[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100654671":3},{"organization":4,"outcomesModule":7,"designInfo":18,"detailedDescription":17,"studyPopulation":17,"armGroups":24,"interventions":46,"overallOfficials":92,"centralContacts":17,"locations":17,"responsibleParty":96,"collaborators":17,"id":98,"slug":99,"hasResults":100,"nctId":101,"briefTitle":102,"officialTitle":103,"acronym":17,"eligibilityCriteria":104,"healthyVolunteers":100,"sex":105,"minAge":106,"maxAge":17,"enrollmentInfo":107,"targetDuration":17,"studyType":110,"phases":111,"briefSummary":113,"conditions":114,"keywords":17,"overallStatus":120,"whyStopped":17,"lastUpdateSubmitDate":121,"lastUpdatePostDateStruct":122,"startDateStruct":125,"completionDateStruct":127,"leadSponsor":129,"locationsCount":17},{"fullName":5,"class":6},"Merck Sharp & Dohme LLC","INDUSTRY",{"primaryOutcomes":8,"secondaryOutcomes":17,"otherOutcomes":17},[9,13],{"measure":10,"description":11,"timeFrame":12},"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.","Up to approximately 27 months",{"measure":14,"description":15,"timeFrame":16},"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.","Up to approximately 24 months",null,{"allocation":19,"interventionModel":20,"interventionModelDescription":17,"primaryPurpose":21,"observationalModel":17,"timePerspective":17,"maskingInfo":22},"NON_RANDOMIZED","PARALLEL","TREATMENT",{"masking":23,"maskingDescription":17,"whoMasked":17},"NONE",[25,35,40],{"label":26,"type":27,"description":28,"interventionNames":29},"Cohort 1 (Gastric)","EXPERIMENTAL","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\u002Fm\\^2\u002Fday of 5-fluorouracil (5-FU) IV on Days 1 through 5, Q3W and 80mg\u002Fm\\^2 of cisplatin IV on Day 1, Q3W OR 1000mg\u002Fm\\^2 of capecitabine orally twice daily on Days 1 through 14, Q3W and 130mg\u002Fm\\^2 oxaliplatin IV on Day 1, Q3W. A cycle is 21 days.",[30,31,32,33,34],"Biological: Pembrolizumab","Drug: Cisplatin","Drug: 5-Fluorouracil","Drug: Oxaliplatin","Drug: Capecitabine",{"label":36,"type":27,"description":37,"interventionNames":38},"Cohort 2 (Biliary)","Participants with advanced\u002Funresectable biliary tract cancer (BTC) will receive 200 mg pembrolizumab IV Q3W for a maximum of 35 cycles plus 1000 mg\u002Fm\\^2 of gemcitabine IV on Days 1 and 8, Q3W and 25 mg\u002Fm\\^2 of cisplatin IV on Days 1 and 8, Q3W for a maximum of 8 cycles. A cycle is 21 days.",[30,31,39],"Drug: Gemcitabine",{"label":41,"type":27,"description":42,"interventionNames":43},"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\u002Fm\\^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.",[30,31,44,45],"Radiation: External Beam Radiotherapy","Radiation: Brachytherapy",[47,55,61,67,72,78,83,88],{"type":48,"name":49,"description":50,"armGroupLabels":51,"otherNames":52},"BIOLOGICAL","Pembrolizumab","Administered as an IV infusion",[26,36,41],[53,54],"MK-3475","KEYTRUDA®",{"type":56,"name":57,"description":50,"armGroupLabels":58,"otherNames":59},"DRUG","Cisplatin",[26,36,41],[60],"Platinol-AQ",{"type":56,"name":62,"description":50,"armGroupLabels":63,"otherNames":64},"5-Fluorouracil",[26],[65,66],"ADRUCIL","5-FU",{"type":56,"name":68,"description":50,"armGroupLabels":69,"otherNames":70},"Oxaliplatin",[26],[71],"ELOXATIN",{"type":56,"name":73,"description":74,"armGroupLabels":75,"otherNames":76},"Capecitabine","Administered as an oral tablet",[26],[77],"XELODA",{"type":56,"name":79,"description":50,"armGroupLabels":80,"otherNames":81},"Gemcitabine",[36],[82],"GEMZAR",{"type":84,"name":85,"description":86,"armGroupLabels":87,"otherNames":17},"RADIATION","External Beam Radiotherapy","External beam radiation per the Radiation Manual",[41],{"type":84,"name":89,"description":90,"armGroupLabels":91,"otherNames":17},"Brachytherapy","Internal radiation - brachytherapy per the Radiation Manual",[41],[93],{"name":94,"affiliation":5,"role":95},"Medical Director","STUDY_DIRECTOR",{"type":97,"investigatorFullName":17,"investigatorTitle":17,"investigatorAffiliation":17,"oldNameTitle":17,"oldOrganization":17},"SPONSOR","100654671","phase-4-a-trial-of-pembrolizumab-with-chemotherapy-or-chemoradiotherapy-in-participants-from-india-with-different-types-of-cancer-mk-3475-g44keynote-g44-100654671",false,"NCT07801027","A Trial of Pembrolizumab With Chemotherapy or Chemoradiotherapy in Participants From India With Different Types of Cancer (MK-3475-G44\u002FKEYNOTE-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)","Inclusion Criteria:\n\nCohort 1:\n\n* 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.\n* Has locally confirmed human epidermal growth factor receptor 2 (HER2) negative cancer.\n\nCohort 2:\n\n\\- Has a histologically confirmed diagnosis of advanced (metastatic) and\u002For unresectable (locally advanced) biliary tract cancer (BTC) (intra or extrahepatic cholangiocarcinoma or gallbladder cancer).\n\nCohort 3:\n\n* Has high-risk locally advanced cervical cancer.\n* Has histologically confirmed squamous cell carcinoma, adenocarcinoma, or adenosquamous carcinoma of the cervix.\n\nAll Cohorts:\n\n* 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.\n* If history of hepatitis C virus (HCV) infection, has undetectable HCV viral load.\n\nExclusion Criteria:\n\nCohort 1:\n\n* Has squamous cell or undifferentiated gastric cancer.\n* Has had previous therapy for locally advanced, unresectable or metastatic gastric\u002FGEJ cancer.\n* Has known active central nervous system (CNS) metastases and\u002For carcinomatous meningitis.\n* Has had major surgery, open biopsy, or significant traumatic injury within 28 days prior to first dose of study.\n* 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.\n\nCohort 2:\n\n* Has ampullary cancer.\n* Has small cell cancer, neuroendocrine tumors, lymphoma, sarcoma, mixed tumor histology, and\u002For mucinous cystic neoplasms.\n* 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\u002Fadjuvant therapy, which is allowed.\n* Has known active CNS metastases and\u002For carcinomatous meningitis.\n* 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.\n\nCohort 3:\n\n\\- 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.\n\nAll Cohorts:\n\n* Has hypokalemia.\n* Has hypomagnesemia.\n* Has hypocalcemia.\n* 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.\n* Has active autoimmune disease that has required systemic treatment in the past 2 years.\n* Has history of (noninfectious) pneumonitis\u002Finterstitial lung disease that required steroids or current pneumonitis\u002Finterstitial lung disease.\n* Has a known additional invasive malignancy that is progressing or has required active treatment within the past 3 years.\n* Has history of human immunodeficiency virus (HIV) infection.\n* Has known active tuberculosis.\n* Has not adequately recovered from major surgery or is having ongoing surgical complications.","ALL","18 Years",{"count":108,"type":109},150,"ESTIMATED","INTERVENTIONAL",[112],"PHASE4","The goal of this study is to assess the safety of pembrolizumab with chemotherapy or chemoradiotherapy in participants in India for:\n\n* 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\n* Advanced and\u002For unresectable biliary tract cancer \\[BTC\\], and\n* High-risk, locally advanced cervical cancer",[115,116,117,118,119],"Neoplasm Malignant","Gastric Neoplasms","Gastroesophageal Junction Adenocarcinoma","Biliary Tract Carcinoma","Uterine Cervical Neoplasms","NOT_YET_RECRUITING","2026-08-28",{"date":123,"type":124},"2026-09-03","ACTUAL",{"date":126,"type":109},"2026-11-06",{"date":128,"type":109},"2030-01-31",{"name":5,"class":6}]