Induction of Immune-mediated aBscOpal Effect thrOugh STEreotactic Radiation Therapy in Metastatic Melanoma Patients Treated by PD-1 + CTLA-4 Inhibitors (BOOSTER MELANOMA)
|The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT03354962|
Recruitment Status : Active, not recruiting
First Posted : November 28, 2017
Last Update Posted : July 20, 2020
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.
|Condition or disease||Intervention/treatment||Phase|
|Melanoma||Combination Product: Nivolumab + Ipilimumab Combination Product: Combined treatment schema||Phase 1 Phase 2|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||6 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||None (Open Label)|
|Official Title:||Induction of Immune-mediated aBscOpal Effect thrOugh STEreotactic Radiation Therapy in Metastatic Melanoma Patients Treated by PD-1 + CTLA-4 Inhibitors (BOOSTER MELANOMA)|
|Actual Study Start Date :||October 15, 2018|
|Actual Primary Completion Date :||February 20, 2020|
|Estimated Study Completion Date :||February 20, 2021|
|Active Comparator: ARM A||
Combination Product: Nivolumab + Ipilimumab
Nivolumab + Ipilimumab alone (standard dosage regimen)
|Experimental: ARM B||
Combination Product: Combined treatment schema
SBRT (recommended optimal dose) with Nivolumab + Ipilimumab (standard dosage regimen)
- Phase I: Dose Limiting Toxicities (DLT) incidence. [ Time Frame: 3 weeks per patient ]
- Phase I: Abscopal effect. [ Time Frame: 6 weeks per patient ]Abscopal effect is defined as a tumor shrinkage ≥ 20% compared to baseline in the control lesion (non-irradiated and distant lesion) at the end of the 6-week period of treatment without evidence of clinical progression.
- Phase II: The primary endpoint is the rate of patients alive without progression at 6 months. [ Time Frame: 6 months per patient ]
- Phase I: Safety will be evaluated using NCI CTCAE V4.03 criteria. [ Time Frame: 15 months per patient ]
- Phase II: Progression Free Survival (PFS) is defined as the time from inclusion until progression or death. [ Time Frame: 24 months per patient ]
- Phase II: Safety will be evaluated using NCI CTCAE V4.03. [ Time Frame: 15 months per patient ]
- Phase II: Pattern of response rate will be followed in irradiated and non-irradiated lesions separately by CT-scan evaluation using RECIST V1.1. [ Time Frame: 24 months per patient ]
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03354962
|Centre Oscar Lambret|
|Centre Eugene Marquis|
|Institut Universitaire du Cancer de Toulouse - Oncopole|
|Toulouse, France, 31059|