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NCTID: NCT02951767
Title: A Study of Atezolizumab in Participants With Locally Advanced or Metastatic Urothelial Bladder Cancer (Cohort 1) Study Summary: This Phase II, single-arm study is designed to evaluate the effect of atezolizumab treatment in participants with locally advanced or metastatic urothelial bladder cancer. Participants will be enrolled into 1 of 2 cohorts. Cohort 1 (reported here) will consist of participants who are treatment-naïve and ineligible for cisplatin-containing chemotherapy. Cohort 2 will contain participants who have progressed during or following a prior platinum-based chemotherapy regimen. The results of the second cohort are reported separately (NCT02108652). Participants in both cohorts will be given a 1200 milligrams (mg) intravenous (IV) dose of atezolizumab on Day 1 of 21-day cycles. Treatment of participants in Cohort 1 will continue until disease progression per Response Evaluation Criteria in Solid Tumors Version 1.1 (RECIST v1.1) or unmanageable toxicity. Treatment of participants in Cohort 2 will continue until loss of clinical benefit or unmanageable toxicity. Sponsor: Hoffmann-La Roche Intervention: Atezolizumab Start Date: 2014-05-31 Last Updated: 2023-03-08 Number of Patients: 119 Recruitment Status: COMPLETED Condition: Bladder Cancer
NCTID: NCT02302807
Title: A Study of Atezolizumab Compared With Chemotherapy in Participants With Locally Advanced or Metastatic Urothelial Bladder Cancer [IMvigor211] Study Summary: This is a Phase III, global, multicenter, open-label, two-arm, randomized, controlled study designed to evaluate the efficacy and safety of atezolizumab compared with chemotherapy in participants with locally advanced or metastatic urothelial bladder cancer (UBC) who have progressed during or following a platinum-containing regimen. The anticipated time on study treatment is based on continued clinical benefit, i.e., until disease progression or unacceptable toxicity. The target sample size is 931 participants. Sponsor: Hoffmann-La Roche Intervention: Atezolizumab (MPDL3280A) [TECENTRIQ], an engineered anti-PDL1 antibody Start Date: 2015-01-13 Last Updated: 2019-08-01 Number of Patients: 931 Recruitment Status: COMPLETED Condition: Bladder Cancer
NCTID: NCT04678583
Title: Anatomical Resection of Liver MetAstases iN patIents With RAS-mutated Colorectal Cancer Study Summary: the ARMANI trial will test the hypothesis, if an anatomic resection (AR) improves long-term outcome vs. a non-anatomical resection (NAR) in patients undergoing surgery for RAS-mutated colorectal liver metastasis (CRLM). Sponsor: Technische Universität Dresden Intervention: Resection of colorectal liver metastases Start Date: 2021-01-01 Last Updated: 2023-10-18 Number of Patients: 240 Recruitment Status: RECRUITING Condition: Colorectal Liver Metastasis
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: NCT01774786
Title: A Study of Pertuzumab in Combination With Trastuzumab and Chemotherapy in Participants With Human Epidermal Growth Factor Receptor 2 (HER2)-Positive Metastatic Gastroesophageal Junction or Gastric Cancer Study Summary: This double-blind, placebo-controlled, randomized, multicenter, international, parallel arm study will evaluate the efficacy and safety of pertuzumab in combination with trastuzumab, fluoropyrimidine and cisplatin as first-line treatment in participants with HER2-positive metastatic gastroesophageal junction (GEJ) or gastric cancer (GC). Participants will be randomized to receive pertuzumab 840 milligrams (mg) or placebo intravenously every 3 weeks (q3w) in combination with trastuzumab (initial dose of 8 milligrams per kilogram <math display="block">mg/kg</math> intravenously <math display="block">IV</math> followed by 6 mg/kg IV q3w) and cisplatin and fluoropyrimidine (capecitabine or 5-fluorouracil) for the first 6 treatment cycles. Participants will continue to receive pertuzumab or placebo and trastuzumab until disease progression occurrence of unacceptable toxicity or withdrawal from the study for another reason. Sponsor: Hoffmann-La Roche Intervention: 5-Fluorouracil Start Date: 2013-06-10 Last Updated: 2020-12-30 Number of Patients: 780 Recruitment Status: COMPLETED Condition: Gastric Cancer
NCTID: NCT02637687
Title: A Study to Test the Safety and Efficacy of the Drug Larotrectinib for the Treatment of Tumors With NTRK-fusion in Children Study Summary: The study is being done to test the safety of a cancer drug called larotrectinib in children. The cancer must have a change in a particular gene (NTRK1, NTRK2 or NTRK3). Larotrectinib blocks the actions of these NTRK genes in cancer cells and can therefore be used to treat cancer. The first study part (Phase 1) is done to determine what dose level of larotrectinib is safe for children, how the drug is absorbed and changed by their bodies and how well the cancer responds to the drug. The main purpose of the second study part (Phase 2) is to investigate how well and how long different cancer types respond to the treatment with larotrectininb. Sponsor: Bayer Intervention: Larotrectinib (Vitrakvi, BAY2757556) Start Date: 2015-12-16 Last Updated: 2023-10-31 Number of Patients: 155 Recruitment Status: ACTIVE_NOT_RECRUITING Condition: Solid Tumors Harboring NTRK Fusion
NCTID: NCT03038100
Title: A Study of Atezolizumab Versus Placebo in Combination With Paclitaxel, Carboplatin, and Bevacizumab in Participants With Newly-Diagnosed Stage III or Stage IV Ovarian, Fallopian Tube, or Primary Peritoneal Cancer Study Summary: This is a Phase III, global, double-blind, 2-arm randomized study designed to compare the efficacy and safety of atezolizumab + paclitaxel + carboplatin + bevacizumab versus placebo + paclitaxel + carboplatin + bevacizumab. Study participants will have Stage 3 or 4 ovarian cancer (OC), fallopian tube cancer (FTC), or primary peritoneal cancer (PPC) with macroscopic residual disease postoperatively (i.e., after primary tumor reductive surgery) or who will undergo neoadjuvant therapy followed by interval surgery. Sponsor: Hoffmann-La Roche Intervention: Paclitaxel Start Date: 2017-03-08 Last Updated: 2023-02-17 Number of Patients: 1301 Recruitment Status: COMPLETED Condition: Ovarian Cancer
NCTID: NCT04924075
Title: Belzutifan/MK-6482 for the Treatment of Advanced Pheochromocytoma/Paraganglioma (PPGL), Pancreatic Neuroendocrine Tumor (pNET), Von Hippel-Lindau (VHL) Disease-Associated Tumors, Advanced Gastrointestinal Stromal Tumor (wt GIST), or Solid Tumors With HIF-2α Related Genetic Alterations (MK-6482-015) Study Summary: This is a study to evaluate the efficacy and safety of belzutifan monotherapy in participants with advanced pheochromocytoma/paraganglioma (PPGL), pancreatic neuroendocrine tumor (pNET), von Hippel-Lindau (VHL) Disease-Associated Tumors, Advanced Gastrointestinal Stromal Tumor (wt GIST), or Advanced Solid Tumors With hypoxia inducible factor-2 alpha (HIF-2α) related genetic alterations. The primary objective of the study is to evaluate the objective response rate (ORR) of belzutifan per Response Evaluation Criteria in Solid Tumors Version 1.1 (RECIST 1.1) by blinded independent central review (BICR). Sponsor: Merck Sharp & Dohme LLC Intervention: Belzutifan Start Date: 2021-08-12 Last Updated: 2023-11-27 Number of Patients: 322 Recruitment Status: RECRUITING Condition: Pheochromocytoma/Paraganglioma
NCTID: NCT02831959
Title: Pivotal, Open-label, Randomized Study of Radiosurgery With or Without Tumor Treating Fields (TTFields) for 1-10 Brain Metastases From Non-small Cell Lung Cancer (NSCLC). Study Summary: The study is a prospective, randomized controlled phase III trial, to test the efficacy, safety and neurocognitive outcomes of advanced NSCLC patients, following stereotactic radiosurgery (SRS) for 1 inoperable brain metastasis or 2-10 brain metastases, treated with NovoTTF-200M and supportive treatment compared to supportive treatment alone. The device is an experimental, portable, battery operated device for chronic administration of alternating electric fields (termed TTFields or TTF) to the region of the malignant tumor, by means of surface, insulated electrode arrays. Sponsor: NovoCure GmbH Intervention: NovoTTF-200M device Start Date: 2016-07 Last Updated: 2023-03-10 Number of Patients: 270 Recruitment Status: ACTIVE_NOT_RECRUITING Condition: Brain Metastases From Non-small Cell Lung Cancer (NSCLC)
