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
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)