Pembrolizumab/Vibostolimab Coformulation (MK-7684A) or Pembrolizumab/Vibostolimab Coformulation Plus Docetaxel Versus Docetaxel for Metastatic Non Small Cell Lung Cancer (NSCLC) With Progressive Disease After Platinum Doublet Chemotherapy and Immunotherapy (MK-7684A-002, KEYVIBE-002)
Public ClinicalTrials.gov record NCT04725188. Field values are reproduced from the official study page; the official ClinicalTrials.gov record remains the source of truth for eligibility, enrollment, and contact information.
Data is sourced from official ClinicalTrials.gov public API records. Always review the official ClinicalTrials.gov record for the latest information.
Official title
A Phase 2, Multicenter, Randomized Study to Compare the Efficacy and Safety of MK-7684A or MK-7684A Plus Docetaxel Versus Docetaxel Monotherapy in the Treatment of Participants With Metastatic Non-small Cell Lung Cancer With Progressive Disease After Treatment With a Platinum Doublet Chemotherapy and Immunotherapy
Brief summary
Reproduced verbatim from the official ClinicalTrials.gov record. Not medical advice.
The main purpose of this study is to compare pembrolizumab/vibostolimab coformulation (MK-7684A) plus docetaxel or pembrolizumab/vibostolimab coformulation to normal saline placebo plus docetaxel. Participants with metastatic non-small cell lung cancer (NSCLC) and progressive disease (PD) after platinum doublet chemotherapy and treatment with one prior anti- programmed cell death 1 (PD-1)/ programmed cell death ligand 1(PD-L1) monoclonal antibody (mAb). MK-7684A is a coformulation product of pembrolizumab/vibostolimab. The dual primary hypotheses of the study are pembrolizumab/vibostolimab coformulation plus docetaxel and pembrolizumab/vibostolimab coformulation is superior to normal saline placebo plus docetaxel with respect to progression free survival (PFS) per Response Evaluation Criteria in Solid Tumors Version 1.1 (RECIST 1.1) by blinded independent central review (BICR).
Study identification
- NCT ID
- NCT04725188
- Recruitment status
- Completed
- Study type
- Interventional
- Phase
- Phase 2
- Enrollment
- 255 participants
Conditions and interventions
Conditions
Interventions
- Pembrolizumab/Vibostolimab coformulation Biological
- Docetaxel Drug
- Placebo Drug
Biological · Drug
Eligibility (public fields only)
- Age range
- 18 Years and older
- Sex
- All
- Healthy volunteers
- Healthy volunteers not accepted
This page does not interpret eligibility. Detailed inclusion and exclusion criteria are on the official ClinicalTrials.gov record.
Study timeline
- Start date
- Apr 19, 2021
- Primary completion
- Jan 25, 2023
- Completion
- Oct 16, 2024
- Last update posted
- Aug 14, 2025
2021 – 2024
United States locations
- U.S. sites
- 10
- U.S. states
- 9
- U.S. cities
- 10
| Facility | City | State | ZIP | Site status |
|---|---|---|---|---|
| Cedars-Sinai Medical Center ( Site 2522) | Los Angeles | California | 90048 | — |
| Illinois Cancer Care ( Site 2534) | Peoria | Illinois | 61615 | — |
| Baptist Health Lexington-Research ( Site 2502) | Lexington | Kentucky | 40503 | — |
| University of Maryland ( Site 2528) | Baltimore | Maryland | 21201 | — |
| Hattiesburg Clinic Hematology/Oncology ( Site 2511) | Hattiesburg | Mississippi | 39401 | — |
| Mercy Research - Cancer and Hematology Center ( Site 2535) | Springfield | Missouri | 65804 | — |
| Mercy Research - David C. Pratt Cancer Center ( Site 2532) | St Louis | Missouri | 63109 | — |
| Montefiore- Einstein Center for Cancer Care-Oncology ( Site 2509) | The Bronx | New York | 10461 | — |
| University of Cincinnati Medical Center-University of Cincinnati Cancer Center ( Site 2526) | Cincinnati | Ohio | 45219 | — |
| St Francis Cancer Center-Research Office ( Site 2531) | Greenville | South Carolina | 29607 | — |
Site contact phone numbers, emails, and investigator names are intentionally not displayed here. Open the official ClinicalTrials.gov record for site contact information.
Non-U.S. locations
This page focuses on the U.S. directory. The official record also lists 85 non-U.S. sites.
About this trial record page
- What this page shows
- Public field values for ClinicalTrials.gov record NCT04725188, including study identification, conditions, interventions, eligibility (age, sex, healthy volunteer), timeline, and U.S. site list.
- What this page does not do
- No medical advice, eligibility judgments, treatment recommendations, study quality scoring, or AI-generated medical summaries. No site contact phone numbers, emails, or investigator names.
- Where the data comes from
- Sourced from the official ClinicalTrials.gov public API. The official record is the source of truth.
- Last refresh
- Last update posted Aug 14, 2025 · Synced Sep 16, 2026
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Open the official record
The complete protocol, eligibility criteria, and contact information for NCT04725188 live on ClinicalTrials.gov.