to 64 weeks later that have: * adverse events * serious adverse events "Adverse events" are any medical problems that the participants have during a study. Doctors keep track of all adverse events that happen in studies, even if they do not think they might be related to the study treatments. An adverse event is considered "serious" when it leads to death, puts the participants' lives at risk, requires hospitalization, causes disability, causes a baby being born with medical problems or is otherwise medically important. Dependent on the treatment group, the participants will either receive the higher amount of aflibercept or standard of care as an intravitreal injection for up to 60 weeks. The study will consist of a test (screening) phase, a treatment phase and an end of study phase. Each participant will be in the study for up to 64 weeks. One visit to the study site is planned during the screening phase, followed by visits approximately every 4 weeks (16 in total) during treatment and one visit at the end of the study. During the study, the study doctors and their team will: * check patients' eye health using various eye examination techniques * measure patients' eye vision (BCVA) * take blood and urine samples * do physical examinations * check vital signs * examine heart health using electrocardiogram (ECG) * do pregnancy tests in women of childbearing age In addition, participants will be asked to fill a questionnaire on vision-related quality of life. Sponsor: Bayer Intervention: Aflibercept, VEGF Trap-Eye(Eylea, BAY86-5321)_higher dose Start Date: 2023-05-15 Last Updated: 2023-10-26 Number of Patients: 822 Recruitment Status: RECRUITING Condition: Macular Edema Secondary to Retinal Vein Occlusion
NCTID: NCT03003520
Title: A Study of Durvalumab in Combination With R-CHOP or Lenalidomide Plus R-CHOP in Previously Untreated High-Risk Diffuse Large B-Cell Lymphoma Study Summary: This Phase 2, two-arm, open-label study is designed to evaluate the safety, clinical activity, and predictive biomarkers of durvalumab in combination with R-CHOP or R2-CHOP, followed by durvalumab consolidation therapy in previously untreated subjects with high-risk diffuse large B-cell lymphoma (DLBCL). Induction treatment with R-CHOP (± lenalidomide) will last for a total of up to 6 to 8 treatment cycles (21 day cycles), and the total time on study treatment, including durvalumab consolidation, will last up to 12 months. On 05-Sep-2017, the US FDA has issued a Partial Clinical Hold on this study resulting in the discontinuation of enrollment into Arm B (Durvalumab + Lenalidomide + R-CHOP). After the US FDA Partial Clinical Hold, new eligible participants have been enrolled in Arm A (Durvalumab + R-CHOP). Sponsor: Celgene Intervention: Durvalumab Start Date: 2017-02-28 Last Updated: 2023-05-22 Number of Patients: 46 Recruitment Status: COMPLETED Condition: Lymphoma, Large B-Cell, Diffuse
NCTID: NCT00342316
Title: Reduced Intensity Conditioning Transplantation Versus Standard of Care in Acute Myeloid Leukemia Study Summary: This study compares overall survival between patients with acute myeloid leukemia, who are in complete remission following initial treatment with chemotherapy and whose remission is maintained either with a transplantation of stem cells obtained from a sibling or unrelated donor or with standard treatment, which is additional chemotherapy. The study hypothesis is that the group transplanted with stem cells from a donor will have a superior survival compared with patients treated with standard of care. Sponsor: Vastra Gotaland Region Intervention: Reduced Intensity Conditioning Stem Cell Transplantation Start Date: 2003-12-18 Last Updated: 2020-01-27 Number of Patients: 340 Recruitment Status: COMPLETED Condition: Acute Myeloid Leukemia
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 \[AJCC\]) 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: 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: 2023-11-18 Number of Patients: 320 Recruitment Status: RECRUITING Condition: Colorectal Cancer
NCTID: NCT02596243
