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Pembrolizumab/Vibostolimab
Pembrolizumab blocks PD-1 to enhance T-cell immunity, while vibostolimab blocks VISTA to further relieve immune suppression in the tumor microenvironment.
Pembrolizumab blocks PD-1 to enhance T-cell immunity, while vibostolimab blocks VISTA to further relieve immune suppression in the tumor microenvironment. Used for Advanced or metastatic melanoma, Non-small cell lung cancer.
At a glance
| Generic name | Pembrolizumab/Vibostolimab |
|---|---|
| Also known as | MK-7684A |
| Sponsor | Merck Sharp & Dohme LLC |
| Drug class | PD-1 inhibitor + VISTA inhibitor combination |
| Target | PD-1 and VISTA |
| Modality | Biologic |
| Therapeutic area | Oncology |
| Phase | Phase 3 |
Mechanism of action
This combination targets two complementary immune checkpoints: pembrolizumab is a PD-1 inhibitor that prevents tumor cells from suppressing T-cell responses, while vibostolimab is a VISTA inhibitor that blocks another inhibitory pathway on immune cells. Together, they aim to overcome multiple layers of immune evasion used by tumors, potentially enhancing anti-tumor immunity beyond single-checkpoint inhibition.
Approved indications
- Advanced or metastatic melanoma
- Non-small cell lung cancer
Common side effects
- Fatigue
- Immune-related colitis
- Pneumonitis
- Rash
- Hepatotoxicity
Key clinical trials
- KEYMAKER-U01 Substudy 01A: Efficacy and Safety Study of Pembrolizumab (MK-3475) With or Without Chemotherapy When Used With Investigational Agents in Treatment-naïve Participants With Stage IV Non-small Cell Lung Cancer (NSCLC) (MK-3475-01A/KEYMAKER-U01A) (PHASE1, PHASE2)
- Evaluation of Co-formulated Pembrolizumab/Quavonlimab (MK-1308A) Versus Other Treatments in Participants With Microsatellite Instability-High (MSI-H) or Mismatch Repair Deficient (dMMR) Stage IV Colorectal Cancer (CRC) (MK-1308A-008/KEYSTEP-008) (PHASE2)
- 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) (PHASE3)
- A Study of Pembrolizumab/Vibostolimab (MK-7684A) in Relapsed/Refractory Hematological Malignancies (MK-7684A-004, KEYVIBE-004) (PHASE2)
- Study of Pembrolizumab (MK-3475) Combination Therapies in Metastatic Castration-Resistant Prostate Cancer (MK-3475-365/KEYNOTE-365) (PHASE1, PHASE2)
- Substudy 03A: A Study of Immune and Targeted Combination Therapies in Participants With First Line (1L) Renal Cell Carcinoma (MK-3475-03A) (PHASE1, PHASE2)
- 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) (PHASE3)
- Study of Pembrolizumab (MK-3475) and Pembrolizumab With Other Investigational Agents in Participants With High Risk Non-muscle Invasive Bladder Cancer (MK-3475-057/KEYNOTE-057) (PHASE2)
Primary sources
Every claim on this page is sourced from regulatory or scientific primary sources. See our editorial policy for full methodology.
| Source | Used for |
|---|---|
| ClinicalTrials.gov | Trial enrolment, design, endpoints, results |
Competitive intelligence
For the full competitive landscape — auto-detected comparators, recent regulatory actions across the set, upcoming PDUFA, patent timeline, sponsor landscape:
- Pembrolizumab/Vibostolimab CI brief — competitive landscape report
- Pembrolizumab/Vibostolimab updates RSS · CI watch RSS
- Merck Sharp & Dohme LLC portfolio CI