Immune-checkpoint Inhibitors and Surrogate Endpoints in Cancer Trials (SURROGATE-ICI)
Completed
- Conditions
- Cancer Treated With Immune-checkpoint Inhibitors
- Interventions
- Drug: Immune checkpoint inhibitor
- Registration Number
- NCT03963518
- Lead Sponsor
- Institut Bergonié
- Brief Summary
The objective of this research work is two-fold: (i) to conduct a systematic literature review to identify surrogate endpoints in this specific drug class (review registered in the PROSPERO database) and (ii) to assess the surrogate properties of candidate surrogate endpoints in the specific context of melanoma cancer.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 300
Inclusion Criteria
- Patients included in phase III randomized clinical trials (RCT)
- Metastatic melanoma
Exclusion Criteria
- N/A
Study & Design
- Study Type
- OBSERVATIONAL
- Study Design
- Not specified
- Arm && Interventions
Group Intervention Description Experimental Immune checkpoint inhibitor immune-checkpoint inhibitor
- Primary Outcome Measures
Name Time Method overall survival 2 years time from randomization to death
- Secondary Outcome Measures
Name Time Method Progression-free survival (PFS) 2 years Time from randomization to progression or death
Trial Locations
- Locations (1)
Institut Bergonié, Comprehensive Cancer Center
🇫🇷Bordeaux, France