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NCT05007106 · ClinicalTrials.gov registry record · Phase 2
MK-7684A With or Without Other Anticancer Therapies in Participants With Selected Solid Tumors (MK-7684A-005) (KEYVIBE-005)
A Phase 2 study, sponsored by Merck Sharp & Dohme.
- Completed
- Registry status
- Phase 2
- Development phase
- 613
- Enrollment target
NCT05007106: Completed Phase 2 study, sponsored by Merck Sharp & Dohme.
NCT05007106 is a Phase 2 study that has completed, run by Merck Sharp & Dohme. The registered enrollment target is 613 participants, above the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (361% higher). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT05007106, a Phase 2 study, has completed, sponsored by Merck Sharp & Dohme.
- COMPLETED
- Registry status
- Phase 2
- Development phase
- 613 participants
- Enrollment target
Study Summary
The purpose of this study is to determine the safety, tolerability, and preliminary efficacy of pembrolizumab/vibostolimab co-formulation (MK-7684A) with or without other anticancer therapies in participants with selected advanced solid tumors. The primary hypothesis is that pembrolizumab/vibostolimab co-formulation is superior to pembrolizumab alone in terms of objective response rate or progression-free survival in participants with cervical cancer.
Primary Outcome
ORR is defined as the percentage of participants who have a Complete Response (CR: Disappearance of all target lesions) or a Partial Response (PR: At least a 30% decrease in the sum of diameters of target lesions) per RECIST 1.1. The percentage of participants who experience a CR or PR as assessed by blinded independent central review based on RECIST 1.1 will be presented.
Interventions
- BIOLOGICAL Pembrolizumab
- DRUG Cisplatin
- DRUG 5-Fluorouracil
- DRUG Lenvatinib
- BIOLOGICAL Pembrolizumab/Vibostolimab Co-Formulation
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 613 participants |
| Start Date | 2021-09-16 |
| Est. Completion | 2025-08-05 |
| Phase | Phase 2 |
What the finished NCT05007106 record still lists
NCT05007106 is an interventional study that assigns participants to a tested intervention. The registered 613 participants enrollment target is mid-sized for trials with a published cap, above the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (361% higher).
The record links to 0 conditions, and to 5 interventions - of which Pembrolizumab is the first listed.
NCT05007106 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT05007106 about?
NCT05007106 is a clinical study titled "MK-7684A With or Without Other Anticancer Therapies in Participants With Selected Solid Tumors (MK-7684A-005) (KEYVIBE-005)". The purpose of this study is to determine the safety, tolerability, and preliminary efficacy of pembrolizumab/vibostolimab co-formulation (MK-7684A) with or without other anticancer therapies in participants with selected advanced solid tumors. The primary hypothesis is that pembrolizumab/vibostolim...
What is the current status of trial NCT05007106?
This trial is currently completed. It is a Phase 2 study. The enrollment target is 613 participants. The study started on 2021-09-16. Estimated completion is 2025-08-05.
What interventions are being tested in trial NCT05007106?
The interventions under investigation include: Pembrolizumab (BIOLOGICAL), Cisplatin (DRUG), 5-Fluorouracil (DRUG), Lenvatinib (DRUG), Pembrolizumab/Vibostolimab Co-Formulation (BIOLOGICAL).
Who is sponsoring clinical trial NCT05007106?
This trial is sponsored by Merck Sharp & Dohme, which has 558 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT05007106's enrollment target sits among peer trials
613 53rd of 2000 higher than 1,948 of 2,000 other Phase 2 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 2 trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
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