Clinical trial · Interventional
The Response to Intralesional IL-2 and/or BCG Treatment for Cutaneous Metastatic Melanoma
NCT03928275CI-TRIAL-00063901withdrawnPhase 2 / Phase 3ClinicalTrials.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Why stopped (as posted): Withdrawn prematurely.
Summary
Brief summary (as posted)
The investigators aim to include 100 local participants over the next 5 years in a two-stage sequential randomized interventional study of intralesional Interleukin-2 (IL-2) and Bacillus Calmette Guerin (BCG) to assess the utility of treating cutaneous metastatic melanoma (CMM).
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 |
|---|---|---|---|
| Cutaneous Metastatic Melanoma | — | UNRESOLVED | — |
Interventions
Interventions (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Combination therapy Interleukin-2 and Bacillus Calmette Guerin | Biological | — | UNRESOLVED |
| Interleukin-2 | Biological | Aldesleukin | ALIAS |
Design
Arms and outcomes
Arms (2)
- type
- EXPERIMENTAL
- label
- Intralesional IL-2 Treatment
- description
- CMM patients will received 4 treatments of intralesional Interleukin-2 two weeks apart over an eight week period.
- interventionNames
- Biological: Interleukin-2
- type
- EXPERIMENTAL
- label
- Combination therapy: Intralesional IL-2 and BCG Treatment
- description
- CMM patients will receive 4 treatments of combination therapy intralesional Interleukin-2 and Bacillus Calmette Guerin two weeks apart over an eight week period.
- interventionNames
- Biological: Combination therapy Interleukin-2 and Bacillus Calmette Guerin
Primary outcomes (1)
- measure
- Number of CMM participants that respond to IL-2 compared to the number of participants that respond to IL-2 and BCG.
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
- Maximum age
- 80 Years
Show eligibility criteria text
Inclusion Criteria: * Patient with cutaneous metastatic melanoma. * Has 4 or more melanoma lesions. * Between18 and 80 years of age. Exclusion Criteria: * Immunocompromized. * Receiving immuno-therapy for other diagnosis. * Inflammatory disease. * Autoimmune disease. * Pregnant * HIV * Test positive for TB
References
Publications (0)
Data not yet available
No reference posted for this study.