Phase 3
N=1,206
Coformulation of Pembrolizumab/Vibostolimab (MK-7684A) Versus Pembrolizumab (MK-3475) Monotherapy for Programmed Cell Death 1 Ligand 1 (PD-L1) Positive Metastatic Non-Small Cell Lung Cancer (MK-7684A-003, KEYVIBE-003)
Lung Neoplasms · Non-Small-Cell Lung Carcinoma
Bottom Line
View on ClinicalTrials.gov: NCT04738487 ↗Enrolled (actual)
1,206
Serious AEs
38.9%
Results posted
Aug 2025
Primary outcome: Primary: Overall Survival (OS) in Participants With PD-L1 TPS ≥50% — 15.7; 20.3 Months — p=0.6712
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 3
- Interventions
- Pembrolizumab/Vibostolimab (Biological); Pembrolizumab (Biological)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- Merck Sharp & Dohme LLC
- Primary completion
- Sep 2024
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Overall Survival (OS) in Participants With PD-L1 TPS ≥50% |
15.7; 20.3 | 0.6712 |
| SECONDARY OS in Participants With PD-L1 TPS ≥1% |
15.0; 16.4 | 0.3320 |
| SECONDARY OS in Participants With PD-L1 TPS 1% to 49% |
14.3; 14.3 | 0.1646 |
| SECONDARY Progression-Free Survival (PFS) in Participants With PD-L1 TPS ≥1% |
— | — |
| SECONDARY PFS in Participants With PD-L1 TPS ≥50% |
— | — |
| SECONDARY PFS in Participants With PD-L1 TPS 1% to 49% |
— | — |
| SECONDARY Objective Response Rate (ORR) in Participants With PD-L1 TPS ≥1% |
— | — |
| SECONDARY ORR in Participants With PD-L1 TPS ≥50% |
— | — |
| SECONDARY ORR in Participants With PD-L1 TPS 1% to 49% |
— | — |
| SECONDARY Duration of Response (DOR) in Participants With PD-L1 TPS ≥50% |
— | — |
| SECONDARY DOR in Participants With PD-L1 TPS 1% to 49% |
— | — |
| SECONDARY DOR in Participants With PD-L1 TPS ≥1% |
— | — |
| SECONDARY Change From Baseline in Global Health Status/Quality of Life (QoL) (Items 29, 30) Combined Score on the European Organization for Research and Treatment of Cancer QoL Questionnaire-Core 30 (EORTC QLQ-C30) in Participants With PD-L1 TPS ≥50% |
— | — |
| SECONDARY Change From Baseline in Global Health Status/QoL (Items 29, 30) Combined Score on the EORTC QLQ-C30 in Participants With PD-L1 TPS 1% to 49% |
— | — |
| SECONDARY Change From Baseline in Global Health Status/QoL (Items 29, 30) Combined Score on the EORTC QLQ-C30 in Participants With PD-L1 TPS ≥1% |
— | — |
| SECONDARY Change From Baseline in Physical Functioning (Items 1-5) Combined Score on the EORTC QLQ-C30 in Participants With PD-L1 TPS ≥50% |
— | — |
| SECONDARY Change From Baseline in Physical Functioning (Items 1-5) Combined Score on the EORTC QLQ-C30 in Participants With PD-L1 TPS 1% to 49% |
— | — |
| SECONDARY Change From Baseline in Physical Functioning (Items 1-5) Combined Score on the EORTC QLQ-C30 in Participants With PD-L1 TPS ≥1% |
— | — |
| SECONDARY Change From Baseline in Role Functioning (Items 6, 7) Combined Score on the EORTC QLQ-C30 in Participants With PD-L1 TPS ≥50% |
— | — |
| SECONDARY Change From Baseline in Role Functioning (Items 6, 7) Combined Score on the EORTC QLQ-C30 in Participants With PD-L1 TPS 1% to 49% |
— | — |
| SECONDARY Change From Baseline in Role Functioning (Items 6, 7) Combined Score on the EORTC QLQ-C30 in Participants With PD-L1 TPS ≥1% |
— | — |
| SECONDARY Change From Baseline in Dyspnea Score (Item 8) on the EORTC QLQ-C30 in Participants With PD-L1 TPS ≥50% |
— | — |
| SECONDARY Change From Baseline in Dyspnea Score (Item 8) on the EORTC QLQ-C30 in Participants With PD-L1 TPS 1% to 49% |
— | — |