NCTID: NCT00419250
Title: A Dose Escalation Study of Lenalidomide in Relapsed or Refractory B-cell Chronic Lymphocytic Leukemia Study Summary: The purpose of this study is to evaluate the safety of lenalidomide and to define the maximum tolerated escalation dose level (MTEDL) when administered by a stepwise dose-escalation schedule in subjects with relapsed or refractory B-cell CLL. Sponsor: Celgene Intervention: lenalidomide Start Date: 2006-12-01 Last Updated: 2019-11-08 Number of Patients: 52 Recruitment Status: COMPLETED Condition: Chronic Lymphocytic Leukemia
NCTID: NCT04459715
Title: A Study of Xevinapant (Debio 1143) in Combination With Platinum-Based Chemotherapy and Standard Fractionation Intensity-Modulated Radiotherapy in Participants With Locally Advanced Squamous Cell Carcinoma of the Head and Neck, Suitable for Definitive Chemoradiotherapy (TrilynX) Study Summary: The primary objective of the study is to demonstrate superior efficacy of Xevinapant (Debio 1143) vs placebo when added to chemoradiotherapy (CRT) in locally advanced squamous cell carcinoma of the head and neck (LA-SCCHN). Sponsor: EMD Serono Research & Development Institute, Inc. Intervention: Xevinapant (Debio 1143) Start Date: 2020-08-07 Last Updated: 2023-10-24 Number of Patients: 730 Recruitment Status: ACTIVE_NOT_RECRUITING Condition: Squamous Cell Carcinoma of the Head and Neck
NCTID: NCT03719690
Title: Safety and Efficacy of Tipifarnib in Head and Neck Cancer With HRAS Mutations and Impact of HRAS on Response to Therapy Study Summary: An international, multicenter, open-label, 2 cohort, non-comparative, pivotal study evaluating the efficacy of tipifarnib in HRAS mutant HNSCC (AIM-HN). The first cohort will assess the objective response rate (ORR) of tipifarnib in subjects with HNSCC with HRAS mutations. The second study cohort, SEQ-HN, is an observational sub-study including HNSCC patients in whom HRAS mutations were not identified (wild type HRAS HNSCC) and who consent to provide first line outcome data and additional follow up. Sponsor: Kura Oncology, Inc. Intervention: Tipifarnib Start Date: 2018-11-05 Last Updated: 2022-11-09 Number of Patients: 284 Recruitment Status: ACTIVE_NOT_RECRUITING Condition: HRAS Gene Mutation
NCTID: NCT03834519
Title: Study of Pembrolizumab (MK-3475) Plus Olaparib Versus Abiraterone Acetate or Enzalutamide in Metastatic Castration-resistant Prostate Cancer (mCRPC) (MK-7339-010/KEYLYNK-010) Study Summary: The purpose of this study is to assess the efficacy and safety of the combination of the polyadenosine 5’-diphosphoribose poly (ADP-ribose) polymerase (PARP) inhibitor olaparib and pembrolizumab in the treatment of participants with mCRPC who have failed to respond to either abiraterone acetate or enzalutamide (but not both) and to chemotherapy. The primary study hypotheses are that the combination of pembrolizumab plus olaparib is superior to abiraterone acetate or enzalutamide with respect to: # Overall Survival (OS) and # Radiographic progression-free survival (rPFS) per Prostate Cancer Working Group (PCWG)-modified Response Evaluation Criteria in Solid Tumors Version 1.1 as assessed by blinded independent central review (BICR) As of Amendment 06, the Data Monitoring Committee (DMC) is no longer applicable. Participants still on treatment may have the option to continue receiving study intervention or SOC if they are deriving clinical benefit, until criteria for discontinuation are met. Participants who are still on study treatment and deriving clinical benefit will no longer have tumor response assessments by BICR. However, local tumor imaging assessments should continue per SOC schedule. In addition, ePRO assessments will no longer be performed and biomarker samples will no longer be collected. Sponsor: Merck Sharp & Dohme LLC Intervention: Pembrolizumab Start Date: 2019-05-02 Last Updated: 2023-11-07 Number of Patients: 793 Recruitment Status: ACTIVE_NOT_RECRUITING Condition: Prostatic Neoplasms
NCTID: NCT04197986
Title: Study of Oral Infigratinib for the Adjuvant Treatment of Subjects With Invasive Urothelial Carcinoma With Susceptible FGFR3 Genetic Alterations Study Summary: This is a Phase 3 multicenter, double-blind, randomized, placebo-controlled study to evaluate the efficacy of infigratinib (an oral targeted FGFR1-3 inhibitor) versus placebo, as adjuvant treatment following surgery in adult subjects with invasive urothelial carcinoma and susceptible FGFR3 genetic alterations (mutations, and gene fusions or rearrangements) who have disease that is considered at high risk for recurrence with surgery alone. The study enrolls subjects with either bladder cancer post radical cystectomy or upper tract urothelial cancer post distal ureterectomy and/or nephrectomy. Study treatment is randomized 1:1 between infigratinib or placebo with treatment up to 1 year or until invasive local, distal, or metastatic disease recurrence confirmed by independent imaging reviewer. Sponsor: QED Therapeutics, Inc. Intervention: Infigratinib Start Date: 2020-03-11 Last Updated: 2023-02-02 Number of Patients: 39 Recruitment Status: TERMINATED Condition: Upper Tract Urothelial Carcinomas
NCTID: NCT00547651
Title: AMR PH GL 2007 CL001 Phase 3 Trial in Patients With Small Cell Lung Cancer After Failure of First-Line Chemotherapy Study Summary: This study drug (Amrubicin) is believed to work by stopping the tumor cells in your body from growing. The purpose of this study is to evaluate the effect of amrubicin compared to topotecan in the treatment of small cell lung cancer. Sponsor: Celgene Intervention: Amrubicin Start Date: 2007-09-01 Last Updated: 2019-11-06 Number of Patients: 637 Recruitment Status: COMPLETED Condition: Small Cell Lung Cancer
NCTID: NCT02108652
Title: A Study of Atezolizumab in Participants With Locally Advanced or Metastatic Urothelial Bladder Cancer (Cohort 2) Study Summary: This Phase II, single-arm study is designed to evaluate the effect of atezolizumab treatment in participants with locally advanced or metastatic urothelial bladder cancer. Participants will be enrolled into 1 of 2 cohorts. Cohort 1 will consist of participants who are treatment-naïve and ineligible for cisplatin-containing chemotherapy. The results of Cohort 1 are reported separately (NCT02951767). Cohort 2 (reported here) will contain participants who have progressed during or following a prior platinum-based chemotherapy regimen. Participants in both cohorts will be given a 1200 milligrams (mg) intravenous (IV) dose of atezolizumab on Day 1 of 21-day cycles. Treatment of participants in Cohort 1 will continue until disease progression per Response Evaluation Criteria in Solid Tumors Version 1.1 (RECIST v1.1) or unmanageable toxicity. Treatment of participants in Cohort 2 will continue until loss of clinical benefit or unmanageable toxicity. Sponsor: Hoffmann-La Roche Intervention: Atezolizumab Start Date: 2014-05-31 Last Updated: 2023-03-08 Number of Patients: 310 Recruitment Status: COMPLETED Condition: Bladder Cancer
NCTID: NCT03662126
Title: KRT-232 Versus Best Available Therapy for the Treatment of Subjects With Myelofibrosis Who Are Relapsed or Refractory to JAK Inhibitor Treatment Study Summary: This study evaluates KRT-232, a novel oral small molecule inhibitor of MDM2, for the treatment of patients with myelofibrosis (MF) who no longer benefit from treatment with a JAK inhibitor. Inhibition of MDM2 is a novel mechanism of action in MF. This study will be conducted in 2 phases. Phase 2 will determine the KRT-232 recommended dose and dosing schedule; Phase 3 will test KRT-232 vs Best Available Therapy (BAT). Patients in the Phase 3 part of the study will be randomized 2:1 to receive either KRT-232 (Arm 1) or BAT (Arm 2). The BAT administered will be determined by the treating physician, with the option to “cross-over” to KRT-232 treatment after 6 months of BAT or if the disease worsens at any time. Sponsor: Kartos Therapeutics, Inc. Intervention: KRT-232 Start Date: 2019-01-15 Last Updated: 2023-04-28 Number of Patients: 385 Recruitment Status: RECRUITING Condition: Primary Myelofibrosis (PMF)
