Clinical trial · Interventional
HD IL-2 + Vemurafenib in Patients With BRAF Mutation Positive Metastatic Melanoma
A Multi-Center Study of High Dose Aldesleukin (Interleukin-2) + Vemurafenib Therapy in Patients With BRAFV600 Mutation Positive 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 led to early closure.
Summary
Brief summary (as posted)
This is a research study to evaluate treatment of metastatic melanoma patients with a combination of drugs. The combination being studied is vemurafenib (also known as Zelboraf®) and High Dose Interleukin-2 (abbreviated as HD IL-2 and known as Proleukin®). The combination of vemurafenib and HD IL-2 immunotherapy may enhance the response.
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 (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| vemurafenib + HD IL-2 | Drug | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- OTHER
- label
- Cohort 1
- description
- Patients who have received less than 7 weeks vemurafenib dosing prior to treatment with HD IL-2
- interventionNames
- Drug: vemurafenib + HD IL-2
- type
- OTHER
- label
- Cohort 2
- description
- Patients who have receive \>7 weeks to 18 weeks vemurafenib dosing prior to treatment with HD IL-2
- interventionNames
- Drug: vemurafenib + HD IL-2
Primary outcomes (2)
- measure
- Assess Complete Response (CR) rate in BRAFV600 mutation positive metastatic melanoma patients who have received vemurafenib plus HD IL-2 at 10 (±3) weeks from the start of HD IL-2 dosing to assess initial response and 26 (±3) weeks to assess and change
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria:
* Male or female patients 18 years of age or older.
* Confirmed and measurable metastatic melanoma with the BRAFV600 mutation.
* Patients with at least one metastatic melanoma lesion accessible. for biopsy prior to vemurafenib treatment if no archived tissue is available.
* Meet the requirements for HD IL-2 therapy per institutional guidelines.
* Meet the requirements for vemurafenib therapy per institutional guidelines.
* Patient must be willing to provide written Informed Consent and participate in study procedures as described in the 12PLK01. Patients consented for 12PLK01 will also be asked to participate in the 10PLK13 PROCLAIM (Proleukin®) registry study.
Exclusion Criteria:
* A patient will not be considered eligible for study participation if any of the following exclusion criteria are met:
* Prior therapy of metastatic disease with any of the following: IL-2, Ipilimumab, or other highly selective BRAF, MEK, NRAS, cMET inhibitors (e.g. GSK2118436 or GSK1120212) and TKIs.
* Exception: with a 6 week washout the following are allowed:
* Adjuvant Ipilimumab,
* Anti PD-1, Anti PD L-1
* Exclusion for Cohort 1 only: vemurafenib treatment \>7 weeks.
* Exclusion for Cohort 2 only: vemurafenib treatment \<7 weeks. (eligible for Cohort 1) or \>18 weeks.
* QTc interval of \>500ms.
* 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 assessment at least 6 weeks after definitive therapy are acceptable.)
* Received investigational drug within 30 days prior to study dosing. Patients may participate in non-interventional or observational clinical study (ies)
* 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 (1)
- DERIVEDClark JI, Singh J, Ernstoff MS, Lao CD, Flaherty LE, Logan TF, Curti B, Agarwala SS, Taback B, Cranmer L, Lutzky J, Luna TL, Aung S, Lawson DH. A multi-center phase II study of high dose interleukin-2 sequenced with vemurafenib in patients with BRAF-V600 mutation positive metastatic melanoma. J Immunother Cancer. 2018 Jul 27;6(1):76. doi: 10.1186/s40425-018-0387-x. PMID 30053905