SAbR Plus Ipilimumab Plus Nivolumab in Metastatic Melanoma Patients

Part of paid clinical trials in Dallas, Texas.

Sponsor
University of Texas Southwestern Medical Center
Study ID
NCT03126461
Phase
PHASE2
Status
Withdrawn

Conditions

Eligibility Criteria

Sex
ALL
Age
18 Years - 99 Years
Healthy Volunteers
Not accepted

Interventions

  • SAbR — RADIATION
    For patients treated on the "GRID A" regimen, a dose of 15-20 Gy will be delivered with the GRID device in either a single field, with prescription to dmax, or with parallel opposed GRID fields (matching beamlets from the opposed directions). For patients treated on the "GRID B" regimen, this same dose will be delivered, with a subsequent regimen of 3 Gy X 10 fractions, with the first of these fractions following the GRID dose.
  • Ipilimumab — DRUG
    ipilimumab 3mg/kg IV q3wk x 4
  • Nivolumab — DRUG
    nivolumab 1 mg/kg IV q3wk x 4

Study Details

A one-arm, single center phase 2 trial of SAbR plus ipilimumab plus nivolumab in advanced metastatic melanoma patients

Key Dates

Start date
Mar 1, 2018
Status verified
Apr 2018
Primary completion
Dec 31, 2022
Completion
Dec 31, 2022

Study Design

Enrollment
0 participants (actual)
Intervention model
SEQUENTIAL
Primary purpose
TREATMENT

Arms

  • Experimental: SAbR plus ipilimumab plus nivolumab
    SAbR/GRID plus ipilimumab 3mg/kg IV q3wk x 4 plus nivolumab 1 mg/kg IV q3wk x 4, followed by nivolumab 240 mg IV q 2wk until progression or intolerable toxicity

Primary Outcome Measure

Change of tumor size from baseline to follow up [ Time Frame: at 12, 24, 36 weeks ]

Locations (1)

FacilityCityStateZIPSite coordinators
University of Texas Southwestern Medical Center - DallasDallasTexas75390-

Find similar trials in Dallas, TX

By condition
Melanoma
By specialty
OncologySkin cancerDermatology
By research site
University of Texas Southwestern Medical Center - Dallas· Dallas, TX

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