Monoclonal Antibody Therapy and Vaccine Therapy in Treating Patients With Resected Stage III or Stage IV Melanoma

Part of paid clinical trials in Tampa, Florida.

Sponsor
Bristol-Myers Squibb
Study ID
NCT00084656
Phase
PHASE2
Status
Completed

Conditions

  • Intraocular Melanoma
  • Melanoma (Skin)

Eligibility Criteria

Sex
ALL
Age
18 Years - 120 Years
Healthy Volunteers
Not accepted

Interventions

  • ipilimumab — BIOLOGICAL
    IV over 90 mins on day 1, wks 1,9,17,25,33,41,53 Dose: 3 mg/kg (Part I), 10 mg/kg (Part II)
  • Tyrosinase/gp100/MART-1 Peptides — BIOLOGICAL
    (All subjects in Part I and HLA-A\*0201 positive subjects only in Part II): SC, day 1 of wks 1,3,5,7,9,11,17, 21,25,33,41,53 Dose: 1 mg peptide emulsified in 1 mL Montanide ISA 51 VG.)

Study Details

RATIONALE: Monoclonal antibodies can locate tumor cells and either kill them or deliver tumor-killing substances to them without harming normal cells. Vaccines may make the body build an immune response to kill tumor cells. Combining the vaccines with Montanide ISA-51 may cause a stronger immune response and kill more tumor cells. Giving monoclonal antibody therapy together with vaccine therapy may be an effective treatment for stage III or stage IV melanoma. PURPOSE: This phase II trial is studying how well giving monoclonal antibody therapy together with vaccine therapy works in treating patients with resected stage III or stage IV melanoma.

Key Dates

Start date
May 31, 2004
Status verified
Apr 2022
Primary completion
Oct 31, 2009
Completion
Oct 31, 2009

Study Design

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

Arms

  • Experimental: Arm 1

Primary Outcome Measure

Percentage of Participants With Immune-related Adverse Events (irAEs) [ Time Frame: Between first dose and 70 days after last dose of study therapy (up to 3 years including maintenance phase) ]

Locations (1)

FacilityCityStateZIPSite coordinators
H. Lee Moffitt Cancer Center and Research Institute at University of South FloridaTampaFlorida33612-9497-

Find similar trials in Tampa, FL

By research site
H. Lee Moffitt Cancer Center and Research Institute at University of South Florida· Tampa, FL

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