Clinical trial · Interventional
HD IL-2 + Ipilimumab in Patients With Metastatic Melanoma
Open-Label, Randomized, Multi-Center Study Comparing the Sequence of High Dose Aldesleukin (Interleukin-2) and Ipilimumab (Yervoy) in Patients With Metastatic Melanoma
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Why stopped (as posted): slow accrual \& early closure
Summary
Brief summary (as posted)
Phase IV, open-label, randomized, two-arm, multi-center study in patients with metastatic melanoma who are treatment naïve or have previously received a single non-immunologic therapy. Treatment Arm 1: "HD IL-2 first, then ipilimumab" Patients will receive two courses (four cycles) of High Dose Interleukin-2 (HD IL-2) followed by one course (four doses) of ipilimumab. Treatment Arm 2: Ipilimumab first then HD IL-2 Patients will receive one course (four doses) of ipilimumab followed by two courses (four cycles) of HD IL-2.
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 |
|---|---|---|---|
| Metastatic Melanoma | Melanoma | CURATED_BROADER | 0.78 |
Interventions
Interventions (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| High Dose Interleukin-2 | Drug | — | UNRESOLVED |
| Ipilimumab | Drug | Ipilimumab | ALIAS |
Design
Arms and outcomes
Arms (2)
- type
- ACTIVE_COMPARATOR
- label
- Treatment Arm 1
- description
- Patients will receive two courses (four cycles) of High Dose Interleukin-2 (HD IL-2) followed by one course (four doses) of ipilimumab.
- interventionNames
- Drug: High Dose Interleukin-2
- Drug: Ipilimumab
- type
- ACTIVE_COMPARATOR
- label
- Treatment Arm 2
- description
- Patients will receive one course (four doses) of ipilimumab followed by two courses (four cycles) of HD IL-2.
- interventionNames
- Drug: High Dose Interleukin-2
- Drug: Ipilimumab
Primary outcomes (1)
- measure
- Estimated One-year OS in the Evaluable Population in Each Treatment Arm Separately
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: * Male or female patients 18 years or older * Confirmed and measurable metastatic melanoma with at least one measurable lesion for evaluation of response * Meets the requirements for HD IL-2 therapy per Institutional guidelines * Meets the requirements for ipilimumab therapy per Institutional guidelines * Treatment naïve or has received only one systemic therapy apart from adjuvant therapy. * At least 4 weeks since last adjuvant therapy or other cancer treatment * Willing and able to give informed consent and participate in study procedures as described in the 12PLK02 and 10PLK13 protocols. Patients consented for 12PLK02 will also be asked to participate in the 10PLK13 PROCLAIM registry study. Exclusion Criteria: * Patients with known or suspected infection with human immunodeficiency virus (HIV), hepatitis C virus (HCV), hepatitis B virus (HBV) or other infectious hepatitis * Pregnant, nursing or planning to become pregnant * Untreated brain metastases. (Brain metastases that have been treated, which no longer require corticosteroid therapy and are without progression by MRI at least 6 weeks after definitive therapy are acceptable.) * Received prior ipilimumab therapy (Prior Adjuvant Ipilimumab and Adjuvant Interferon are permitted with a minimum 4 week washout) * Received prior HD IL-2 therapy. * Received investigational drug within 30 days prior to study dosing. Patients may participate in non-interventional or observational clinical studies, including the 10PLK13 PROCLAIM registry study. * Concomitant disease or condition that would interfere with the conduct of the study or that would, in the opinion of the Investigator, pose an unacceptable risk to the patient in this study.
References
Publications (0)
Data not yet available