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NCTID: NCT03430843

Title: A Study of Tislelizumab (BGB-A317) Versus Chemotherapy as Second Line Treatment in Participants With Advanced Esophageal Squamous Cell Carcinoma 
Study Summary: The purpose of this study is to evaluate the efficacy and safety of tislelizumab as second line treatment in participants with advanced unresectable/metastatic ESCC that has progressed during or after first line therapy. 
Sponsor: BeiGene 
Intervention: Tislelizumab 
Start Date: 2018-01-26 
Last Updated: 2023-01-18 
Number of Patients: 513 
Recruitment Status: COMPLETED 
Condition: Esophageal Squamous Cell Carcinoma (ESCC) 

NCTID: NCT04429087

Title: A Study to Test Different Doses of BI 764532 in Patients With Small Cell Lung Cancer and Other Neuroendocrine Tumours That Are Positive for DLL3 
Study Summary: This study is open to adults with small cell lung cancer and other neuroendocrine cancers that are positive for the tumour marker delta-like 3 (DLL3). The study is in people with advanced cancer for whom previous treatment was not successful or no standard treatment exists.  The purpose of this study is to find out the highest dose of BI 764532 and the best treatment schedule that people can tolerate. BI 764532 is an antibody-like molecule (DLL3/CD3 bispecific) that may help the immune system fight cancer. In this study, BI 764532 is given to people for the first time. That means no clinical data are available for BI 764532.  Participants get BI 764532 in regular intervals. If there is benefit for the participants and if they can tolerate it, the treatment is given for a maximum of 3 years.  During this time, participants visit the study site about 20 times depending on the response to the treatment. Doctors record any unwanted effects and regularly check the general health of the participants. 
Sponsor: Boehringer Ingelheim 
Intervention: BI 764532 
Start Date: 2020-07-15 
Last Updated: 2023-08-22 
Number of Patients: 193 
Recruitment Status: RECRUITING 
Condition: Patients With Small Cell Lung Carcinoma and Other Neoplasms 

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: NCT05572515

Title: A Study Comparing Teclistamab Monotherapy Versus Pomalidomide, Bortezomib, Dexamethasone (PVd) or Carfilzomib, Dexamethasone (Kd) in Participants With Relapsed or Refractory Multiple Myeloma 
Study Summary: The purpose of this study is to compare the efficacy of teclistamab with PVd/Kd. 
Sponsor: Janssen Research & Development, LLC 
Intervention: Teclistamab 
Start Date: 2023-03-29 
Last Updated: 2023-09-13 
Number of Patients: 590 
Recruitment Status: RECRUITING 
Condition: Relapsed or Refractory Multiple Myeloma 

NCTID: NCT05508867

Title: A Study of Coformulated Favezelimab/Pembrolizumab (MK-4280A) Versus Physician’s Choice Chemotherapy in PD-(L)1-refractory, Relapsed or Refractory Classical Hodgkin Lymphoma (MK-4280A-008) 
Study Summary: The purpose of this study is to compare efficacy of coformulated favezelimab/pembrolizumab (MK-4280A) with physician’s choice chemotherapy of bendamustine or gemcitabine in participants with PD-(L)1-refractory, relapsed or refractory classical Hodgkin Lymphoma. The study will also assess the safety and tolerability of coformulated favezelimab/pembrolizumab. The primary study hypotheses are that coformulated favezelimab/pembrolizumab is superior to physician’s choice chemotherapy with respect to progression-free survival (PFS) and overall survival (OS). 
Sponsor: Merck Sharp & Dohme LLC 
Intervention: favezelimab/pembrolizumab 
Start Date: 2022-10-18 
Last Updated: 2023-11-27 
Number of Patients: 360 
Recruitment Status: RECRUITING 
Condition: Hodgkin Lymphoma 

NCTID: NCT00932451

Title: An Investigational Drug, PF-02341066, Is Being Studied In Patients With Advanced Non-Small Cell Lung Cancer With A Specific Gene Profile Involving The Anaplastic Lymphoma Kinase (ALK) Gene 
Study Summary: This is a Phase 2 trial that will evaluate the safety and efficacy of PF-02341066 in patients with advanced non-small cell lung cancer with a specific gene profile involving the ALK gene. This trial will also allow patients from a Phase 3 trial who received standard of care chemotherapy (Study A8081007) to receive PF-02341066. 
Sponsor: Pfizer 
Intervention: PF-02341066 
Start Date: 2010-01 
Last Updated: 2017-01-13 
Number of Patients: 1069 
Recruitment Status: COMPLETED 
Condition: Carcinoma, Non-Small-Cell Lung 