Title: Phase 2 Clinical Trial to Evaluate the Safety and Efficacy of Plasmid DNA Therapeutic Vaccine(GX-188E) Study Summary: The purpose of this study is to access the efficacy and safety of GX-188E according the protocol in patients with Cervical Intraepithelial Neoplasia 2, 2/3 or 3 (CIN3) Sponsor: Genexine, Inc. Intervention: GX-188E Start Date: 2015-08 Last Updated: 2017-07-12 Number of Patients: 134 Recruitment Status: UNKNOWN Condition: Cervical Intraepithelial Neoplasia
NCTID: NCT04770896
Title: A Study of Atezolizumab With Lenvatinib or Sorafenib Versus Lenvatinib or Sorafenib Alone in Hepatocellular Carcinoma Previously Treated With Atezolizumab and Bevacizumab Study Summary: This is a Phase III, open-label, multicenter, randomized, two-arm study designed to evaluate the efficacy and safety of atezolizumab plus either lenvatinib or sorafenib versus lenvatinib or sorafenib alone in participants with locally advanced or metastatic Hepatocellular Carcinoma (HCC) who have progressed on prior systemic treatment with atezolizumab plus bevacizumab combination. Sponsor: Hoffmann-La Roche Intervention: Atezolizumab Start Date: 2021-04-26 Last Updated: 2023-11-13 Number of Patients: 554 Recruitment Status: RECRUITING Condition: Unresectable Hepatocellular Carcinoma
NCTID: NCT02106546
Title: Study Comparing Veliparib Plus Carboplatin and Paclitaxel Versus Placebo Plus Carboplatin and Paclitaxel in Previously Untreated Advanced or Metastatic Squamous Non-Small Cell Lung Cancer Study Summary: The purpose of this study is to evaluate the safety and efficacy of the addition of veliparib plus carboplatin and paclitaxel versus the addition of placebo plus carboplatin and paclitaxel in adults with advanced or metastatic squamous non-small cell lung cancer (NSCLC). Sponsor: AbbVie Intervention: Carboplatin Start Date: 2014-04-10 Last Updated: 2020-11-17 Number of Patients: 970 Recruitment Status: COMPLETED Condition: Squamous Non-Small Cell Lung Cancer
NCTID: NCT00400478
Title: A Multicentre, Randomized Phase III Study of Rituximab as Maintenance Treatment Versus Observation in Patients With Aggressive B-cell Lymphoma: NHL-13 Study Summary: This is a randomized, open label, phase III study to evaluate the ability of rituximab maintenance therapy to prolong event-free survival in aggressive NHL. Patients will be screened after successful standard induction therapy (CR or Cru following standard R-CHOP-like therapy with 8 infusions of rituximab plus CHOP-like chemotherapy (4-8 cycles). Patients will be followed until an event occurs as defined in the protocol. To evaluate the clinical efficacy of rituximab maintenance therapy as compared to observation in patients with aggressive B-cell Non-Hodgkins lymphoma or follicular lymphoma grade 3b who have achieved a complete remission after appropriate first-line therapy, measured by event-free survival (EFS), 440 patients with DLCBL or follicular NHL grade 3 (220 per arm) will be recruited. Sponsor: Arbeitsgemeinschaft medikamentoese Tumortherapie Intervention: Rituximab Start Date: 2006-01 Last Updated: 2016-05-26 Number of Patients: 683 Recruitment Status: COMPLETED Condition: Diffuse Large B-Cell Lymphoma (DLBCL)
NCTID: NCT04688931
Title: A Phase 3 Study of UGN-102 for Low Grade Intermediate Risk Non-Muscle Invasive Bladder Cancer Study Summary: This is a global, randomized, controlled, open-label Phase 3 study designed to assess the long-term efficacy and safety of UGN-102 (mitomycin) for intravesical solution with or without (±) transurethral resection of bladder tumors (TURBT) versus TURBT alone for the treatment of patients with low grade intermediate risk non-muscle invasive bladder cancer (LG IR NMIBC). Sponsor: UroGen Pharma Ltd. Intervention: UGN-102 Start Date: 2021-02-19 Last Updated: 2023-08-03 Number of Patients: 282 Recruitment Status: TERMINATED Condition: Bladder Cancer
NCTID: NCT00664170
Title: A Bioequivalence Study of Docetaxel for Injectable Emulsion (ANX-514) in Patients With Advanced Cancer Study Summary: The purpose of this study is to compare an injectable emulsion form of docetaxel to Taxotere in patients with advanced cancer. Sponsor: Mast Therapeutics, Inc. Intervention: ANX-514 Start Date: 2008-04 Last Updated: 2009-05-28 Number of Patients: 39 Recruitment Status: COMPLETED Condition: Advanced Cancer