NCTID: NCT05359445
Title: IMA401 TCER® in Recurrent and/or Refractory Solid Tumors Study Summary: Primary objective: * To determine the maximum tolerated dose and/or recommended dose for extension for IMA401 Secondary objectives: * To characterize the safety and tolerability of IMA401 * To evaluate initial anti-tumor activity of IMA401 * To describe the pharmacokinetics of IMA401 Sponsor: Immatics Biotechnologies GmbH Intervention: IMA401 (Phase Ia) Start Date: 2022-05-19 Last Updated: 2023-11-07 Number of Patients: 50 Recruitment Status: RECRUITING Condition: Refractory Cancer
NCTID: NCT05794906
Title: A Study to Compare Darolutamide Given With Androgen Deprivation Therapy (ADT) With ADT in Men With Hormone Sensitive Prostate Cancer and Raise of Prostate Specific Antigen (PSA) Levels After Local Therapies Study Summary: Researchers are looking for a better way to treat men at high-risk of biochemical recurrence (BCR) of prostate cancer. BCR means that in men who had prostate cancer and were treated by either surgery and/ or radiation therapy, the blood level of a specific protein called PSA rises. PSA is a marker of prostate cancer cells activity. The PSA increase means that the cancer has come back even though conventional imaging such as computed tomography (CT) scans, magnetic resonance imaging (MRI) and bone scans does not show any lesion of prostate cancer. Recently a more sensitive imaging method called prostate-specific membrane antigen <math display="block">PSMA</math> positron emission tomography <math display="block">PET</math>) /computed tomography <math display="block">CT</math>) scan may identify prostate cancer lesions not detectable by conventional imaging. Men with BCR have a higher risk of their cancer spreading to other parts of the body, particularly when PSA levels raised to a certain limit within a short period of time after local therapies. Once the cancer spreads to other parts of the body, it can become even harder to treat. In men with prostate cancer, male sex hormones (also called androgens) like testosterone can help the cancer grow and spread. To reduce androgens levels in these patients, there are treatments that block androgens production in the body called androgen deprivation therapy (ADT). ADT is often used to stop prostate cancer. Another way to stop prostate cancer growth and spread is to block the action of androgen receptors on prostate cancer cells called androgen receptor inhibitors (ARIs). The new generation ARIs including darolutamide can block the action of androgens receptors and are available for the treatment of prostate cancer in addition to ADT. It is already known that men with prostate cancer benefit from these treatments. The main objective of this study is to learn if the combination of darolutamide and ADT prolongs the time that the participants live without their cancer getting worse, or to death due to any cause, compared to placebo (which is a treatment that looks like a medicine but does not have any medicine in it) and ADT given for a pre-specified duration of 24 months. To do this, the study team will measure the time from the date of treatment allocation to the finding of new cancer spread in the participants by using PSMA PET/CT, or death due to any cause. The PSMA PET/CT scans is performed using a radioactive substance called a “tracer” that specifically binds to the prostate-specific membrane antigen (PSMA) which is a protein often found in large amounts on prostate cancer cells. To avoid bias in treatment, the study participants will be randomly (by chance) allocated to one of two treatment groups. Based on the allocated treatment group, the participants will either take darolutamide plus ADT or placebo plus ADT twice daily as tablets by mouth. The study will consist of a test (screening) phase, a treatment phase and a follow-up phase. The treatment duration is pre-specified to be 24 months unless the cancer gets worse, the participants have medical problems, or they leave the study for any reason. In addition, image guided radiotherapy (IGRT) or surgery is allowed and your doctor will explain the benefits and risks of this type of therapy. During the study, the study team will: * take blood and urine samples. * measure PSA and testosterone levels in the blood samples * do physical examinations * check the participants’ overall health * examine heart health using electrocardiogram (ECG) * check vital signs * check cancer status using PSMA PET/CT scans, CT, MRI and bone scans * take tumor samples (if required) * ask the participants if they have medical problems About 30 days after the participants have taken their last treatment, the study doctors and their team will check the participants’ health and if their cancer worsened. The study team will continue to check this and regularly ask the participants questions about medical problems and subsequent therapies until they leave the study for any reason or until they leave the study for any reason or until the end of the study, whatever comes first. Sponsor: Bayer Intervention: Darolutamide (BAY1841788, Nubeqa) Start Date: 2023-04-03 Last Updated: 2023-11-28 Number of Patients: 750 Recruitment Status: RECRUITING Condition: Biochemically Recurrent Prostate Cancer
NCTID: NCT02715804
Title: A Study of PEGylated Recombinant Human Hyaluronidase in Combination With Nab-Paclitaxel Plus Gemcitabine Compared With Placebo Plus Nab-Paclitaxel and Gemcitabine in Participants With Hyaluronan-High Stage IV Previously Untreated Pancreatic Ductal Adenocarcinoma Study Summary: The purpose of this study is to compare the efficacy and safety of PEGylated Recombinant Human Hyaluronidase (PEGPH20) combined with nab-paclitaxel plus gemcitabine (PAG treatment), compared with placebo combined with nab-paclitaxel plus gemcitabine (AG treatment), in participants with hyaluronan (HA)-high Stage IV previously untreated pancreatic ductal adenocarcinoma (PDA). Sponsor: Halozyme Therapeutics Intervention: Biological: PEGylated Recombinant Human Hyaluronidase (PEGPH20) Start Date: 2016-03-14 Last Updated: 2020-07-14 Number of Patients: 492 Recruitment Status: TERMINATED Condition: Pancreatic Ductal Carcinoma
NCTID: NCT02519582
Title: Drug Trial to Investigate the Safety and Efficacy of Niclosamide Tablets in Patients With Metastases of a Colorectal Cancer Progressing After Therapy Study Summary: Phase II trial evaluating the safety and efficacy of oral appliqued niclosamide in patients who are progressive with metachronous or synchronous metastases of colorectal cancer among the previous therapy (Nikolo). Monocentric open-label clinical trial of phase II. All patients received 2 g p.o. niclosamide daily until progression (according to RECIST) or unacceptable toxicity or discontinuation of study for other reasons. Sponsor: Charite University, Berlin, Germany Intervention: Niclosamide Start Date: 2015-08 Last Updated: 2018-09-12 Number of Patients: 37 Recruitment Status: UNKNOWN Condition: Colorectal Cancer
NCTID: NCT04835805
Title: A Study to Evaluate the Safety and Activity of Belvarafenib as a Single Agent and in Combination With Either Cobimetinib or Cobimetinib Plus Nivolumab in Patients With NRAS-mutant Advanced Melanoma. Study Summary: This study will evaluate the safety, pharmacokinetics, and activity of belvarafenib as a single agent and in combination with either cobimetinib or cobimetinib plus nivolumab in patients with NRAS-mutant advanced melanoma who have received anti-PD-1/PD-L1 therapy. Sponsor: Genentech, Inc. Intervention: Belvarafenib Start Date: 2021-05-13 Last Updated: 2023-11-03 Number of Patients: 128 Recruitment Status: RECRUITING Condition: Melanoma
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: NCT03428217
