drugset / Trial / NCT07801027

A Trial of Pembrolizumab With Chemotherapy or Chemoradiotherapy in Participants From India With Different Types of Cancer (MK-3475-G44/KEYNOTE-G44)

NCT07801027 ↗

Phase 4 Not yet recruiting 150 enrolled Merck Sharp & Dohme LLC
Non-randomizedParallel-groupOpen-labelTreatment

Summary

The goal of this study is to assess the safety of pembrolizumab with chemotherapy or chemoradiotherapy in participants in India for: * Advanced gastric or gastroesophageal junction \[GEJ\] cancer that is (human epidermal growth factor receptor 2 \[HER2\]-negative and has a programmed death-ligand 1 \[PD-L1\] combined positive score \[CPS\] ≥1 * Advanced and/or unresectable biliary tract cancer \[BTC\], and * High-risk, locally advanced cervical cancer

Timeline

Start
2026-11-06
Primary completion
2030-01-31
Completion
2030-01-31

Drugs

EvaluationDrugModalityDoseRoute
Subject Capecitabine Small molecule 1000 mg/m2 Oral
Subject Cisplatin Other / unclassified 25 mg/m2 Intravenous
Subject Cisplatin Other / unclassified 40 mg/m2 Intravenous
Subject Cisplatin Other / unclassified 80 mg/m2 Intravenous
Subject Gemcitabine Small molecule 1000 mg/m2 Intravenous
Subject Oxaliplatin Small molecule 130 mg/m2 Intravenous
Subject Pembrolizumab Monoclonal antibody 200 mg Intravenous
Subject fluorouracil Small molecule 800 mg/m2 Intravenous