Active — Not RecruitingPhase 2

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

Germany24 participantsStarted 2024-04-17

Plain-language 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).

Who can participate

Age range18 Years

SexALL

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Inclusion criteria

✓. Participant provides written informed consent.
✓. Male/female Participants who are at least 18 years of age on the day of signing informed consent.
✓. Participant is, in the investigator's judgement, willing and able to comply with the study protocol.
✓. Participant has histologically confirmed diagnosis of cholangiocarcinoma or gallbladder cancer.
✓. Participant is not eligible for surgery.
✓. Participants must have HER2-positive disease defined as either IHC 3+ or IHC 2+, the latter in combination with FISH+, as assessed locally on primary tumor OR positively confirmed by NGS-analysis OR positively confirmed by mRNA
✓. Participant has an Eastern Cooperative Oncology Group (ECOG) performance status of 0 to 1. Evaluation of ECOG is to be performed within 7 days prior to the first dose of study intervention.
✓. Male Participants must agree to use a contraception as detailed in Appendix 3 of this protocol during the treatment period and for at least 7 months after the last dose of study treatment and refrain from donating sperm during this period.

Exclusion criteria

What they're measuring

ORR

Timeframe: 6 months

Trial details

NCT IDNCT06178445

SponsorInstitut für Klinische Krebsforschung IKF GmbH at Krankenhaus Nordwest

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2026-12

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