NCT05226598|CompletedPhase 3ResultsDMCFDA Drug

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)

A Randomized, Double-Blind, Phase 3 Study of Pembrolizumab/Vibostolimab Coformulation (MK-7684A) in Combination With Chemotherapy Versus Pembrolizumab Plus Chemotherapy as First Line Treatment for Participants With Metastatic Non-Small Cell Lung Cancer (MK-7684A-007/KEYVIBE-007)

Merck Sharp & Dohme LLC ClinicalTrials.gov

Compare

6 other identifiers

7684A-007MK-7684A-007KEYVIBE-007jRCT20312200982023-506074-12-00U1111-1293-2114

Study Type

interventional

Target

739

Locations

19 countries

Sites

149

Timeline

RegisteredFeb 2022

StartedMar 2022

CompletionJan 2026

Brief 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%.

Trial Health

On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Strong global presence with extensive site network

Enrollment

739

participants targeted

Target at P75+ for phase_3

Timeline

Completed

Started Mar 2022

Typical duration for phase_3

Geographic Reach

19 countries

149 active sites

Status

completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

3.8 years study duration

First Submitted

Initial submission to the registry

January 26, 2022

Completed

12 days until next milestone

First Posted

Study publicly available on registry

February 7, 2022

Completed

2 months until next milestone

Study Start

First participant enrolled

March 24, 2022

Completed

2.5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 24, 2024

Completed

1.1 years until next milestone

Results Posted

Study results publicly available

November 13, 2025

Completed

2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

January 9, 2026

Completed

Last Updated

February 5, 2026

Status Verified

January 1, 2026

Enrollment Period

2.5 years

First QC Date

January 26, 2022

Results QC Date

September 22, 2025

Last Update Submit

January 16, 2026

Conditions

Metastatic Non-Small Cell Lung Cancer

Outcome Measures

Primary Outcomes (1)

Overall Survival (OS) in Participants With Programmed Cell Death-Ligand 1 (PD-L1) Tumor Proportion Score (TPS) ≥1%
OS is defined as the time from the date of randomization to death due to any cause. The OS is reported for all participants with PD-L1 positive tumors (PD-L1 TPS≥1%). The OS was calculated using the product-limit (Kaplan-Meier) method for censored data.
Up to approximately 29 months

Secondary Outcomes (18)

Overall Survival (OS) in All Participants
Up to approximately 29 months
Progression-Free Survival (PFS)
Up to approximately 29 months
Objective Response Rate (ORR)
Up to approximately 29 months
Duration of Response (DOR)
Up to approximately 29 months
Change From Baseline in the Global Health Status/Quality of Life (Items 29 and 30) Combined Score on the European Organization for Research and Treatment of Cancer Quality of Life Questionnaire-Core 30 (EORTC QLQ-C30)
Baseline and Up to approximately 29 months
+13 more secondary outcomes

Study Arms (2)

MK-7684A + Chemotherapy

EXPERIMENTAL

Participants receive pembrolizumab/vibostolimab (co-formulation of 200mg pembrolizumab and 200 mg vibostolimab) via intravenous (IV) infusion on Day 1 of each cycle (cycle length = 3 weeks) for up to 35 cycles (up to \~2 years) PLUS paclitaxel IV (on Day 1 of each cycle) OR nab-paclitaxel IV (on Days 1, 8, and 15 of each cycle) and carboplatin IV (on Day 1 of each cycle) for 4 cycles for Squamous NSCLC; PLUS carboplatin IV (on Day 1 of each cycle) Or cisplatin IV (on Day 1 of each cycle) for 4 cycles and pemetrexed IV (on Day 1 of each cycle) until progression, intolerable adverse events, or participant/physician decision for Non-squamous.

Biological: Pembrolizumab/VibostolimabDrug: CarboplatinDrug: CisplatinDrug: PaclitaxelDrug: Nab-paclitaxelDrug: Pemetrexed

Pembrolizumab + Chemotherapy

ACTIVE COMPARATOR

Participants receive pembrolizumab 200 mg via IV infusion on Day 1 of each cycle (cycle length = 3 weeks) for up to 35 cycles (up to \~2 years) PLUS paclitaxel IV (on Day 1 of each cycle) OR nab-paclitaxel IV (on Days 1, 8, and 15 of each cycle) and carboplatin IV (on Day 1 of each cycle) for 4 cycles for Squamous NSCLC; PLUS carboplatin IV (on Day 1 of each cycle) Or cisplatin IV (on Day 1 of each cycle) for 4 cycles and pemetrexed IV (on Day 1 of each cycle) until progression, intolerable adverse events, or participant/physician decision for Non-squamous.

Drug: CarboplatinDrug: CisplatinDrug: PaclitaxelDrug: Nab-paclitaxelDrug: PemetrexedBiological: Pembrolizumab

Interventions

Pembrolizumab/VibostolimabBIOLOGICAL

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

Also known as: MK-7684A

MK-7684A + Chemotherapy

CarboplatinDRUG

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

Also known as: PARAPLATIN®, Paraplatin NovaPlus ®