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: NCT04597125

Title: Investigation of Radium-223 Dichloride (Xofigo), a Treatment That Gives Off Radiation That Helps Kill Cancer Cells, Compared to a Treatment That Inactivates Hormones (New Antihormonal Therapy, NAH) in Patients With Prostate Cancer That Has Spread to the Bone Getting Worse on or After Earlier NAH 
Study Summary: Researchers in this study want to compare how well drug radium-223 dichloride (Xofigo) and new (novel) anti-hormonal (NAH) therapy work in participants with prostate gland cancer which has spread to the bone and progressed on or after one line of NAH therapy. Meanwhile researchers want to compare the safety of radium-223 dichloride and NAH therapy. Radium-223 dichloride is known as a radioactive drug that is taken up by bones after it is injected into the body. It works by giving off a type of radioactivity that travels a very short distance and kills the tumor cells that have spread to the bone without major effects to the healthy cells. It has been approved in many countries for the treatment of patients with prostate cancer which has spread to the bone. The NAH drugs used in this study will be either abiraterone acetate (Zytiga) (plus prednisone/prednisolone) or enzalutamide (Xtandi). Both of them are standard approved medications which are used in the treatment of advanced prostate cancer.  Participants in this study will receive either Radium-223 dichloride or a NAH therapy. Radium-223 dichloride will be given as an infusion into one of the veins on Day 1 of each 4-week cycle for a total of up to 6 cycles. Oral NAH therapy will be given per the standard approved dose once daily until the disease has progressed. Participants will visit the hospital or clinic every 2 weeks for the first 6 cycles, and only on the first day of each cycle from cycle 7 and onwards. Observation for each participant will last for about 2 years in total. Blood and urine samples will be collected from the participants and participants will be asked to complete questionnaires about the well-being and the pain. 
Sponsor: Bayer 
Intervention: Radium-223 dichloride (Xofigo, BAY88-8223) 
Start Date: 2020-11-09 
Last Updated: 2023-11-14 
Number of Patients: 696 
Recruitment Status: RECRUITING 
Condition: Metastatic Castrate Resistant Prostate Cancer (mCRPC) 

NCTID: NCT04209855

Title: A Study of Mirvetuximab Soravtansine vs. Investigator’s Choice of Chemotherapy in Platinum-Resistant, Advanced High-Grade Epithelial Ovarian, Primary Peritoneal, or Fallopian Tube Cancers With High Folate Receptor-Alpha Expression 
Study Summary: This Phase 3 study is designed to compare the efficacy and safety of mirvetuximab soravtansine vs. investigator’s choice chemotherapy in patients with platinum-resistant high-grade epithelial ovarian cancer, primary peritoneal, or fallopian tube cancer, whose tumors express a high-level of FRα. Patients will be, in the opinion of the Investigator, appropriate for single-agent therapy for their next line of therapy. Folate receptor alpha (FRα) positivity will be defined by the Ventana FOLR1 (FOLR1-2.1) CDx assay. 
Sponsor: ImmunoGen, Inc. 
Intervention: Mirvetuximab Soravtansine 
Start Date: 2019-12-31 
Last Updated: 2023-03-06 
Number of Patients: 453 
Recruitment Status: ACTIVE_NOT_RECRUITING 
Condition: Epithelial Ovarian Cancer 

NCTID: NCT02986516

Title: Sacral Chordoma: Surgery Versus Definitive Radiation Therapy in Primary Localized Disease 
Study Summary: Comparative study on surgery versus definitive radiation therapy in primary localized sacral chordoma 
Sponsor: Italian Sarcoma Group 
Intervention: Randomized Cohort 
Start Date: 2017-03-16 
Last Updated: 2023-09-13 
Number of Patients: 100 
Recruitment Status: RECRUITING 
Condition: Chordoma 

