Status: Closed
Activation Date: 2016AUG18
Closing Date: 2019OCT01
Phase: II
Description: A Phase II Study of Durvalumab (MEDI4736) With or Without Tremelimumab in Patients With Metastatic Castration Resistant Prostate Cancer
Eligibility: Patients with histologically confirmed adenocarcinoma of the prostate that is castrate resistant. Must have disease progression either PSA, objective or both as well as surgical or medical castration with testosterone levels <50mg/dL. An available tissue block from primary or metastatic tumour as well as accessible disease suitable for fresh biopsy and consent to biopsy prior to treatment is required. Patients must have measurable disease per RECIST 1.1. Patients may have received prior treatment with docetaxel chemotherapy, tyrosine kinase or other targeted agents. Failure/progression on abiraterone and/or enzalutamide is required. Antiandrogens must have been discontinued for < 4 weeks prior to study entry (6 weeks for bicalutamide). No prior immunotherapy or vaccines, treatment with oncolytics viruses is permissible. No prior history of immunodeficiency, or use or immunosuppressive agents within 28 days of randomization.
Objective: Primary - To determine the objective response rate (RECIST 1.1 and irRECIST) in patients with metastatic castration resistant prostate cancer (mCRPC) treated with durvalumab alone or in combination with tremelimumab. Secondary - To determine the prostate-specific antigen (PSA) response rate as time to PSA progression; To evaluate time to objective disease progression; To evaluate the toxicity and tolerability of durvalumab alone or in combination with tremelimumab. Exploratory - To explore the utility of tissue and blood based biomarkers to select patients for treatment with durvalumab alone or in combination with tremelimumab.
Participation: Limited to invited centres
Lay Description: The purpose of this study is to determine what effects two immunotherapy drugs (durvalumab and tremelimumab) have on you and your prostate cancer. Participants in this study will be randomized to either receive durvalumab alone or in combination with tremelimumab. This study will also be looking at the side effects of these two drugs. Researchers conducting the study will be looking to see if these immunotherapy drugs are able to help slow down the growth of your cancer.
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Hide Tissue Samples
Disease Site | Trial Code | Patients Accrued | Patients - Blocks | Patients - Slides | Patients - Blocks and/or Slides |
IND | I232 | 52 | 48 | 51 | 51 |
(Core size is 0.6 mm)
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Fluid SamplesDisease Site | Trial Code | Patients Accrued | TMA Blocks | Patients on TMA Blocks |
IND | I232 | 52 | 1 | 5 |
Disease Site | Trial Code | Patients Accrued | Patients - Whole Blood | Patients - Cellular Component of Blood | Patients - DNA extracted from Blood | Patients - RNA extracted from Blood | Patients - Plasma | Patients - Serum | Patients - Urine | Patients - Buccal |
IND | I232 | 52 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 |