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

PRIMARY OUTCOMES

Primary Outcome 1 - Measure: Objective Response Rate (ORR) per Response Evaluation Criteria in Solid Tumors (RECIST) 1.1 as Assessed by Blinded Independent Central Review (BICR)

Primary Outcome 1 - Timeframe: Up to approximately 2 years

Primary Outcome 2 - Measure: Progression-Free Survival (PFS) per RECIST 1.1 as Assessed by BICR

Primary Outcome 2 - Timeframe: Up to approximately 2 years

Primary Outcome 3 - Measure: ORR per RECIST 1.1 as Assessed by Investigator in Participants with Selected Solid Tumors

Primary Outcome 3 - Timeframe: Up to approximately 2 years

Primary Outcome 4 - Measure: PFS per RECIST 1.1 as Assessed by Investigator at 9 months

Primary Outcome 4 - Timeframe: 9 months

Primary Outcome 5 - Measure: PFS per RECIST 1.1 as Assessed by Investigator at 12 months

Primary Outcome 5 - Timeframe: 12 months

CONDITION

• 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

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.

Gender: All

Minimum Age: 18 Years

Maximum Age: N/A

Healthy Volunteers: No

OFFICIAL INFORMATION

Name: Medical Director

Role: Study Director

Affiliation: Merck Sharp & Dohme LLC

Overall Contact

Name: N/A

Phone: N/A

Email: N/A

LOCATION