Clinical trial · Interventional
Ipilimumab With or Without Vaccine Therapy in Treating Patients With Previously Treated Stage IV Melanoma
A Randomized Phase II Study of Fixed Dose Ipilimumab (MDX-010) 10 mg/kg Given Alone or in Combination With Two gp100 Peptides Emulsified With Montanide ISA-51 VG for Previously Treated HLA-A * 0201 Positive Subjects With 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, such as ipilimumab, can block tumor growth in different ways. Some block the ability of tumor cells to grow and spread. Others find tumor cells and help kill them or carry tumor-killing substances to them. Vaccines made from gp100 peptides may help the body build an effective immune response to kill tumor cells. Giving ipilimumab together with vaccine therapy may be an effective treatment for melanoma. PURPOSE: This randomized phase II trial is studying ipilimumab and vaccine therapy to see how well they work compared to ipilimumab alone in treating patients with previously treated stage 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 (Skin) | Melanoma | ONTOLOGY_EXACT | 0.85 |
Interventions
Interventions (4)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| gp100:209-217(210M) peptide vaccine | Biological | — | UNRESOLVED |
| gp100:280-288(288V) peptide vaccine | Biological | — | UNRESOLVED |
| incomplete Freund's adjuvant | Biological | — | UNRESOLVED |
| ipilimumab | Biological | Ipilimumab | ALIAS |
Design
Arms and outcomes
Arms (0)
[]Primary outcomes (1)
- measure
- Clinical response
Secondary outcomes (4)
- measure
- Safety and toxicity
- measure
- Immunologic response
- measure
- Response rate
- measure
- Overall survival
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 16 Years
Show eligibility criteria text
DISEASE CHARACTERISTICS:
* Histologically confirmed stage IV melanoma
* HLA-A\*0201 positive disease
* Previously treated metastatic disease
* Clinically evaluable and measurable disease
* No mucosal or ocular melanoma
* No evidence of active brain metastases
PATIENT CHARACTERISTICS:
* ECOG performance status 0-2
* WBC ≥ 2,500/mm³
* Absolute neutrophil count ≥ 1,000/mm³
* Absolute lymphocyte count ≥ 500/mm³
* Platelet count ≥ 75,000/mm³
* Hemoglobin ≥ 9 g/dL
* Creatinine \< 2.5 mg/dL
* AST ≤ 2 times upper limit of normal (ULN) (5 times ULN if liver metastases are present)
* Bilirubin normal (\< 3.0 mg/dL if Gilbert's syndrome is present)
* Hepatitis B surface antigen negative
* HIV negativity
* No hepatitis C virus antibodies
* Not pregnant or nursing
* Negative pregnancy test
* Fertile patients must use effective contraception
* No other prior malignancy except for any of the following:
* Adequately treated basal cell or squamous cell skin cancer
* Superficial bladder cancer
* Carcinoma in situ of the cervix
* Any other cancer from which patient has been disease free for \> 5 years
* No active immune-mediated disease requiring active therapy with any form of steroid or immunosuppressive therapy
* No documented history of any of the following:
* Inflammatory bowel disease
* Regional enteritis
* Connective tissue disorders, such as systemic lupus erythematosus
* Rheumatoid arthritis
* Immune-mediated inflammatory eye disease
* Sjögren's syndrome
* Inflammatory neurologic disorder, such as multiple sclerosis
* Any immune-mediated disease that can cause life-threatening symptoms or severe organ/tissue damage, in the opinion of the principal investigator
* History of vitiligo or immune-mediated thyroiditis allowed
* Skin rashes associated with previous therapy allowed provided patient has recovered from treatment-related toxicity to \< grade 1
* No active infection
* No systemic hypersensitivity to any of the study drugs
* History of local reactions (e.g., delayed hypersensitivity or glaucomatous reactions) to Montanide ISA-51 allowed
* No underlying medical condition that, in the opinion of the investigator, would preclude study treatment
PRIOR CONCURRENT THERAPY:
* At least 3 weeks since prior systemic treatment (6 weeks for nitrosoureas) and recovered
* No prior ipilimumab or gp100 vaccines
* More than 4 weeks since prior steroids
* No concurrent systemic or topical corticosteroids or immunosuppressive agents (e.g., cyclosporine or chemotherapy agents), including steroid enemas, inhaled steroids, or steroid eye drops
* Hormone-replacement therapy allowedReferences
Publications (1)
- BACKGROUNDDowney SG, Klapper JA, Smith FO, Yang JC, Sherry RM, Royal RE, Kammula US, Hughes MS, Allen TE, Levy CL, Yellin M, Nichol G, White DE, Steinberg SM, Rosenberg SA. Prognostic factors related to clinical response in patients with metastatic melanoma treated by CTL-associated antigen-4 blockade. Clin Cancer Res. 2007 Nov 15;13(22 Pt 1):6681-8. doi: 10.1158/1078-0432.CCR-07-0187. Epub 2007 Nov 2. PMID 17982122