Title: CANTATA: CB-839 With Cabozantinib vs. Cabozantinib With Placebo in Patients With Metastatic Renal Cell Carcinoma Study Summary: Tthe primary objective of this study is to compare blinded Independent Radiology Committee (IRC)-adjudicated progression free survival (PFS) of patients treated with CB-839 + cabozantinib (CB-Cabo) versus placebo + cabozantinib (Pbo-Cabo) for advanced or metastatic clear-cell RCC (ccRCC). Sponsor: Calithera Biosciences, Inc Intervention: CB-839 Start Date: 2018-04-24 Last Updated: 2023-03-20 Number of Patients: 444 Recruitment Status: COMPLETED Condition: Advanced Renal Cell Carcinoma
NCTID: NCT02039726
Title: (QuANTUM-R): An Open-label Study of Quizartinib Monotherapy vs. Salvage Chemotherapy in Acute Myeloid Leukemia (AML) Subjects Who Are FLT3-ITD Positive Study Summary: The primary objective of the study is to determine whether quizartinib monotherapy prolongs overall survival (OS) compared to salvage chemotherapy in subjects with FMS-like tyrosine kinase 3 - Internal Tandem Duplication (FLT3-ITD) positive AML who are refractory to or have relapsed within 6 months, after first-line AML therapy. Sponsor: Daiichi Sankyo, Inc. Intervention: Quizartinib Start Date: 2014-05 Last Updated: 2021-02-24 Number of Patients: 367 Recruitment Status: COMPLETED Condition: AML
NCTID: NCT00428220
Title: A Continuation Study Using Sunitinib Malate For Patients Leaving Treatment On A Previous Sunitinib Study. Study Summary: This is a study using sunitinib for patients ending treatment on a previous sunitinib malate protocol to continue to receive sunitinib. The patient must have been enrolled in one of the following studies: A6181030, A6181064, A6181078, A6181087, A6181094, A6181107, A6181108, A6181110, A6181111, A6181112, A6181113, A6181120, A6181126 and A6181170. Other Pfizer sponsored sunitinib studies may be included in the future. Sponsor: Pfizer Intervention: sunitinib Start Date: 2007-07 Last Updated: 2019-06-27 Number of Patients: 223 Recruitment Status: COMPLETED Condition: Metastatic Breast Cancer
NCTID: NCT04527991
Title: Study of Sacituzumab Govitecan-hziy (IMMU-132) Versus Treatment of Physician’s Choice in Participants With Metastatic or Locally Advanced Unresectable Urothelial Cancer Study Summary: The primary objective of this study is to assess overall survival (OS) with sacituzumab govitecan-hziy in comparison with treatment of physician’s choice (TPC) in participants with metastatic or locally advanced unresectable urothelial cancer (UC). Sponsor: Gilead Sciences Intervention: Sacituzumab Govitecan-hziy Start Date: 2021-01-13 Last Updated: 2023-06-22 Number of Patients: 696 Recruitment Status: ACTIVE_NOT_RECRUITING Condition: Locally Advanced or Metastatic Unresectable Urothelial Cancer
NCTID: NCT04657991
Title: A Clinical Trial of Three Study Medicines (Encorafenib, Binimetinib, and Pembrolizumab) in Patients With Advanced or Metastatic Melanoma Study Summary: The purpose of this study is to learn about the effects of three study medicines (encorafenib, binimetinib, and pembrolizumab) given together for the treatment of melanoma that: * is advanced or metastatic (spread to other parts of the body); * 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 once every 3 weeks as an intravenous (IV) infusion (given directly into a vein). In addition, half of the participants will take encorafenib and binimetinib orally (by mouth) at home every day. Participants may receive pembrolizumab for up to two years. Those participants taking encorafenib and binimetinib can continue until their melanoma is no longer responding. 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: 2021-01-15 Last Updated: 2023-11-07 Number of Patients: 624 Recruitment Status: RECRUITING Condition: Melanoma
NCTID: NCT01147939
Title: Study of Elacytarabine Versus Investigator’s Choice in Patients With Late Stage Acute Myeloid Leukaemia (AML) Study Summary: The purpose of the study is to assess the efficacy and safety of elacytarabine versus investigator’s choice treatment in patients with relapsed or refractory acute myeloid leukemia (AML). Sponsor: Clavis Pharma Intervention: Elacytarabine Start Date: 2010-06 Last Updated: 2013-09-27 Number of Patients: 381 Recruitment Status: COMPLETED Condition: Acute Myeloid Leukemia (AML)
NCTID: NCT03434379
Title: A Study of Atezolizumab in Combination With Bevacizumab Compared With Sorafenib in Patients With Untreated Locally Advanced or Metastatic Hepatocellular Carcinoma Study Summary: This study will evaluate the efficacy and safety of atezolizumab in combination with bevacizumab compared with sorafenib in participants with locally advanced or metastatic Hepatocellular Carcinoma (HCC) who have received no prior systemic treatment. Sponsor: Hoffmann-La Roche Intervention: Atezolizumab Start Date: 2018-03-15 Last Updated: 2023-10-23 Number of Patients: 558 Recruitment Status: COMPLETED Condition: Carcinoma, Hepatocellular
NCTID: NCT01641939
Title: A Study of Trastuzumab Emtansine Versus Taxane in Participants With Human Epidermal Growth Factor Receptor 2 (HER2)-Positive Advanced Gastric Cancer Study Summary: This multicenter, randomized, adaptive Phase II/III study will evaluate the efficacy and safety of trastuzumab emtansine (T-DM1) compared to standard taxane (docetaxel or paclitaxel) treatment in participants with human epidermal growth factor receptor 2 (HER2)-positive advanced gastric cancer. At the start of the trial (stage 1), participants will be randomized with a ratio 2:2:1 to one of three treatment arms: Arm A: trastuzumab emtansine 3.6 milligram per kilogram (mg/kg) per intravenous injection (IV) every 3 weeks; Arm B: trastuzumab emtansine 2.4 mg/kg IV every week; Arm C: standard taxane therapy (docetaxel 75 milligram per meter square <math display="block">mg/m\^2</math> IV every 3 weeks or paclitaxel 80 mg/m^2 kg IV every week per investigator choice). At the end of the first stage of the study, the dose and schedule of trastuzumab emtansine that will be used in the second stage of the study will be selected by an Independent Data Monitoring Committee (IDMC). The regimen selection analysis will be made after approximately 100 participants across all three study arms have been treated for at least 12 weeks. Once a trastuzumab emtansine regimen has been selected, Stage I participants who were assigned to the treatment arm which was selected for Stage II of the study and participants who were in the standard taxane group will continue to receive their assigned treatment regimen. Stage I participants who were assigned to the regimen that was not selected for further evaluation will continue to receive their assigned regimen and will continue to be followed for efficacy and safety. In Stage II of the study, additional participants will be recruited and randomized with a ratio 2:1 to either the selected regimen of trastuzumab emtansine or to the standard taxane therapy. Participants will receive study treatment until disease progression, unacceptable toxicity, initiation of another cancer therapy or withdrawal. Sponsor: Hoffmann-La Roche Intervention: Taxane Start Date: 2012-09-03 Last Updated: 2017-05-12 Number of Patients: 415 Recruitment Status: TERMINATED Condition: Gastric Cancer
NCTID: NCT05665595
Title: A Study of Adjuvant Pembrolizumab/Vibostolimab (MK-7684A) Versus Pembrolizumab for Resected High-Risk Melanoma in Participants With High-Risk Stage II-IV Melanoma (MK-7684A-010/KEYVIBE-010) Study Summary: The primary purpose of this study is to compare pembrolizumab/vibostolimab to pembrolizumab with respect to recurrence-free survival (RFS). The primary hypothesis is that pembrolizumab/vibostolimab is superior to pembrolizumab with respect to RFS as assessed by the investigator in participants with high-risk resected Stage IIB, IIC, III and IV melanoma. Sponsor: Merck Sharp & Dohme LLC Intervention: Pembrolizumab/Vibostolimab Start Date: 2023-01-19 Last Updated: 2023-11-24 Number of Patients: 1560 Recruitment Status: RECRUITING Condition: Melanoma
NCTID: NCT05470595
