drugset
drugset / Trial / NCT05007106

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

NCT05007106 ↗

Phase 2 Completed 613 enrolled Merck Sharp & Dohme LLC
RandomizedParallel-groupOpen-labelTreatment

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.

Timeline

Start
2021-09-16
Primary completion
2025-08-05
Completion
2025-08-05

Drugs

EvaluationDrugModalityDoseRoute
Subject Pembrolizumab Monoclonal antibody 200 mg Intravenous
Subject Vibostolimab Monoclonal antibody 200 mg Intravenous
Background Bevacizumab Monoclonal antibody — Intravenous
Background Capecitabine Small molecule — Oral
Background Carboplatin Small molecule — Intravenous
Background Cisplatin Other / unclassified — Intravenous
Background Docetaxel Small molecule — Intravenous
Background Gemcitabine Small molecule — Intravenous
Background Lenvatinib Small molecule 8 mg Oral
Background Lenvatinib Small molecule 12 mg Oral
Background Lenvatinib Small molecule 20 mg Oral
Background Oxaliplatin Small molecule — Intravenous
Background Paclitaxel Small molecule — Intravenous
Background fluorouracil Small molecule 800 mg/m2 Intravenous

Indications

cholangiocarcinoma endometrium neoplasm gallbladder neoplasm gastric neoplasm head and neck squamous cell carcinoma hepatocellular carcinoma neoplasm of esophagus ovarian neoplasm triple-negative breast carcinoma urinary bladder neoplasm uterine cervix neoplasm