Study identifier:D2615C00001
ClinicalTrials.gov identifier:NCT02546661
EudraCT identifier:2015-002228-25
CTIS identifier:N/A
An Open-Label, Randomised, Multi-Drug, Biomarker-Directed, Multi-Centre, Multi-arm Phase 1b Study in patients with Muscle Invasive Bladder Cancer (MIBC) who have progressed on prior treatment (BISCAY).
Muscle invasive bladder cancer
Phase 1
No
AZD4547, MEDI4736, Olaparib, AZD1775, Vistusertib, AZD9150, Selumetinib
All
117
Interventional
18 Years - 130 Years
Allocation: Randomized
Endpoint Classification: Safety/Efficacy
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Verified 01 Sept 2024 by AstraZeneca
AstraZeneca
-
No locations available
Arms | Assigned Interventions |
---|---|
Experimental: Module A: AZD4547 Monotherapy AZD4547 will be given orally twice daily until disease progression. Patients who receive AZD4547 as monotherapy will have the option to cross over to durvalumab as monotherapy at the point of objective progression, as long as the following criteria are met: • The investigator believes it is in the patient’s interest to receive durvalumab; • The patient consents to the continued treatment; • It is clinically appropriate for the patient to continue on durvalumab treatment; • The patient satisfies the key eligibility criteria for receiving durvalumab treatment. | Drug: AZD4547 AZD4547 Monotherapy vs. MEDI4736 (durvalumab) + AZD4547 1:1 Randomization. |
Experimental: Module A: MEDI4736 (durvalumab) + AZD4547 AZD4547 will be given orally twice daily until disease progression. Patients will also receive MEDI 4736 (durvalumab) by IV infusion once every 4 weeks. | Drug: AZD4547 AZD4547 Monotherapy vs. MEDI4736 (durvalumab) + AZD4547 1:1 Randomization. Drug: MEDI4736 MEDI4736 Other Name: Durvalumab |
Experimental: Module B: MEDI4736 (durvalumab) + Olaparib MEDI4736 (durvalumab) will be given by IV infusion once every 4 weeks. Olaparib will be given orally twice daily. | Drug: MEDI4736 MEDI4736 Other Name: Durvalumab Drug: Olaparib MEDI4736 (durvalumab) + Olaparib Other Name: Lynparza |
Experimental: Module C: MEDI4736 (durvaluamb) + AZD1775 MEDI4736 (durvalumab) will be given by IV infusion once every 4 weeks. AZD1775 will be given orally in approximate 12 hour intervals over 3 days (6 doses) on Days 1-3, 8-10, and 15-17 of 28 day cycles. | Drug: MEDI4736 MEDI4736 Other Name: Durvalumab Drug: AZD1775 MEDI4736 (durvalumab) + AZD1775 |
Experimental: Module D: MEDI4736 (durvalumab) monotherapy MEDI 4736 (durvalumab) will be given by IV infusion once every 4 weeks. | Drug: MEDI4736 MEDI4736 Other Name: Durvalumab |
Experimental: Module E: MEDI4736 (durvalumab) + Vistusertib MEDI4736 (durvalumab) will be given by IV infusion once every 4 weeks. Vistusertib will be given orally twice per day on an intermittent schedule (2 days on, 5 days off). | Drug: MEDI4736 MEDI4736 Other Name: Durvalumab Drug: Vistusertib MEDI4736 (durvalumab) + Vistusertib |
Experimental: Module F: MEDI4736 (durvaluamb) + AZD9150 AZD9150 will be given as monotherapy on Days -7, -5, and -3 of a one week lead-in period. Combination dosing with IV AZD9150 followed by IV MEDI4736 (durvalumab) begins on Day 1 of each 28 day cycle. Thereafter AZD9150 is given weekly and MEDI4736 is given once every 4 weeks. | Drug: MEDI4736 MEDI4736 Other Name: Durvalumab Drug: AZD9150 MEDI4736 (durvalumab) + AZD9150 |
Experimental: Module G: MEDI4736 + Selumetinib | Drug: MEDI4736 MEDI4736 Other Name: Durvalumab Drug: Selumetinib MEDI4736 (durvalumab) + Selumetinib |