Title: A Single-arm Trial of Atezolizumab/Platinum/Etoposide for the Treatment of Advanced Large-cell Neuroendocrine Cancer of the Lung Study Summary: This phase II clinical trial evaluates the efficacy, safety and tolerability of Atezolizumab in addition to standard of care chemotherapy (Platinum/Etoposide) in LCNEC. Sponsor: Technische Universität Dresden Intervention: Atezolizumab Start Date: 2022-01-18 Last Updated: 2023-11-02 Number of Patients: 67 Recruitment Status: RECRUITING Condition: Large Cell Neuroendocrine Carcinoma of the Lung
NCTID: NCT05075122
Title: Tolerability and Efficacy of UV1 Vaccine in Patients With Recurrent or Metastatic Head and Neck Squamous Cell Carcinoma Planned for First-line Treatment With Pembrolizumab Study Summary: The primary objective of this study is to determine the clinical performance of UV1 vaccination as add on to standard pembrolizumab treatment in patients with recurrent or metastatic PD-L1 positive (CPS >=1) head and neck squamous cell carcinoma. Secondary objectives are to determine the efficacy in terms of overall survival ,objective response rate and duration of response. Moreover, this study will explore patient subgroups most likely deriving benefit from a targeted immunotherapy approach combining a checkpoint inhibitor with a cancer vaccine and help to establish liquid biopsy tumor monitoring in HNSCC. Sponsor: Martin-Luther-Universität Halle-Wittenberg Intervention: UV1 Start Date: 2021-08-02 Last Updated: 2022-03-09 Number of Patients: 75 Recruitment Status: RECRUITING Condition: Head and Neck Squamous Cell Carcinoma
NCTID: NCT03731260
Title: (PIONEER) Study to Evaluate Efficacy and Safety of Avapritinib (BLU-285), A Selective KIT Mutation-targeted Tyrosine Kinase Inhibitor, Versus Placebo in Patients With Indolent Systemic Mastocytosis Study Summary: This is a Phase 2, randomized, double-blind, placebo-controlled study comparing the efficacy and safety of avapritinib + best supportive care (BSC) with placebo + BSC in patients with indolent systemic mastocytosis (ISM) whose symptoms are not adequately controlled by BSC. The study will be conducted in 3 parts. All patients will receive treatment with avapritinib during Part 3 including those rolling over from the placebo group. Sponsor: Blueprint Medicines Corporation Intervention: Avapritinib Start Date: 2019-04-16 Last Updated: 2023-06-15 Number of Patients: 251 Recruitment Status: ACTIVE_NOT_RECRUITING Condition: Indolent Systemic Mastocytosis
NCTID: NCT02923921
Title: Study of Pegilodecakin (LY3500518) With FOLFOX Compared to FOLFOX Alone Second-line Tx in Participants With Metastatic Pancreatic Cancer Study Summary: To compare the efficacy of pegilodecakin in combination with FOLFOX versus FOLFOX alone in participants with metastatic pancreatic cancer as measured by overall survival. Sponsor: Eli Lilly and Company Intervention: Pegilodecakin Start Date: 2017-03-01 Last Updated: 2020-10-19 Number of Patients: 567 Recruitment Status: COMPLETED Condition: Pancreatic Cancer
NCTID: NCT03624231
Title: Feasibility & Efficacy of Durvalumab+Tremelimumab+RT and Durvalumab+RT in Non-resect. Locally Advanced HPVnegativ HNSCC Study Summary: Phase II trial evaluating to assess the feasibility and efficacy as first-line therapy for patients with non-resectable locally advanced HPV negative HNSCC of Durvalumab a PDL1-Inhibitor plus Tremelimumab a CTLA-4- Inhibitor in combination with radiotherapy and Durvalumab in combination with radiotherapy as first-line therapy. 2-arm, randomized, multicenter, phase II. Step 1 is Registration. All patients need to sign the informed consent form for registration. Tumor tissue then be send to the central lab for defining the HPV status. If the patient is HPV negative the site will be notified if they can further proceed to patient randomization. Step 2 is Randomization of all eligible patients with a centrally diagnosed, HPV negative tumor in one of the two arms (Durvalumab plus Tremelimumab + radiotherapy; Durvalumab + radiotherapy) after signing the informed consent form for step 2. Sponsor: Ulrich Keilholz Intervention: Durvalumab Start Date: 2018-08-15 Last Updated: 2023-08-31 Number of Patients: 18 Recruitment Status: COMPLETED Condition: Squamous Cell Carcinoma of the Head and Neck
NCTID: NCT02454972
Title: Clinical Trial of Lurbinectedin (PM01183) in Selected Advanced Solid Tumors Study Summary: Multicenter, open-label, exploratory, phase II clinical trial to evaluate the efficacy and safety of PM01183 in previously treated patients with advanced solid tumors Sponsor: PharmaMar Intervention: lurbinectedin (PM01183) Start Date: 2015-08-25 Last Updated: 2023-03-02 Number of Patients: 345 Recruitment Status: COMPLETED Condition: Advanced Solid Tumors
NCTID: NCT04666038
Title: Study of LOXO-305 Versus Investigator’s Choice (IdelaR or BR) in Patients With Previously Treated Chronic Lymphocytic Leukemia (CLL)/Small Lymphocytic Lymphoma (SLL) Study Summary: This is a study for patients with chronic lymphocytic leukemia (CLL) or small lymphocytic leukemia (SLL) who have previously received treatment with at least a BTK inhibitor. The main purpose is to compare LOXO-305 to idelalisib plus rituximab or bendamustine plus rituximab. Participation could last up to four years, and possibly longer, if the disease does not progress. Sponsor: Loxo Oncology, Inc. Intervention: LOXO-305 Start Date: 2021-03-09 Last Updated: 2023-11-01 Number of Patients: 250 Recruitment Status: RECRUITING Condition: Chronic Lymphocytic Leukemia
NCTID: NCT03049189
Title: Efficacy and Safety of 177Lu-edotreotide PRRT in GEP-NET Patients Study Summary: The purpose of the study is to evaluate efficacy and safety of Peptide Receptor Radionuclide Therapy (PRRT) with 177Lu-Edotreotide compared to targeted molecular therapy with Everolimus in patients with inoperable, progressive, somatostatin receptor-positive (SSTR+), neuroendocrine tumours of gastroenteric or pancreatic origin (GEP-NET). Sponsor: ITM Solucin GmbH Intervention: 177Lu-edotreotide PRRT Start Date: 2017-02-02 Last Updated: 2023-08-22 Number of Patients: 309 Recruitment Status: ACTIVE_NOT_RECRUITING Condition: Neuroendocrine Tumors
NCTID: NCT00273338
Title: DN-101 in Combination With Docetaxel in Androgen-Independent Prostate Cancer (AIPC) (AIPC Study of Calcitriol Enhancing Taxotere [ASCENT-2]) Study Summary: The primary objective of this study is: * To evaluate the effect of DN-101 in combination with docetaxel (ASCENT regimen) on survival in metastatic androgen-independent prostate cancer The secondary objectives of this study are: * To determine the effect of the ASCENT regimen on the rate of thromboembolic events (blood clots) * To determine the effect of the ASCENT regimen on prevention of skeletal-related events (fractures) * A Separate sub-study will be conducted at selected study sites in North America to determine the population PK of DN-101. Sponsor: Novacea Intervention: calcitriol Start Date: 2006-01 Last Updated: 2007-11-06 Number of Patients: 1200 Recruitment Status: TERMINATED Condition: Prostate Cancer
NCTID: NCT00719212
Title: Study of AMG 479 as Second Line Therapy in Patients With Recurrent Platinum-sensitive Ovarian Cancer Study Summary: The purpose of this study is to obtain an estimate of the objective response rate (ORR) of AMG 479 in patients with recurrent platinum-sensitive ovarian epithelial (including fallopian tube and primary peritoneal) carcinoma failing frontline chemotherapy. Sponsor: Translational Research in Oncology Intervention: AMG 479 Start Date: 2009-01 Last Updated: 2016-01-11 Number of Patients: 61 Recruitment Status: COMPLETED Condition: Ovarian Neoplasms
NCTID: NCT03767348
Title: Study of RP1 Monotherapy and RP1 in Combination With Nivolumab Study Summary: RPL-001-16 is a Phase 1/2, open label, dose escalation and expansion clinical study of RP1 alone and in combination with nivolumab in adult subjects with advanced and/or refractory solid tumors, to determine the maximum tolerated dose (MTD) and recommended Phase 2 dose (RP2D), as well as to evaluate preliminary efficacy. Sponsor: Replimune Inc. Intervention: RP1 Start Date: 2017-09-20 Last Updated: 2023-08-02 Number of Patients: 340 Recruitment Status: RECRUITING Condition: Cancer
NCTID: NCT02450331