NCTID: NCT03185013
Title: REVEAL 1 (Evaluation of VGX-3100 and Electroporation for the Treatment of Cervical HSIL) Study Summary: HPV-301 is a prospective, randomized, double-blind, placebo controlled Phase 3 study to determine the efficacy, safety, and tolerability of VGX-3100 administered by intramuscular (IM) injection followed by electroporation (EP) delivered with CELLECTRA™ 5PSP in adult women with histologically confirmed cervical high grade squamous intraepithelial lesion (HSIL) (cervical intraepithelial neoplasia grade 2 \[CIN2\] or grade 3 \[CIN3\]) associated with human papillomavirus (HPV) 16 and/or HPV-18. Sponsor: Inovio Pharmaceuticals Intervention: VGX-3100 Start Date: 2017-06-28 Last Updated: 2023-07-27 Number of Patients: 201 Recruitment Status: COMPLETED Condition: Cervical Dysplasia
NCTID: NCT04307576
Title: A Treatment Study Protocol for Participants 0-45 Years With Acute Lymphoblastic Leukaemia Study Summary: ALLTogether collects the experience of previously successful treatment of infants, children and young adults, with ALL from a number of well-renowned study groups into a new master protocol, which is both a comprehensive system for stratification and treatment of ALL in this age-group as well as the basis for several randomised and interventional trials included in the study-design. Sponsor: Mats Heyman Intervention: Omitted Doxorubicin Start Date: 2020-07-13 Last Updated: 2023-11-21 Number of Patients: 6430 Recruitment Status: RECRUITING Condition: Leukemia, Acute Lymphoblastic
NCTID: NCT04380636
Title: Study of Pembrolizumab With Concurrent Chemoradiation Therapy Followed by Pembrolizumab With or Without Olaparib in Stage III Non-Small Cell Lung Cancer (NSCLC) (MK-7339-012/KEYLYNK-012) Study Summary: The purpose of this study is to assess the efficacy and safety of pembrolizumab in combination with concurrent chemoradiation therapy followed by either pembrolizumab with olaparib placebo (Arm 1) or with olaparib (Arm 2) compared to concurrent chemoradiation therapy followed by durvalumab (Arm 3) in participants with unresectable, locally advanced NSCLC. Arms 1 and 2 will be studied in a double-blind design and Arm 3 will be open-label. The primary hypotheses are: 1. Pembrolizumab with concurrent chemoradiation therapy followed by pembrolizumab with olaparib is superior to concurrent chemoradiation therapy followed by durvalumab with respect to progression-free survival (PFS) and overall survival (OS) 2. Pembrolizumab with concurrent chemoradiation therapy followed by pembrolizumab is superior to concurrent chemoradiation therapy followed by durvalumab with respect to PFS and OS Sponsor: Merck Sharp & Dohme LLC Intervention: Pembrolizumab Start Date: 2020-07-06 Last Updated: 2023-11-07 Number of Patients: 870 Recruitment Status: RECRUITING Condition: Lung Neoplasms
NCTID: NCT03989258
Title: Personalised Risk-based Breast Cancer Prevention and Screening Study Summary: This is a cohort study, applied research and T3 translational genomics to estimate the impact of genetic risk for breast cancer detection in the screening program. The study group base consists of 28 389 female participants, currently in the age-group 22-79, in the Biobank of Estonian Genome Centre. The study is aimed to demonstrate the usability of personalised approach for adjusting and stratifying screening recommendations, based on predicted genetic risk estimates for breast cancer in the situation, where the genome data could be available from all women who have given informed consent for that. The project includes both the detection of moderate and high hereditary breast cancer risk carriers as well as high risk polygenic risk-score (consisting several single nucleotide polymorphisms) carriers among healthy individuals for application of personalised prevention and screening strategies. Sponsor: Tartu University Hospital Intervention: Mammography outside official screening Start Date: 2018-10-01 Last Updated: 2019-06-20 Number of Patients: 28389 Recruitment Status: UNKNOWN Condition: Breast Cancer
NCTID: NCT05677958
