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

NCT06178445 · Status: ACTIVE_NOT_RECRUITING · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 24

Last updated 2026-03-27

No results posted yet for this study

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).

Conditions

  • Biliary Tract Cancer
  • HER2 Gene Mutation
  • HER2

Interventions

DRUG

SOC plus trastuzumab and pembrolizumab

SOC treatment with gemcitabine/cisplatin in combination with trastuzumab and pembrolizumab

Sponsors & Collaborators

  • Medizinische Hochschule Hannover, Germany, Prof. Dr. Arndt Vogel

    collaborator UNKNOWN

  • MSD Sharp & Dohme GmbH, Germany

    collaborator UNKNOWN

  • Institut für Klinische Krebsforschung IKF GmbH at Krankenhaus Nordwest

    lead OTHER

Principal Investigators

  • Salah-Eddin Al-Batran, Prof. Dr. · Frankfurter Institut fuer Klinische Krebsforschung IKF GmbH

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2024-04-17
Primary Completion
2026-12-31
Completion
2027-07-31

Countries

  • Germany

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06178445 on ClinicalTrials.gov