Phase II Randomized Trial of Ipilimumab Versus Ipilimumab and Radiotherapy in Metastatic Melanoma

Part of paid clinical trials in New York, New York.

Sponsor
NYU Langone Health
Study ID
NCT01689974
Phase
PHASE2
Status
Terminated

Conditions

Eligibility Criteria

Sex
ALL
Age
19 Years - 80 Years
Healthy Volunteers
Not accepted

Interventions

  • Ipilimumab — DRUG
    Ipilimumab will be administered alone on day 4, 25, 46 and 67.
  • Radiation Therapy — RADIATION
    Radiation is given over one week interval On the fourth day of radiation (day 4)Ipilimumab is administered and repeated on Days 25, 46 and 67.

Study Details

An attractive area of research regards immune manipulations to recover some of the patient's immune response to his/her tumor, a strategy that has the advantages of being both natural and potentially long-lasting.\[1\] We propose to combine immunotherapy with radiotherapy directed to a metastatic site, to create a "hub" for in vivo immunization to the tumor, to enable "tumor rejection" at the other metastatic sites. This "in vivo immunization" is explored as a viable alternative to an individualized vaccine approach. Preclinical data generated by us and others support a "proof of principle" clinical trial that may open the field to an alternative use of radiotherapy in a novel partnership with cancer immunotherapy.\[2\]

Key Dates

Start date
Jan 31, 2013
Status verified
Jan 2018
Primary completion
Mar 31, 2015
Completion
Mar 31, 2015

Study Design

Enrollment
10 participants (actual)
Allocation
RANDOMIZED
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT

Arms

  • Other: Arm A: Ipilimumab
    Ipilimumab administered alone Day 4, 25, 46, and 67
  • Other: Arm B: Ipilimumab and Radiation
    Radiation Therapy and Ipilimumab. Radiation treatment is administered for 5 fractions (sessions) over 1 week. On Day 4 treatment with Ipilimumab begins and continues on Days 25, 46, and 67.

Primary Outcome Measure

Response Rates of Ipilimumab Alone and of Ipilimumab With Radiation Therapy and to Estimate the Difference Between Response Rates With Ipilimumab Alone and Ipilimumab With Radiation Therapy [ Time Frame: 2 years ]

Locations (1)

FacilityCityStateZIPSite coordinators
NYU Clinical Cancer CenterNew YorkNew York10016-

Find similar trials in New York, NY

By condition
Melanoma
By specialty
OncologySkin cancerDermatology
By research site
NYU Clinical Cancer Center· New York, NY

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