Clinical trial · Interventional
Study of NY-ESO-1 ISCOMATRIX® in Patients With High-risk, Resected Melanoma
Randomized, Double-blind Phase II Trial of NY-ESO-1 ISCOMATRIX® Vaccine and ISCOMATRIX® Adjuvant Alone in Patients With Resected Stage Ilc, Illb, lIIc, or IV Malignant Melanoma
NCT00199901CI-TRIAL-00061372completedPhase 2Results postedClinicalTrials.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)
The purpose of this trial is to assess whether treatment with NY-ESO-1 ISCOMATRIX® vaccine improves outcomes for people with Malignant Melanoma which has been removed, but is at high risk of relapse.
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 |
|---|---|---|---|
| ISCOMATRIX® adjuvant | Biological | — | UNRESOLVED |
| NY-ESO-1 ISCOMATRIX® | Biological | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- ACTIVE_COMPARATOR
- label
- Vaccine
- description
- NY-ESO-1 ISCOMATRIX® vaccine
- interventionNames
- Biological: NY-ESO-1 ISCOMATRIX®
- type
- PLACEBO_COMPARATOR
- label
- Adjuvant Alone
- description
- ISCOMATRIX® adjuvant alone
- interventionNames
- Biological: ISCOMATRIX® adjuvant
Primary outcomes (1)
- measure
- Rate of Relapse-free Survival at 18 Months
- timeFrame
- 18 months
- description
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: * Histologically proven malignant melanoma. * Tumor expression of NY-ESO-1 antigen by immunohistochemistry. * Fully resected AJCC stage IIc, IIIb, IIIc or IV melanoma. * Within six months of surgery for melanoma. * Full recovery from surgery. * No immunotherapy or systemic adjuvant therapy for melanoma since most recent relapse and/or resection. (Previous adjuvant therapy accepted providing patient relapsed and resected after this.) * Age 18 years or older. * Able to give written informed consent. * Vital laboratory parameters within normal range, or protocol specified ranges. Exclusion Criteria: * Other serious or significant illnesses. * Resected cerebral metastases. * Ocular melanoma. * Other malignancy within last 3 years, except for treated non-melanoma skin cancer and cervical cancer in situ. * Using immunosuppressive drugs. * Anticoagulation. * Known HIV positivity. * Chemotherapy or radiation therapy in last four weeks (6 weeks for nitrosourea drugs). * Not available for immunological and clinical follow-up assessments. * Participation in prior clinical trial involving an investigational agent within last 4 weeks. * Previous isolated limb perfusion (ILP). * Pregnancy or breastfeeding. * Refusal or inability to use effective means of contraception for women of childbearing potential. * Mental impairment that may compromise ability to give informed consent and to comply with study requirements.
References
Publications (0)
Data not yet available
No reference posted for this study.