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Clinical Trials/NCT00084656
NCT00084656CompletedPhase 2

An Extended Dosing, Two-phase Study of MDX-010 as Monotherapy or in Combination With Tyrosinase/gp100/MART-1 Peptides Emulsified With Montanide ISA 51 VG in the Treatment of Subjects With Resected Stage III or Stage IV Melanoma

Bristol-Myers Squibb2 sites in 1 country77 target enrollmentStarted: May 31, 2004Last updated:
Conditions

Trial Snapshot

Phase
Phase 2
Status
Completed
Sponsor
Enrollment
77
Locations
2
Primary Endpoint
Percentage of Participants With Immune-related Adverse Events (irAEs)

Study Overview

Brief Summary

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.

Detailed Description

OBJECTIVES:

Primary

  • Achieve at least a 40% autoimmune breakthrough event rate, as defined by the induction of grade 1, grade 2, or acceptable grade 3 drug-related autoimmune adverse events, in patients with resected stage III or IV melanoma treated with anti-cytotoxic T-lymphocyte-associated antigen-4 monoclonal antibody (MDX-010) and peptide vaccine comprising tyrosinase, gp100 antigen, and MART-1 antigen emulsified in Montanide ISA-51.

Secondary

  • Determine the incidence of drug-related autoimmune adverse events of any grade in patients treated with this regimen.
  • Determine the time to disease relapse in patients treated with this regimen.
  • Determine the immunologic response in patients treated with this regimen.

Study Design

Study Type
Interventional
Allocation
Na
Intervention Model
Single Group
Primary Purpose
Treatment
Masking
None

Eligibility Criteria

Ages
18 Years to 120 Years (Adult, Older Adult)
Sex
All
Accepts Healthy Volunteers
No

Inclusion Criteria

  • Not provided

Exclusion Criteria

  • Not provided

Outcomes

Primary Outcomes

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)

Percentage of participants who experienced an irAE during the course of the study defined by the induction of Grade 1, Grade 2, or acceptable Grade 3 drug-related irAEs. For the purposes of this trial, acceptable drug-related irAEs are skin-related immune-mediated adverse events \< or = Grade 3 (potentially reversible inflammation \< Grade 4 that can be attributable to a local antitumor reaction that could potentially be a therapeutic response will also be considered an acceptable irAE). Note: The confidence interval was calculated using the Clopper Pearson method

Time to Disease Relapse

Time Frame: up to 3 years

To determine the time (months) from first dose to disease relapse. Time to disease relapse is defined from the start of treatment to the first occurrence of any new lesion (reported by the investigator on physical exam or diagnostic imaging assessments that are attributed to metastatic melanoma) or death. Participants who neither relapse nor died will be censored on the date of their last tumor evaluation. Median estimated using Kaplan-Meier method; A two-sided 95% CI for median in each treatment group was computed via the log-log transformation method.

Secondary Outcomes

  • Number of Participants With Drug-related irAEs of Any Grade(Between first dose and 70 days after last dose of study therapy (up to 3 years including maintenance phase))
  • Number of Participants Experiencing Hematology-related Lab Abnormalities(Between first dose and 70 days after last dose of study therapy (up to 3 years including maintenance phase))
  • Immunologic Response to the Dose Regimen(up to 3 years)
  • Number of Participants Experiencing Serum Chemistry-related Lab Abnormalities(Between first dose and 70 days after last dose of study therapy (up to 3 years including maintenance phase))
  • Time to Disease Relapse(up to 3 years)

Investigators

Sponsor
Bristol-Myers Squibb
Sponsor Class
Industry
Responsible Party
Sponsor

Study Sites (2)

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