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Durvalumab Plus Tremelimumab Combination Immunotherapy With or Without Weekly Paclitaxel in Patients With Advanced Biliary Tract Carcinoma (BTC) After Failure of Platinum-based Chemotherapy: a Randomized Non-comparative Two-arm Phase II Study

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Trial Profile

Durvalumab Plus Tremelimumab Combination Immunotherapy With or Without Weekly Paclitaxel in Patients With Advanced Biliary Tract Carcinoma (BTC) After Failure of Platinum-based Chemotherapy: a Randomized Non-comparative Two-arm Phase II Study

Status: Active, no longer recruiting
Phase of Trial: Phase II

Latest Information Update: 09 Jan 2024

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At a glance

  • Drugs Durvalumab (Primary) ; Paclitaxel (Primary) ; Tremelimumab (Primary)
  • Indications Biliary cancer
  • Focus Therapeutic Use
  • Acronyms IMMUNO-BIL; IMMUNOBIL PRODIGE 57

Most Recent Events

  • 04 Jan 2024 Status changed from recruiting to active, no longer recruiting.
  • 06 Mar 2023 Planned End Date changed from 31 Dec 2022 to 31 Dec 2024.
  • 07 Jun 2022 The protocol was amended to modify the T schedule (300 mg at cycle 1 [T300], amended Arm A) due to higher efficacy reported in other tumors as compared to T75 mg x 4. The new primary endpoint was the overall survival (OS) rate at 6 months (M6) in amended Arm A (D + T300) with a Fleming two-stage design .

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