Phase 2
N=76
Monoclonal Antibody Therapy and Vaccine Therapy in Treating Patients With Resected Stage III or Stage IV Melanoma
Intraocular Melanoma · Melanoma (Skin)
Bottom Line
View on ClinicalTrials.gov: NCT00084656 ↗Enrolled (actual)
76
Serious AEs
29.0%
Results posted
Apr 2022
Primary outcome: Primary: Percentage of Participants With Immune-related Adverse Events (irAEs) — 80.0; 72.0; 65.4 Percentage of participants
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 2
- Interventions
- ipilimumab (Biological); Tyrosinase/gp100/MART-1 Peptides (Biological)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- Bristol-Myers Squibb
- Primary completion
- Oct 2009
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Percentage of Participants With Immune-related Adverse Events (irAEs) |
80.0; 72.0; 65.4 | — |
| PRIMARY Time to Disease Relapse |
NA | — |
| SECONDARY Number of Participants With Drug-related irAEs of Any Grade |
24; 24; 24 | — |
| SECONDARY Immunologic Response to the Dose Regimen |
5; 1; 0; 5; 2; 1 | — |
| SECONDARY Number of Participants Experiencing Hematology-related Lab Abnormalities |
5; 1; 0; 0; 0; 0 | — |
| SECONDARY Number of Participants Experiencing Serum Chemistry-related Lab Abnormalities |
5; 6; 7; 0; 1; 1 | — |
| SECONDARY Time to Disease Relapse |
NA | — |
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.
Eligibility Criteria
DISEASE CHARACTERISTICS:
- Histologically confirmed melanoma
- Stage III (≥ 3 positive lymph nodes) or stage IV disease
- Mucosal or ocular melanoma allowed
- Completely resected within the past 6 months
- Patients with stage III resected melanoma rendered free of disease may have failed, been ineligible for, or refused prior treatment with interferon alfa
- Positive staining of tumor tissue for at least one of the following:
- Antibody HMB-45 for gp100
- Antibody HMB-45 for tyrosinase
- Antibody HMB-45 for MART-1
- HLA-A*0201 positive by DNA allele-specific polymerase chain reaction assay
PATIENT CHARACTERISTICS:
Age
- 18 and over
Performance status
- ECOG 0-1
Life expectancy
- At least 6 months
Hematopoietic
- WBC ≥ 2,500/mm^3
- Absolute neutrophil count ≥ 1,500/mm^3
- Platelet count ≥ 100,000/mm^3
- Hematocrit ≥ 30%
- Hemoglobin ≥ 10 g/dL
Hepatic
- AST ≤ 3 times upper limit of normal (ULN)*
- Bilirubin ≤ ULN* (< 3.0 mg/dL for patients with Gilbert's syndrome)
- No significant hepatic disease that would preclude study participation
- Hepatitis B surface antigen negative
- Hepatitis C antibody negative NOTE: * Unless attributable to disease
Renal
- Creatinine ≤ 2.0 mg/dL
- No significant renal disease that would preclude study participation
Cardiovascular
- No significant cardiac disease that would preclude study participation
Pulmonary
- No significant pulmonary disease that would preclude study participation
Immunologic
- No history of any of the following:
- Inflammatory bowel disease or any other autoimmune bowel disease
- Systemic lupus erythematosus
- Rheumatoid arthritis
- Autoimmune ocular disease
- No systemic hypersensitivity to Montanide ISA-51 or any vaccine component
- No active infection requiring therapy
- HIV negative
Other
- No other malignancy within the past 5 years except adequately treated basal cell or squamous cell skin cancer, superficial bladder cancer, or carcinoma in situ of the cervix
- No significant gastrointestinal disease that would preclude study participation
- No significant psychiatric disease that would preclude study participation
- No other medical condition that would preclude study participation
- Not pregnant or nursing
- Negative pregnancy test
- Fertile patients must use effective contraception during and for at least 4 months after study participation
PRIOR CONCURRENT THERAPY:
Biologic therapy
- See Disease Characteristics
- No prior anti-cytotoxic T-lymphocyte-associated antigen-4 monoclonal antibody (MDX-010)
- No prior gp100 antigen, MART-1 antigen, or tyrosinase peptide
- At least 4 weeks since prior immunotherapy for melanoma and recovered
- No other concurrent immunotherapy
Chemotherapy
- At least 4 weeks since prior chemotherapy for melanoma (6 weeks for nitrosoureas) and recovered
- No concurrent chemotherapy
Endocrine therapy
- At least 4 weeks since prior hormonal therapy for melanoma and recovered
- At least 4 weeks since prior systemic, inhaled, or topical corticosteroids
- No concurrent systemic, inhaled, or topical corticosteroids
Radiotherapy
- At least 4 weeks since prior radiotherapy for melanoma and recovered
Surgery
- See Disease Characteristics
- At least 4 weeks since prior surgery for melanoma and recovered
Other
- No concurrent immunosuppressive agents (e.g., cyclosporine and its analog)
- Concurrent analgesic therapy allowed provided the dose is stable for the past 14 days
Data sourced from ClinicalTrials.gov (NCT00084656). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.