Immunotherapy With Durva and Treme With or Without Capecitabine in Adjuvant Treatment for Biliary Tract Cancer

Sponsor
Institut für Klinische Krebsforschung IKF GmbH at Krankenhaus Nordwest
Study ID
NCT05239169
Phase
PHASE2
Status
Completed

Conditions

  • Biliary Tract Cancer (CCA)
  • Distal Cholangiocarcinoma
  • Gall Bladder Carcinoma
  • Hilar Cholangiocarcinoma
  • Intrahepatic Cholangiocarcinoma

Eligibility Criteria

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

Interventions

  • Durvalumab — DRUG
    Durvalumab at a fixed dose of 1500 mg as an IV infusion over 1 hour, on day 1 together with the Tremelimumab infusion. Durvalumab only infusion to be repeated every 4 weeks for a maximum of 12 months on day 1 of each cycle.
  • Tremelimumab — DRUG
    Tremelimumab at a fixed dose of 300 mg as an IV infusion over 1 hour on day 1 of cycle 1.
  • Capecitabine — DRUG
    Capecitabine at 1250 mg/m² p.o. twice a day on days 1 to 14 of a 3-weekly cycle (eight cycles).

Study Details

This is an interventional, prospective multicenter, open-label, phase II study in patients after curative surgery for BTC in a classic adjuvant situation, consisting of a two arm feasibility pilot part with a randomized pick-the-winner design and an option to proceed into a randomized phase 2/3 trial in order to compare the winner with the current SOC (capecitabine).

Key Dates

Start date
May 23, 2022
Status verified
Apr 2025
Primary completion
Feb 20, 2025
Completion
Feb 20, 2025

Study Design

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

Arms

  • Experimental: A: Cape+Durva+Treme
    Capecitabine + Durvalumab + Tremelimumab
  • Active Comparator: B: Durva+Treme
    Durvalumab + Tremelimumab

Primary Outcome Measure

Recurrence free survival at 12 months (RFS@12). [ Time Frame: 12 months ]

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