MedTrace Logo

Durvalumab and Tremelimumab With Gemcitabine or Gemcitabine/Cisplatin Compared to Gemcitabine/Cisplatin in CCA Patients

NCT03473574 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 128

Last updated 2023-06-15

No results posted yet for this study

Summary

To determine the efficacy in terms of objective response rate (ORR) of the combination of durvalumab and tremelimumab in addition with gemcitabine or in addition with gemcitabine and cisplatin in treatment-naïve patients with advanced, unresectable and/or metastatic cholangio- and gallbladder carcinoma (CCA).

Conditions

  • Cholangiocarcinoma
  • Gall Bladder Carcinoma
  • Cholangiocarcinoma Non-resectable
  • Gallbladder Carcinoma Non-Resectable

Interventions

BIOLOGICAL

Durvalumab

immune checkpoint inhibitor

DRUG

Gemcitabine

standard chemotherapy

DRUG

Cisplatin

standard chemotherapy

BIOLOGICAL

Tremelimumab

immune checkpoint inhibitor

Sponsors & Collaborators

  • AstraZeneca

    collaborator INDUSTRY

  • AIO-Studien-gGmbH

    lead OTHER

Principal Investigators

  • Arndt Vogel, Prof. Dr. · Hannover Medical School

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2018-05-02
Primary Completion
2022-03-15
Completion
2022-03-15

Countries

  • Germany

Study Locations

More Related Trials

Entities

Drugs
Diseases
Companies

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 NCT03473574 on ClinicalTrials.gov