MK-7684A With or Without Other Anticancer Therapies in Participants With Selected Solid Tumors (MK-7684A-005)

• Status: Recruiting
• Trial end date: 2025-02-19
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Merck Sharp & Dohme Corp.
• Treatments: Fluorouracil; Lenvatinib; Paclitaxel; Pembrolizumab

Criteria

Inclusion Criteria:

• One of the following histologically or cytologically confirmed, advanced (locally recurrent unresectable or metastatic) solid tumors:

• Squamous cell carcinoma, adenosquamous carcinoma, or adenocarcinoma of the cervix

• Endometrial cancer

• Head and neck swuamous 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)

• 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).

• History of congestive heart failure or myocardial infarction within 6 months of treatment (for participants who will receive paclitaxel in their assigned allocation arm).