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NCT07801027Not yet recruitingPhase 4

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

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)

Source: ClinicalTrials.gov · Last updated 3 Sept 2026

Brief summary (registry, in English)

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

Status (registry)
Not yet recruiting
Phase (registry)
Phase 4
Study type
Interventional
Enrollment
150 (estimated)
First submitted
28 Aug 2026
Start date
6 Nov 2026
Primary completion date
31 Jan 2030
Lead sponsor
Merck Sharp & Dohme LLC
NCT number
NCT07801027

What you commit to

  • Study type: Interventional · Phase 4
  • Planned participants: 150
  • From 6 Nov 2026 to the primary completion date, 31 Jan 2030
  • No sites listed in no country
  • Visits and tests: ask the trial team, the registry does not list them

Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.

Who cannot take part

Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.

Prior treatment

  • Has had previous therapy for locally advanced, unresectable or metastatic gastric/GEJ cancer.
  • 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 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.
  • 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:
  • 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 not adequately recovered from major surgery or is having ongoing surgical complications.

Other illness

  • Has squamous cell or undifferentiated gastric cancer.
  • Has ampullary cancer.
  • Has small cell cancer, neuroendocrine tumors, lymphoma, sarcoma, mixed tumor histology, and/or mucinous cystic neoplasms.
  • 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.

Other

  • Cohort 1:
  • Has known active central nervous system (CNS) metastases and/or carcinomatous meningitis.
  • Has known active CNS metastases and/or carcinomatous meningitis.
  • Has hypokalemia.
  • Has hypomagnesemia.
  • Has hypocalcemia.

Who the study is looking for

  • 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.

Age in the registry: 18 years to - · Sex: All · Does not accept healthy volunteers

Full criteria on ClinicalTrials.gov

This page is information, not medical advice. Discuss any trial with your doctor.