HD IL-2 + Vemurafenib in Patients With BRAF Mutation Positive Metastatic Melanoma

• Status: Terminated
• Trial end date: 2014-11-01
• Target enrollment: 0
• Participant gender: All

Summary

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.

• Phase: Phase 4
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Clinigen, Inc.; Prometheus Laboratories
• Collaborator: Prometheus Laboratories
• Treatments: Vemurafenib

Criteria

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.