Clinical trial · Interventional
MK-7684A With or Without Other Anticancer Therapies in Participants With Selected Solid Tumors (MK-7684A-005) (KEYVIBE-005)
A Multicenter, Open-label, Phase 2 Basket Study of MK-7684A, a Co-formation of Vibostolimab (MK-7684) With Pembrolizumab (MK-3475), With or Without Other Anticancer Therapies in Participants With Selected Solid Tumors
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 29, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260929-000001
Summary
Brief summary (as posted)
The purpose of this study is to determine the safety, tolerability, and preliminary efficacy of pembrolizumab/vibostolimab co-formulation (MK-7684A) with or without other anticancer therapies in participants with selected advanced solid tumors. The primary hypothesis is that pembrolizumab/vibostolimab co-formulation is superior to pembrolizumab alone in terms of objective response rate or progression-free survival in participants with cervical cancer.
Conditions
Conditions (11)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Cholangiocarcinoma | Cholangiocarcinoma | ONTOLOGY_EXACT | 0.98 |
| Endometrial Neoplasms | Endometrial Neoplasm | ONTOLOGY_EXACT | 0.98 |
| Esophageal Neoplasms | Esophageal Neoplasm | ONTOLOGY_EXACT | 0.98 |
| Gallbladder Neoplasms | Gallbladder Neoplasm | ONTOLOGY_EXACT | 0.98 |
| Hepatocellular Carcinoma | Hepatocellular Carcinoma | ONTOLOGY_EXACT | 0.98 |
| Ovarian Neoplasms | Ovarian Neoplasm | ONTOLOGY_EXACT | 0.98 |
| Squamous Cell Carcinoma of Head and Neck | Head and Neck Squamous Cell Carcinoma | ALIAS | 0.90 |
Interventions
Interventions (12)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| 5-Fluorouracil | Drug | Fluorouracil | ALIAS |
| Bevacizumab | Drug | Bevacizumab | ALIAS |
| Capecitabine | Drug | Capecitabine | ALIAS |
| Carboplatin | Drug | Carboplatin | ALIAS |
| Cisplatin | Drug | Cisplatin | ALIAS |
| Docetaxel | Drug | Docetaxel | ALIAS |
| Gemcitabine | Drug | Gemcitabine | ALIAS |
| Lenvatinib | Drug | Lenvatinib | ALIAS |
| Oxaliplatin |
Design
Arms and outcomes
Arms (9)
- type
- EXPERIMENTAL
- label
- Pembrolizumab/Vibostolimab Co-Formulation
- description
- Participants receive pembrolizumab/vibostolimab (coformulation of 200 mg pembrolizumab and 200 mg vibostolimab) via intravenous (IV) infusion every 3 weeks (Q3W) up to 35 cycles. Participants receiving pembrolizumab/vibostolimab (coformulation of 200 mg pembrolizumab and 200 mg vibostolimab) will be given the option to transition to pembrolizumab monotherapy.
- interventionNames
- Biological: Pembrolizumab/Vibostolimab Co-Formulation
- Biological: Pembrolizumab
- type
- EXPERIMENTAL
- label
- Pembrolizumab
- description
- Participants receive pembrolizumab 200 mg via IV infusion Q3W up to 35 cycles.
- interventionNames
- Biological: Pembrolizumab
- type
- EXPERIMENTAL
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: * One of the following histologically or cytologically confirmed, advanced (unresectable or metastatic) solid tumors: * Squamous cell carcinoma, adenosquamous carcinoma, or adenocarcinoma of the cervix * Endometrial cancer * Head and neck squamous cell carcinoma (HNSCC) * Unresectable biliary adenocarcinoma (gallbladder or biliary tree \[intrahepatic or extrahepatic\] cholangiocarcinoma) * Adenocarcinoma or squamous cell carcinoma of the esophagus or advanced/metastatic Siewert type 1 adenocarcinoma of the gastroesophageal junction (GEJ). * Triple-negative breast cancer (TNBC) * Hepatocellular carcinoma (HCC) * Urothelial carcinoma of the renal pelvis, ureter, bladder, or urethra * Ovarian cancer * Gastric cancer * Measurable disease per RECIST v1.1 as assessed by BICR or local site investigator. * Adequately controlled blood pressure (BP) with or without antihypertensive medications. * Human immunodeficiency virus (HIV)-infected participants must have well controlled HIV on anti-retroviral therapy (ART). * Male participants must agree to follow contraceptive guidance. * Female participants are not pregnant or breastfeeding, not a woman of child-bearing potential (WOCBP) or is a WOCBP and agrees to follow contraceptive guidance. * Adequate organ function. Exclusion Criteria: * History of a second malignancy, unless potentially curative treatment has been completed with no evidence of malignancy for 3 years. * Prior therapy with anti-programmed cell-death (PD-1), anti-PD-L1, anti-PD-L2, or anti-T-cell immunoreceptor with Ig and ITIM domains (TIGIT) agent. * Prior systemic anticancer therapy including investigational agents within 4 weeks before randomization/allocation. * Received a live or live-attenuated vaccine within 30 days before the first dose of study intervention. Administration of killed vaccines are allowed. * Diagnosis of immunodeficiency or is receiving chronic systemic steroid therapy 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. * Active infection requiring systemic therapy. * Concurrent active hepatitis B and hepatitis C virus infection. * History of allogenic tissue/solid organ transplant. * Previous treatment with lenvatinib (for participants who will receive lenvatinib in their assigned treatment arm). * Has clinically significant cardiovascular disease within 12 months from first dose of study intervention.
References
Publications (0)
Data not yet available