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Study of Pembrolizumab/Vibostolimab Coformulation (MK-7684A) in Combination With Chemotherapy Versus Pembrolizumab Plus Chemotherapy in Participants With Metastatic Non-Small Cell Lung Cancer (MK-7684A-007/KEYVIBE-007)

NCT05226598 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 739

Last updated 2026-02-05

Study results available
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Summary

The primary hypothesis is that pembrolizumab/vibostolimab (MK-7684A) in combination with chemotherapy is superior to pembrolizumab in combination with chemotherapy with respect to overall survival (OS) in participants with programmed cell death-ligand 1 (PD-L1) tumor proportion score (TPS) ≥1%.

Conditions

  • Metastatic Non-Small Cell Lung Cancer

Interventions

BIOLOGICAL

Pembrolizumab/Vibostolimab

Co-formulation of pembrolizumab 200 mg/20 mL vial and vibostolimab 200 mg administered as IV infusion for up to 35 administrations

DRUG

Carboplatin

Carboplatin 10 mg/ml administered as IV infusion Q3W for 4 administrations

DRUG

Cisplatin

Cisplatin 1 mg/ml administered as IV infusion Q3W for 4 administrations

DRUG

Paclitaxel

Paclitaxel 6mg/ml administered as IV infusion Q3W for 4 administrations

DRUG

Nab-paclitaxel

Nab-paclitaxel 100 mg/vial administered as IV infusion Days 1, 8, and 15 of each 21-day cycle for 4 administrations

DRUG

Pemetrexed

Pemetrexed 500 mg/vial administered as IV infusion Q3W until progression, intolerable adverse event (AE), or participant or physician decision

BIOLOGICAL

Pembrolizumab

Pembrolizumab 25 mg/mL administered as IV infusion Q3W for up to 35 administrations

Sponsors & Collaborators

Principal Investigators

  • Medical Director · Merck Sharp & Dohme LLC

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
TRIPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2022-03-24
Primary Completion
2024-09-24
Completion
2026-01-09
FDA Drug
Yes

Countries

  • United States
  • Argentina
  • Austria
  • Brazil
  • Chile
  • China
  • Colombia
  • France
  • Germany
  • Israel
  • Japan
  • Mexico
  • Poland
  • South Korea
  • Spain
  • Taiwan
  • Thailand
  • Turkey (Türkiye)
  • United Kingdom

Study Locations

More Related Trials

Entities

Drugs
Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05226598 on ClinicalTrials.gov