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

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.

Conditions

• 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

Interventions

BIOLOGICAL

Pembrolizumab/Vibostolimab Co-Formulation

Pembrolizumab 200 mg plus vibostolimab 200 mg administered via IV infusion Q3W

BIOLOGICAL

Pembrolizumab

Pembrolizumab 200 mg administered via IV infusion Q3W.

DRUG

Lenvatinib

Lenvatinib 20 mg, 12 mg, or 8 mg (dependent on cancer type and body weight) administered via oral capsule QD

DRUG

5-Fluorouracil

5-FU 800 mg/m\^2/day administered via continuous IV infusion on each of days 1 to 5 Q3W for up to 35 cycles

DRUG

Cisplatin

Cisplatin administered via IV infusion

DRUG

Paclitaxel

Paclitaxel administered via IV infusion at investigator's choice of dose

DRUG

Gemcitabine

Gemcitabine administered via IV infusion on Day 1 and Day 8 of each 3-week cycle, until PD or unacceptable toxicity

DRUG

Carboplatin

Carboplatin administered via IV infusion at investigator's choice of dose and frequency

DRUG

Docetaxel

For participants who cannot receive paclitaxel due to hypersensitivity or adverse event (AE), docetaxel administered via IV infusion Q3W, Day 1 of each cycle for up to 5 cycles

DRUG

Bevacizumab

Bevacizumab (or biosimilars such as MVASI®, Zirabev®, Aybintio®, ALYMSYS®, Abevmy®, Onbevezy®, Vegzelma®) administered via IV infusion Q3W; Day 1 of each 3-week cycle for up to 15 cycles

DRUG

Capecitabine

Capecitabine administered via oral tablet twice daily on Days 1 to 14 of each cycle (Q3W) for up to 35 cycles

DRUG

Oxaliplatin

Oxaliplatin administered via IV infusion Q3W up to 35 cycles

Sponsors & Collaborators

• Merck Sharp & Dohme LLC

  lead INDUSTRY

Principal Investigators

• Medical Director · Merck Sharp & Dohme LLC

Study Design

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Model

PARALLEL

Eligibility

Min Age

18 Years

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2021-09-16

Primary Completion

2025-08-05

Completion

2025-08-05

FDA Drug

Yes

Countries

• United States
• Canada
• Chile
• Colombia
• France
• Germany
• Israel
• Italy
• Japan
• Netherlands
• Poland
• South Korea
• Spain
• Taiwan
• Turkey (Türkiye)

Study Locations