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Not yet recruitingNCT07801027Updated Sep 3, 2026

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

A Phase 4 interventional study of Pembrolizumab and Cisplatin in Neoplasm Malignant, Gastric Neoplasms and Gastroesophageal Junction Adenocarcinoma, sponsored by Merck Sharp & Dohme LLC. Not yet recruiting. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-09-03.

Sponsored by Merck Sharp & Dohme LLC · Phase 4, Interventional, and Treatment

Phase
Phase 4
Study type
Interventional
Enrollment
150
Allocation
Non-randomized
Ages
18 Years and older
Sex
All
01

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
02

Conditions studied

  • Neoplasm Malignant
  • Gastric Neoplasms
  • Gastroesophageal Junction Adenocarcinoma
  • Biliary Tract Carcinoma
  • Uterine Cervical Neoplasms
03

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
No

Inclusion criteria

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.

Exclusion criteria

Exclusion Criteria:

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:

  • Has hypokalemia.
  • Has hypomagnesemia.
  • Has hypocalcemia.
  • Received prior therapy with an anti-programmed cell death protein 1 (PD-1), anti-PD-L1, or anti-programmed death-ligand 2 (PD-L2) agent, or with an agent directed to another stimulatory or coinhibitory T-cell receptor.
  • Has active autoimmune disease that has required systemic treatment in the past 2 years.
  • Has history of (noninfectious) pneumonitis/interstitial lung disease that required steroids or current pneumonitis/interstitial lung disease.
  • Has a known additional invasive malignancy that is progressing or has required active treatment within the past 3 years.
  • Has history of human immunodeficiency virus (HIV) infection.
  • Has known active tuberculosis.
  • Has not adequately recovered from major surgery or is having ongoing surgical complications.
04

Study design

Phase
Phase 4
Primary purpose
Treatment
Allocation
Non-randomized
Intervention model
Parallel assignment
Masking
None (open label)
Enrollment
150 participants (estimated)

Study 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.

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

  • 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.

    Biological: Pembrolizumab · Drug: Cisplatin · Drug: Gemcitabine

  • 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.

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

Interventions

  • BiologicalPembrolizumab

    Administered as an IV infusion

    Also known as: MK-3475, KEYTRUDA®

  • DrugCisplatin

    Administered as an IV infusion

    Also known as: Platinol-AQ

  • Drug5-Fluorouracil

    Administered as an IV infusion

    Also known as: ADRUCIL, 5-FU

  • DrugOxaliplatin

    Administered as an IV infusion

    Also known as: ELOXATIN

  • DrugCapecitabine

    Administered as an oral tablet

    Also known as: XELODA

  • DrugGemcitabine

    Administered as an IV infusion

    Also known as: GEMZAR

  • RadiationExternal Beam Radiotherapy

    External beam radiation per the Radiation Manual

  • RadiationBrachytherapy

    Internal radiation - brachytherapy per the Radiation Manual

05

What researchers measure

Primary outcomes

  1. 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.

    Time frame: Up to approximately 27 months

  2. 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.

    Time frame: Up to approximately 24 months

06

Study locations

No study locations are listed for this record.

07

References and documents

Individual participant data

Plan to share: Yes — https://trialstransparency.msdclinicaltrials.com/pdf/ProcedureAccessClinicalTrialData.pdf

No publications or documents are linked to this record.

08

Registry details

Key details

Study ID
NCT07801027
Lead sponsor
Merck Sharp & Dohme LLC
Responsible party
Sponsor
First posted
Sep 3, 2026
Start date
Nov 6, 2026 (estimated)
Primary completion
Jan 31, 2030 (estimated)
Completion
Jan 31, 2030 (estimated)
Last update
Sep 3, 2026

Study contacts

Medical Director
study director · Merck Sharp & Dohme LLC

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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