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: NCT04886804

Title: A Study to Test Different Doses of BI 1810631 in People With Different Types of Advanced Cancer (Solid Tumours With Changes in the HER2 Gene) 
Study Summary: The study has 2 parts. The first part is open to adults with different types of advanced cancer (solid tumours with changes in the HER2 gene) for whom previous treatment was not successful. The second part is open to people with non-small cell lung cancer with a specific mutation in the HER2 gene.  The purpose of the first study part is to find the highest dose of a medicine called BI 1810631 the participants can tolerate. Once this dose is found, it will be used in the second study part to tests whether BI 1810631 can make tumours shrink.  In this study, BI 1810631 is given to people for the first time. Participants take BI 1810631 as tablets once a day or twice a day.  The participants are in the study for as long as they benefit from and can tolerate treatment. Study doctors regularly check the participants’ health and monitor the tumours. The doctors also take note of any unwanted effects that could have been caused by BI 1810631. 
Sponsor: Boehringer Ingelheim 
Intervention: BI 1810631 
Start Date: 2021-06-22 
Last Updated: 2023-11-28 
Number of Patients: 371 
Recruitment Status: RECRUITING 
Condition: Neoplasm Metastasis 

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: NCT04181827

Title: A Study Comparing JNJ-68284528, a CAR-T Therapy Directed Against B-cell Maturation Antigen (BCMA), Versus Pomalidomide, Bortezomib and Dexamethasone (PVd) or Daratumumab, Pomalidomide and Dexamethasone (DPd) in Participants With Relapsed and Lenalidomide-Refractory Multiple Myeloma 
Study Summary: The purpose of this study is to compare the efficacy of JNJ-68284528 (ciltacabtagene autoleucel <math display="block">cilta-cel</math>) with standard therapy, either Pomalidomide, Bortezomib and Dexamethasone (PVd) or Daratumumab, Pomalidomide and Dexamethasone (DPd). 
Sponsor: Janssen Research & Development, LLC 
Intervention: JNJ-68284528 
Start Date: 2020-06-12 
Last Updated: 2023-11-09 
Number of Patients: 419 
Recruitment Status: ACTIVE_NOT_RECRUITING 
Condition: Multiple Myeloma 

NCTID: NCT05696626

Title: Evaluation of Lasofoxifene Combined With Abemaciclib Compared With Fulvestrant Combined With Abemaciclib in Locally Advanced or Metastatic ER+/HER2- Breast Cancer With an ESR1 Mutation 
Study Summary: The goal of this clinical trial is to assess the efficacy, safety and tolerability of the combination of lasofoxifene and abemaciclib compared to fulvestrant and abemaciclib for the treatment of pre- and postmenopausal women and men who have previously received ribociclib or palbociclib-based treatment and have locally advanced or metastatic estrogen receptor positive (ER+)/human epidermal growth factor 2 negative (HER2-) breast cancer with an estrogen receptor 1 (ESR1) mutation.  The main question the study aims to answer is:  • To compare the efficacy of the combination of lasofoxifene and abemaciclib with that of fulvestrant and abemaciclib Participants will receive either receive 5 mg/d of oral lasofoxifene plus oral abemaciclib 150 mg twice a day or the combination of fulvestrant 500 mg intramuscular (IM) on Days 1, 15, and 29 and then once monthly thereafter plus oral abemaciclib 150 mg twice a day. 
Sponsor: Sermonix Pharmaceuticals Inc. 
Intervention: Lasofoxifene in combination with abemaciclib 
Start Date: 2023-10-31 
Last Updated: 2023-11-14 
Number of Patients: 400 
Recruitment Status: RECRUITING 
Condition: Metastatic Breast Cancer 

NCTID: NCT00932893

Title: An Investigational Drug, PF-02341066 Is Being Studied Versus Standard Of Care In Patients With Advanced Non-Small Cell Lung Cancer With A Specific Gene Profile Involving The Anaplastic Lymphoma Kinase (ALK) Gene 
Study Summary: This is a Phase 3 trial comparing the safety and anti-tumor activity of PF-02341066 versus pemetrexed or docetaxel in patients with advanced non-small cell lung cancer with specific gene profile involving the ALK gene after failure of one previous chemotherapy regimen that included one platinum drug. 
Sponsor: Pfizer 
Intervention: PF-02341066 
Start Date: 2009-09 
Last Updated: 2017-01-02 
Number of Patients: 347 
Recruitment Status: COMPLETED 
Condition: Carcinoma, Non-Small-Cell Lung 

