drugset / Trial / NCT02799901

Nivolumab Plus Radiotherapy in Advanced Melanoma

NCT02799901 ↗

Phase 2 Completed 72 enrolled Centre Hospitalier Universitaire de Nice
NaSingle-groupOpen-labelTreatment

Summary

Combining nivolumab with conventional multisite high dose radiotherapy seems to be an interesting approach that could increase the antitumoral effect of nivolumab by increasing the diversity and quantity of tumoral antigen presentation thanks to radiotherapy. Multifractionated high dose radiotherapy (HR) targeting various tumor sites could also increase occurrence of tumor mutations and the diversity of the T-cell receptor repertoire of intratumoral T cells. The purpose of this study is to combine nivolumab with 3 fractions of HR of one metastasis for each tumor site (defined as skin/muscle, thoracic, abdomen, bone, other). The investigators hypothesize that combining nivolumab with multisite, multifractionated HR increases the overall survival rate at 1 year compared to published data with nivolumab alone.

Timeline

Start
2017-03-03
Primary completion
2021-07-28
Completion
2021-07-28

Drugs

EvaluationDrugModalityDoseRoute
Subject Nivolumab Monoclonal antibody — —

Indications