Can adding immunotherapy to standard cancer care be safe for indian patients?
NCT ID NCT07801027
First seen Sep 03, 2026 · Last updated Sep 04, 2026 · Updated 1 time
Summary
This trial tests whether pembrolizumab, an immunotherapy drug, is safe when combined with chemotherapy or chemoradiotherapy for people in India with advanced gastric or gastroesophageal junction cancer, advanced biliary tract cancer, or high-risk locally advanced cervical cancer. About 150 participants will receive the combination treatment. The main goal is to track side effects and how many people stop treatment due to them.
What this could mean
Our plain-language read of the trial. This is informational only, not medical advice or a prediction.
- Active substance
- pembrolizumab (an immunotherapy drug) combined with chemotherapy or chemoradiotherapy
- What this could lead to
- If it works, this could confirm that pembrolizumab combined with standard treatments is safe for people in India with these cancers, supporting its wider use.
- What could go wrong
- This is a phase 4 safety study, not a test of how well the treatment works. Side effects from combining immunotherapy with chemo or radiation may still occur.
This is an AI summary of the original study and may miss details. Read our disclaimer.
Study facts
What this study's own registry entry says, in plain language.
- Phase
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Phase 4
Runs after approval, following long-term safety and how well the treatment works in everyday use.
- Participants
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About 150 people
The number the study aims to enrol. It can still change while the study runs.
- Expected to start
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Nov 2026
An estimate. Start dates often move.
- Expected to finish
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Jan 2030
An estimate. End dates often move.
- Lead sponsor
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A company
The lead sponsor is a pharmaceutical, biotech, or medical-device company.
Who can take part
This study's own entry requirements. Only the study team can say for certain whether you qualify.
- Ages
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18 years and older
- Sex
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Anyone
- Healthy volunteers
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Not accepted
This study is not open to healthy volunteers. The entry requirements below say who it is open to.
Show the full entry requirements Hide the full entry requirements
Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.
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.
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Conditions
The condition(s) this trial relates to.
As listed by the trial registrant
The condition terms exactly as the trial's registrant entered them.
How to take part
Only the study team decides who joins. These are the ways to reach them.
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The official record
The full official record for this study. This one lists no contact details, but it is the first place any would appear.
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A doctor treating you
A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.
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