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: NCT03468426

Title: A Study to Test Different Doses of BI 836880 Combined With Ezabenlimab in Patients With Advanced Non-small Cell Lung Cancer Followed by Other Types of Advanced Solid Tumours 
Study Summary: This study has 2 parts. The first part was open to adults with advanced non-small cell lung cancer. The second part was open also to adults with other types of advanced cancer of the lung, brain, skin, and liver. After early encouraging results, more people with liver cancer can now take part in the study. The participants get a combination of two medicines called BI 836880 and ezabenlimab.  BI 836880 is a type of an antibody that blocks new blood vessel formation. New blood vessels are needed by the tumour to continue growing. Ezabenlimab is an antibody that may help the immune system fight cancer (immune checkpoint inhibitor).  The purpose of the first part of the study was to find out the highest dose of the BI 836880 that the participants can tolerate in combination with BI 754091. After the best dose of BI 836880 for the combination with ezabenlimab was found, it is used in the second part of the study. The purpose of the second part is to see whether the combination of BI 836880 and BI 754091 is able to make tumours shrink.  The participants are in the study as long as they benefit from and can tolerate treatment. During this time, they get infusions of BI 836880 and ezabenlimab every 3 weeks. The doctors also regularly check the general health of the participants. 
Sponsor: Boehringer Ingelheim 
Intervention: BI 836880 
Start Date: 2018-05-03 
Last Updated: 2023-11-28 
Number of Patients: 252 
Recruitment Status: ACTIVE_NOT_RECRUITING 
Condition: Non-squamous, Non-Small-Cell Lung Cancer 

NCTID: NCT01212991

Title: A Safety and Efficacy Study of Oral MDV3100 in Chemotherapy-Naive Patients With Progressive Metastatic Prostate Cancer 
Study Summary: The purpose of this study is to determine the benefit of enzalutamide versus placebo as assessed by overall survival and progression-free survival in patients with progressive metastatic prostate cancer who have failed androgen deprivation therapy but not yet received chemotherapy. 
Sponsor: Pfizer 
Intervention: Enzalutamide 
Start Date: 2010-09-16 
Last Updated: 2020-03-17 
Number of Patients: 1717 
Recruitment Status: COMPLETED 
Condition: Prostate 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: NCT04195750

Title: A Study of Belzutifan (MK-6482) Versus Everolimus in Participants With Advanced Renal Cell Carcinoma (MK-6482-005) 
Study Summary: The primary objective of this study is to compare belzutifan to everolimus 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 to compare everolimus with respect to overall survival (OS). The hypothesis is that belzutifan is superior to everolimus with respect to PFS and OS. 
Sponsor: Merck Sharp & Dohme LLC 
Intervention: Belzutifan 
Start Date: 2020-02-27 
Last Updated: 2022-08-01 
Number of Patients: 736 
Recruitment Status: ACTIVE_NOT_RECRUITING 
Condition: Carcinoma, Renal Cell 

NCTID: NCT04778397

Title: Study of Magrolimab in Combination With Azacitidine Versus Physician’s Choice of Venetoclax in Combination With Azacitidine or Intensive Chemotherapy in Patients With TP53 Mutant Acute Myeloid Leukemia That Have Not Been Treated 
Study Summary: The goal of this clinical study is to compare the effectiveness of the study drugs, magrolimab in combination with azacitidine, versus venetoclax in combination with azacitidine in participants with previously untreated TP53 mutant acute myeloid leukemia (AML). 
Sponsor: Gilead Sciences 
Intervention: Magrolimab 
Start Date: 2021-07-01 
Last Updated: 2023-10-11 
Number of Patients: 346 
Recruitment Status: ACTIVE_NOT_RECRUITING 
Condition: Acute Myeloid Leukemia 

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: NCT04895722

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

NCTID: NCT05512377

Title: Brightline-2: A Study to Test Whether Brigimadlin (BI 907828) Helps People With Cancer in the Biliary Tract, Pancreas, Lung or Bladder 
Study Summary: This study is open to adults with advanced cancer in the biliary tract, pancreas, lung, or bladder. This is a study for people for whom previous treatment was not successful or no treatment exists.  The purpose of this study is to find out whether a medicine called BI 907828 helps people with cancer in the biliary tract, pancreas, lung, or bladder. BI 907828 is a so-called MDM2 inhibitor that is being developed to treat cancer. All participants take BI 907828 as a tablet once every 3 weeks. Participants may continue to take BI 907828 as long as they benefit from treatment and can tolerate it. They visit the study site regularly. At the study site, doctors regularly check the size of the tumour and whether it has spread to other parts of the body. The doctors also regularly check participants’ health and take note of any unwanted effects. 
Sponsor: Boehringer Ingelheim 
Intervention: brigimadlin 
Start Date: 2022-11-25 
Last Updated: 2023-11-28 
Number of Patients: 155 
Recruitment Status: RECRUITING 
Condition: Pancreatic Neoplasms 

