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

Sponsor
AIO-Studien-gGmbH
Study ID
NCT03473574
Phase
PHASE2
Status
Completed

Conditions

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

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • Durvalumab — BIOLOGICAL
    immune checkpoint inhibitor
  • Gemcitabine — DRUG
    standard chemotherapy
  • Cisplatin — DRUG
    standard chemotherapy
  • Tremelimumab — BIOLOGICAL
    immune checkpoint inhibitor

Study Details

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).

Key Dates

Start date
May 2, 2018
Status verified
Jun 2023
Primary completion
Mar 15, 2022
Completion
Mar 15, 2022

Study Design

Enrollment
128 participants (actual)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Experimental: Arm A
    Durvalumab in combination with Tremelimumab (Regimen 1) and Gemcitabine
  • Experimental: Arm B
    Durvalumab in combination with Tremelimumab (Regimen 1), Gemcitabine and Cisplatin
  • Other: Arm C
    Gemcitabine in combination with Cisplatin
  • Experimental: Arm D
    Durvalumab in combination with Tremelimumab (Regimen 2), Gemcitabine and Cisplatin
  • Experimental: Arm E
    Durvalumab in combination with Gemcitabine and Cisplatin

Primary Outcome Measure

Objective response rate (ORR) [ Time Frame: 30 months ]

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