NCT05007106

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

A Multicenter, Open-label, Phase 2 Basket Study of MK-7684A, a Co-formation of Vibostolimab (MK-7684) With Pembrolizumab (MK-3475), With or Without Other Anticancer Therapies in Participants With Selected Solid Tumors

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 613 (actual)
• Sponsor: Merck Sharp & Dohme LLC · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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

Type	Name	Description
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

Timeline

• Start date: 2021-09-16
• Primary completion: 2025-08-05
• Completion: 2025-08-05
• First posted: 2021-08-16
• Last updated: 2025-08-14

Locations

73 sites across 15 countries: United States, Canada, Chile, Colombia, France, Germany, Israel, Italy, Japan, Netherlands, Poland, South Korea, Spain, Taiwan, Turkey (Türkiye)

Regulatory

• FDA-regulated drug study