Title: Protein Intake in Patients With Colorectal or Lung Cancer When Receiving a Nutritional Supplement Study Summary: The PROTEOS study is an randomized controlled, open label, parallel-group, multi-centre and multicounty interventional study to assess the acceptance and implementation of Compact Protein, a low volume, energy dense and high protein oral nutritional support in clinical practice according to the ESPEN guidelines in colorectal and lung cancer patients undergoing chemo(radio)- or immunotherapy treatment. Sponsor: Nutricia Research Intervention: 125 mL Fortimel/Nutridrink Compact Protein Start Date: 2019-01-17 Last Updated: 2023-01-10 Number of Patients: 126 Recruitment Status: COMPLETED Condition: Colorectal Cancer
NCTID: NCT03721978
Title: REVEAL 2 Trial (Evaluation of VGX-3100 and Electroporation for the Treatment of Cervical HSIL) Study Summary: HPV-303 is a prospective, randomized, double-blind, placebo-controlled phase 3 study of VGX-3100 delivered intramuscularly (IM) followed by electroporation (EP) delivered with CELLECTRA™ 5PSP in adult women with histologically confirmed high-grade squamous intraepithelial lesions (HSIL) (cervical intraepithelial neoplasia grade 2 \[CIN2\] or grade 3 \[CIN3\]) of the cervix, associated with HPV-16 and/or HPV-18. Sponsor: Inovio Pharmaceuticals Intervention: VGX-3100 Start Date: 2019-04-09 Last Updated: 2022-10-17 Number of Patients: 203 Recruitment Status: COMPLETED Condition: Cervical Dysplasia
NCTID: NCT03829332
Title: Efficacy and Safety Study of Pembrolizumab (MK-3475) With or Without Lenvatinib (MK-7902/E7080) in Adults With Programmed Cell Death-Ligand 1 (PD-L1)-Positive Treatment-naïve Nonsmall Cell Lung Cancer (NSCLC) (MK-7902-007/E7080-G000-314/LEAP-007) Study Summary: The purpose of this study is to assess the safety and efficacy of pembrolizumab (MK-3475) combined with lenvatinib (MK-7902/E7080) compared to pembrolizumab alone (with placebo for lenvatinib) in treatment-naïve adults with no prior systemic therapy for their metastatic non-small cell lung cancer (NSCLC) whose tumors have a programmed cell death-ligand 1 (PD-L1) Tumor Proportion Score (TPS) greater than or equal to 1%. The primary study hypotheses are that: 1) the combination of pembrolizumab and lenvatinib is superior to pembrolizumab alone as assessed by Progression-free Survival (PFS) per Response Evaluation Criteria in Solid Tumors version 1.1 (RECIST 1.1); and 2) the combination of pembrolizumab and lenvatinib is superior to pembrolizumab alone as assessed by Overall Survival (OS). Sponsor: Merck Sharp & Dohme LLC Intervention: Pembrolizumab Start Date: 2019-03-13 Last Updated: 2022-10-28 Number of Patients: 623 Recruitment Status: ACTIVE_NOT_RECRUITING Condition: Non-small Cell Lung Cancer
NCTID: NCT01840332
Title: Method of Endogenous TSH Stimulation in the Follow-up of Differentiated Thyroid Cancer Study Summary: The treatment of differentiated thyroid cancer (DCT) includes surgery followed by radioiodine treatment. In the follow-up of patients it is necessary to induce TSH elevation to test for cancer recurrence. One of the options is to stop L-thyroxin replacement for several weeks. Current pilot study aims to induce the necessary TSH elevation by decreasing the L-thyroxin dose. The main hypothesis is that necessary TSH stimulation will be achieved during 4-6 weeks in majority of patients. Sponsor: University of Tartu Intervention: L-thyroxin Start Date: 2013-04 Last Updated: 2014-03-14 Number of Patients: 20 Recruitment Status: COMPLETED Condition: Thyroid Cancer
NCTID: NCT03911128
Title: A Treatment Protocol for Participants 0-45 Years With Acute Lymphoblastic Leukaemia Study Summary: The pilot study collects the experience of previously successful treatment of infants, children and young adults, with ALL from a number of well-renowned study groups into a new platform protocol, which is both a comprehensive system for stratification and treatment of ALL in this age-group as well as the basis for several randomised trials included in the study-design. The pilot study is implemented as a master protocol without study specific interventions, thus as an observational study. The pilot study is for countries/study-groups who intend to join ALLTogether1 (including experimental interventions). For these countries the pilot study is crucial to optimise diagnostics, registration systems, collaborations with vendors, logistics and data-checks before starting the main study. The study only includes "standard of care" treatment included in the master protocol. Sponsor: Mats Heyman Intervention: Observational Start Date: 2019-08-29 Last Updated: 2023-08-30 Number of Patients: 500 Recruitment Status: RECRUITING Condition: Leukemia, Acute Lymphoblastic
