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
Study ID
NCT07801027
Phase
PHASE4
Status
Not Yet Recruiting

Notify me when recruiting opens

Save your spot on the interest list for this study. We'll keep your details with this study so our team can follow up when recruiting opens.

Not yet recruiting

Add your contact details and location so we can keep your interest tied to this study.

Conditions

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

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • Pembrolizumab — BIOLOGICAL
    Administered as an IV infusion
  • Cisplatin — DRUG
    Administered as an IV infusion
  • 5-Fluorouracil — DRUG
    Administered as an IV infusion
  • Oxaliplatin — DRUG
    Administered as an IV infusion
  • Capecitabine — DRUG
    Administered as an oral tablet
  • Gemcitabine — DRUG
    Administered as an IV infusion
  • External Beam Radiotherapy — RADIATION
    External beam radiation per the Radiation Manual
  • Brachytherapy — RADIATION
    Internal radiation - brachytherapy per the Radiation Manual

Study Details

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

Key Dates

First listed
Sep 3, 2026
Start date
Nov 6, 2026
Status verified
Aug 2026
Primary completion
Jan 31, 2030
Completion
Jan 31, 2030

Study Design

Enrollment
150 participants (estimated)
Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Experimental: Cohort 1 (Gastric)
    Participants with human epidermal growth factor receptor 2 (HER2)-negative advanced gastric or gastroesophageal junction (GEJ) adenocarcinoma with programmed death-ligand 1 (PD-L1) combined positive score (CPS) ≥1 will receive 200 mg of pembrolizumab intravenously (IV) every 3 weeks (Q3W) for maximum of 35 cycles plus either 800mg/m\^2/day of 5-fluorouracil (5-FU) IV on Days 1 through 5, Q3W and 80mg/m\^2 of cisplatin IV on Day 1, Q3W OR 1000mg/m\^2 of capecitabine orally twice daily on Days 1 through 14, Q3W and 130mg/m\^2 oxaliplatin IV on Day 1, Q3W. A cycle is 21 days.
  • Experimental: Cohort 2 (Biliary)
    Participants with advanced/unresectable biliary tract cancer (BTC) will receive 200 mg pembrolizumab IV Q3W for a maximum of 35 cycles plus 1000 mg/m\^2 of gemcitabine IV on Days 1 and 8, Q3W and 25 mg/m\^2 of cisplatin IV on Days 1 and 8, Q3W for a maximum of 8 cycles. A cycle is 21 days.
  • Experimental: Cohort 3 (Cervical)
    Participants with high-risk locally advanced cervical cancer will receive 200 mg pembrolizumab IV Q3W for a maximum of 35 cycles plus 40 mg/m\^2 of cisplatin IV weekly for up to 5 infusions concurrent with radiotherapy (RT) and external beam RT and brachytherapy (BT). A cycle is 21 days.

Primary Outcome Measure

Number of Participants Who Experienced One or More Adverse Events (AEs) [ Time Frame: Up to approximately 27 months ]

Related Studies