Expanded Access Program With Nivolumab in Combination With Ipilimumab in Patients With Tumors Unable to be Removed by Surgery or Metastatic Melanoma (CheckMate218)

February 6, 2017 updated by: Bristol-Myers Squibb

Expanded Access Program With Nivolumab (BMS-936558) in Combination With Ipilimumab (Yervoy®) in Subjects With Unresectable or Metastatic Melanoma

The purpose of this study is to provide treatment with nivolumab in combination with ipilimumab to subjects who are anti-(CTLA)-4 and anti-PD-1 treatment-naive and have unresectable or metastatic melanoma.

Study Overview

Status

No longer available

Conditions

Intervention / Treatment

Study Type

Expanded Access

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Canada
      • Quebec, Canada, G1R 2J6
        • Chuq Centre Hospitalier Universitaire De Quebec
    • Alberta
      • Edmonton, Alberta, Canada, T6G 1Z2
        • Cross Cancer Institute
    • British Columbia
      • Vancouver, British Columbia, Canada, V5Z 4E6
        • British Columbia Cancer Agency
    • Ontario
      • Kitchener, Ontario, Canada, N2G 1G3
        • Grand River Hospital
      • London, Ontario, Canada, N6A 4L6
        • London Health Sciences Centre
      • Oshawa, Ontario, Canada, L1G 2B9
        • Lakeridge Health Oshawa
      • Toronto, Ontario, Canada, M5G 2M9
        • Princess Margaret Hospital
      • Toronto, Ontario, Canada, M4N 3M5
        • Sunnybrook Health Science Centre
    • Quebec
      • Montreal, Quebec, Canada, H4A 3J1
        • McGill University Health Center
  • United States
    • Arizona
      • Gilbert, Arizona, United States, 85234
        • Banner MD Anderson Cancer Center
      • Phoenix, Arizona, United States, 85054
        • Mayo Clinic Arizona
    • California
      • Bakersfield, California, United States, 93309
        • 6501 Truxtun Avenue
      • La Jolla, California, United States, 92093
        • UC San Diego Moores Cancer Center
      • Los Angeles, California, United States, 90095
        • 100 UCLA Medical Plaza
      • Redondo Beach, California, United States, 90277
        • 514 North Prospect Ave
      • San Francisco, California, United States, 94115
        • University of California San Francisco
      • San Francisco, California, United States, 94115
        • California Pacific Medical Center Research Institute
      • Santa Monica, California, United States, 90404
        • Angeles Clinic and Research Institute
      • Santa Monica, California, United States, 93454
        • 1325 East Church Street
    • Colorado
      • Aurora, Colorado, United States, 80045
        • University of Colorado Hospital
      • Littleton, Colorado, United States, 80120
        • Rocky Mountain Cancer Centers
    • Connecticut
      • New Haven, Connecticut, United States, 06519
        • Smilow Cancer Hospital at Yale University Cancer Center
    • District of Columbia
      • Washington, District of Columbia, United States, 20007
        • Georgetown-Lombardi Comprehensive Cancer Center
    • Florida
      • Hollywood, Florida, United States, 33021
        • Memorial Regional Hospital
      • Jacksonville, Florida, United States, 32256
        • Cancer Specialists of North Florida
      • Jacksonville, Florida, United States, 32224
        • 4500 San Pablo Road South
      • Longwood, Florida, United States, 32750
        • UF Health Cancer Center at Orlando Health
      • Miami Beach, Florida, United States, 33140
        • Mount Sinai Medical Center
      • Orlando, Florida, United States, 32804
        • Florida Hospital Cancer Institute
      • Tampa, Florida, United States, 33612
        • H. Lee Moffitt Cancer Center & Research Institute
    • Georgia
      • Atlanta, Georgia, United States, 30322
        • Winship Cancer Institute
      • Newnan, Georgia, United States, 30265
        • 600 Celebrate Life Parkway
    • Illinois
      • Evanston, Illinois, United States, 60201
        • Evanston Premier Healthcare Research LLC
      • Niles, Illinois, United States, 60714
        • Oncology Specialists, SC
    • Kentucky
      • Louisville, Kentucky, United States, 40202
        • Local Institution
    • Maryland
      • Baltimore, Maryland, United States, 21231
        • Johns Hopkins Sidney Kimmel Comprehensive Cancer Center
      • Baltimore, Maryland, United States, 21204
        • MedStar Health Research Institute
      • Bethesda, Maryland, United States, 20817
        • Center for Cancer and Blood Disorders
    • Massachusetts
      • Boston, Massachusetts, United States, 02215
        • Beth Israel Deaconess Medical Center
      • Boston, Massachusetts, United States, 02215
        • Dana Farber Cancer Institute
      • Boston, Massachusetts, United States, 02214
        • Massachusetts General Hospital
    • Michigan
      • Ann Arbor, Michigan, United States, 48109
        • University of Michigan Comprehensive Cancer Center
      • Detroit, Michigan, United States, 48201
        • Karmanos Cancer Institute
      • Grand Rapids, Michigan, United States, 49503
        • Cancer and Hematology Centers of Western Michigan
    • Minnesota
      • Rochester, Minnesota, United States, 55905
        • Mayo Clinic
    • Missouri
      • Saint Louis, Missouri, United States, 63110
        • Washington University School of Medicine
    • Nevada
      • Las Vegas, Nevada, United States, 89148
        • Comprehensive Cancer Centers of Nevada
    • New Jersey
      • Morristown, New Jersey, United States, 07960-1089
        • Atlantic Health System
    • New York
      • New York, New York, United States, 10017
        • Memorial Sloan-Kettering Cancer Center
      • New York, New York, United States, 10016
        • NYU Langone Medical Center
    • North Carolina
      • Charlotte, North Carolina, United States, 28204
        • Carolinas Healthcare System
    • Oklahoma
      • Tulsa, Oklahoma, United States, 74146
        • Tulsa Cancer Institute PLLC
    • Oregon
      • Portland, Oregon, United States, 97213
        • Northwest Cancer Specialists PC
    • Pennsylvania
      • Allentown, Pennsylvania, United States, 18103
        • Lehigh Valley Health Network
      • Bethlehem, Pennsylvania, United States, 18015
        • St Luke's Hospital
    • South Carolina
      • Easley, South Carolina, United States, 29640
        • Greenville Health System
    • Tennessee
      • Nashville, Tennessee, United States, 37203
        • Tennessee Oncology PLLC
    • Texas
      • Austin, Texas, United States, 78731
        • Texas Oncology
      • Houston, Texas, United States, 77030
        • MD Anderson Cancer Center
      • Midland, Texas, United States, 79701
        • Texas Oncology
      • Paris, Texas, United States, 75460
        • Texas Oncology
    • Virginia
      • Richmond, Virginia, United States, 23230
        • Virginia Cancer Institute
      • Roanoke, Virginia, United States, 24014
        • Oncology and Hematology Associates of Southwest Virginia, Inc
      • Winchester, Virginia, United States, 22601
        • Shenandoah Oncology Association
    • Washington
      • Seattle, Washington, United States, 98109
        • Seattle Cancer Care Alliance
    • Wisconsin
      • Madison, Wisconsin, United States, 53792
        • University of Wisconsin

