NCT03293784

TNF-Inhibitor as Immune Checkpoint Inhibitor for Advanced MELanoma

TNF-Inhibitor as Immune Checkpoint Inhibitor for Advanced MELanoma - A Phase Ib Clinical Study

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 33 (actual)
• Sponsor: Institut Claudius Regaud · Academic / Other
• Sex: All
• Age: 18 Years – 70 Years
• Healthy volunteers: Not accepted

Summary

This is a Phase 1b, open-label study of immune checkpoints inhibitors Nivolumab+Ipilimumab administered in combination with the anti-TNF-α either Infliximab or Certolizumab, in patients with advanced melanoma.

Detailed description

The study will be conducted in 2 consecutive parts: * Part 1 with 2 parallel cohorts (Nivolumab+Ipilimumab administered in combination with anti-TNF-α Certolizumab (Cohort 1) and Nivolumab+Ipilimumab administered in combination with anti-TNF-α 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.

Conditions

• Melanoma

Interventions

Type	Name	Description
COMBINATION_PRODUCT	Nivolumab+Ipilimumab in combination with Anti TNF-α Certolizumab	Induction phase: Nivolumab (1mg/kg) and Ipilimumab (3 mg/kg) injected at Week 0, 3, 6, and 9 with Certolizumab injected at the dose of 400mg at weeks 0, 3, and 6, and at the dose of 200mg at week 9. Maintenance phase: Nivolumab (3 mg/kg) alone injected from week 12 and then every 2 weeks with Certolizumab (200 mg) injected from week 12 and then every 2 weeks.
COMBINATION_PRODUCT	Nivolumab+Ipilimumab in combination with Anti TNF-α Infliximab	Induction phase: Nivolumab (1mg/kg) and Ipilimumab 3 mg/kg injected at Week 0, 3, 6, and 9 with Infliximab (5mg/kg) injected at weeks 0, 3 and 6. Maintenance phase: Nivolumab (3 mg/kg) alone injected from week 12 and then every 2 weeks with Infliximab (5mg/kg) injected from week 14 and then every 8 weeks.

Timeline

• Start date: 2017-10-16
• Primary completion: 2019-12-06
• Completion: 2023-08-10
• First posted: 2017-09-26
• Last updated: 2026-03-30

Locations

1 site across 1 country: France