Induction of Immune-mediated aBscOpal Effect thrOugh STEreotactic Radiation Therapy in Metastatic Melanoma Patients Treated by PD-1 + CTLA-4 Inhibitors (BOOSTER MELANOMA)

Sponsor
Institut Claudius Regaud
Study ID
NCT03354962
Phase
PHASE1/PHASE2
Status
Terminated

Conditions

Eligibility Criteria

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

Interventions

  • Nivolumab + Ipilimumab — COMBINATION_PRODUCT
    Nivolumab + Ipilimumab alone (standard dosage regimen)
  • Combined treatment schema — COMBINATION_PRODUCT
    SBRT (recommended optimal dose) with Nivolumab + Ipilimumab (standard dosage regimen)

Study Details

This study is a phase I/II, multicenter, open-label study starting with a phase I part followed by a Phase II part. The phase I part of the study aims at evaluating the safety and efficacy (in terms of abscopal effect at week 6) of the treatment combination schema of Stereotactic Body Radiation Therapy (SBRT) and PD-1 plus CTLA-4 inhibitors in patients with metastatic melanoma. Patients will be assigned in one of 3 cohorts depending the metastatic site. 18 patients will be enrolled in each cohort. Once the recommended optimal radiotherapy dose has been declared for the 3 cohorts, patients will be enrolled in the phase II part of the study in order to evaluate the activity (progression-free survival at 6 months) of SBRT given in combination with immune checkpoints inhibitors in patients with metastatic melanoma. 66 patients will be included in the phase II.

Key Dates

Start date
Oct 15, 2018
Status verified
Dec 2020
Primary completion
Feb 20, 2020
Completion
Oct 27, 2020

Study Design

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

Arms

  • Active Comparator: ARM A
  • Experimental: ARM B

Primary Outcome Measure

Phase I: Dose Limiting Toxicities (DLT) incidence. [ Time Frame: 3 weeks per patient ]

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