NCTID: NCT04634877

Title: Study of Pembrolizumab (MK-3475) in Combination With Adjuvant Chemotherapy With or Without Radiotherapy in Participants With Newly Diagnosed Endometrial Cancer After Surgery With Curative Intent (MK-3475-B21 / KEYNOTE-B21 / ENGOT-en11 / GOG-3053) 
Study Summary: The purpose of this study is to compare pembrolizumab + adjuvant chemotherapy with placebo + adjuvant chemotherapy, with or without radiotherapy, with respect to disease-free survival (DFS) as assessed radiographically by the investigator or by histopathologic confirmation of suspected disease recurrence, and with respect to overall survival (OS). The primary hypotheses are that pembrolizumab + adjuvant chemotherapy is superior to placebo + adjuvant chemotherapy, with or without radiotherapy, with respect to DFS as assessed radiographically by the investigator or by histopathologic confirmation of suspected disease recurrence, and with respect to OS. 
Sponsor: Merck Sharp & Dohme LLC 
Intervention: Pembrolizumab 
Start Date: 2021-01-10 
Last Updated: 2023-11-21 
Number of Patients: 990 
Recruitment Status: ACTIVE_NOT_RECRUITING 
Condition: Endometrial Neoplasms 

NCTID: NCT05083169

Title: A Study of Teclistamab in Combination With Daratumumab Subcutaneously (SC) (Tec-Dara) Versus Daratumumab SC, Pomalidomide, and Dexamethasone (DPd) or Daratumumab SC, Bortezomib, and Dexamethasone (DVd) in Participants With Relapsed or Refractory Multiple Myeloma 
Study Summary: The purpose of this study is to compare the efficacy of teclistamab daratumumab (Tec-Dara) with daratumumab subcutaneously (SC) in combination with pomalidomide and dexamethasone (DPd) or daratumumab SC in combination with bortezomib and dexamethasone (DVd). 
Sponsor: Janssen Research & Development, LLC 
Intervention: Daratumumab 
Start Date: 2021-10-14 
Last Updated: 2023-11-09 
Number of Patients: 587 
Recruitment Status: ACTIVE_NOT_RECRUITING 
Condition: Multiple Myeloma 

NCTID: NCT05116189

Title: Pembrolizumab/Placebo Plus Paclitaxel With or Without Bevacizumab for Platinum-resistant Recurrent Ovarian Cancer (MK-3475-B96/KEYNOTE-B96/ENGOT-ov65) 
Study Summary: The primary objective is to compare pembrolizumab plus paclitaxel with or without bevacizumab to placebo plus paclitaxel with or without bevacizumab, with respect to progression-free survival (PFS) per Response Evaluation Criteria in Solid Tumors (RECIST) 1.1 as assessed by the investigator. The hypotheses are that pembrolizumab plus paclitaxel with or without bevacizumab is superior to placebo plus paclitaxel with or without bevacizumab, with respect to PFS per RECIST 1.1 as assessed by the investigator for participants with programmed cell death ligand 1 (PD-L1) positive tumors (Combined Positive Score <math display="block">CPS</math> ≥1) and that pembrolizumab plus paclitaxel with or without bevacizumab is superior to placebo plus paclitaxel with or without bevacizumab, with respect to PFS per RECIST 1.1 as assessed by the investigator for all participants. 
Sponsor: Merck Sharp & Dohme LLC 
Intervention: Pembrolizumab 
Start Date: 2021-12-13 
Last Updated: 2023-08-08 
Number of Patients: 616 
Recruitment Status: ACTIVE_NOT_RECRUITING 
Condition: Ovarian Cancer 

