RecruitingPhase 2NCT06178445

Efficacy and Safety of GemCis Plus Trastuzumab Plus Pembrolizumab in Previously Untreated HER2-positive Biliary Tract Cancer

Sponsor

Institut für Klinische Krebsforschung IKF GmbH at Krankenhaus Nordwest

Enrollment

24 participants

Start Date

Apr 17, 2024

Study Type

INTERVENTIONAL

Conditions

Biliary Tract Cancer HER2 HER2 Gene Mutation

Summary

This is a multicenter, single arm, prospective, open-label phase II trial investigating the clinical activity triplet regimen consisting of a combination of chemotherapy (gemcitabine/cisplatin) + trastuzumab + pembrolizumab as first-line treatment for cholangiocarcinoma and gallbladder cancer patients. Patients suffering from previously untreated HER2 (human epidermal growth factor receptor 2) positive, unresectable cholangiocarcinoma and gallbladder cancer will be included in the study and are scheduled to receive triplet regimen consisting of a combination of pembrolizumab, trastuzumab and gemcitabine/cisplatin (GemCis).

Eligibility

Min Age: 18 Years

Plain Language Summary

Simplified for easier understanding

This trial is testing whether adding trastuzumab (an anti-HER2 targeted therapy) and pembrolizumab (an immunotherapy drug) to standard gemcitabine plus cisplatin chemotherapy improves outcomes for people with HER2-positive biliary tract cancer (cancers of the bile ducts or gallbladder) that cannot be surgically removed. **You may be eligible if...** - You are 18 or older with confirmed cholangiocarcinoma (bile duct cancer) or gallbladder cancer - Your tumor tests HER2-positive (IHC 3+, or IHC 2+ confirmed by other testing) - You are not eligible for surgery - You have not yet received chemotherapy for your advanced biliary tract cancer - You have good performance status (ECOG 0-1) **You may NOT be eligible if...** - Your tumor is HER2-negative - You have already received systemic chemotherapy for this cancer - You have a history of autoimmune disease requiring systemic treatment - You are pregnant or breastfeeding - You have serious heart conditions Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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