NCTID: NCT02825628
Title: Study of ODX (Osteodex) in Metastatic Castration Resistant Prostate Cancer (CRPC) Study Summary: This is a phase II randomised, double-blind, dose finding, repeat dose Phase II multicentre study of ODX for the treatment of patients with castration resistant prostate cancer (CRPC) and skeletal metastases. The primary objective is to evaluate the relative change from baseline in response markers related to bone metabolism (alkaline phosphatase (B-ALP) and S P1NP) at 12 weeks of three different doses of ODX (3.0, 6.0 and 9.0 mg/kg ODX). Sponsor: DexTech Medical AB Intervention: Osteodex Start Date: 2016-05 Last Updated: 2019-02-15 Number of Patients: 55 Recruitment Status: UNKNOWN Condition: Prostate Cancer Metastatic
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: 2023-11-18 Number of Patients: 2300 Recruitment Status: RECRUITING Condition: Solid Tumors
NCTID: NCT00625898
Title: BETH Study: Treatment of HER2 Positive Breast Cancer With Chemotherapy Plus Trastuzumab vs Chemotherapy Plus Trastuzumab Plus Bevacizumab Study Summary: The trial will determine the value of adding bevacizumab to chemotherapy plus trastuzumab in patients with resected node-positive or high risk node-negative, HER2-positive breast cancer. Sponsor: NSABP Foundation Inc Intervention: Docetaxel Start Date: 2008-04 Last Updated: 2020-09-10 Number of Patients: 3509 Recruitment Status: TERMINATED Condition: Breast Cancer
NCTID: NCT00636740
Title: Multi-Center Phase II Study to Compare MER-101 20mg Tablets to Intravenous Zometa 4mg in Male Bisphosphonate-Naive, Hormone Refractory Prostate Cancer Patients Study Summary: The objective of MER-101-03 is to examine the effects of two different dosing regimens of MER-101 20mg tablets versus Zometa 4mg IV infusion once-monthly therapy. The effects will be monitored on a weekly basis by measuring various markers of bone metabolism. Patients to be enrolled will be those who have not received any previous bisphosphonate therapy. The study will be carried out on prostate cancer patients who are no longer on hormone therapy. Treatment in the study will be for a 2-month period. Sponsor: Merrion Pharmaceuticals, LLC Intervention: Zoledronic Acid 20mg Tablets Start Date: 2008-02 Last Updated: 2009-02-20 Number of Patients: 30 Recruitment Status: COMPLETED Condition: Hormone-Refractory Prostate Cancer
NCTID: NCT03322540
Title: Pembrolizumab Plus Epacadostat vs Pembrolizumab Plus Placebo in Metastatic Non-Small Cell Lung Cancer (KEYNOTE-654-05/ECHO-305-05) Study Summary: The purpose of this study is to evaluate the efficacy and safety of pembrolizumab plus epacadostat compared to pembrolizumab plus placebo as first-line treatment in participants with metastatic non-small cell lung cancer (NSCLC) expressing high levels of programmed cell death ligand 1 (PD-L1). Sponsor: Incyte Corporation Intervention: Pembrolizumab Start Date: 2017-12-15 Last Updated: 2022-01-24 Number of Patients: 154 Recruitment Status: COMPLETED Condition: Lung Cancer
NCTID: NCT00003013
Title: Chemotherapy Plus Surgery in Treating Women With Breast Cancer Study Summary: RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die. Combining surgery with chemotherapy may kill more tumor cells. It is not yet known which treatment regimen is more effective for breast cancer. PURPOSE: Randomized phase III trial to study the effectiveness of chemotherapy plus surgery in treating women who have breast cancer. Sponsor: Fondazione IRCCS Istituto Nazionale dei Tumori, Milano Intervention: CMF regimen Start Date: 1996-10 Last Updated: 2013-09-17 Number of Patients: 450 Recruitment Status: COMPLETED Condition: Breast Cancer
