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NCT04976634 · ClinicalTrials.gov registry record · Phase 2
Pembrolizumab Plus Lenvatinib in Combination With Belzutifan in Solid Tumors (MK-6482-016)
A Phase 2 study of Neoplasm Malignant, sponsored by Merck Sharp & Dohme.
- Active
- Registry status
- Phase 2
- Development phase
- 730
- Enrollment target
- 20
- Study locations
NCT04976634: Active Phase 2 study of Neoplasm Malignant, sponsored by Merck Sharp & Dohme.
NCT04976634 is a Phase 2 study of Neoplasm Malignant that is active but no longer recruiting, run by Merck Sharp & Dohme. The registered enrollment target is 730 participants, above the 187-participant average among 7 other Neoplasm Malignant trials with a reported enrollment target (290% higher). The trial reports 20 study locations across 15 states. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT04976634, a Phase 2 study of Neoplasm Malignant, is active but no longer recruiting, sponsored by Merck Sharp & Dohme.
- ACTIVE NOT RECRUITING
- Registry status
- Phase 2
- Development phase
- 730 participants
- Enrollment target
- 20
- Study locations
Study Summary
The purpose of this study is to determine the safety and efficacy of belzutifan in combination with pembrolizumab and lenvatinib in multiple solid tumors including hepatocellular carcinoma (HCC), colorectal cancer (CRC), pancreatic ductal adenocarcinoma (PDAC), biliary tract cancer (BTC), endometrial cancer (EC),and esophageal squamous cell carcinoma (ESCC). There is no formal hypothesis testing in this study.
Primary Outcome
Occurrence of any of the following will be considered a DLT if possibly, probably, or definitely related to study treatment administration: Grade 4 nonhematologic toxicity; Grade 4 hematologic toxicity lasting \>7 days; Grade 4 thrombocytopenia-any duration; Grade 3 thrombocytopenia if associated with clinically significant hemorrhage; Febrile neutropenia Grade 3 or Grade 4; Grade 3 nonhematologic toxicity lasting \>5 days despite optimal supportive care; Grade 3 hypertension not controlled by a
Conditions Studied
Interventions
- DRUG Pembrolizumab
- DRUG Belzutifan
- DRUG Lenvatinib
Study Locations (20)
California
- City of Hope Comprehensive Cancer Center ( Site 5002) - Duarte
- Cedars-Sinai Medical Center ( Site 5045) - Los Angeles
- UCSF Medical Center at Mission Bay ( Site 5021) - San Francisco
Virginia
- Inova Schar Cancer Institute ( Site 5039) - Fairfax
- Blue Ridge Cancer Care ( Site 5053) - Roanoke
New South Wales
- Gosford Hospital-Oncology Trials ( Site 4004) - Gosford
- Westmead Hospital-Department of Medical Oncology ( Site 4001) - Westmead
Victoria
- Northern Hospital-Department of Medical Oncology ( Site 4003) - Epping
- Cabrini Hospital - Malvern-Cabrini Institute ( Site 4000) - Malvern
Arizona
- University of Arizona Cancer Center-University of Arizona Cancer Center - North Campus ( Site 5047) - Tucson
Connecticut
- Yale-New Haven Hospital-Yale Cancer Center ( Site 5013) - New Haven
District of Columbia
- Sibley Memorial Hospital ( Site 5051) - Washington D.C.
Florida
- University of Florida College of Medicine ( Site 5015) - Gainesville
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 730 participants |
| Start Date | 2021-08-18 |
| Est. Completion | 2027-03-22 |
| Phase | Phase 2 |
What the registry record for NCT04976634 still lists
NCT04976634 is an interventional study that assigns participants to a tested intervention. The registered 730 participants enrollment target is mid-sized for trials with a published cap, above the 187-participant average among 7 other Neoplasm Malignant trials with a reported enrollment target (290% higher).
The record links to 1 condition, with Neoplasm Malignant appearing as the primary indexed condition, and to 3 interventions - of which Pembrolizumab is the first listed.
NCT04976634 names 20 study sites across 15 states, led by California, Virginia, New South Wales.
Frequently Asked Questions
What is clinical trial NCT04976634 about?
NCT04976634 is a clinical study titled "Pembrolizumab Plus Lenvatinib in Combination With Belzutifan in Solid Tumors (MK-6482-016)". The purpose of this study is to determine the safety and efficacy of belzutifan in combination with pembrolizumab and lenvatinib in multiple solid tumors including hepatocellular carcinoma (HCC), colorectal cancer (CRC), pancreatic ductal adenocarcinoma (PDAC), biliary tract cancer (BTC), endometria...
What is the current status of trial NCT04976634?
This trial is currently active not recruiting. It is a Phase 2 study. The enrollment target is 730 participants. The study started on 2021-08-18. Estimated completion is 2027-03-22.
What conditions does trial NCT04976634 study?
This clinical trial studies the following conditions: Neoplasm Malignant.
What interventions are being tested in trial NCT04976634?
The interventions under investigation include: Pembrolizumab (DRUG), Belzutifan (DRUG), Lenvatinib (DRUG).
Who is sponsoring clinical trial NCT04976634?
This trial is sponsored by Merck Sharp & Dohme, which has 558 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT04976634 being conducted?
This trial has 20 study locations across Arizona, California, Connecticut, District of Columbia, Florida. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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