Clinical trial · Interventional
Vaccination Plus Ontak in Patients With Metastatic Melanoma
Randomized Phase II Study of Multipeptide Vaccination With or Without Regulatory T Cell Depletion Using Ontak in Patients With Metastatic Melanoma
NCT00515528CI-TRIAL-00049623terminatedPhase 2Results postedClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Why stopped (as posted): The immune monitoring data failed to demonstrate an improvement in any biologic endpoint with denileukin diftitox.
Summary
Brief summary (as posted)
The purpose of this study is to determine if an experimental melanoma vaccine can produce an immune response in patients with metastatic melanoma, and if combining this vaccine with the drug Ontak can improve these immune responses. It is also hoped that this will lead to tumor shrinkage.
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 (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| 4-peptide melanoma vaccine | Biological | — | UNRESOLVED |
| Ontak | Drug | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- EXPERIMENTAL
- label
- Vaccine Alone
- description
- Subjects received vaccine immunization injected intra-dermally or subcutaneously on day 1. The vaccine was an emulsification consisting of 250 mcg each of the following peptides: Melan-A, gp100, MAGE-3, and NA17 as well as GM-CSF 125 mcg and Montanide. A second and third vaccination was given at 2 weeks and 4 weeks after the first. If there was no evidence of cancer progression, additional courses of three vaccinations administered at 2 week intervals were administered until disease progression.
- interventionNames
- Biological: 4-peptide melanoma vaccine
- type
- EXPERIMENTAL
- label
- Vaccine plus Ontak
- description
- Subjects in Vaccine plus Ontak received the same vaccination strategy as Vaccine alone group but additionally received a single dose of denileukin diftitox(18 mcg/kg) 4 days prior to the first vaccine administration
- interventionNames
- Biological: 4-peptide melanoma vaccine
- Drug: Ontak
Primary outcomes (1)
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: * Melanoma with evidence of metastatic disease * Life expectancy of at least 12 weeks. * Karnofsky performance status index of greater than or equal to 80%. * Adequate hematopoietic, renal, and hepatic function, defined as: * Patient must express HLA-A2 * Tumor biopsy: patient must agree to undergo biopsy of accessible tumor before and after therapy, when feasible, to study tumor cell properties and characteristics of immune cells. * EKG without evidence of arrhythmia or changes that indicate acute ischemia. * Pulse oximetry showing oxygen saturation of at least 90% on room air. Exclusion Criteria: * Significant cardiovascular disease, or cardiac arrhythmia requiring medical intervention. * Pregnant or nursing women. * Biological therapy in the 4 weeks prior to the start of dosing. * Patients with intrinsic immunosuppression, including seropositivity for HIV antibody. * Serious concurrent infection, including active tuberculosis, hepatitis B, or hepatitis C. * Concurrent systemic corticosteroids (except physiologic replacement doses)or other immunosuppressive drugs (eg. cyclosporin A). * Psychiatric illness that may make compliance to the clinical protocol unmanageable or may compromise the ability of the patient to give informed consent. * Active or history of autoimmune disease * Active gastrointestinal bleeding or uncontrolled peptic ulcer disease. * Presence of untreated brain metastases.
References
Publications (1)
- DERIVEDLuke JJ, Zha Y, Matijevich K, Gajewski TF. Single dose denileukin diftitox does not enhance vaccine-induced T cell responses or effectively deplete Tregs in advanced melanoma: immune monitoring and clinical results of a randomized phase II trial. J Immunother Cancer. 2016 Jun 21;4:35. doi: 10.1186/s40425-016-0140-2. eCollection 2016. PMID 27330808