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
The goal of this study is to assess the safety of pembrolizumab with chemotherapy or chemoradiotherapy in participants in India for:
Cohort 1:
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:
All Cohorts:
Exclusion Criteria:
Cohort 1:
Cohort 2:
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:
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
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
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
Administered as an IV infusion
Also known as: MK-3475, KEYTRUDA®
Administered as an IV infusion
Also known as: Platinol-AQ
Administered as an IV infusion
Also known as: ADRUCIL, 5-FU
Administered as an IV infusion
Also known as: ELOXATIN
Administered as an oral tablet
Also known as: XELODA
Administered as an IV infusion
Also known as: GEMZAR
External beam radiation per the Radiation Manual
Internal radiation - brachytherapy per the Radiation Manual
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
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
No study locations are listed for this record.
Plan to share: Yes — https://trialstransparency.msdclinicaltrials.com/pdf/ProcedureAccessClinicalTrialData.pdf
No publications or documents are linked to this record.
This study is not yet recruiting, as verified in Aug 2026. You cannot join it, but the record below documents what was studied.
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Merck Sharp & Dohme LLC