Study to Compare the Effect of Ipilimumab Retreatment With That of Chemotherapy in Advanced Melanoma

Part of paid clinical trials in Birmingham, Alabama.

Sponsor
Bristol-Myers Squibb
Study ID
NCT01709162
Phase
PHASE2
Status
Terminated

Conditions

Eligibility Criteria

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

Interventions

Study Details

The purpose of the study is to determine whether additional doses of ipilimumab have a positive effect on survival in the treatment of advanced melanoma that has progressed after successful initial treatment with ipilimumab.

Key Dates

Start date
Mar 31, 2013
Status verified
Sep 2015
Primary completion
Jul 31, 2014
Completion
Jul 31, 2014

Study Design

Enrollment
31 participants (actual)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Experimental: Ipilimumab, 3 mg/kg
    Participants received ipilimumab, 3 mg/kg, by intravenous infusion, every 3 weeks for a total of 4 doses or until disease progression, unacceptable toxicity, or withdrawal of consent
  • Active Comparator: Chemotherapy
    Participants received the investigator's choice of chemotherapy, administered per package instructions.

Primary Outcome Measure

Overall Survival [ Time Frame: From randomization to death or last known alive date, assessed up to 15.6 months ]

Locations (7)

FacilityCityStateZIPSite coordinators
Birmingham Hematology & Oncology Associates LlcBirminghamAlabama35205-
Rocky Mountain Cancer CentersAuroraColorado80012-
Investigative Clinical Research Of Indiana, LlcIndianapolisIndiana46260-
Cancer Center Of KansasWichitaKansas67214-
Comprehensive Cancer Center Of NevadaLas VegasNevada89148-
Lehigh Valley HospitalAllentownPennsylvania18103-
Texas Oncology Sammons Cancer CenterDallasTexas75246-

Find similar trials in Birmingham, AL

By condition
Melanoma
By specialty
OncologySkin cancerDermatology
By research site
Birmingham Hematology & Oncology Associates Llc· Birmingham, ALRocky Mountain Cancer Centers· Aurora, COInvestigative Clinical Research Of Indiana, Llc· Indianapolis, INCancer Center Of Kansas· Wichita, KSComprehensive Cancer Center Of Nevada· Las Vegas, NVLehigh Valley Hospital· Allentown, PA

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