Clinical trial · Interventional
Safety Study of IL-21/Ipilimumab Combination in the Treatment of Melanoma
A Phase I Dose Escalation Study of BMS-982470 (Recombinant Interleukin 21, rIL-21) in Combination With Ipilimumab in Subjects With Unresectable Stage III or Stage IV Melanoma
NCT01489059CI-TRIAL-00015500completedPhase 1ClinicalTrials.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 study is to determine whether the combination of interleukin-21 (IL-21) and Ipilimumab in subjects with melanoma is safe, and provide preliminary information on the clinical benefits of the combination compared with Ipilimumab alone
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 |
|---|---|---|---|
| BMS-982470 (recombinant interleukin-21) | Biological | — | UNRESOLVED |
| Ipilimumab | Biological | Ipilimumab | ALIAS |
Design
Arms and outcomes
Arms (5)
- type
- EXPERIMENTAL
- label
- Part 1 - Arm 1: BMS-982470 (Daily x 5) + Ipilimumab
- description
- Dose Escalation
- interventionNames
- Biological: BMS-982470 (recombinant interleukin-21)
- Biological: Ipilimumab
- type
- EXPERIMENTAL
- label
- Part 1 - Arm 2: BMS-982470 (Weekly) + Ipilimumab
- description
- Dose Escalation
- interventionNames
- Biological: BMS-982470 (recombinant interleukin-21)
- Biological: Ipilimumab
- type
- EXPERIMENTAL
- label
- Part 2 - Arm 1: BMS-982470 (Daily x 5) + Ipilimumab
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
For more information regarding BMS clinical trial participation, please visit www.BMSStudyConnect.com. Inclusion Criteria: * Unresectable Stage III or Stage IV melanoma * Part 1 Dose Escalation: Prior melanoma treatment allowed except for the following: ipilimumab, BMS-982470 (rIL-21), anti-Programmed Death-1 (anti-PD-1), anti-programmed death-ligand 1 (anti-PD-L1), anti-PD-L2 or anti-CD137 * Part 2 Cohort expansion: Prior treatment for melanoma is not allowed, except for adjuvant therapy with interferon alpha or melanoma vaccines which are permitted * Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1 * Measurable disease by computed tomography (CT) or magnetic resonance imaging (MRI) * Normal liver function tests Exclusion Criteria: * Part 1 Dose escalation: subjects with ≤ 2 brain metastases of stable size, ≥ 4 weeks post-radiation treatment, and off steroids are allowed * Part 2 Cohort expansion: subjects with known or suspected brain metastases and uveal melanoma are excluded * Autoimmune disease
References
Publications (0)
Data not yet available
No reference posted for this study.