NCTID: NCT04607421

Title: A Study of Encorafenib Plus Cetuximab With or Without Chemotherapy in People With Previously Untreated Metastatic Colorectal Cancer 
Study Summary: The purpose of this study is to evaluate two study medicines (encorafenib plus cetuximab) taken alone or together with standard chemotherapy for the potential treatment of colorectal cancer that:  * has spread to other parts of the body (metastatic); * has a certain type of abnormal gene called “BRAF”; and * has not received prior treatment.  Participants in this study will receive one of the following study treatments:  * Encorafenib plus cetuximab: These participants will receive encorafenib by mouth at home every day and cetuximab once every two weeks by intravenous (IV) infusion (an injection into the vein) at the study clinic. * Encorafenib plus cetuximab with chemotherapy: These participants will receive encorafenib and cetuximab in the way described in the bullet above. Additionally, they will receive standard chemotherapy by IV infusion and oral treatment at home. * Chemotherapy alone: These participants will receive chemotherapy, the standard treatment for this condition, by IV infusion at the study clinics and oral treatment at home.  The study team will monitor how each participant responds to the study treatment for up to about 3 years. 
Sponsor: Pfizer 
Intervention: Encorafenib 
Start Date: 2020-12-21 
Last Updated: 2023-09-11 
Number of Patients: 815 
Recruitment Status: RECRUITING 
Condition: Neoplasms 

NCTID: NCT05882058

Title: DAREON™-5: A Study to Test Whether Different Doses of BI 764532 Help People With Small Cell Lung Cancer or Other Neuroendocrine Cancers 
Study Summary: This study is open to adults with small cell lung cancer and other neuroendocrine tumours. The study is in people with advanced cancer for whom previous treatment was not successful or no standard treatment exists.  The purpose of this study is to find a suitable dose of BI 764532 that people with advanced cancer can tolerate when taken alone. 2 different doses of BI 764532 are tested in this study. Another purpose is to check whether BI 764532 can make tumours shrink. BI 764532 is an antibody-like molecule (DLL3/CD3 bispecific) that may help the immune system fight cancer.  Participants are put into 2 groups randomly, which means by chance. One group gets dose 1 of BI 764532 and the other group gets dose 2 of BI 764532. Participants get BI 764532 infusions into a vein when starting treatment. If there is benefit for the participants and if they can tolerate it, the treatment is given up to the maximum duration of the study. During this time, participants visit the study site regularly. The total number of visits depends on how they respond to and tolerate the treatment. The first study visits include an over-night stay to monitor participants’ safety. Doctors record any unwanted effects and regularly check the general health of the participants. 
Sponsor: Boehringer Ingelheim 
Intervention: BI 764532 
Start Date: 2023-09-25 
Last Updated: 2023-11-18 
Number of Patients: 120 
Recruitment Status: RECRUITING 
Condition: Small Cell Lung Carcinoma 

NCTID: NCT04173494

Title: A Study of Momelotinib Versus Danazol in Symptomatic and Anemic Myelofibrosis Participants (MOMENTUM) 
Study Summary: MOMENTUM is a randomized, double-blind, active control Phase 3 trial intended to confirm the differentiated clinical benefits of the investigational drug momelotinib (MMB) versus danazol (DAN) in symptomatic and anemic participants who have previously received an approved Janus kinase inhibitor (JAKi) therapy for myelofibrosis (MF). The purpose of this clinical study is to compare the effectiveness and safety of MMB to DAN in treating and reducing: 1) disease related symptoms, 2) the need for blood transfusions and 3) splenomegaly, in adults with primary MF, post-polycythemia vera MF or post-essential thrombocythemia MF. The study is planned in countries including, but not limited to: Australia, Austria, Belgium, Bulgaria, Canada, Czech Republic, Denmark, France, Germany, Hungary, Israel, Italy, New Zealand, Poland, Romania, Singapore, South Korea, Spain, Sweden, Taiwan, United Kingdom (UK) and United States (US).  Participants must be symptomatic with a Myelofibrosis Symptom Assessment Form (MFSAF) version (v) 4.0 Total Symptom Score of >= 10 at screening, and be anemic with hemoglobin (Hgb) < 10 gram/deciliter (g/dL). For participants with ongoing JAKi therapy at screening, JAKi therapy must be tapered over a period of at least 1 week, followed by a 2-week non-treatment washout interval prior to randomization.  Participants will be randomized 2:1 to orally self-administer blinded treatment: MMB plus placebo or DAN plus placebo. Participants randomized to receive MMB who complete the randomized treatment period to the end of Week 24 may continue to receive MMB in the open-label extended treatment period to the end of Week 204 (a total period of treatment of approximately 4 years) if the participants tolerates and continues to benefit from MMB.  Participants randomized to receive DAN may cross-over to MMB open-label treatment in the following circumstances: at the end of Week 24 if they complete the randomized treatment period; or at the end of Week 24 if they discontinue treatment with DAN but continue study assessments and do not receive prohibited medications including alternative active anti-MF therapy; or at any time during the randomized treatment period if they meet the protocol-defined criteria for radiographically confirmed symptomatic splenic progression. Participants randomized to receive DAN who are receiving clinical benefit at the end of Week 24 may choose to continue DAN therapy up to Week 48. The comparator treatment, DAN, is an approved medication in the US and in some other countries and is recommended by national guidelines as a treatment for anemia in MF. 
Sponsor: Sierra Oncology LLC - a GSK company 
Intervention: Momelotinib 
Start Date: 2020-02-07 
Last Updated: 2023-11-01 
Number of Patients: 195 
Recruitment Status: COMPLETED 
Condition: Primary Myelofibrosis 

