Phase 3
Completed N=739
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)
Source: ClinicalTrials.gov NCT05226598 ↗Enrolled (actual)
739
Serious AEs
52.9%
Results posted
Nov 2025
Primary outcomePrimary: Overall Survival (OS) in Participants With Programmed Cell Death-Ligand 1 (PD-L1) Tumor Proportion Score (TPS) ≥1% — 19.4; 23.5 Months — p=0.8335
◆ Published Evidence
Emerging
16citations · ~8 / year
The KEYVIBE program: vibostolimab and pembrolizumab for the treatment of advanced malignancies.
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%.
Linked Publications
-
The KEYVIBE program: vibostolimab and pembrolizumab for the treatment of advanced malignancies.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Overall Survival (OS) in Participants With Programmed Cell Death-Ligand 1 (PD-L1) Tumor Proportion Score (TPS) ≥1% |
19.4; 23.5 | 0.8335 |
| SECONDARY Overall Survival (OS) in All Participants |
20.0; 19.7 | 0.5104 |
| SECONDARY Progression-Free Survival (PFS) |
— | — |
| SECONDARY Objective Response Rate (ORR) |
— | — |
| SECONDARY Duration of Response (DOR) |
— | — |
| SECONDARY 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) |
— | — |
| SECONDARY Change From Baseline in Physical Functioning (Items 1-5) Combined Score on the EORTC QLQ-C30 |
— | — |
| SECONDARY Change From Baseline for Role Functioning (Items 6 and 7) Combined Score on the EORTC QLQ-C30 |
— | — |
| SECONDARY Change From Baseline in Dyspnea Score (Item 8) on the EORTC QLQ-C30 |
— | — |
| SECONDARY Change From Baseline in Cough Score (Item 31) on the European Organization for Research and Treatment of Cancer Quality of Life Lung Cancer-Specific Questionnaire Module (EORTC QLQ-LC13) |
— | — |
| SECONDARY Change From Baseline in Chest Pain Score (Item 40) on the EORTC QLQ- LC13 |
— | — |
| SECONDARY Time to Deterioration (TTD) in the Global Health Status/Quality of Life (Items 29 and 30) Combined Score on the EORTC QLQ-C30 |
— | — |
| SECONDARY TTD in Physical Functioning (Items 1-5) Combined Score on the EORTC QLQ- C30 |
— | — |
| SECONDARY TTD in Role Functioning (Items 6 and 7) Combined Score on the EORTC QLQ-C30 |
— | — |
| SECONDARY TTD in Dyspnea Score (Item 8) on the EORTC QLQ-C30 |
— | — |
| SECONDARY TTD in Cough Score (Item 31) on the EORTC QLQ-LC13 |
— | — |
| SECONDARY TTD in Chest Pain Score (Item 40) on the EORTC QLQ-LC13 |
— | — |
| SECONDARY Number of Participants Who Experienced One or More Adverse Events (AEs) |
— | — |
| SECONDARY Number of Participants Who Discontinued Study Intervention Due to an AE |
— | — |
Eligibility Criteria
The main inclusion and exclusion criteria include but are not limited to the following:
Inclusion Criteria
- A histologically or cytologically confirmed diagnosis of Stage IV squamous or non-squamous NSCLC
- Has not received prior systemic treatment for metastatic NSCLC
- Has measurable disease based on RECIST 1.1, as determined by the local site assessment
- Has a life expectancy of at least 3 months
- Males: Use contraception unless confirmed to be azoospermic; Females: Women of childbearing potential use highly effective contraceptive method
Exclusion Criteria
- Known additional malignancy that is progressing or has required active treatment within the past 3 years
- Known active central nervous system (CNS) metastases and/or carcinomatous meningitis
- Severe hypersensitivity to MK-7684, MK-7684A, pembrolizumab, chemotherapy components, and/or any of its excipients
- Diagnosis of immunodeficiency or is receiving chronic systemic steroid therapy (in dosing exceeding 10 mg daily of prednisone equivalent) or any other form of immunosuppressive therapy within 7 days before the first dose of study medication
- Active autoimmune disease that has required systemic treatment in past 2 years, except replacement therapy (eg, thyroxine, insulin, or physiologic corticosteroid)
- History of (noninfectious) pneumonitis/interstitial lung disease that required steroids or has current pneumonitis/interstitial lung disease
- Has an active infection requiring systemic therapy
- Has a known history of human immunodeficiency virus (HIV), Hepatitis B or/and Hepatitis C virus
- Received prior systemic anticancer therapy for metastatic disease
- Received a live or live attenuated vaccine within 30 days before the first dose of study intervention. Administration of killed vaccines are allowed
- History of allogeneic tissue/solid organ transplant
- Is unable to interrupt aspirin or other nonsteroidal anti-inflammatory drugs (NSAIDs), other than an aspirin dose ≤1.3 g/day, for a 5-day period (8-day period for long-acting agents, such as piroxicam)
- Is unable or unwilling to take folic acid or vitamin B12 supplementation
- Currently participating in or has participated in a study of an investigational agent or has used an investigational device within 4 weeks before the first dose of study intervention
Data sourced from ClinicalTrials.gov (NCT05226598) and the linked publication. Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.