TNF-Inhibitor as Immune Checkpoint Inhibitor for Advanced MELanoma

Sponsor
Institut Claudius Regaud
Study ID
NCT03293784
Phase
PHASE1
Status
Completed

Conditions

Eligibility Criteria

Sex
ALL
Age
18 Years - 70 Years
Healthy Volunteers
Not accepted

Interventions

  • Nivolumab+Ipilimumab in combination with Anti TNF-α Certolizumab — COMBINATION_PRODUCT
    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.
  • Nivolumab+Ipilimumab in combination with Anti TNF-α Infliximab — COMBINATION_PRODUCT
    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.

Study Details

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.

Key Dates

Start date
Oct 16, 2017
Status verified
Mar 2026
Primary completion
Dec 6, 2019
Completion
Aug 10, 2023

Study Design

Enrollment
33 participants (actual)
Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Other: COHORT 1
    Nivolumab+Ipilimumab in combination with Anti TNF-α Certolizumab
  • Other: COHORT 2
    Nivolumab+Ipilimumab in combination with Anti TNF-α Infliximab

Primary Outcome Measure

Dose Limiting Toxicities (DLT) incidence, in part 1 of the study. [ Time Frame: 12 weeks per patient (part 1) ]

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