Clinical trial · Observational
IL-2 "SELECT" Tissue Collection Protocol in Patients With Advanced Melanoma
The High-Dose Aldesleukin (IL-2) "SELECT" Trial: A Prospective Tissue Collection Protocol to Investigate Predictive Models of Response to High-Dose IL-2 Treatments in Patients With Advance 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)
The purpose of this study is to determine which participants with melanoma have a better response to IL-2 and to identify markers that may predict response to IL-2 by collecting participant information (for example; cancer diagnosis and history, prior treatments for cancer, etc.) blood and tumor samples prior to treatment and tumor measurements after treatment.
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 |
|---|---|---|---|
| Malignant Melanoma | Melanoma | ALIAS | 0.90 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| IL-2 | Drug | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- label
- IL-2 subjects
- description
- Subjects receiving IL-2 for advanced melanoma
- interventionNames
- Drug: IL-2
Primary outcomes (1)
- measure
- To determine if DASL subclassification can identify a group of patients with advanced melanoma who are significantly more likely to respond to high dose IL-2 based on therapy than the historical 16% response rate in an unselected patient population
- timeFrame
- 2 years
Secondary outcomes (5)
- measure
- To validate the usefulness of serum fibronectin and VEGF levels as negative predictors of response
- timeFrame
- 2 years
- measure
- To explore the predictive value of several genetic polymorphisms associated with immune function
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: * Malignant melanoma that is metastatic or unresectable * Eligible to receive high-dose IL-2 * Tissue block available with adequate tumor to perform RNA extraction and DASL analysis Exclusion Criteria: * Prior immunotherapy for unresectable or metastatic disease * Untreated brain metastases, leptomeningeal disease, or seizure disorder
References
Publications (0)
Data not yet available