NCTID: NCT04447118

Title: Phase 3 Study of Pyrotinib Versus Docetaxel in Patients With Advanced Non-squamous NSCLC Harboring a HER2 Exon 20 Mutation Who Failed Platinum Based Chemotherapy 
Study Summary: This is a randomized, positive-controlled, open-label, international multicenter, Phase 3 clinical study to compare the efficacy and safety of pyrotinib versus docetaxel in patients with advanced non-squamous NSCLC harboring a HER2 exon 20 mutation who failed platinum based chemotherapy. 
Sponsor: Jiangsu HengRui Medicine Co., Ltd. 
Intervention: Pyrotinib 
Start Date: 2020-09-11 
Last Updated: 2023-03-08 
Number of Patients: 151 
Recruitment Status: ACTIVE_NOT_RECRUITING 
Condition: Non-squamous NSCLC 

NCTID: NCT04895358

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

NCTID: NCT05879978

Title: A Study to Test How Well Different Doses of BI 764532 in Combination With Ezabenlimab Are Tolerated by People With Small Cell Lung Cancer and Other Neuroendocrine Tumours That Are Positive for DLL3 
Study Summary: This study is open to adults with small cell lung cancer and other neuroendocrine tumours that are positive for the tumour marker Delta-like 3 (DLL3). The study is in people with advanced cancer for whom previous treatment was not successful or no standard treatment exists.  The purpose of this study is to find out the highest dose of BI 764532 that people can tolerate when taken together with another medicine called ezabenlimab. BI 764532 and ezabenlimab are antibodies that may help the immune system fight cancer. Participants get BI 764532 and ezabenlimab as infusions into a vein.  If there is benefit for the participants and if they can tolerate it, the treatment is given for a maximum of 3 years. During this time, participants visit the study site about every week. The visits also depend on the response to the treatment. At the study visits, the doctors check the health of the participants, take necessary laboratory tests, and note any health problems that could have been caused by the study treatment. 
Sponsor: Boehringer Ingelheim 
Intervention: BI 764532 
Start Date: 2023-05-31 
Last Updated: 2023-11-03 
Number of Patients: 30 
Recruitment Status: RECRUITING 
Condition: Small Cell Lung Carcinoma (SCLC) 

NCTID: NCT05218499

Title: Brightline-1: A Study to Compare BI 907828 With Doxorubicin in People With a Type of Cancer Called Dedifferentiated Liposarcoma 
Study Summary: This study is open to people with a type of cancer called dedifferentiated liposarcoma. People with advanced liposarcoma aged 18 or older who are not receiving any other cancer treatment can participate.  The purpose of this study is to compare a medicine called BI 907828 with doxorubicin in people with liposarcoma. BI 907828 is a so-called MDM2 inhibitor that is being developed to treat cancer. Doxorubicin is a medicine already used to treat cancer including liposarcoma.  During the study, participants get either BI 907828 or doxorubicin. Every 3 weeks, participants take BI 907828 as tablets or doxorubicin as an infusion into a vein. Participants can switch to BI 907828 treatment if they did not benefit from doxorubicin treatment.  Participants can continue treatment in the study as long as they benefit from it and can tolerate it.  Doctors regularly check the size of the tumour and check whether it has spread to other parts of the body. The doctors also regularly check participants’ health and take note of any unwanted effects. 
Sponsor: Boehringer Ingelheim 
Intervention: BI 907828 
Start Date: 2022-03-25 
Last Updated: 2023-11-07 
Number of Patients: 400 
Recruitment Status: ACTIVE_NOT_RECRUITING 
Condition: Liposarcoma, Dedifferentiated 

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