Nivolumab Plus Radiotherapy in Advanced Melanoma

Sponsor
Centre Hospitalier Universitaire de Nice
Study ID
NCT02799901
Phase
PHASE2
Status
Completed

Conditions

Eligibility Criteria

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

Interventions

  • Nivolumab — BIOLOGICAL
    Injection of nivolumab
  • hypofractionned radiotherapy — RADIATION
    radiation

Study Details

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.

Key Dates

Start date
Mar 3, 2017
Status verified
Nov 2023
Primary completion
Jul 28, 2021
Completion
Jul 28, 2021

Study Design

Enrollment
72 participants (actual)
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT

Arms

  • Experimental: Patient
    patient with Advanced melanoma

Primary Outcome Measure

overall survival [ Time Frame: 1 year ]

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