Title: A Study of Atezolizumab Versus Observation as Adjuvant Therapy in Participants With High-Risk Muscle-Invasive Urothelial Carcinoma (UC) After Surgical Resection Study Summary: This Phase III, open-label, randomized, multicenter study is to evaluate the efficacy and safety of adjuvant treatment with atezolizumab compared with observation in participants with muscle-invasive UC who are at high risk for recurrence following resection. Eligible participants were randomized by a 1:1 ratio into atezolizumab group or control group. Sponsor: Hoffmann-La Roche Intervention: Atezolizumab Start Date: 2015-10-05 Last Updated: 2023-06-18 Number of Patients: 809 Recruitment Status: TERMINATED Condition: Carcinoma, Transitional Cell
NCTID: NCT03498521
Title: A Phase II Randomized Study Comparing the Efficacy and Safety of Targeted Therapy or Cancer Immunotherapy Versus Platinum-Based Chemotherapy in Patients With Cancer of Unknown Primary Site Study Summary: This study will compare the efficacy and safety of molecularly-guided therapy versus standard platinum-containing chemotherapy in participants with poor-prognosis cancer of unknown primary site (CUP; non-specific subset) who have achieved disease control after 3 cycles of first-line platinum based induction chemotherapy. Sponsor: Hoffmann-La Roche Intervention: Alectinib Start Date: 2018-07-10 Last Updated: 2023-11-18 Number of Patients: 790 Recruitment Status: ACTIVE_NOT_RECRUITING Condition: Cancer of Unknown Primary Site
NCTID: NCT00828919
Title: Continuing Access to Axitinib (A406- AG- 013736 ) For Patients Previously Receiving AG 013736 In Clinical Trials Study Summary: To allow continuation of axitinib (AG 013736) treatment to patients experiencing clinical benefit in a closing axitinib trial Sponsor: Pfizer Intervention: axitinib Start Date: 2003-03-07 Last Updated: 2023-10-16 Number of Patients: 52 Recruitment Status: COMPLETED Condition: Solid Tumors
NCTID: NCT01606566
Title: A Study to Evaluate the Safety and Efficacy of Amphinex Induced PCI of Bleomycin for Recurrent Head and Neck Cancer. Study Summary: The purpose of this study is to evaluate the efficacy and safety of Amphinex induced PCI of bleomycin (‘PC-A11’) with superficial and/or interstitial laser light application in patients with recurrent SCCHN. Sponsor: PCI Biotech AS Intervention: Amphinex induced PCI of bleomycin Start Date: 2012-04 Last Updated: 2022-02-18 Number of Patients: 26 Recruitment Status: TERMINATED Condition: Recurrent Head and Neck 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: NCT02678572
Title: Percutaneous Hepatic Perfusion in Patients With Hepatic-dominant Ocular Melanoma Study Summary: This study will evaluate patients who have melanoma that has spread from the eye to the liver: Patients in the study will be treated with Melphalan/HDS up to 6 total treatment, and will be followed until death. This study will evaluate the safety and effects of the treatment on how long patients live and how long it takes for the cancer to advance or respond to the treatment. Sponsor: Delcath Systems Inc. Intervention: Melphalan/HDS Start Date: 2016-02-01 Last Updated: 2023-04-03 Number of Patients: 102 Recruitment Status: ACTIVE_NOT_RECRUITING Condition: Melanoma, Ocular
NCTID: NCT05987332
Title: IDE196 (Darovasertib) in Combination With Crizotinib as First-line Therapy in Metastatic Uveal Melanoma Study Summary: This is a Phase 2/3, multi-arm, multi-stage, open-label study of human leukocyte antigen (HLA)-A*02:01 negative participants with metastatic uveal melanoma (MUM) who will be randomized to receive either IDE196 + crizotinib or investigator’s choice of treatment (pembrolizumab, ipilimumab + nivolumab, or dacarbazine). Sponsor: IDEAYA Biosciences Intervention: IDE196 Start Date: 2023-10-31 Last Updated: 2023-11-27 Number of Patients: 380 Recruitment Status: RECRUITING Condition: Metastatic Uveal Melanoma
NCTID: NCT04503278
Title: A Trial to Evaluate the Safety and Efficacy of CLDN6 CAR-T +/- CLDN6 RNA-LPX Study Summary: This is a Phase I/IIa, FIH, open-label, multicenter, dose escalation trial with expansion cohorts to evaluate safety and preliminary efficacy of CLDN6 CAR-T/CLDN6 CAR-T(A) with or without CLDN6 RNA-LPX in patients with CLDN6-positive relapsed or refractory advanced solid tumors. The trial started with CLDN6 RNA-LPX, a liposomal formulation comprising an unmodified RNA. In order to optimize CAR-T cell persistence in patients, an alternative RNA-LPX, CLDN6 modRNA-LPX, will be tested once the RP2D dose for CLDN6 CAR-T(A) ± CLDN6 RNA-LPX is identified. Sponsor: BioNTech Cell & Gene Therapies GmbH Intervention: CLDN6 CAR-T/CLDN6 CAR-T(A) Start Date: 2020-09-16 Last Updated: 2023-11-27 Number of Patients: 114 Recruitment Status: RECRUITING Condition: Solid Tumor
NCTID: NCT05020236
Title: MagnetisMM-5: Study of Elranatamab (PF-06863135) Monotherapy and Elranatamab + Daratumumab Versus Daratumumab + Pomalidomide + Dexamethasone in Participants With Relapsed/Refractory Multiple Myeloma Study Summary: The purpose of this study is to evaluate whether the BCMA-CD3 bispecific antibody elranatamab, alone and/or in combination with the anti-CD38 monoclonal antibody, daratumumab, can provide more benefit to people with multiple myeloma compared to a combination therapy including daratumumab, pomalidomide, and dexamethasone. People with multiple myeloma who have received previous treatment including lenalidomide and a proteasome inhibitor will be enrolled in the study. Part 1 of the study will assess the safety and activity of different doses of elranatamab in combination with daratumumab. People participating in Part 2 of the study will be randomly assigned to receive either elranatamab alone, elranatamab plus daratumumab, or daratumumab, pomalidomide, and dexamethasone. Part 2 will compare the safety and activity of (1) elranatamab alone compared to daratumumab, pomalidomide, and dexamethasone, and (2) elranatamab plus daratumumab compared to daratumumab, pomalidomide, and dexamethasone. Part 3 of the study will evaluate an alternative dosing schedule of elranatamab in combination with daratumumab. Participants in all parts of the study will receive study treatment until their disease progresses, they experience unacceptable side effects, or they choose to no longer participate in the study. Sponsor: Pfizer Intervention: Elranatamab Start Date: 2021-10-04 Last Updated: 2023-08-24 Number of Patients: 854 Recruitment Status: RECRUITING Condition: Multiple Myeloma
NCTID: NCT00501735
Title: Forodesine in the Treatment of Cutaneous T-Cell Lymphoma Study Summary: This is a Phase II, non-randomized, open-label, single-arm trial that will be conducted at up to 50 sites in North America, Europe and Australia. This study is designed to assess objective response (OR) <math display="block">complete response (CR) or partial response (PR)</math> in subjects with cutaneous manifestations of CTCL with a requirement for maintenance of such objective response for at least 28 days in subjects with stage IIB, III, and IVA CTCL. Additionally, this study will evaluate the safety and tolerability of CTCL subjects Stages IB, IIA, IIB, III, or IVA treated with oral forodesine. Sponsor: BioCryst Pharmaceuticals Intervention: Forodesine 200 mg Start Date: 2007-07 Last Updated: 2012-01-23 Number of Patients: 144 Recruitment Status: COMPLETED Condition: Cutaneous T-cell Lymphoma (CTCL),
NCTID: NCT04083235
Title: A Study to Assess the Effectiveness and Safety of Irinotecan Liposome Injection, 5-fluorouracil/Leucovorin Plus Oxaliplatin in Patients Not Previously Treated for Metastatic Pancreatic Cancer, Compared to Nab-paclitaxel+Gemcitabine Treatment Study Summary: The purpose of this study is to look at the efficacy and safety of Irinotecan liposome injection in combination with other approved drugs used for cancer therapy, namely 5 fluorouracil/leucovorin (5FU/LV) plus oxaliplatin compared to nab-paclitaxel + gemcitabine treatment in improving the overall survival of patients not previously treated for metastatic pancreatic cancer. Sponsor: Ipsen Intervention: Irinotecan Liposomal Injection Start Date: 2020-02-11 Last Updated: 2023-10-26 Number of Patients: 770 Recruitment Status: ACTIVE_NOT_RECRUITING Condition: Metastatic Adenocarcinoma of the Pancreas
