Durvalumab and Tremelimumab and Best Supportive Care vs Best Supportive Care in Patients With Advanced Colorectal Cancer
- Sponsor
- Canadian Cancer Trials Group
- Study ID
- NCT02870920
- Phase
- PHASE2
- Status
- Completed
Conditions
Eligibility Criteria
- Sex
- ALL
- Age
- 18 Years - N/A
- Healthy Volunteers
- Not accepted
Interventions
- Tremelimumab — DRUG
- Durvalumab — DRUG
- Best Supportive Care — OTHER
Study Details
The standard or usual treatment for this disease is treatment with drugs and other treatments that may help to make a patient better or may improve their quality of life. This treatment is known as "best supportive care" (BSC). Although patients with best supportive care can feel better for some months, the cancer usually continues to grow.
Key Dates
- Start date
- Oct 12, 2016
- Status verified
- Jun 2022
- Primary completion
- Oct 18, 2018
- Completion
- Jun 7, 2022
Study Design
- Enrollment
- 180 participants (actual)
- Allocation
- RANDOMIZED
- Intervention model
- PARALLEL
- Primary purpose
- TREATMENT
Arms
- Active Comparator: Best Supportive CareBest supportive care available
- Experimental: Durvalumab plus Tremelimumab and Best Supportive CareTremelimumab 75mg IV 60 minutes Day 1, cycles 1-4 Durvalumab 1500mg IV 60 minutes Day 1 every 28 days. Plus best supportive care
Primary Outcome Measure
Overall Survival [ Time Frame: 24 months ]
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