Monoclonal Antibody Therapy and Vaccine Therapy in Treating Patients With Resected Stage III or Stage IV Melanoma
- Conditions
- Intraocular MelanomaMelanoma (Skin)
- Interventions
- Biological: ipilimumabBiological: Tyrosinase/gp100/MART-1 Peptides
- Registration Number
- NCT00084656
- Lead Sponsor
- Bristol-Myers Squibb
- 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.
OUTLINE: This is an open-label study.
Patients receive anti-cytotoxic T-lymphocyte-associated antigen-4 monoclonal antibody (MDX-010) IV over 90 minutes on day 1 of weeks 1, 9, 17, 25, 33, 41, and 53 and peptide vaccine comprising tyrosinase, gp100 antigen, and MART-1 antigen emulsified in Montanide ISA-51 subcutaneously on day 1 of weeks 1, 3, 5, 7, 9, 11, 17, 21, 25, 33, 41, and 53.
Patients are followed every 3 months for 2 years, every 6 months for 2 years, and then annually thereafter.
PROJECTED ACCRUAL: A total of 25 patients will be accrued for this study.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 77
Not provided
Not provided
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- Arm && Interventions
Group Intervention Description Arm 1 Tyrosinase/gp100/MART-1 Peptides - Arm 1 ipilimumab -
- Primary Outcome Measures
Name Time Method Percentage of Participants With Immune-related Adverse Events (irAEs) 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 methodTime to Disease Relapse 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 Outcome Measures
Name Time Method 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) The number of participants who experienced a drug-related irAE of any grade over the course of the study.
Note: The confidence interval was calculated using the Clopper Pearson methodNumber 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) The number of participants who experienced a Hematology-related laboratory abnormality (grade 1-4 and grade 3-4 categories, grade 4 being the worst) during the course of the study.
Laboratory tests were graded using the NCI Common Terminology Criteria for Adverse Events (CTCAE), version 3.0.Immunologic Response to the Dose Regimen up to 3 years The secondary objective was to determine the immunologic response to the dosing regimen, via Human Anti-Human Antibody (HAHA) Assessment, displayed by number of participants observed as HAHA positive or negative.
Note: If participant had at least one post-baseline HAHA result with increase in titer over pre-study, the participant is counted as HAHA Positive.
A participant with all negative post-baseline results is counted as HAHA negative.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) The number of participants who experienced a Serum Chemistry-related laboratory abnormality (grade 1-4 and grade 3-4 categories, grade 4 being the worst) during the course of the study.
Laboratory tests were graded using the NCI Common Terminology Criteria for Adverse Events (CTCAE), version 3.0.Time to Disease Relapse 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.
Trial Locations
- Locations (1)
H. Lee Moffitt Cancer Center and Research Institute at University of South Florida
🇺🇸Tampa, Florida, United States