NCTID: NCT04363801
Title: A Study of DKN-01 in Combination With Tislelizumab ± Chemotherapy in Patients With Gastric or Gastroesophageal Cancer Study Summary: A Phase 2, Multicenter, Open-Label Study of DKN-01 in Combination with Tislelizumab ± Chemotherapy as First-Line or Second-Line Therapy in Adult Patients with Inoperable, Locally Advanced or Metastatic Gastric or Gastroesophageal Junction Adenocarcinoma Sponsor: Leap Therapeutics, Inc. Intervention: DKN-01 300mg Start Date: 2020-07-29 Last Updated: 2023-09-29 Number of Patients: 232 Recruitment Status: RECRUITING Condition: Gastric Cancer
NCTID: NCT01265901
Title: IMA901 in Patients Receiving Sunitinib for Advanced/Metastatic Renal Cell Carcinoma Study Summary: The primary objective of the phase III study is to investigate whether IMA901 can prolong overall survival in patients with metastatic and/or locally advanced renal cell carcinoma (RCC) when added to standard first-line therapy with sunitinib. Secondary objectives include a subgroup analysis of overall survival in patients defined by a certain biomarker signature, the investigation of progression-free survival, best tumor response, safety, and immunological parameters. Sponsor: Immatics Biotechnologies GmbH Intervention: Sunitinib Start Date: 2010-12 Last Updated: 2017-10-12 Number of Patients: 339 Recruitment Status: COMPLETED Condition: Metastatic Renal Cell Carcinoma
NCTID: NCT04486378
Title: A Phase II Clinical Trial Comparing the Efficacy of RO7198457 Versus Watchful Waiting in Patients With ctDNA-positive, Resected Stage II (High Risk) and Stage III Colorectal Cancer Study Summary: This is a multi-site, open-label, Phase II, randomized, trial to compare the efficacy of RO7198457 versus watchful waiting in patients with circulating tumor DNA (ctDNA) positive, surgically resected Stage II/III rectal cancer, or Stage II (high risk)/Stage III colon cancer. Sponsor: BioNTech SE Intervention: RO7198457 intravenous (i.v.) Start Date: 2021-03-08 Last Updated: 2023-11-08 Number of Patients: 201 Recruitment Status: RECRUITING Condition: Colorectal Cancer Stage II
NCTID: NCT02088541
Title: Selinexor (KPT-330) in Older Patients With Relapsed AML Study Summary: This is a randomized, multicenter, open-label, phase 2 study of the SINE compound, selinexor given orally versus specified investigator choices (one of three potential salvage therapies). Participants age ≥ 60 years with relapsed or refractory AML of any type except for AML M3, after one prior therapy only, who have never undergone and who are not currently eligible for stem cell transplantation and are currently deemed unfit for intensive chemotherapy. Sponsor: Karyopharm Therapeutics Inc Intervention: Selinexor Start Date: 2014-03 Last Updated: 2023-01-26 Number of Patients: 317 Recruitment Status: COMPLETED Condition: Acute Myeloid Leukemia (AML)
NCTID: NCT00219557
Title: AG-013736 In Combination With Gemcitabine Versus Gemcitabine Alone For Patients With Metastatic Pancreatic Cancer Study Summary: This is a Phase 2 study being conducted at multiple centers in the United States, Europe and Canada. Patients having pancreatic cancer that is locally advanced or that has spread to other parts of the body (i.e., metastatic) are eligible to participate. Patients must have not had any prior systemic treatment for advanced disease. The purpose of the study is to test whether the angiogenesis inhibitor Axitinib <math display="block">AG-013736</math> in combination with gemcitabine is an effective treatment for advanced pancreatic cancer vs. gemcitabine alone by overall survival. Sponsor: Pfizer Intervention: Gemcitabine Start Date: 2005-07-05 Last Updated: 2019-05-14 Number of Patients: 111 Recruitment Status: COMPLETED Condition: Pancreatic Neoplasms
NCTID: NCT04471844
Title: Pivotal, Randomized, Open-label Study of Optune® (Tumor Treating Fields) Concomitant With RT & TMZ for the Treatment of Newly Diagnosed GBM Study Summary: To test the effectiveness and safety of Optune® given concomitantly with radiation therapy (RT) and temozolomide (TMZ) in newly diagnosed GBM patients, compared to radiation therapy and temozolomide alone. In both arms, Optune® and maintenance temozolomide are continued following radiation therapy. Sponsor: NovoCure GmbH Intervention: Optune® Start Date: 2020-12-08 Last Updated: 2023-11-01 Number of Patients: 950 Recruitment Status: RECRUITING Condition: Glioblastoma Multiforme
NCTID: NCT01479244
Title: Efficacy and Safety Study of NeuVax™ (Nelipepimut-S or E75) Vaccine to Prevent Breast Cancer Recurrence Study Summary: Purpose of this trial: # To assess the efficacy and safety of NeuVax™ administered with adjuvant Leukine® (sargramostim, GM-CSF). # To evaluate and compare the disease free survival (DFS) in the vaccinated and control subjects. Sponsor: Galena Biopharma, Inc. Intervention: NeuVax™ vaccine Start Date: 2011-11 Last Updated: 2017-02-27 Number of Patients: 758 Recruitment Status: COMPLETED Condition: Breast Cancer With Low to Intermediate HER2 Expression
NCTID: NCT01849874
Title: A Study of MEK162 vs. Physician’s Choice Chemotherapy in Patients With Low-grade Serous Ovarian, Fallopian Tube or Peritoneal Cancer Study Summary: The MILO Study (MEK Inhibitor in Low-grade Serous Ovarian Cancer) is a Phase 3 study during which patients with recurrent or persistent low-grade serous (LGS) carcinomas of the ovary, fallopian tube or primary peritoneum will receive either investigational study drug MEK162 or a chemotherapy chosen by the physician (liposomal doxorubicin, paclitaxel or topotecan). Patients will be followed to compare the effectiveness of the study drug to that of the selected chemotherapies. Patients may be eligible to crossover from physician’s choice chemotherapy to MEK162 if they meet certain inclusion criteria including centrally confirmed disease progression. Approximately 360 patients from North America, Europe and Australia will be enrolled in this study. Sponsor: Pfizer Intervention: MEK162, MEK inhibitor; oral Start Date: 2013-06-27 Last Updated: 2023-10-30 Number of Patients: 341 Recruitment Status: TERMINATED Condition: Low-grade Serous Ovarian Cancer
NCTID: NCT03326674
Title: Tesetaxel Plus Reduced Dose of Capecitabine vs. Capecitabine in HER2 Negative, HR Positive, LA/MBC Study Summary: CONTESSA is a multinational, multicenter, randomized, Phase 3 study of tesetaxel in patients with HER2 negative, HR positive LA/MBC previously treated with a taxane in the neoadjuvant or adjuvant setting. The primary objective of the study is to compare the efficacy of tesetaxel plus a reduced dose of capecitabine versus the approved dose of capecitabine alone based on progression-free survival (PFS) as assessed by the Independent Radiologic Review Committee (IRC). 685 patients were enrolled. Sponsor: Odonate Therapeutics, Inc. Intervention: Tesetaxel and Capecitabine Start Date: 2017-12-21 Last Updated: 2021-07-30 Number of Patients: 685 Recruitment Status: TERMINATED Condition: Breast Cancer
NCTID: NCT03643276