| SECONDARY Change From Baseline in Dyspnea Score (Item 8) on the EORTC QLQ-C30 in Participants With PD-L1 TPS ≥1% |
— | — |
| 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) in Participants With PD-L1 TPS ≥50% |
— | — |
| SECONDARY Change From Baseline in Cough Score (Item 31) on the EORTC QLQ-LC13 in Participants With PD-L1 TPS 1% to 49% |
— | — |
| SECONDARY Change From Baseline in Cough Score (Item 31) on the EORTC QLQ-LC13 in Participants With PD-L1 TPS ≥1% |
— | — |
| SECONDARY Change From Baseline in Chest Pain Score (Item 40) on the EORTC QLQ-LC13 in Participants With PD-L1 TPS ≥50% |
— | — |
| SECONDARY Change From Baseline in Chest Pain Score (Item 40) on the EORTC QLQ-LC13 in Participants With PD-L1 TPS 1% to 49% |
— | — |
| SECONDARY Change From Baseline in Chest Pain Score (Item 40) on the EORTC QLQ-LC13 in Participants With PD-L1 TPS ≥1% |
— | — |
| SECONDARY Time to Deterioration (TTD) in Global Health Status/QoL (Items 29, 30) Combined Score on the EORTC QLQ-C30 in Participants With PD-L1 TPS ≥50% |
— | — |
| SECONDARY TTD in Global Health Status/QoL (Items 29, 30) Combined Score on the EORTC QLQ-C30 in Participants With PD-L1 TPS 1% to 49% |
— | — |
| SECONDARY TTD in Global Health Status/QoL (Items 29, 30) Combined Score on the EORTC QLQ-C30 in Participants With PD-L1 TPS ≥1% |
— | — |
| SECONDARY TTD in Physical Functioning (Items 1-5) Combined Score on the EORTC QLQ-C30 in Participants With PD-L1 TPS ≥50% |
— | — |
| SECONDARY TTD in Physical Functioning (Items 1-5) Combined Score on the EORTC QLQ-C30 in Participants With PD-L1 TPS ≥1% to 49% |
— | — |
| SECONDARY TTD in Physical Functioning (Items 1-5) Combined Score on the EORTC QLQ-C30 in Participants With PD-L1 TPS ≥1% |
— | — |
| SECONDARY TTD in Role Functioning (Items 6, 7) Combined Score on the EORTC QLQ-C30 in Participants With PD-L1 TPS ≥50% |
— | — |
| SECONDARY TTD in Role Functioning (Items 6, 7) Combined Score on the EORTC QLQ-C30 in Participants With PD-L1 TPS 1% to 49% |
— | — |
| SECONDARY TTD in Role Functioning (Items 6, 7) Combined Score on the EORTC QLQ-C30 in Participants With PD-L1 TPS ≥1% |
— | — |
| SECONDARY TTD in Dyspnea Score (Item 8) on the EORTC QLQ-C30 in Participants With PD-L1 TPS ≥50% |
— | — |
| SECONDARY TTD in Dyspnea Score (Item 8) on the EORTC QLQ-C30 in Participants With PD-L1 TPS 1% to 49% |
— | — |
| SECONDARY TTD in Dyspnea Score (Item 8) on the EORTC QLQ-C30 in Participants With PD-L1 TPS ≥1% |
— | — |
| SECONDARY TTD in Cough Score (Item 31) on the EORTC QLQ-LC13 in Participants With PD-L1 TPS ≥50% |
— | — |
| SECONDARY TTD in Cough Score (Item 31) on the EORTC QLQ-LC13 in Participants With PD-L1 TPS 1% to 49% |
— | — |
| SECONDARY TTD in Cough Score (Item 31) on the EORTC QLQ-LC13 in Participants With PD-L1 TPS ≥1% |
— | — |
| SECONDARY TTD in in Chest Pain Score (Item 40) on the EORTC QLQ-LC13 in Participants With PD-L1 TPS ≥50% |
— | — |
| SECONDARY TTD in in Chest Pain Score (Item 40) on the EORTC QLQ-LC13 in Participants With PD-L1 TPS 1% to 49% |
— | — |
| SECONDARY TTD in in Chest Pain Score (Item 40) on the EORTC QLQ-LC13 in Participants With PD-L1 TPS ≥1% |
— | — |
| SECONDARY Number of Participants Who Experienced One or More Adverse Events (AEs) |
— | — |
| SECONDARY Number of Participants Who Discontinued Study Intervention Due to an Adverse Event (AE) |
— | — |
Summary
Researchers are looking for new ways to treat people with metastatic non-small cell lung cancer (NSCLC) that is PD-L1 positive.
