Immunotherapy With Ipilimumab and Nivolumab Preceded or Not by a Targeted Therapy With Encorafenib and Binimetinib

Sponsor
European Organisation for Research and Treatment of Cancer - EORTC
Study ID
NCT03235245
Phase
PHASE2
Status
Active Not Recruiting

Conditions

  • Stage IV Melanoma
  • Unresectable Stage III Melanoma

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • Nivolumab + Ipilimumab — DRUG
    nivolumab 3 mg/kg q3w + ipilimumab 1 mg/kg q3w for 4 injections followed by nivolumab 480 mg IV q4w until completion of 2 years total treatment or progression.
  • Encorafenib + Binimetinib — DRUG
    encorafenib 450 mg QD + binimetinib 45 mg BID orally for 12 weeks

Study Details

This is a multicenter, 2-arm open-label, randomized comparative phase II study. The objective of this trial is to prospectively evaluate whether a sequential approach with an induction period of 12 weeks with encorafenib + binimetinib followed by combination immunotherapy with nivolumab + ipilimumab improves progression free survival compared to combination immunotherapy nivolumab + ipilimumab alone in patients with BRAF V600 mutation-positive unresectable or metastatic melanoma.

Key Dates

Start date
Oct 30, 2018
Status verified
Jul 2025
Primary completion
Oct 24, 2023
Completion
Jan 31, 2027

Study Design

Enrollment
271 participants (actual)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Active Comparator: ARM A: Nivolumab + Ipilimumab
    nivolumab 3 mg/kg q3w + ipilimumab 1 mg/kg q3w for 4 injections followed by nivolumab 480 mg IV q4w until completion of 2 years total treatment or progression. Then treatment will be left at the investigator choice and continued until the 2nd progression.
  • Experimental: ARM B: Encorafenib + Binimetinib + Nivolumab + Ipilimumab
    encorafenib 450 mg QD + binimetinib 45 mg BID orally for 12 weeks followed, after a week of pause, by nivolumab 3 mg/kg q3w + ipilimumab 1 mg/kg q3w for 4 injections, followed by nivolumab 480 mg IV q4w until completion of 2 years total treatment or progression. Then patients will be rechallenged with encorafenib 450 mg QD + binimetinib 45 mg BID orally continuously until the 2nd progression.

Primary Outcome Measure

Progression Free Survival (PFS) [ Time Frame: 4.1 years from first patient in ]

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