Clinical trial · Interventional
Monoclonal Antibody Therapy and Vaccine Therapy in Treating Patients With Resected Stage III or Stage IV Melanoma
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
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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.
Conditions
Conditions (2)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Intraocular Melanoma | Uveal Melanoma | ALIAS | 0.90 |
| Melanoma (Skin) | Melanoma | ONTOLOGY_EXACT | 0.85 |
Interventions
Interventions (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| ipilimumab | Biological | Ipilimumab | ALIAS |
| Tyrosinase/gp100/MART-1 Peptides | Biological | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- Arm 1
- interventionNames
- Biological: ipilimumab
- Biological: Tyrosinase/gp100/MART-1 Peptides
Primary outcomes (2)
- measure
- Percentage of Participants With Immune-related Adverse Events (irAEs)
- timeFrame
- Between first dose and 70 days after last dose of study therapy (up to 3 years including maintenance phase)
- description
- 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
- measure
- Time to Disease Relapse
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
- Maximum age
- 120 Years
Show eligibility criteria text
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
References
Publications (2)
- DERIVEDGarg SK, Ott MJ, Mostofa AGM, Chen Z, Chen YA, Kroeger J, Cao B, Mailloux AW, Agrawal A, Schaible BJ, Sarnaik A, Weber JS, Berglund AE, Mule JJ, Markowitz J. Multi-Dimensional Flow Cytometry Analyses Reveal a Dichotomous Role for Nitric Oxide in Melanoma Patients Receiving Immunotherapy. Front Immunol. 2020 Feb 25;11:164. doi: 10.3389/fimmu.2020.00164. eCollection 2020. PMID 32161584
- DERIVEDSarnaik AA, Yu B, Yu D, Morelli D, Hall M, Bogle D, Yan L, Targan S, Solomon J, Nichol G, Yellin M, Weber JS. Extended dose ipilimumab with a peptide vaccine: immune correlates associated with clinical benefit in patients with resected high-risk stage IIIc/IV melanoma. Clin Cancer Res. 2011 Feb 15;17(4):896-906. doi: 10.1158/1078-0432.CCR-10-2463. Epub 2010 Nov 24. PMID 21106722