* Metastatic means cancer that has spread to other parts of the body.
* PD-L1 positive means that PD-L1 is found on the cancer cells. PD-L1 is a protein that can help the cancer hide from the body's immune system.
The goal of this study is to learn if people who receive vibostolimab and pembrolizumab live longer overall and without the cancer getting worse than people who receive pembrolizumab alone.
Eligibility Criteria
Inclusion Criteria
- Has a histologically or cytologically confirmed diagnosis of Stage IV: M1a, M1b, or M1c non-small cell lung cancer (NSCLC) per the American Joint Committee on Cancer (AJCC) Staging Manual, version 8
- Has measurable disease based on Response Evaluation Criteria in Solid Tumors (RECIST) 1.1, as determined by the local site assessment
- Has confirmation that epidermal growth factor receptor (EGFR)-, anaplastic lymphoma kinase (ALK)-, or reactive oxygen species proto-oncogene 1 (ROS1)-directed therapy is not indicated as primary therapy and absence of ALK and ROS1 gene rearrangements
- Has provided tumor tissue that demonstrates Programmed Cell Death 1 Ligand 1 (PD-L1) expression in ≥1% of tumor cells as assessed by immunohistochemistry (IHC) at a central laboratory
- Has an Eastern Cooperative Oncology Group (ECOG) performance score of 0 or 1 assessed within 7 days prior to randomization
- Has a life expectancy of at least 3 months
- A female participant is eligible to participate if she is not pregnant or breastfeeding, and at least one of the following conditions applies:
- Is not a woman of childbearing potential (WOCBP)
- Is a WOCBP and using a contraceptive method that is highly effective (with a failure rate of <1% per year), with low user dependency or be abstinent from heterosexual intercourse as their preferred and usual lifestyle (abstinent on a long term and persistent basis), during the intervention period and for at least 120 days after the last dose of study intervention
- Has adequate organ function
Exclusion Criteria
- Has a known history of an additional malignancy, except if the participant has undergone potentially curative therapy with no evidence of that disease recurrence for at least 3 years since initiation of that therapy
- Has received prior systemic chemotherapy or other targeted or biological antineoplastic therapy for their metastatic NSCLC.
- Prior treatment with chemotherapy and/or radiation as part of neoadjuvant/adjuvant or chemoradiation therapy for nonmetastatic NSCLC is allowed as long as therapy was completed at least 6 months before the diagnosis of metastatic NSCLC.
- Participants must have recovered from all AEs due to previous therapies to Grade ≤1 or baseline. Participants with Grade ≤2 neuropathy may be eligible. Participants with endocrine-related AEs Grade ≤2 requiring treatment or hormone replacement may be eligible.
- Has received prior therapy with an anti-programmed cell death receptor 1 (PD-1), anti-programmed cell death receptor ligand 1 (PD-L1), or anti-programmed cell death receptor ligand 2 (PD-L2) agent or with an agent directed to another stimulatory or co-inhibitory T-cell receptor (eg, cytotoxic T-lymphocyte-associated protein 4 (CTLA-4), OX-40, CD137)
- Has received previous treatment with another agent targeting the T cell immunoreceptor with immunoglobulin (Ig) and immunoreceptor tyrosine-based inhibition motif (ITIM) domains (TIGIT) receptor pathway
- Has received radiotherapy within 2 weeks of start of study intervention. Participants must have recovered from all radiation-related toxicities, not require corticosteroids, and not have had radiation pneumonitis. A 1-week washout is permitted for palliative radiation (≤2 weeks of radiotherapy) to non-central nervous system (CNS) disease
- Has received a live or live-attenuated vaccine within 30 days prior to the first dose of study intervention. Administration of killed vaccines is allowed.
- Any licensed COVID-19 vaccine (including for Emergency Use) in a particular country is allowed in the study as long as they are mRNA vaccines, adenoviral vaccines, or inactivated vaccines. These vaccines will be treated just as any other concomitant therapy.
- Investigational vaccines (i.e., those not licensed or approved for Emergency Use) are not allowed.
- Is currently participating in or has participated in a study of an investigational agent or has used an investigational device within 4 weeks prio
Data sourced from ClinicalTrials.gov (NCT04738487). 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.