Title: Treatment Protocol for Children and Adolescents With Acute Lymphoblastic Leukemia - AIEOP-BFM ALL 2017 Study Summary: The understanding of acute lymphoblastic leukemia (ALL) in childhood and adolescence has largely changed due to extensive genetic research in recent years: ALL is now considered to be a very heterogeneous disease group. The leukemia cells present themselves with quite differently activated regulatory mechanisms of the malignant phenotype. The introduction of more accurate methods of assessing therapy response (“minimal residual disease <math display="block">MRD</math> tests”) has provided new insights into very different mechanisms of action, including factors influenced by host factors; this has had practical clinical consequences for the use of more individualized therapy. Multimodal therapies have enabled a cure level of over 80% for ALL in this age group. However, the own and international study data show that the therapy toxicity of the contemporary chemotherapy concepts has become unacceptably high, in particular with respect to those intensified therapies used for the treatment of patients at high risk of ALL relapse. The AIEOP-BFM ALL 2017 study therefore aims for an innovative integrated approach that will not only adapt the risk stratification to new prognostic markers using more comprehensive diagnostics, but above all, qualitatively reorient the therapy. The most important consequence will be that this study is testing immunotherapy with the bispecific antibody blinatumomab as an alternative to particularly intensive and toxic chemotherapy elements in precursor B-cell ALL (pB-ALL) patients with detectable chemotherapy resistance and at high risk of relapse. With the aim to complement the effects of the conventional chemotherapy, Blinatumomab is in addition tested in the large group of pB-ALL patients at intermediate relapse risk with seemingly unremarkable leukemia, but who account for a large proportion of all relapses. Targeted therapy is also used in the form of the proteasome inhibitor bortezomib for patients with pB-ALL and slow response to the drugs of the induction chemotherapy with the aim to overcome intrinsic chemotherapy resistance of the ALL cells. In patients with T-lineage ALL, who have particularly poor chances for cure after relapse, the established consolidation chemotherapy has proved to be particularly effective. This chemotherapy phase is therefore tested in a longer and more intensive form in such T-ALL patients with intermediate or slow early treatment response with the aim to reduce the relapses rate in this subgroup. Sponsor: Martin Schrappe Intervention: Blinatumomab Start Date: 2018-07-15 Last Updated: 2022-11-02 Number of Patients: 5000 Recruitment Status: RECRUITING Condition: Acute Lymphoblastic Leukemia, Pediatric
NCTID: NCT02521870
Title: A Trial of Intratumoral Injections of SD-101 in Combination With Pembrolizumab in Patients With Metastatic Melanoma or Recurrent or Metastatic Head and Neck Squamous Cell Carcinoma Study Summary: This is a phase 1b/2, open-label, multicenter trial designed to evaluate the safety, tolerability, biologic activity, and preliminary efficacy of intratumoral SD-101 injections in combination with intravenous pembrolizumab in patients with metastatic melanoma or recurrent or metastatic head and neck squamous cell carcinoma (HNSCC). This study will be conducted in 2 phases. Phase 1 evaluates SD-101 given in combination with pembrolizumab in melanoma populations (anti-PD-1/L1 naïve and anti-PD-1/L1 experienced with progressive disease) in up to 4 Dose Escalation cohorts to identify a recommended Phase 2 dose (RP2D) to be evaluated in up to 4 Dose Expansion cohorts in Phase 2. Phase 2 also includes up to 4 Dose Expansion cohorts of patients with HNSCC (anti-PD-1/L1 naïve and anti-PD-1/L1 experienced with progressive disease). Sponsor: Dynavax Technologies Corporation Intervention: SD-101(1) Start Date: 2015-09 Last Updated: 2021-08-03 Number of Patients: 241 Recruitment Status: TERMINATED Condition: Metastatic Melanoma
NCTID: NCT04022876
Title: A Study of ALRN-6924 for the Prevention of Chemotherapy-induced Side Effects (Chemoprotection) Study Summary: This is a Phase 1b, multicenter, 2-part study of ALRN-6924 for the prevention of chemotherapy-induced side effects. Part 1 SCLC is an open-label, multicenter study of ALRN-6924 for the prevention of chemotherapy-induced side effects in patients with p53-mutated ED SCLC undergoing 2nd-line treatment with topotecan. (Part 1 has completed enrollment). Part 2 NSCLC is a randomized, double-blind, placebo-controlled, multicenter study of ALRN-6924 for the prevention of chemotherapy-induced side effects in patients with p53-mutated advanced NSCLC of adenocarcinoma histology receiving 1st-line treatment with carboplatin plus pemetrexed with or without immunotherapy. Sponsor: Aileron Therapeutics, Inc. Intervention: ALRN-6924 Start Date: 2019-09-03 Last Updated: 2022-10-10 Number of Patients: 35 Recruitment Status: TERMINATED Condition: Non Small Cell Lung Cancer
NCTID: NCT02576431
Title: A Study to Test the Effect of the Drug Larotrectinib in Adults and Children With NTRK-fusion Positive Solid Tumors Study Summary: This research study is done to test how well different types of cancer respond to the drug called larotrectinib. The cancer must have a change in a particular gene (NTRK1, NTRK2 or NTRK3). Larotrectinib is a drug that blocks the actions of these NTRK genes in cancer cells and can therefore be used to treat cancer. Sponsor: Bayer Intervention: BAY2757556 (Larotrectinib, Vitrakvi) Start Date: 2015-09-30 Last Updated: 2023-11-07 Number of Patients: 204 Recruitment Status: RECRUITING Condition: Solid Tumors Harboring NTRK Fusion
NCTID: NCT03906331
Title: Expanded Access for the Treatment of Cancers With Rearranged During Transfection (RET) Activation Study Summary: Expanded access for participants with cancer with RET activation who are ineligible for an ongoing selpercatinib (also known as LOXO-292) clinical trial or have other considerations that prevent access to selpercatinib through an existing clinical trial. The treating physician/investigator contacts Lilly when, based on their medical opinion, a patient meets the criteria for inclusion in the expanded access program. Sponsor: Loxo Oncology, Inc. Intervention: Selpercatinib Start Date: NA Last Updated: 2023-10-02 Number of Patients: NA Recruitment Status: AVAILABLE Condition: Non Small Cell Lung Cancer
NCTID: NCT01282424
Title: Efficacy and Safety Study of Idelalisib in Participants With Indolent B-Cell Non-Hodgkin Lymphomas Study Summary: The primary objective will be to assess the overall response rate and to evaluate the efficacy and safety of idelalisib (IDELA; GS-1101) in participants with previously treated indolent Non-Hodgkin Lymphoma (iNHL) that is refractory both to rituximab and to alkylating-agent-containing chemotherapy. Eligible participants will initiate oral therapy with idelalisib at a starting dose of 150 mg taken twice per day. Treatment with idelalisib can continue in compliant participants as long as the study is still ongoing and the participants appear to be benefiting from treatment with acceptable safety. Sponsor: Gilead Sciences Intervention: Idelalisib Start Date: 2011-03-18 Last Updated: 2019-07-11 Number of Patients: 125 Recruitment Status: COMPLETED Condition: Follicular 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: NCT01801111
Title: A Study of Alectinib (RO5424802) in Participants With Non-Small Cell Lung Cancer Who Have Anaplastic Lymphoma Kinase (ALK) Mutation and Failed Crizotinib Treatment Study Summary: This open-label, non-randomized, multicenter, Phase 1/2 study will evaluate the safety and efficacy of alectinib in participants with non-small cell lung cancer who have ALK mutation and failed crizotinib treatment. In Part 1, cohorts of participants will receive escalating doses of alectinib orally twice daily. In Part 2, participants will receive the recommended phase 2 dose (RP2D) of alectinib as determined in Part 1. Treatment will continue in Part 1 and Part 2 on the same dose until disease progression. In Part 3, following disease progression, participants without epidermal growth factor receptor (EGFR) mutation will be offered continued treatment with alectinib, participants with EGFR mutations will be offered a combination of alectinib and erlotinib. Sponsor: Hoffmann-La Roche Intervention: Erlotinib Start Date: 2013-06-20 Last Updated: 2018-11-02 Number of Patients: 138 Recruitment Status: COMPLETED Condition: Non-Small-Cell Lung Carcinoma
NCTID: NCT03086369
Title: A Study of Nab-Paclitaxel and Gemcitabine With or Without Olaratumab (LY3012207) in Participants With Metastatic Pancreatic Cancer Study Summary: The purpose of this study is to determine the safety and efficacy of nab-paclitaxel and gemcitabine with or without olaratumab in the treatment of first-line metastatic pancreatic cancer. Sponsor: Eli Lilly and Company Intervention: Olaratumab Start Date: 2017-06-22 Last Updated: 2022-06-28 Number of Patients: 184 Recruitment Status: COMPLETED Condition: Metastatic Pancreatic Cancer
