MK-7684A With or Without Other Anticancer Therapies in Participants With Selected Solid Tumors (MK-7684A-005) (KEYVIBE-005)
Completed · Phase 2
Conditions studied: Uterine Cervical Neoplasms, Endometrial Neoplasms, Squamous Cell Carcinoma of Head and Neck, Gallbladder Neoplasms, Cholangiocarcinoma, Esophageal Neoplasms, Triple Negative Breast Neoplasms, Hepatocellular Carcinoma, Urinary Bladder Neoplasms, Ovarian Neoplasms, Stomach Neoplasms
In brief
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.
Key facts
- Study ID
- NCT05007106
- Run by
- Merck Sharp & Dohme LLC
- People needed
- 613
- Starts
- 2021-09-16
- Expected to finish
- 2025-08-05
- Last updated by the study team
- 2025-08-14
Who can join
Age: 18 and older. Sex: any. Healthy volunteers: not accepted.
You may qualify if…
- 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.
You may not qualify if…
- 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.
Where it is running
- City of Hope Comprehensive Cancer Center ( Site 1001) — Duarte, California, United States
- University of California, Irvine (UCI) Health - UC Irvine Me-Chao Family Comprehensive Cancer Cente — Orange, California, United States
- Karmanos Cancer Institute ( Site 1007) — Detroit, Michigan, United States
- Memorial Sloan Kettering - Basking Ridge ( Site 1023) — Basking Ridge, New Jersey, United States
- Memorial Sloan Kettering - Monmouth ( Site 1022) — Middletown, New Jersey, United States
- Memorial Sloan Kettering - Bergen ( Site 1025) — Montvale, New Jersey, United States
- Memorial Sloan Kettering- Commack ( Site 1021) — Commack, New York, United States
- Memorial Sloan Kettering - Westchester ( Site 1020) — Harrison, New York, United States
- Memorial Sloan Kettering Cancer Center ( Site 1002) — New York, New York, United States
- Memorial Sloan Kettering - Nassau ( Site 1026) — Uniondale, New York, United States
- Oklahoma Cancer Specialists and Research Institute, LLC ( Site 1024) — Tulsa, Oklahoma, United States
- Sanford Cancer Center-Gynecologic Oncology ( Site 1015) — Sioux Falls, South Dakota, United States
- Houston Methodist Hospital ( Site 1017) — Houston, Texas, United States
- Kingston Health Sciences Centre-Kingston General Hospital Site ( Site 1051) — Kingston, Ontario, Canada
- Princess Margaret Cancer Centre ( Site 1056) — Toronto, Ontario, Canada
- James Lind Centro de Investigacion del Cancer ( Site 1404) — Temuco, Araucania, Chile
- FALP-UIDO ( Site 1401) — Santiago, Region M. de Santiago, Chile
- Oncovida ( Site 1405) — Santiago, Region M. de Santiago, Chile
- Bradfordhill-Clinical Area ( Site 1402) — Santiago, Region M. de Santiago, Chile
- Fundacion Colombiana de Cancerología Clinica Vida ( Site 1422) — Medellín, Antioquia, Colombia
- Clinica de la Costa S.A.S. ( Site 1421) — Barranquilla, Atlántico, Colombia
- Instituto Nacional de Cancerología-Clinical Oncology ( Site 1425) — Bogotá, Cundinamarca, Colombia
- Oncologos del Occidente ( Site 1424) — Pereira, Risaralda Department, Colombia
- Fundación Cardiovascular de Colombia ( Site 1423) — Piedecuesta, Santander Department, Colombia
- Alaska Womens Cancer Care ( Site 1016) — Anchorage, Alaska, United States
Full record on ClinicalTrials.gov
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