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

NCT07801027 · Status: NOT_YET_RECRUITING · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 150

Last updated 2026-09-03

No results posted yet for this study

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

Conditions

  • Neoplasm Malignant
  • Gastric Neoplasms
  • Gastroesophageal Junction Adenocarcinoma
  • Biliary Tract Carcinoma
  • Uterine Cervical Neoplasms

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

Sponsors & Collaborators

Principal Investigators

  • Medical Director · Merck Sharp & Dohme LLC

Study Design

Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

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

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT07801027 on ClinicalTrials.gov