Clinical Trial: NCT04738487
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)
Status:
TERMINATEDPhase:
Phase 3| Lead Sponsor: | Merck Sharp & Dohme LLC |
| Information Provided By: | Merck Sharp & Dohme LLC |
| Last Update Posted: | 2026-09-17 |
Study Overview
Brief 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.
Official Title
A Phase 3, Multicenter, Randomized, Double-Blind Study of MK-7684 With Pembrolizumab as a Coformulation (MK-7684A) Versus Pembrolizumab Monotherapy as First Line Treatment for Participants With PD-L1 Positive Metastatic Non-Small Cell Lung Cancer
Conditions
Lung Neoplasms, Non-Small-Cell Lung Carcinoma
Intervention / Treatment
- Biological: Pembrolizumab/Vibostolimab
- Biological: Pembrolizumab
Other Study ID Numbers
- 7684A-003
- MK-7684A-003
- jRCT2021210025
- KEYVIBE-003
- PHRR230831-006054
- 2023-505362-28-00
- U1111-1291-5552
- 2020-004049-35
- 2023
Start Date (Actual)
2021-04-07
Primary Completion Date (Actual)
2024-09-05
Study Completion Date (Actual)
2026-01-27
Enrollment (Actual)
1264
Study Type
Interventional
Phase
Phase 3
| Lead Sponsor: | Merck Sharp & Dohme LLC |
| Information Provided By: | Merck Sharp & Dohme LLC |
| Last Update Posted: | 2026-09-17 |
Study Overview
Brief 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.
Official Title
A Phase 3, Multicenter, Randomized, Double-Blind Study of MK-7684 With Pembrolizumab as a Coformulation (MK-7684A) Versus Pembrolizumab Monotherapy as First Line Treatment for Participants With PD-L1 Positive Metastatic Non-Small Cell Lung Cancer
Conditions
Lung Neoplasms, Non-Small-Cell Lung Carcinoma
Intervention / Treatment
- Biological: Pembrolizumab/Vibostolimab
- Biological: Pembrolizumab
Other Study ID Numbers
- 7684A-003
- MK-7684A-003
- jRCT2021210025
- KEYVIBE-003
- PHRR230831-006054
- 2023-505362-28-00
- U1111-1291-5552
- 2020-004049-35
- 2023
Start Date (Actual)
2021-04-07
Primary Completion Date (Actual)
2024-09-05
Study Completion Date (Actual)
2026-01-27
Enrollment (Actual)
1264
Study Type
Interventional
Phase
Phase 3