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Durvalumab + Tremelimumab ± Paclitaxel in Advanced BTC After Platinum Chemotherapy.

Study acronym: IMMUNO-BIL
StatusActive, Not Recruiting
PhasePhase 2
Started
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Record History

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  1. Study completion date: Dec 31, 2024 to Dec 31, 2025v7
  2. Trial status: Recruiting to Active, Not Recruitingv6 Show 4 more changesShow less
    • Primary completion date: Oct 30, 2022 to Jul 28, 2022
    • Secondary endpoints revised (8)
    • Site details revised at 28 of 28 sites
    • Study title shortened, about 12 words
  3. Study completion date: Dec 31, 2022 to Dec 31, 2024v5
  4. Primary completion date: Dec 30, 2020 to Oct 30, 2022v4 Show 7 more changesShow less
    • Primary endpoint revised
    • Enrollment target: 102 to 106
    • Study completion date: Oct 31, 2021 to Dec 31, 2022
    • Interventions: Durvalumab (Drug), Paclitaxel (Drug), Tremelimumab (Drug) to Durvalumab (Drug), Tremelimumab (Drug)
    • Secondary endpoints: 7 to 8
    • Site details revised at 16 of 28 sites
    • Study arms: 2 to 1
  5. Primary completion date: Sep 30, 2020 to Dec 30, 2020v3
  6. Trial status: Not Yet Recruiting to Recruiting
    • Start date changed from estimate of Oct 20, 2018 to Nov 9, 2018
    • Site details revised at 28 of 28 sites
    v2
  7. Study First Submitted
  • Stopped: an ongoing trial was terminated, suspended or withdrawn.
  • Notable: the trial’s plan changed such as a big move in its timeline or size, a new primary endpoint, sponsor or phase, or recruiting opened or resumed.
  • Minor: routine progress and housekeeping, such as sites added or enrollment closed.
IMMUNO-BIL is a non-comparative randomized 1:1 phase II study. This study will assess the efficacy and safety of the combination of durvalumab plus tremelimumab with or without weekly paclitaxel in patients with advanced BTC after failure of platinum-based chemotherapy. On the 25th June 2019, the maximum DLT event number was reached (6/10) in the durvalumab plus tremelimumab combination with paclitaxel Arm (Arm B). According to the Pocock boundary described in the protocol, GERCOR has updated the study to discontinue enrollment in Arm B (durvalumab plus tremelimumab with paclitaxel) . No safety concerns were raised by the IDMC in Arm A. Consequently, the study will resume with Arm A (durvalumab plus tremelimumab) only, without randomization. Discontinuation of ARM B(June 2019): Durvalumab plus tremelimumab plus paclitaxel One cycle equals 4 weeks (D1=D28); Durvalumab: 1,500 mg by IV infusion on D1, until progression or unacceptable toxicity or withdrawal of consent. Tremelimumab: 75 mg by IV infusion on D1 for the first 4 cycles. Paclitaxel: 80 mg/m2, every week for 3 weeks (D1-D8-D15), by IV infusion, until progression or unacceptable toxicity or withdrawal of consent (at least 6 cycles, at the discretion of the investigator). December 2020: Tremelimumab dosage modification based on the results of the Study 22 study (Kelley RK, et al. ASCO20 Virtual Scientific Program 2020) showing increased efficacy (response rate and progression-free survival) without safety concerns with one dose of tremelimumab 300 mg (cycle 1) instead of four doses of 75 mg (cycle 1 to cycle 4) in combination with durvalumab 1,500 mg Q4W in hepatocellular carcinoma. Following these results, we have changed the tremelimumab 75 mg x 4 schedule for the 300 mg x 1 schedule. The inclusion of 106 additional patients will be required to adequately evaluate the efficacy of this administration schedule. ARM A : Durvalumab plus tremelimumab ( patients included before 31/12/2020) One cycle equals 4 weeks (D1=D28); Durvalumab: 1,500 mg by IV infusion on D1, until progression or unacceptable toxicity or withdrawal of consent. Tremelimumab: 75 mg by IV infusion on D1 for the first 4 cycles.
Trial Details
NCT Number NCT03704480
Lead Sponsor GERCOR - Multidisciplinary Oncology Cooperative Group
Collaborators: AstraZeneca
Conditions
(from sponsor)		 Advanced Biliary Tract Carcinoma
Enrollment 106 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov