Durvalumab With or Without Tremelimumab in Metastatic Castration Resistant Prostate Cancer

Sponsor
Canadian Cancer Trials Group
Study ID
NCT02788773
Phase
PHASE2
Status
Completed

Conditions

Eligibility Criteria

Sex
MALE
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

Study Details

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.

Key Dates

Start date
Dec 15, 2016
Status verified
May 2025
Primary completion
Nov 22, 2021
Completion
May 1, 2025

Study Design

Enrollment
52 participants (actual)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Experimental: Arm A - Durvalumab plus Tremelimumab
    Durvalumab-IV for 60 minutes day 1 every 4 weeks Tremelimumab-IV every 60 minutes day 1, cycles 1-4
  • Experimental: Arm B - Durvalumab alone
    Durvalumab-IV for 60 minutes day 1 every 4 weeks

Primary Outcome Measure

Objective Response Rate Measured by RECIST 1.1 [ Time Frame: 2 years ]

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