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NCT04738487 · ClinicalTrials.gov registry record · Phase 3
Coformulation of Pembrolizumab/Vibostolimab (MK-7684A) Versus Pembrolizumab (MK-3475) Monotherapy for Programmed Cell Death 1 Ligand 1 (PD-L1) Positive Metastatic Non-Small Cell Lung Cancer (MK-7684A-003, KEYVIBE-003)
A Phase 3 study of Non-Small-Cell Lung Carcinoma and Lung Neoplasms, sponsored by Merck Sharp & Dohme.
- Completed
- Registry status
- Phase 3
- Development phase
- 1,264
- Enrollment target
- 20
- Study locations
NCT04738487: Completed Phase 3 study of Non-Small-Cell Lung Carcinoma and Lung Neoplasms, sponsored by Merck Sharp & Dohme.
NCT04738487 is a Phase 3 study of Non-Small-Cell Lung Carcinoma and Lung Neoplasms that has completed, run by Merck Sharp & Dohme. The registered enrollment target is 1,264 participants, above the 194-participant average among 30 other Non-Small-Cell Lung Carcinoma trials with a reported enrollment target (552% higher). The trial reports 20 study locations across 13 states. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT04738487, a Phase 3 study of Non-Small-Cell Lung Carcinoma and Lung Neoplasms, has completed, sponsored by Merck Sharp & Dohme.
- COMPLETED
- Registry status
- Phase 3
- Development phase
- 1,264 participants
- Enrollment target
- 20
- Study locations
Study Summary
Researchers are looking for new ways to treat people with metastatic non-small cell lung cancer (NSCLC) that is PD-L1 positive. * Metastatic means cancer that has spread to other parts of the body. * PD-L1 positive means that PD-L1 is found on the cancer cells. PD-L1 is a protein that can help the cancer hide from the body's immune system. The goal of this study is to learn if people who receive vibostolimab and pembrolizumab live longer overall and without the cancer getting worse than people who receive pembrolizumab alone.
Primary Outcome
OS was defined as the time from randomization to death due to any cause.
Conditions Studied
Interventions
- BIOLOGICAL Pembrolizumab
- BIOLOGICAL Pembrolizumab/Vibostolimab
Study Locations (20)
Other
- Instituto Nacional de Câncer José Alencar Gomes da Silva - INCA ( Site 0204) - Rio de Janeiro
- ICESP - INSTITUTO DO CÂNCER DO ESTADO DE SÃO PAULO-Pesquisa Clinica ( Site 0200) - São Paulo
- Núcleo de Pesquisa Clínica da Rede São Camilo ( Site 0207) - São Paulo
Ontario
- Hamilton Health Sciences-Juravinski Cancer Centre ( Site 0104) - Hamilton
- Kingston Health Sciences Centre-Kingston General Hospital Site ( Site 0102) - Kingston
- Lakeridge Health ( Site 0106) - Oshawa
Missouri
- Mercy Research - Cancer and Hematology Center ( Site 0032) - Springfield
- Mercy Research - David C. Pratt Cancer Center ( Site 0025) - St Louis
New York
- Perlmutter Cancer Center at NYU Langone Hospital - Long Island ( Site 0022) - Mineola
- Memorial Sloan Kettering Cancer Center ( Site 0013) - New York
Rio Grande do Sul
- ONCOSITE - Centro de Pesquisa Clinica em Oncologia ( Site 0206) - Ijuí
- Irmandade da Santa Casa de Misericórdia de Porto Alegre-Centro de Pesquisa Novos Tratamentos em Cân - Porto Alegre
Florida
- Boca Raton Regional Hospital ( Site 0004) - Boca Raton
Illinois
- Illinois Cancer Care ( Site 0026) - Peoria
Pennsylvania
- Fox Chase Cancer Center-Hematology/Oncology ( Site 0030) - Philadelphia
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 1,264 participants |
| Start Date | 2021-04-07 |
| Est. Completion | 2026-01-27 |
| Phase | Phase 3 |
What the finished NCT04738487 record still lists
NCT04738487 is an interventional study that assigns participants to a tested intervention. Its 1,264 participants enrollment target places it among the larger protocols in the corpus, above the 194-participant average among 30 other Non-Small-Cell Lung Carcinoma trials with a reported enrollment target (552% higher).
The record links to 2 conditions, with Non-Small-Cell Lung Carcinoma appearing as the primary indexed condition, and to 2 interventions - of which Pembrolizumab is the first listed.
NCT04738487 names 20 study sites across 13 states, led by Other, Ontario, Missouri.
Frequently Asked Questions
What is clinical trial NCT04738487 about?
NCT04738487 is a clinical study titled "Coformulation of Pembrolizumab/Vibostolimab (MK-7684A) Versus Pembrolizumab (MK-3475) Monotherapy for Programmed Cell Death 1 Ligand 1 (PD-L1) Positive Metastatic Non-Small Cell Lung Cancer (MK-7684A-003, KEYVIBE-003)". Researchers are looking for new ways to treat people with metastatic non-small cell lung cancer (NSCLC) that is PD-L1 positive. * Metastatic means cancer that has spread to other parts of the body. * PD-L1 positive means that PD-L1 is found on the cancer cells. PD-L1 is a protein that can help the ...
What is the current status of trial NCT04738487?
This trial is currently completed. It is a Phase 3 study. The enrollment target is 1,264 participants. The study started on 2021-04-07. Estimated completion is 2026-01-27.
What conditions does trial NCT04738487 study?
This clinical trial studies the following conditions: Non-Small-Cell Lung Carcinoma, Lung Neoplasms.
What interventions are being tested in trial NCT04738487?
The interventions under investigation include: Pembrolizumab (BIOLOGICAL), Pembrolizumab/Vibostolimab (BIOLOGICAL).
Who is sponsoring clinical trial NCT04738487?
This trial is sponsored by Merck Sharp & Dohme, which has 558 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT04738487 being conducted?
This trial has 20 study locations across Florida, Illinois, Missouri, New York, Pennsylvania. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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