Biliary Tract Carcinoma, Gastric Neoplasms, Gastroesophageal Junction Adenocarcinoma, Neoplasm Malignant, Uterine Cervical Neoplasms
Conditions
Brief 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 score \[CPS\] ≥1 * Advanced and/or unresectable biliary tract cancer \[BTC\], and * High-risk, locally advanced cervical cancer
Interventions
BIOLOGICALPembrolizumab
Administered as an IV infusion
DRUGCisplatin
Administered as an IV infusion
DRUG5-Fluorouracil
Administered as an IV infusion
DRUGOxaliplatin
Administered as an IV infusion
DRUGCapecitabine
Administered as an oral tablet
DRUGGemcitabine
Administered as an IV infusion
RADIATIONExternal Beam Radiotherapy
External beam radiation per the Radiation Manual
RADIATIONBrachytherapy
Internal radiation - brachytherapy per the Radiation Manual
Sponsors
Merck Sharp & Dohme LLC
Study design
Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Number of Participants Who Experienced One or More Adverse Events (AEs) | Up to approximately 27 months | 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. |
| Number of Participants Who Discontinued Study Intervention Due to an AE | Up to approximately 24 months | 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. |
Contacts
STUDY_DIRECTORMedical Director
Merck Sharp & Dohme LLC
Outcome results
None listed