Study Stopped
slow accrual led to early closure.
HD IL-2 + Vemurafenib in Patients With BRAF Mutation Positive Metastatic Melanoma
PROCLIVITY01
A Multi-Center Study of High Dose Aldesleukin (Interleukin-2) + Vemurafenib Therapy in Patients With BRAFV600 Mutation Positive Metastatic Melanoma
1 other identifier
interventional
53
1 country
21
Brief 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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for phase_4
Started Aug 2012
Typical duration for phase_4
21 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
August 1, 2012
CompletedFirst Submitted
Initial submission to the registry
September 7, 2012
CompletedFirst Posted
Study publicly available on registry
September 11, 2012
CompletedPrimary Completion
Last participant's last visit for primary outcome
November 1, 2014
CompletedStudy Completion
Last participant's last visit for all outcomes
November 1, 2014
CompletedFebruary 1, 2021
January 1, 2021
2.3 years
September 7, 2012
January 28, 2021
Conditions
Keywords
Outcome Measures
Primary Outcomes (2)
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
assessment of tumor response in patients with CR or near CR (\> 90%) after discontinuation of vemurafenib, based on RECIST criteria
10 weeks, 26 weeks
compare safety between patients treated with vemurafenib and HD IL-2 versus historical HD IL-2 alone
incidence of adverse events
through study completion, an average of 1 year
Secondary Outcomes (1)
Compare PFS
1 year
Study Arms (2)
Cohort 1
OTHERPatients who have received less than 7 weeks vemurafenib dosing prior to treatment with HD IL-2
Cohort 2
OTHERPatients who have receive \>7 weeks to 18 weeks vemurafenib dosing prior to treatment with HD IL-2
Interventions
Eligibility Criteria
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:
- 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
- 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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Clinigen, Inc.lead
- Prometheus Laboratoriescollaborator
Study Sites (21)
University Arizona Cancer Center
Tucson, Arizona, 85719, United States
Moores UCSD Cancer Center
La Jolla, California, 92093, United States
MSMC Research Program
Miami Beach, Florida, 33140, United States
Emory University School of Medicine
Atlanta, Georgia, 30322, United States
Loyola University Medical Center, Div of Hematology/Oncology
Maywood, Illinois, 60153, United States
Luther General Cancer Care Institute
Park Ridge, Illinois, 60068, United States
Indiana University
Indianapolis, Indiana, 46202, United States
University of Iowa Hospitals and Clinics
Iowa City, Iowa, 52242, United States
University of Kansas
Kansas City, Kansas, 66160-0003, United States
Hematology/Oncology Clinic
Baton Rouge, Louisiana, 70809, United States
University of Michigan, Comprehensive Cancer Center
Ann Arbor, Michigan, 48109, United States
Karmanos Cancer Institute
Detroit, Michigan, 48201, United States
University of Minnesota Masonic Cancer Center
Minneapolis, Minnesota, 55455, United States
Dartmouth-Hitchcock Medical Center
Lebanon, New Hampshire, 03756, United States
John Theurer Cancer Center at Hackensack University Medical Center
Hackensack, New Jersey, 07601, United States
Columbia University Medical Center, Herbert Irving Comprehensive Cancer Center
New York, New York, 10032, United States
The Christ Hospital Cancer Center
Cincinnati, Ohio, 45219, United States
Case Comprehensive Cancer Center
Cleveland, Ohio, 44106, United States
Providence Cancer Center
Portland, Oregon, 97213, United States
St. Luke's Hospital, Anderson Campus
Easton, Pennsylvania, 18045, United States
UPMC Cancer Centers
Pittsburgh, Pennsylvania, 15232, United States
Related Publications (1)
Clark 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: 30053905DERIVED
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Tharak Rao, MD
Prometheus Laboratories
Study Design
- Study Type
- interventional
- Phase
- phase 4
- Allocation
- NON RANDOMIZED
- Masking
- NONE
- Purpose
- OTHER
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
September 7, 2012
First Posted
September 11, 2012
Study Start
August 1, 2012
Primary Completion
November 1, 2014
Study Completion
November 1, 2014
Last Updated
February 1, 2021
Record last verified: 2021-01
Data Sharing
- IPD Sharing
- Will not share