RADVAX™: A STRATIFIED PHASE I/II DOSE ESCALATION TRIAL OF HYPOFRACTIONATED RADIOTHERAPY FOLLOWED BY IPILIMUMAB IN METASTATIC MELANOMA

Part of paid clinical trials in Philadelphia, Pennsylvania.

Sponsor
Abramson Cancer Center at Penn Medicine
Study ID
NCT01497808
Phase
PHASE1/PHASE2
Status
Completed

Conditions

Eligibility Criteria

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

Interventions

  • Ipilimumab — DRUG
  • Stereotactic Body Radiation Therapy — RADIATION

Study Details

The primary objective is to determine the maximum tolerated hypofractionated radiotherapy dose (MTD) to a solitary metastatic focus ('index lesion') when followed by ipilimumab, in metastatic melanoma patients without brain involvement The secondary objectives are to determine late toxicity, immune-related clinical responses and immune pharmacodynamic changes after hypofractionated radiotherapy followed by ipilimumab

Key Dates

Start date
Nov 29, 2011
Status verified
Jul 2021
Primary completion
Dec 29, 2013
Completion
Oct 12, 2015

Study Design

Enrollment
22 participants (actual)
Allocation
NON_RANDOMIZED
Intervention model
SEQUENTIAL
Primary purpose
TREATMENT

Arms

  • Experimental: Ipilimumab and Radiotherapy (8 Gy x 2)
  • Experimental: Ipilimumab and Radiotherapy (8 Gy x 3)
  • Experimental: Ipilimumab and Radiotherapy (6 Gy x 2)
  • Experimental: Ipilimumab and Radiotherapy (6 Gy x 3)

Primary Outcome Measure

Dose-limiting Toxicity (DLT) [ Time Frame: 30 days ]

Locations (1)

FacilityCityStateZIPSite coordinators
Abramson Cancer Center of the Universirty of PennsylvaniaPhiladelphiaPennsylvania19104-

Find similar trials in Philadelphia, PA

By condition
Melanoma
By specialty
OncologySkin cancerDermatology
By research site
Abramson Cancer Center of the Universirty of Pennsylvania· Philadelphia, PA

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