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

NCT07801027 | Not Yet Recruiting Phase 4

• 3 other identifiers: 3475-G44MK-3475-G44KEYNOTE-G44
• Study Type: interventional
• Target: 150
• Locations: 0 countries
• Sites: N/A

Brief 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

Outcome Measures

Primary Outcomes (2)

• Number of Participants Who Experienced One or More Adverse Events (AEs)

  An AE is any untoward medical occurrence in a clinical study participant, temporally associated with the use of study intervention, whether or not considered related to the study intervention. The number of participants that experience AEs will be reported.

  Up to approximately 27 months

• Number of Participants Who Discontinued Study Intervention Due to an AE

  An AE is any untoward medical occurrence in a clinical study participant, temporally associated with the use of study intervention, whether or not considered related to the study intervention. The number of participants who discontinue study intervention due to AEs will be reported.

  Up to approximately 24 months

Study Arms (3)

Cohort 1 (Gastric)

EXPERIMENTAL

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.

Biological: Pembrolizumab; Drug: Cisplatin; Drug: 5-Fluorouracil; Drug: Oxaliplatin; Drug: Capecitabine

Cohort 2 (Biliary)

EXPERIMENTAL

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.

Biological: Pembrolizumab; Drug: Cisplatin; Drug: Gemcitabine

Cohort 3 (Cervical)

EXPERIMENTAL

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.

Biological: Pembrolizumab; Drug: Cisplatin; Radiation: External Beam Radiotherapy; Radiation: Brachytherapy

Interventions

Pembrolizumab BIOLOGICAL

Administered as an IV infusion

Also known as: MK-3475, KEYTRUDA®

Cohort 1 (Gastric); Cohort 2 (Biliary); Cohort 3 (Cervical)

Cisplatin DRUG

Administered as an IV infusion

Also known as: Platinol-AQ

Cohort 1 (Gastric); Cohort 2 (Biliary); Cohort 3 (Cervical)

5-Fluorouracil DRUG

Administered as an IV infusion

Also known as: ADRUCIL, 5-FU

Cohort 1 (Gastric)

Oxaliplatin DRUG

Administered as an IV infusion

Also known as: ELOXATIN

Cohort 1 (Gastric)

Capecitabine DRUG

Administered as an oral tablet

Also known as: XELODA

Cohort 1 (Gastric)

Gemcitabine DRUG

Administered as an IV infusion

Also known as: GEMZAR

Cohort 2 (Biliary)

External Beam Radiotherapy RADIATION

External beam radiation per the Radiation Manual

Cohort 3 (Cervical)

Brachytherapy RADIATION

Internal radiation - brachytherapy per the Radiation Manual

Cohort 3 (Cervical)

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Cohort 1:
• The participant must have a histologically or cytologically confirmed diagnosis of locally advanced unresectable or metastatic gastric or gastroesophageal junction (GEJ) adenocarcinoma, with locally confirmed programmed death-ligand 1 (PD-L1) CPS ≥1.
• Has locally confirmed human epidermal growth factor receptor 2 (HER2) negative cancer.
• Cohort 2:
• \- Has a histologically confirmed diagnosis of advanced (metastatic) and/or unresectable (locally advanced) biliary tract cancer (BTC) (intra or extrahepatic cholangiocarcinoma or gallbladder cancer).
• Cohort 3:
• Has high-risk locally advanced cervical cancer.
• Has histologically confirmed squamous cell carcinoma, adenocarcinoma, or adenosquamous carcinoma of the cervix.
• All Cohorts:
• If hepatitis B surface antigen (HBsAg)-positive, has undetectable hepatitis B virus (HBV) viral load and has received HBV antiviral therapy for at least 4 weeks and will continue it.
• If history of hepatitis C virus (HCV) infection, has undetectable HCV viral load.

You may not qualify if:

• Cohort 1:
• Has squamous cell or undifferentiated gastric cancer.
• Has had previous therapy for locally advanced, unresectable or metastatic gastric/GEJ cancer.
• Has known active central nervous system (CNS) metastases and/or carcinomatous meningitis.
• Has had major surgery, open biopsy, or significant traumatic injury within 28 days prior to first dose of study.
• Had active hemoptysis (bright red blood of at least 0.5 teaspoon) within 3 weeks or tumor bleeding within 2 weeks prior to the first dose of study intervention.
• Cohort 2:
• Has ampullary cancer.
• Has small cell cancer, neuroendocrine tumors, lymphoma, sarcoma, mixed tumor histology, and/or mucinous cystic neoplasms.
• Has had previous systemic therapy for advanced (metastatic) or unresectable (locally advanced) BTC (intra or extrahepatic cholangiocarcinoma or gallbladder cancer), with the exception of neoadjuvant/adjuvant therapy, which is allowed.
• Has known active CNS metastases and/or carcinomatous meningitis.
• Had active hemoptysis (bright red blood of at least 0.5 teaspoon) within 3 weeks or tumor bleeding within 2 weeks prior to the first dose of study intervention.
• Cohort 3:
• \- Has undergone a previous hysterectomy defined as removal of the entire uterus or will have a hysterectomy as part of their initial cervical cancer therapy.
• All Cohorts:

Sponsors & Collaborators

• Merck Sharp & Dohme LLC: lead

MeSH Terms

Conditions

Neoplasms; Stomach Neoplasms; Uterine Cervical Neoplasms

Interventions

pembrolizumab; Cisplatin; Fluorouracil; Oxaliplatin; Capecitabine; Gemcitabine; Brachytherapy

Condition Hierarchy (Ancestors)

Gastrointestinal Neoplasms; Digestive System Neoplasms; Neoplasms by Site; Digestive System Diseases; Gastrointestinal Diseases; Stomach Diseases; Uterine Neoplasms; Genital Neoplasms, Female; Urogenital Neoplasms; Uterine Cervical Diseases; Uterine Diseases; Genital Diseases, Female; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Genital Diseases

Intervention Hierarchy (Ancestors)

Chlorine Compounds; Inorganic Chemicals; Nitrogen Compounds; Platinum Compounds; Uracil; Pyrimidinones; Pyrimidines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Coordination Complexes; Organic Chemicals; Deoxycytidine; Cytidine; Pyrimidine Nucleosides; Deoxyribonucleosides; Nucleosides; Nucleic Acids, Nucleotides, and Nucleosides; Radiotherapy; Therapeutics

Study Officials

• Medical Director

  Merck Sharp & Dohme LLC

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 28, 2026
• First Posted: September 3, 2026
• Study Start (Estimated): November 6, 2026
• Primary Completion (Estimated): January 31, 2030
• Study Completion (Estimated): January 31, 2030
• Last Updated: September 3, 2026

Record last verified: 2026-08

Data Sharing

• IPD Sharing: Will share