NCT03354962

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

• Status: Terminated
• Phase: Phase 1 / Phase 2
• Study type: Interventional
• Enrollment: 6 (actual)
• Sponsor: Institut Claudius Regaud · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

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.

Conditions

• Melanoma

Interventions

Type	Name	Description
COMBINATION_PRODUCT	Nivolumab + Ipilimumab	Nivolumab + Ipilimumab alone (standard dosage regimen)
COMBINATION_PRODUCT	Combined treatment schema	SBRT (recommended optimal dose) with Nivolumab + Ipilimumab (standard dosage regimen)

Timeline

• Start date: 2018-10-15
• Primary completion: 2020-02-20
• Completion: 2020-10-27
• First posted: 2017-11-28
• Last updated: 2020-12-04

Locations

6 sites across 1 country: France