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Neoplasm MalignantPhase 4NCT07801027

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 study testing Pembrolizumab, Cisplatin and 5-Fluorouracil in people with Neoplasm Malignant and Gastric Neoplasms, run by Merck Sharp & Dohme LLC.

Not yet recruiting

Opening soon. The study is approved but enrolment has not started yet. Sites may already take enquiries.

Official record
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Trial 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… Read more about this study

Who is it for?
Ages 18 years and older
What is being tested?
Pembrolizumab, Cisplatin and 5-Fluorouracil
Could I receive a placebo?
No, everyone receives an active treatment
How many people
150 participants
Where
No sites listed yet
Study dates
6 Nov 2026to 31 Jan 2030
Phase
Phase 4
Are there results?
Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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:
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  • 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.

Who cannot join

  • 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.
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  • 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.

About this study

Official title: 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)

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
Medical subject headings
Neoplasms, Stomach Neoplasms, Uterine Cervical Neoplasms

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • PembrolizumabBiological

    Also called MK-3475, KEYTRUDA®

    Administered as an IV infusion

  • CisplatinDrug

    Also called Platinol-AQ

    Administered as an IV infusion

  • 5-FluorouracilDrug

    Also called ADRUCIL, 5-FU

    Administered as an IV infusion

  • OxaliplatinDrug

    Also called ELOXATIN

    Administered as an IV infusion

  • CapecitabineDrug

    Also called XELODA

    Administered as an oral tablet

  • GemcitabineDrug

    Also called GEMZAR

    Administered as an IV infusion

  • External Beam RadiotherapyRadiation

    External beam radiation per the Radiation Manual

  • BrachytherapyRadiation

    Internal radiation - brachytherapy per the Radiation Manual

Study groups in NCT07801027
Study groupRoleWhat they receive
Cohort 1 (Gastric)ExperimentalParticipants 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.
Receives: Biological: Pembrolizumab; Drug: Cisplatin; Drug: 5-Fluorouracil; Drug: Oxaliplatin; Drug: Capecitabine
Cohort 2 (Biliary)ExperimentalParticipants 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.
Receives: Biological: Pembrolizumab; Drug: Cisplatin; Drug: Gemcitabine
Cohort 3 (Cervical)ExperimentalParticipants 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.
Receives: Biological: Pembrolizumab; Drug: Cisplatin; Radiation: External Beam Radiotherapy; Radiation: Brachytherapy

What is being measured

The primary outcome is the main question the study is designed to answer.

  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.

    Measured: 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.

    Measured: Up to approximately 24 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted3 Sep 2026
  2. Study start6 Nov 2026 (estimated)
  3. Primary completion31 Jan 2030 (estimated)
  4. Study completion31 Jan 2030 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 4
Primary purpose
Treatment
Allocation
Non-randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
150 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT07801027
Sponsor's protocol ID
3475-G44
Other IDs
MK-3475-G44, KEYNOTE-G44
Status last verified
Aug 2026
First submitted
28 Aug 2026
Last updated
3 Sep 2026
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
Yes: https://trialstransparency.msdclinicaltrials.com/pdf/ProcedureAccessClinicalTrialData.pdf

Questions about this trial

What is this clinical trial studying?

A Phase 4 study testing Pembrolizumab, Cisplatin and 5-Fluorouracil in people with Neoplasm Malignant and Gastric Neoplasms, run by Merck Sharp & Dohme LLC.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 11 inclusion and 25 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: opening soon, as of the sponsor's last update on 3 Sep 2026. Status can change between updates, so confirm with the study contact before making plans.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Number of Participants Who Experienced One or More Adverse Events (AEs) (time frame: Up to approximately 27 months). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT07801027.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 3 Sep 2026.

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