Overview
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.
Eligibility
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.