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)
| Registry | NCT07801027 |
|---|---|
| Status | Not yet recruiting |
| Phase | Phase 4 |
| Study type | Interventional; non randomized, parallel, masking: none, treatment |
| Enrollment | 150 (Estimated) |
| Sponsor | Merck Sharp & Dohme LLC (Industry) |
| Conditions | Neoplasm Malignant, Gastric Neoplasms, Gastroesophageal Junction Adenocarcinoma, Biliary Tract Carcinoma, Uterine Cervical Neoplasms |
| Interventions | Pembrolizumab, Cisplatin, 5-Fluorouracil, Oxaliplatin, Capecitabine, Gemcitabine, External Beam Radiotherapy, Brachytherapy (Biological, drug, radiation) |
| Dates | start 2026-11-06 (estimated), primary completion 2030-01-31 (estimated), completion 2030-01-31 (estimated), first posted 2026-09-03, last updated 2026-09-03 |
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All trials for Neoplasm Malignant All trials for Gastric Neoplasms All trials of Pembrolizumab All trials of Cisplatin
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
| Arm | Type | Interventions | Description |
|---|---|---|---|
| Cohort 1 (Gastric) | Experimental | Biological: Pembrolizumab; Drug: Cisplatin; Drug: 5-Fluorouracil; Drug: Oxaliplatin; Drug: Capecitabine | 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. |
| Cohort 2 (Biliary) | Experimental | Biological: Pembrolizumab; Drug: Cisplatin; Drug: Gemcitabine | 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. |
| Cohort 3 (Cervical) | Experimental | Biological: Pembrolizumab; Drug: Cisplatin; Radiation: External Beam Radiotherapy; Radiation: Brachytherapy | 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. |
Sex: All, ages: 18 Years to any
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: 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.