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Clinical Trials (PDQ®)

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

Basic Trial Information
Trial Description
     Summary
     Further Trial Information
     Eligibility Criteria
Trial Contact Information

Basic Trial Information

PhaseTypeStatusAgeSponsorProtocol IDs
Phase IVTreatmentActive18 and overOther12PLK01
NCT01683188

Trial Description

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.

Further Study Information

This will be an open-label, uncontrolled two-arm, multi-center study in patients with metastatic melanoma with BRAFV600 oncogene mutations. Patients will initially receive treatment with vemurafenib interspersed with two courses of High Dose IL-2 (HD IL-2). Patients are eligible for the study if they have melanoma positive for the BRAFV600 mutation, have been on vemurafenib therapy for 0-18 weeks, have responding or stable disease if on vemurafenib, and meet the requirements for dosing with HD IL-2 and all protocol inclusion and exclusion criteria.

Two Cohorts will be enrolled, differing only in how they are characterized prior to HD IL-2 treatment:

Cohort 1: will consist of 135 patients naïve to vemurafenib and HD IL-2 therapy. Patients in Cohort 1 will have an initial evaluation and receive a defined 6 (± 1) week course of vemurafenib before beginning HD IL-2. This Cohort will be used to define study size and statistical validity with the comparator being historic controls (using data from the BRAF positive patients from the Melanoma SELECT study Protocol IIT10PLK06).

Cohort 2: will consist of up to 50 patients who have been on vemurafenib therapy for >7 to 18 weeks with stable or responding disease before starting HD IL-2. Patients in Cohort 2 will have an initial evaluation and will begin HD IL-2 treatment after >7 to 18 weeks of treatment with vemurafenib. This Cohort is designed to evaluate whether additive or synergistic clinical benefit or toxicity is observed in BRAFV600 mutation positive metastatic melanoma patients treated with vemurafenib as a single agent for >7 to18 weeks prior to the first course of HD IL-2 therapy in conjunction with continued vemurafenib.

Patients in both cohorts will discontinue dosing vemurafenib prior to each treatment with HD IL-2 and resume dosing after each discharge. Patients will receive up to two courses (four cycles) of HD IL-2 and will be evaluated for their disease responses at 10 weeks (±3 weeks) from the start of HD IL-2 dosing, and 26 weeks (±3 weeks) from the start of HD IL-2 dosing. QTc intervals will be reviewed daily for changes during each cycle of HD IL-2 dosing.

Administration of vemurafenib and HD IL-2 will be according to the respective Package Inserts and according to the Institution's standard of care. The investigator will determine the number of HD IL-2 cycles each patient will receive, according to the investigator's discretion and medical judgment.

Eligibility 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.

