Clinical trial · Interventional
Vaccine Therapy and Monoclonal Antibody Therapy in Treating Patients With Stage IV Melanoma
An Open-label Study Of MDX-010 In Combination With gp100 Peptides Emulsified With Montanide ISA 51 In The Treatment Of Patients With Stage IV Melanoma
NCT00032045CI-TRIAL-00010882completedPhase 2ClinicalTrials.gov clinicaltrialsProvenance
- 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: Vaccines made from peptides may make the body build an immune response to kill tumor cells. Monoclonal antibodies can locate tumor cells and either kill them or deliver tumor-killing substances to them without harming normal cells. Combining vaccine therapy with a monoclonal antibody may cause a stronger immune response and kill more tumor cells. PURPOSE: Phase II trial to study the effectiveness of combining vaccine therapy with monoclonal antibody therapy in treating patients who have 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 (3)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| gp100 antigen | Biological | — | UNRESOLVED |
| incomplete Freund's adjuvant | Biological | — | UNRESOLVED |
| ipilimumab | Biological | Ipilimumab | ALIAS |
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 16 Years
Show eligibility criteria text
DISEASE CHARACTERISTICS: * Histologically confirmed stage IV melanoma * Mucosal or ocular melanoma allowed * Clinically evaluable disease * HLA-A\*0201 positive PATIENT CHARACTERISTICS: Age: * 16 and over Performance status: * Karnofsky 60-100% Life expectancy: * At least 6 months Hematopoietic: * WBC at least 2,500/mm\^3 * Absolute neutrophil count at least 1,500/mm\^3 * Platelet count at least 100,000/mm\^3 * Hemoglobin at least 10 g/dL * Hematocrit at least 30% Hepatic: * AST no greater than 3 times upper limit of normal (ULN) * Bilirubin no greater than ULN (less than 3.0 mg/dL in patients with Gilbert's syndrome) * Hepatitis B surface antigen negative * Hepatitis C antibody nonreactive Renal: * Creatinine less than 2.0 mg/dL Immunologic: * Antinuclear antibody negative * Thyroglobulin antibody normal * Rheumatoid factor normal * HIV negative * No prior autoimmune disease (including uveitis and autoimmune inflammatory eye disease) * No active infection * No hypersensitivity to Montanide ISA-51 Other: * Not pregnant or nursing * Negative pregnancy test * Fertile patients must use effective contraception * 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 other underlying medical condition that would preclude study therapy PRIOR CONCURRENT THERAPY: Biologic therapy: * At least 3 weeks since prior immunotherapy for melanoma and recovered * No prior gp100 peptides * No prior anti-cytotoxic T-lymphocyte-associated antigen-4 monoclonal antibody Chemotherapy: * At least 3 weeks since prior chemotherapy for melanoma and recovered * No concurrent chemotherapy Endocrine therapy: * At least 3 weeks since prior hormonal therapy for melanoma and recovered * At least 4 weeks since prior systemic or topical corticosteroids * No concurrent topical or systemic corticosteroids Radiotherapy: * At least 3 weeks since prior radiotherapy for melanoma and recovered Surgery: * Not specified Other: * No other concurrent immunosuppressive agents (e.g., cyclosporine and its analog)
References
Publications (5)
- BACKGROUNDMaker AV, Attia P, Rosenberg SA. Analysis of the cellular mechanism of antitumor responses and autoimmunity in patients treated with CTLA-4 blockade. J Immunol. 2005 Dec 1;175(11):7746-54. doi: 10.4049/jimmunol.175.11.7746. PMID 16301685
- BACKGROUNDMaker AV, Phan GQ, Attia P, Yang JC, Sherry RM, Topalian SL, Kammula US, Royal RE, Haworth LR, Levy C, Kleiner D, Mavroukakis SA, Yellin M, Rosenberg SA. Tumor regression and autoimmunity in patients treated with cytotoxic T lymphocyte-associated antigen 4 blockade and interleukin 2: a phase I/II study. Ann Surg Oncol. 2005 Dec;12(12):1005-16. doi: 10.1245/ASO.2005.03.536. Epub 2005 Oct 21. PMID 16283570
- RESULTAttia P, Phan GQ, Maker AV, Robinson MR, Quezado MM, Yang JC, Sherry RM, Topalian SL, Kammula US, Royal RE, Restifo NP, Haworth LR, Levy C, Mavroukakis SA, Nichol G, Yellin MJ, Rosenberg SA. Autoimmunity correlates with tumor regression in patients with metastatic melanoma treated with anti-cytotoxic T-lymphocyte antigen-4. J Clin Oncol. 2005 Sep 1;23(25):6043-53. doi: 10.1200/JCO.2005.06.205. Epub 2005 Aug 8. PMID 16087944
- RESULTPhan GQ, Yang JC, Sherry RM, Hwu P, Topalian SL, Schwartzentruber DJ, Restifo NP, Haworth LR, Seipp CA, Freezer LJ, Morton KE, Mavroukakis SA, Duray PH, Steinberg SM, Allison JP, Davis TA, Rosenberg SA. Cancer regression and autoimmunity induced by cytotoxic T lymphocyte-associated antigen 4 blockade in patients with metastatic melanoma. Proc Natl Acad Sci U S A. 2003 Jul 8;100(14):8372-7. doi: 10.1073/pnas.1533209100. Epub 2003 Jun 25. PMID 12826605
- DERIVEDSchadendorf D, Hodi FS, Robert C, Weber JS, Margolin K, Hamid O, Patt D, Chen TT, Berman DM, Wolchok JD. Pooled Analysis of Long-Term Survival Data From Phase II and Phase III Trials of Ipilimumab in Unresectable or Metastatic Melanoma. J Clin Oncol. 2015 Jun 10;33(17):1889-94. doi: 10.1200/JCO.2014.56.2736. Epub 2015 Feb 9. PMID 25667295