52 Participants Needed

Durvalumab +/- Tremelimumab for Prostate Cancer

Recruiting at 10 trial locations
Age: 18+
Sex: Male
Trial Phase: Phase 2
Sponsor: Canadian Cancer Trials Group
Must be taking: LHRH therapy
No Placebo GroupAll trial participants will receive the active study treatment (no placebo)
Prior Safety DataThis treatment has passed at least one previous human trial
Breakthrough TherapyThis drug has been fast-tracked for approval by the FDA given its high promise

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

SH

Sebastien Hotte

Principal Investigator

Juravinski Cancer Centre at Hamilton Health Sciences, Hamilton, ON Canada

EW

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

I am a man and will use birth control if my partner can have children.
My testosterone levels are below 50 ng/dL due to treatment.
Patients must have at least one measurable lesion as defined by RECIST 1.1
See 6 more

Exclusion Criteria

Patients with hypersensitivity to durvalumab or tremelimumab
I have not received a live vaccine in the last 30 days.
I have cancer that has spread to my brain.
See 6 more

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

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.

16 weeks

Follow-up

Participants are monitored for safety and effectiveness after treatment

2 years

Treatment Details

Interventions

  • Durvalumab
  • Tremelimumab
Trial Overview The trial is testing Durvalumab alone versus its combination with Tremelimumab on metastatic castration-resistant prostate cancer. It aims to understand their effects on this cancer type and monitor any side effects from these drugs when used separately or together.
Participant Groups
2Treatment groups
Experimental Treatment
Group I: Arm B - Durvalumab aloneExperimental Treatment1 Intervention
Durvalumab-IV for 60 minutes day 1 every 4 weeks
Group II: Arm A - Durvalumab plus TremelimumabExperimental Treatment2 Interventions
Durvalumab-IV for 60 minutes day 1 every 4 weeks Tremelimumab-IV every 60 minutes day 1, cycles 1-4

Durvalumab is already approved in European Union, United States, Japan for the following indications:

🇪🇺
Approved in European Union as Imfinzi for:
  • Locally advanced, unresectable non-small cell lung cancer (NSCLC)
🇺🇸
Approved in United States as Imfinzi for:
  • Extensive-stage small cell lung cancer (ES-SCLC)
  • Limited-stage small cell lung cancer (LS-SCLC)
  • Locally advanced or metastatic urothelial carcinoma
🇯🇵
Approved in Japan as Imfinzi for:
  • Not specified in provided sources

Find a Clinic Near You

Who Is Running the Clinical Trial?

Canadian Cancer Trials Group

Lead Sponsor

Trials
135
Recruited
70,300+

AstraZeneca

Industry Sponsor

Trials
4,491
Recruited
290,540,000+

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

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