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

Sponsor
Bristol-Myers Squibb (Industry)
Overall Status
No longer available
CT.gov ID
NCT02186249
Collaborator
(none)
66
Locations

Study Details

Study Description

Brief Summary

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.

Condition or Disease Intervention/Treatment Phase

Study Design

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

Outcome Measures

Primary Outcome Measures

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years and Older
    Sexes Eligible for Study:
    All

    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

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Banner MD Anderson Cancer Center Gilbert Arizona United States 85234
    2 Mayo Clinic Arizona Phoenix Arizona United States 85054
    3 6501 Truxtun Avenue Bakersfield California United States 93309
    4 UC San Diego Moores Cancer Center La Jolla California United States 92093
    5 100 UCLA Medical Plaza Los Angeles California United States 90095
    6 514 North Prospect Ave Redondo Beach California United States 90277
    7 California Pacific Medical Center Research Institute San Francisco California United States 94115
    8 University of California San Francisco San Francisco California United States 94115
    9 Angeles Clinic and Research Institute Santa Monica California United States 90404
    10 1325 East Church Street Santa Monica California United States 93454
    11 University of Colorado Hospital Aurora Colorado United States 80045
    12 Rocky Mountain Cancer Centers Littleton Colorado United States 80120
    13 Smilow Cancer Hospital at Yale University Cancer Center New Haven Connecticut United States 06519
    14 Georgetown-Lombardi Comprehensive Cancer Center Washington District of Columbia United States 20007
    15 Memorial Regional Hospital Hollywood Florida United States 33021
    16 4500 San Pablo Road South Jacksonville Florida United States 32224
    17 Cancer Specialists of North Florida Jacksonville Florida United States 32256
    18 UF Health Cancer Center at Orlando Health Longwood Florida United States 32750
    19 Mount Sinai Medical Center Miami Beach Florida United States 33140
    20 Florida Hospital Cancer Institute Orlando Florida United States 32804
    21 H. Lee Moffitt Cancer Center & Research Institute Tampa Florida United States 33612
    22 Winship Cancer Institute Atlanta Georgia United States 30322
    23 600 Celebrate Life Parkway Newnan Georgia United States 30265
    24 Evanston Premier Healthcare Research LLC Evanston Illinois United States 60201
    25 Oncology Specialists, SC Niles Illinois United States 60714
    26 Local Institution Louisville Kentucky United States 40202
    27 Medstar Health Research Institute Baltimore Maryland United States 21204
    28 Johns Hopkins Sidney Kimmel Comprehensive Cancer Center Baltimore Maryland United States 21231
    29 Center For Cancer and Blood Disorders Bethesda Maryland United States 20817
    30 Massachusetts General Hospital Boston Massachusetts United States 02214
    31 Beth Israel Deaconess Medical Center Boston Massachusetts United States 02215
    32 Dana Farber Cancer Institute Boston Massachusetts United States 02215
    33 University of Michigan Comprehensive Cancer Center Ann Arbor Michigan United States 48109
    34 Karmanos Cancer Institute Detroit Michigan United States 48201
    35 Cancer and Hematology Centers of Western Michigan Grand Rapids Michigan United States 49503
    36 Mayo Clinic Rochester Minnesota United States 55905
    37 Washington University School of Medicine Saint Louis Missouri United States 63110
    38 Comprehensive Cancer Centers of Nevada Las Vegas Nevada United States 89148
    39 Atlantic Health System Morristown New Jersey United States 07960-1089
    40 NYU Langone Medical Center New York New York United States 10016
    41 Memorial Sloan-Kettering Cancer Center New York New York United States 10017
    42 Carolinas Healthcare System Charlotte North Carolina United States 28204
    43 Tulsa Cancer Institute PLLC Tulsa Oklahoma United States 74146
    44 Northwest Cancer Specialists PC Portland Oregon United States 97213
    45 Lehigh Valley Health Network Allentown Pennsylvania United States 18103
    46 St Luke's Hospital Bethlehem Pennsylvania United States 18015
    47 Greenville Health System Easley South Carolina United States 29640
    48 Tennessee Oncology PLLC Nashville Tennessee United States 37203
    49 Texas Oncology Austin Texas United States 78731
    50 MD Anderson Cancer Center Houston Texas United States 77030
    51 Texas Oncology Midland Texas United States 79701
    52 Texas Oncology Paris Texas United States 75460
    53 Virginia Cancer Institute Richmond Virginia United States 23230
    54 Oncology and Hematology Associates of Southwest Virginia, Inc Roanoke Virginia United States 24014
    55 Shenandoah Oncology Association Winchester Virginia United States 22601
    56 Seattle Cancer Care Alliance Seattle Washington United States 98109
    57 University of Wisconsin Madison Wisconsin United States 53792
    58 Cross Cancer Institute Edmonton Alberta Canada T6G 1Z2
    59 British Columbia Cancer Agency Vancouver British Columbia Canada V5Z 4E6
    60 Grand River Hospital Kitchener Ontario Canada N2G 1G3
    61 London Health Sciences Centre London Ontario Canada N6A 4L6
    62 Lakeridge Health Oshawa Oshawa Ontario Canada L1G 2B9
    63 Sunnybrook Health Science Centre Toronto Ontario Canada M4N 3M5
    64 Princess Margaret Hospital Toronto Ontario Canada M5G 2M9
    65 McGill University Health Center Montreal Quebec Canada H4A 3J1
    66 Chuq Centre Hospitalier Universitaire de Quebec Quebec Canada G1R 2J6

    Sponsors and Collaborators

    • Bristol-Myers Squibb

    Investigators

    • Study Director: Bristol-Myers Squibb, Bristol-Myers Squibb

    Study Documents (Full-Text)

    None provided.

    More Information

    Additional Information:

    Publications

    None provided.
    Responsible Party:
    Bristol-Myers Squibb
    ClinicalTrials.gov Identifier:
    NCT02186249
    Other Study ID Numbers:
    • CA209-218
    First Posted:
    Jul 10, 2014
    Last Update Posted:
    Feb 8, 2017
    Last Verified:
    Feb 1, 2017
    Additional relevant MeSH terms:
    Melanoma
    Nivolumab
    Ipilimumab

    Study Results

    No Results Posted as of Feb 8, 2017