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NOT YET RECRUITING
NCT07801027
PHASE4

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

Sponsor: Merck Sharp & Dohme LLC

View on ClinicalTrials.gov

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

Official title: A Prospective, Open-label, Phase 4 Study to Evaluate the Safety of Pembrolizumab (KEYTRUDA®) in Combination With Indication-specific Chemotherapy or Chemoradiotherapy in Participants Across Multiple Indications in India (KEYNOTE-G44)

Key Details

Gender

All

Age Range

18 Years - Any

Study Type

INTERVENTIONAL

Enrollment

150

Start Date

2026-11-06

Completion Date

2030-01-31

Last Updated

2026-09-03

Healthy Volunteers

No

Interventions

BIOLOGICAL

Pembrolizumab

Administered as an IV infusion

DRUG

Cisplatin

Administered as an IV infusion

DRUG

5-Fluorouracil

Administered as an IV infusion

DRUG

Oxaliplatin

Administered as an IV infusion

DRUG

Capecitabine

Administered as an oral tablet

DRUG

Gemcitabine

Administered as an IV infusion

RADIATION

External Beam Radiotherapy

External beam radiation per the Radiation Manual

RADIATION

Brachytherapy

Internal radiation - brachytherapy per the Radiation Manual