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

Stopped early · Phase 4

Conditions studied: Metastatic Melanoma

In brief

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.

Key facts

Study ID

NCT01683188

Run by

Clinigen, Inc.

People needed

53

Starts

2012-08-01

Expected to finish

2014-11-01

Last updated by the study team

2021-02-01

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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.

You may not qualify if…

• 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.

Where it is running

• University Arizona Cancer Center — Tucson, Arizona, United States
• Moores UCSD Cancer Center — La Jolla, California, United States
• MSMC Research Program — Miami Beach, Florida, United States
• Emory University School of Medicine — Atlanta, Georgia, United States
• Loyola University Medical Center, Div of Hematology/Oncology — Maywood, Illinois, United States
• Luther General Cancer Care Institute — Park Ridge, Illinois, United States
• Indiana University — Indianapolis, Indiana, United States
• University of Iowa Hospitals and Clinics — Iowa City, Iowa, United States
• University of Kansas — Kansas City, Kansas, United States
• Hematology/Oncology Clinic — Baton Rouge, Louisiana, United States
• University of Michigan, Comprehensive Cancer Center — Ann Arbor, Michigan, United States
• Karmanos Cancer Institute — Detroit, Michigan, United States
• University of Minnesota Masonic Cancer Center — Minneapolis, Minnesota, United States
• Dartmouth-Hitchcock Medical Center — Lebanon, New Hampshire, United States
• John Theurer Cancer Center at Hackensack University Medical Center — Hackensack, New Jersey, United States
• Columbia University Medical Center, Herbert Irving Comprehensive Cancer Center — New York, New York, United States
• The Christ Hospital Cancer Center — Cincinnati, Ohio, United States
• Case Comprehensive Cancer Center — Cleveland, Ohio, United States
• Providence Cancer Center — Portland, Oregon, United States
• St. Luke's Hospital, Anderson Campus — Easton, Pennsylvania, United States
• UPMC Cancer Centers — Pittsburgh, Pennsylvania, United States

Full record on ClinicalTrials.gov

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