TNF-Inhibitor as Immune Checkpoint Inhibitor for Advanced MELanoma
Last updated on July 2021Recruitment
- Recruitment Status
- Recruiting
- Estimated Enrollment
- Same as current
Summary
- Conditions
- Melanoma
- Type
- Interventional
- Phase
- Phase 1
- Design
- Allocation: Non-RandomizedIntervention Model: Parallel AssignmentMasking: None (Open Label)Primary Purpose: Treatment
Participation Requirements
- Age
- Between 18 years and 70 years
- Gender
- Both males and females
Description
The study will be conducted in 2 consecutive parts: Part 1 with 2 parallel cohorts (Nivolumab+Ipilimumab administered in combination with anti-TNF-? Certolizumab (Cohort 1) and Nivolumab+Ipilimumab administered in combination with anti-TNF-? Infliximab (Cohort 2)). 6 patients will be included in eac...
The study will be conducted in 2 consecutive parts: Part 1 with 2 parallel cohorts (Nivolumab+Ipilimumab administered in combination with anti-TNF-? Certolizumab (Cohort 1) and Nivolumab+Ipilimumab administered in combination with anti-TNF-? Infliximab (Cohort 2)). 6 patients will be included in each cohort. Part 2 (expansion phase) will then be scheduled after the most promising combination has been confirmed; the choice of the combination will be based on safety, efficacy, and PD data observed in both cohorts during the Part 1 of the study.
Tracking Information
- NCT #
- NCT03293784
- Collaborators
- Not Provided
- Investigators
- Principal Investigator: Nicolas MEYER Institut Claudius Regaud
Get Well Soon