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

N/A

Genders Eligible for Study

All

Description

For more information regarding BMS clinical trial participation, please visit www.BMSStudyConnect.com

Inclusion Criteria:

  • Men and women 18 years and older
  • Eastern Cooperative Oncology Group (ECOG) Performance Status of 0-1
  • Histologically-confirmed unresectable stage III or stage IV melanoma, as per American Joint Committee on Cancer (AJCC) staging system, Including mucosal and ocular melanoma
  • Subjects must be anti-CTLA-4 treatment-naive and anti-PD-1 treatment-naive. Subjects may have had other prior systemic treatment for localized or metastatic disease
  • Subjects with brain metastases are eligible if these have been treated and there is no magnetic resonance imaging (MRI) evidence of progression for at least 2 weeks after treatment is complete and within 28 days prior to first dose of study drug administration. There must also be no requirement for high doses of systemic corticosteroids that could result in Immunosuppression (>10 mg/day prednisone equivalent) for at least 2 weeks prior to study drug administration

Exclusion Criteria:

  • Active (symptomatic) and not treated brain metastases or leptomeningeal metastases
  • Life expectancy < 6 weeks
  • Subjects with active, known, or suspected autoimmune disease. Subjects with Type I diabetes mellitus, hypothyroidism only requiring hormone replacement, skin disorders (such as vitiligo, psoriasis, or alopecia) not requiring systemic treatment, or conditions not expected to recur in absence of an external trigger are permitted to enroll
  • Subjects with a condition requiring systemic treatment with either corticosteroids (>10 mg daily prednisone equivalents) or other immunosuppressive medications within 14 days of treatment. Inhaled or topical steroids and adrenal replacement steroid doses > 10 mg daily prednisone equivalent are permitted in the absence of active autoimmune disease
  • Subjects who received prior therapy with an anti-CTLA-4, anti-PD-1, anti-PD-L1 or anti-PD-L2, anti-CT137 (or any other antibody or drug specifically targeting T-cell costimulation or checkpoint pathways) or subject is expected to require any other form of systemic antineoplastic therapy while receiving nivolumab

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Bristol-Myers Squibb

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

First Submitted

July 8, 2014

First Submitted That Met QC Criteria

July 8, 2014

First Posted (Estimate)

July 10, 2014

Study Record Updates

Last Update Posted (Estimate)

February 8, 2017

Last Update Submitted That Met QC Criteria

February 6, 2017

Last Verified

February 1, 2017

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • CA209-218

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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