Durvalumab +/- Tremelimumab for Prostate Cancer
Trial Summary
What is the purpose of this trial?
The purpose of this study is to find out the effects of giving durvalumab alone or in combination with tremelimumab on this type of cancer. In addition, this study will look at the side effects of durvalumab when given alone or in combination with tremelimumab.
Research Team
Sebastien Hotte
Principal Investigator
Juravinski Cancer Centre at Hamilton Health Sciences, Hamilton, ON Canada
Eric W Winquist
Principal Investigator
London Regional Cancer Program, London ON Canada
Eligibility Criteria
Men over 18 with advanced prostate cancer that's resistant to castration and has progressed despite treatment. They must have tried treatments like abiraterone or enzalutamide, can't have had certain immune therapies before, and need functioning major organs. No brain metastases or serious autoimmune diseases in the last 3 years, except for some exceptions like stable thyroid conditions.Inclusion Criteria
Exclusion Criteria
Timeline
Screening
Participants are screened for eligibility to participate in the trial
Treatment
Participants receive Durvalumab alone or in combination with Tremelimumab. Durvalumab is administered intravenously for 60 minutes on day 1 every 4 weeks. Tremelimumab is administered intravenously for 60 minutes on day 1, cycles 1-4.
Follow-up
Participants are monitored for safety and effectiveness after treatment
Treatment Details
Interventions
- Durvalumab
- Tremelimumab
Durvalumab is already approved in European Union, United States, Japan for the following indications:
- Locally advanced, unresectable non-small cell lung cancer (NSCLC)
- Extensive-stage small cell lung cancer (ES-SCLC)
- Limited-stage small cell lung cancer (LS-SCLC)
- Locally advanced or metastatic urothelial carcinoma
- Not specified in provided sources
Find a Clinic Near You
Who Is Running the Clinical Trial?
Canadian Cancer Trials Group
Lead Sponsor
AstraZeneca
Industry Sponsor
Sir Pascal Soriot
AstraZeneca
Chief Executive Officer since 2012
Veterinary Medicine from École nationale vétérinaire d'Alfort, MBA from HEC Paris
Dr. Cristian Massacesi
AstraZeneca
Chief Medical Officer since 2021
MD from Marche Polytechnic University, Oncology training at Royal Marsden Hospital, Kaplan Comprehensive Cancer Center, and European Institute of Oncology
Pascal Soriot
AstraZeneca
Chief Executive Officer since 2012
Veterinary Medicine from École nationale vétérinaire d'Alfort, MBA from HEC Paris
Cristian Massacesi
AstraZeneca
Chief Medical Officer since 2021
MD from Marche Polytechnic University, Medical Oncology training at Royal Marsden Hospital, Kaplan Comprehensive Cancer Center, and European Institute of Oncology