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NCT04725188 · ClinicalTrials.gov registry record · Phase 2
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)
A Phase 2 study, sponsored by Merck Sharp & Dohme.
- Completed
- Registry status
- Phase 2
- Development phase
- 255
- Enrollment target
NCT04725188 is a Phase 2 study that has completed, run by Merck Sharp & Dohme. The registered enrollment target is 255 participants.
The verdict
NCT04725188, a Phase 2 study, has completed, sponsored by Merck Sharp & Dohme.
- COMPLETED
- Registry status
- Phase 2
- Development phase
- 255 participants
- Enrollment target
Study Summary
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).
Interventions
- DRUG Placebo
- DRUG Docetaxel
- BIOLOGICAL Pembrolizumab/Vibostolimab coformulation
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 255 participants |
| Start Date | 2021-04-20 |
| Est. Completion | 2024-10-17 |
| Phase | Phase 2 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT04725188
The ClinicalTrials.gov registry entry for NCT04725188 describes a study currently listed as completed, categorized as Phase 2. The registered enrollment target is 255 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Merck Sharp & Dohme, which has 558 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 3 interventions - of which Placebo is the first listed.
NCT04725188 reports 0 study locations.
Frequently Asked Questions
What is clinical trial NCT04725188 about?
NCT04725188 is a clinical study titled "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)". 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 plat...
What is the current status of trial NCT04725188?
This trial is currently completed. It is a Phase 2 study. The enrollment target is 255 participants. The study started on 2021-04-20. Estimated completion is 2024-10-17.
What interventions are being tested in trial NCT04725188?
The interventions under investigation include: Placebo (DRUG), Docetaxel (DRUG), Pembrolizumab/Vibostolimab coformulation (BIOLOGICAL).
Who is sponsoring clinical trial NCT04725188?
This trial is sponsored by Merck Sharp & Dohme, which has 558 total clinical trials registered on ClinicalTrials.gov.
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