Clinical trial · Interventional
Novel Adjuvants for Peptide-Based Melanoma Vaccines
An Open Label Study of MDX-CTLA4 in Combination With Tyrosinase/gp100/MART-1 Peptides Emulsified With Montanide ISA 51 in the Treatment of Patients With Resected Stage III or IV Melanoma
NCT00028431CI-TRIAL-00014638completedPhase 1ClinicalTrials.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)
This is a study to determine the efficacy of a melanoma vaccine chemotherapy cocktail composed of CTLA-4 antibody; tyrosinase, gp100, and MART-1 peptides; and incomplete Freund's adjuvant (IFA) with or without interleukin-12 in patients with resected stage III or IV melanoma.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Melanoma | Melanoma | ONTOLOGY_EXACT | 0.98 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| MDX-CTLA4 Antibody; Tyrosinase/gp100/MART-1 Peptides Melanoma Vaccine | Biological | — | UNRESOLVED |
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion criteria: * Diagnosis of stage III or IV cutaneous, mucosal, or ocular melanoma * Completely resected disease or disease-free * HLA-A2.1 positive * Tumor tissue available for immunohistochemical analysis and staining positive for at least 1 of the specified antigens * At least 1 month since prior therapy for cancer, including radiotherapy and adjuvant therapy * WBC count at least 3,000/mm3 * Granulocyte count at least 1,500/mm3 * Platelet count at least 100,000/mm3 * Hemoglobin at least 9.0 gm/dL * Creatinine no greater than 2.0 mg/dL * Bilirubin no greater than 2.0 mg/dL * SGOT/SGPT no greater than 2.5 times upper limit of normal * ECOG performance status 0-1 * Have failed alpha-interferons (patients with resected stage III disease) Exclusion criteria: * Prior treatment with tyrosinase: 368-376(370D), gp100:209-217(210M), and MART-1:26-35(27L) peptides * Steroid therapy or other immunosuppressive medication requirement * Major systemic infections (e.g., pneumonia or sepsis) * Coagulation or bleeding disorders * Major medical illnesses of the gastrointestinal, cardiovascular, or respiratory systems * Allergic reaction to Montanide ISA 51 (incomplete Freund's adjuvant) * History of uveitis or autoimmune inflammatory eye disease * Other active autoimmune disease * Positive for hepatitis B surface antigen, hepatitis C antibody, or HIV antibody * Pregnant or nursing
References
Publications (0)
Data not yet available
No reference posted for this study.