Trial Contact Information

Trial Lead Organizations/Sponsors

Prometheus Therapeutics and Diagnostics

James Lowder, MDPrincipal Investigator

Theresa LunaPh: 858-882-8058
  Email: tluna@prometheuslabs.com

Trial Sites

U.S.A.
Arizona
  Tucson
 Arizona Cancer Center at University of Arizona Health Sciences Center
 Amy Bauland Ph: 520-694-0859
  Email: abauland@uacc.arizona.edu
 Lee Duncan CranmerPrincipal Investigator
California
  La Jolla
 Rebecca and John Moores UCSD Cancer Center
 Suzanna Lee, MPH Ph: 858-822-4171
  Email: sml012@ucsd.edu
 Gregory A. DanielsPrincipal Investigator
Florida
  Miami Beach
 MSMC Research Program
 Yvonne Nunez, BSHSA Ph: 305-674-2625
  Email: yenrique@msmc.com
 Jose Lutzky, MDPrincipal Investigator
Georgia
  Atlanta
 Winship Cancer Institute of Emory University
 Tatiana Kurilo, MPH Ph: 404-778-1842
  Email: tkurilo@emory.edu
 David Lawson, MDPrincipal Investigator
Illinois
  Maywood
 Loyola University Medical Center, Div of Hematology/Oncology
 Ann L Clark, RN, BSN, MSN, CCRC, CCRP Ph: (708) 327 3221
  Email: alausch@lumc.edu
 Joseph I. ClarkPrincipal Investigator
  Park Ridge
 Luther General Cancer Care Institute
 Gina Kanevsky, MD, CRA, Primary Study Coord. Ph: 847-410-0660
  Email: gkanevsky@oncmed.net
 Sigrun HallmeyerPrincipal Investigator
Indiana
  Indianapolis
 Indiana University Melvin and Bren Simon Cancer Center
 Michele Niland, RN, BSN, OCN Ph: 317-278-0778
 Theodore Logan, MDPrincipal Investigator
Iowa
  Iowa City
 Holden Comprehensive Cancer Center at University of Iowa
 Melanie Frees, RN Ph: 319-356-1228
  Email: melanie-frees@uiowa.edu
 Mohammed MilhemPrincipal Investigator
Louisiana
  Baton Rouge
 Hematology-Oncology Clinic
 Evie Key, RN, BSN, BA Ph: 225-767-0822
  Email: eviekey@hoc.brcoxmail.com
 Gerald Miletello, MDPrincipal Investigator
Michigan
  Ann Arbor
 University of Michigan Comprehensive Cancer Center
 Susan Patton, RN Ph: 734-936-8773
 Christopher D. LaoPrincipal Investigator
  Detroit
 Barbara Ann Karmanos Cancer Institute
 Lawrence Flaherty, MD Ph: 313-576-8725
  Email: flaherty@karmanos.org
 Contact Person Ph: 800-527-6266
 Lawrence Flaherty, MDPrincipal Investigator
Minnesota
  Minneapolis
 Masonic Cancer Center at University of Minnesota
 Carrie McCann, RN Ph: 612-626-2569
  Email: mcca0313@umn.edu
 Venkatesh Rudrapatna, MD, MPHPrincipal Investigator
New Hampshire
  Lebanon
 Norris Cotton Cancer Center at Dartmouth-Hitchcock Medical Center
 Eryn Bagley Ph: 603-650-4035
  Email: eryn.m.bagley@hitchcock.org
 Marc Stuart ErnstoffPrincipal Investigator
New Jersey
  Hackensack
 Hackensack University Medical Center Cancer Center
 Danielle Blair, RN, BSN, OCN Ph: 551-996-5809
  Email: dblair@hackensackumc.org
 Robert S. AlterPrincipal Investigator
New York
  New York
 Herbert Irving Comprehensive Cancer Center at Columbia University Medical Center
 Amiya R. Vaz Ph: 212-305-1317
  Email: av2454@columbia.edu
 Bret Taback, MDPrincipal Investigator
Ohio
  Cincinnati
 Christ Hospital Cancer Center
 Pam Manfresca, RN, BSN, OCN Ph: 513-585-0844
  Email: pam.manfresca@thechristhospital.com
 Philip D. LemingPrincipal Investigator
  Cleveland
 Case Comprehensive Cancer Center
 Donna Prots, RN Ph: 216-844-5393
  Email: Donna.prots@uhhospitals.org
 Henry Koon, MDPrincipal Investigator
Oregon
  Portland
 Providence Cancer Center at Providence Portland Medical Center
 Chris Fountain, RN, OCN Ph: 503-215-2691
  Email: christopher.fountain@providence.org
 Brendan D. CurtiPrincipal Investigator
Pennsylvania
  Easton
 Saint Luke's Hospital - Anderson Campus
 Rose Cabral Ph: 484-503-4151
  Email: Rosemarie.Cabral@sluhn.org
 Tracy Max, MS, CCRP Ph: 484-526-5190
  Email: Tracy.Max@sluhn.org
 Sanjiv S. AgarwalaPrincipal Investigator
  Pittsburgh
 UPMC Cancer Centers
 Mollie Maguire, RN, BSN Ph: 412-623-4004
  Email: maguiremd@upmc.edu
 John Munn KirkwoodPrincipal Investigator

Link to the current ClinicalTrials.gov record.
NLM Identifer NCT01683188
ClinicalTrials.gov processed this data on November 12, 2014

Note: Information about this trial is from the ClinicalTrials.gov database. The versions designated for health professionals and patients contain the same text. Minor changes may be made to the ClinicalTrials.gov record to standardize the names of study sponsors, sites, and contacts. Cancer.gov only lists sites that are recruiting patients for active trials, whereas ClinicalTrials.gov lists all sites for all trials. Questions and comments regarding the presented information should be directed to ClinicalTrials.gov.

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