Summary
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.
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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.