Overview

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).