Neoplasms

All Conditions

Digestive System Diseases

Rare Diseases

Carcinoma

Cholangiocarcinoma

Biliary Tract Neoplasms

Gastrointestinal Neoplasms

Digestive System Neoplasms

Biliary Tract Diseases

Gastrointestinal Diseases

Bile Duct Cancer

Biliary Tract Cancer

Gallbladder Cancer

Antineoplastic Agents

All Drugs and Chemicals

Gemcitabine

Pembrolizumab

Trastuzumab

Cisplatin

Antineoplastic Agents, Immunological

Immune Checkpoint Inhibitors

* Gemcitabine: 1000 mg/m2 on day 1 and day 8 of each 21-days cycle (Q3W)
* Cisplatin: 25 mg/m2 on day 1 and day 8 of each 21-days cycle
* Trastuzumab: initial dose 8 mg/kg, then 6 mg/kg on day 1 of each 21-days cycle
* Pembrolizumab: 200 mg on day 1 of each 21-days cycle

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

SOC plus trastuzumab and pembrolizumab

Arndt Vogel, Prof. Dr.

Michelle Tez

Dominik P Modest, Prof. Dr.

Thorsten O Goetze, Prof. Dr.

Alexander Stein, Prof. Dr.

Anna L Saborowski, PD Dr.

Salah-Eddin Al-Batran, Prof. Dr.

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).

All eligible patients will receive SOC treatment with gemcitabine/cisplatin in combination with trastuzumab and pembrolizumab.

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

defined as proportion of subjects with complete response (CR) or partial response (RP) according to unconfirmed RECIST v1.1 at 6 months after treatment initiation

defined as time from enrolment until the date of first objectively documented progression according to RECIST v1.1

defined as time from enrolment to the date of death of any cause

defined as proportion of patients without progression after 6, 9 and 12 months

defined as proportion of patients without progression after 9 months

defined as proportion of patients without progression after 12 months

Spots Global Cancer Trial Database for soc plus trastuzumab and pembrolizumab