Phase 2
Completed N=76
Monoclonal Antibody Therapy and Vaccine Therapy in Treating Patients With Resected Stage III or Stage IV Melanoma
Intraocular Melanoma · Melanoma (Skin)
Source: ClinicalTrials.gov NCT00084656 ↗
Enrolled (actual)
76
Serious AEs
29.0%
Results posted
Apr 2022
Primary outcomePrimary: Percentage of Participants With Immune-related Adverse Events (irAEs) — 80.0; 72.0; 65.4 Percentage of participants
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.
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 | — |
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. Informational only — not medical advice.