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

Description

The purpose of this study is to provide treatment with Nivolumab in combination with Ipilimumab and to assess the safety and tolerability of this combination in subjects who are anti-cytotoxic T lymphocyte associated antigen (CTLA)-4 treatment-naive and have unresectable or metastatic melanoma.

Study Start Date

Not specified

Estimated Completion Date

Not specified

Interventions

  • Drug: Nivolumab
  • Drug: Ipilimumab

Specialties

  • Oncology: Dermatologic Oncology
  • Pharmacy: Chemotherapy/Oncology
  • Dermatology: Dermatologic Oncology
  • Physician Assistant: Clinical Pharmacology,Hematology/Oncology

MeSH Terms

  • Ipilimumab
  • Melanoma
  • Nivolumab

Study ID

Bristol-Myers Squibb -- CA209-218

Status

Available

Trial ID

NCT02186249

Study Type

Expanded Access

Trial Phase

N/A

Enrollment Quota

Not Listed

Sponsor

Bristol-Myers Squibb

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

Inclusion Criteria

  • Histologically confirmed stage III (unresectable) or stage IV melanoma, as per American Joint Committee on Cancer (AJCC) 2010 staging system, including mucosal melanoma
  • Eastern Cooperative Oncology Group (ECOG) Performance Status (PS) 0-1
  • Anti-CTLA-4 treatment-na├»ve patients who may have had other prior systemic treatment for localized or metastatic disease. Note that prior systemic therapy is permitted if it was completed at least 4 weeks prior to first dose, and all related adverse events have either returned to baseline or stabilized
  • Primary mucosal melanoma is allowed
  • 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 equivalents) for at least 2 weeks prior to study drug administration
  • Men and women, aged 18 years

Exclusion Criteria

  • Active (symptomatic) and not treated brain metastases or leptomeningeal metastases
  • Life expectancy < 6 weeks
  • Subjects diagnosed with primary ocular melanoma
  • Subjects with active, known or suspected autoimmune disease
  • 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
  • Prior treatment in any Nivolumab or Ipilimumab clinical study (including those who have been randomized to control)
  • Any positive test for hepatitis B virus or hepatitis C virus indicating acute or chronic infection
  • Known history of testing positive for Human immunodeficiency virus (HIV) or known Acquired immunodeficiency syndrome (AIDS)

Gender

Both

Ages

18 Years and older

Accepts Healthy Volunteers

Not Listed

Study Locations and Contact Information (84)

Study Location Distance Name Phone Email
Beth Israel Deaconess Medical Center - Boston, Massachusetts 2.4 miles F Stephen Hodi Site 0017 617-632-9265 None
Beth Israel Deaconess Medical Center - Boston, Massachusetts 2.4 miles None None None
Dana Farber Cancer Institute - Boston, Massachusetts 2.4 miles F Stephen Hodi Site 0015 617-632-4715 None
Massachusetts General Hospital - Boston, Massachusetts 3.2 miles None None None
Massachusetts General Hospital - Boston, Massachusetts 3.2 miles F Stephen Hodi Site 0016 617-643-1540 None
Smilow Cancer Hospital at Yale University Cancer Center - New Haven, Connecticut 120.2 miles None None None
Smilow Cancer Hospital at Yale University Cancer Center - New Haven, Connecticut 120.2 miles Mario Sznol Site 0002 203-785-6221 None
Memorial SloanKettering Cancer Center - New York, New York 186.0 miles Paul Chapman Site 0004 646-888-4162 None
NYU Langone Medical Center - New York, New York 186.5 miles None None None
NYU Langone Medical Center - New York, New York 186.5 miles Anna Pavlick Site 0014 212-731-5431 None
St Lukes Hospital - Bethlehem, Pennsylvania 252.7 miles Sanjiv Agarwala Site 0013 610-954-4434 None
St Lukes Hospital - Bethlehem, Pennsylvania 252.7 miles None None None
Lehigh Valley Health Network - Allentown, Pennsylvania 257.9 miles None None None
Lehigh Valley Health Network - Allentown, Pennsylvania 257.9 miles Suresh Nair Site 0001 610-402-7880 None
Medstar Health Research Institute - Baltimore, Maryland 353.7 miles Michael Atkins Site 0020 443-777-7364 None
Medstar Health Research Institute - Baltimore, Maryland 353.7 miles None None None
Johns Hopkins Sidney Kimmel Comprehensive Cancer Center - Baltimore, Maryland 357.9 miles William Sharfman Site 0007 410-583-2970 None
Center For Cancer and Blood Disorders - Bethesda, Maryland 394.0 miles Ralph Boccia Site 0069 301-571-0019 None
GeorgetownLombardi Comprehensive Cancer Center - Washington, District of Columbia 394.4 miles None None None
GeorgetownLombardi Comprehensive Cancer Center - Washington, District of Columbia 394.4 miles Michael Atkins Site 0008 202-444-4883 None
Shenandoah Oncology Association - Winchester, Virginia 431.1 miles None None None
Shenandoah Oncology Association - Winchester, Virginia 431.1 miles William Houck Site 0053 540-662-1108 None
Virginia Cancer Institute - Richmond, Virginia 473.6 miles James May Site 0055 804-330-7990 None
Oncology and Hematology Associates of Southwest Virginia Inc - Roanoke, Virginia 589.0 miles Jennifer Vaughn Site 0048 540-982-0237 None
Karmanos Cancer Institute - Detroit, Michigan 611.5 miles None None None
Karmanos Cancer Institute - Detroit, Michigan 611.5 miles Amy Weise Site 0023 906-225-3922 None
University of Michigan Comprehensive Cancer Center - Ann Arbor, Michigan 645.2 miles Christopher Lao Site 0011 734-615-4762 None
Carolinas Healthcare System - Charlotte, North Carolina 720.9 miles Pennock Gregory Site 0019 520-629-4624 None
Cancer and Hematology Centers of Western Michigan - Grand Rapids, Michigan 741.6 miles Nehal Lakhani Site 0063 616-954-5550 None
Greenville Health System - Easley, South Carolina 810.4 miles William Edenfield Site 0044 864-679-3926 None
Greenville Health System - Easley, South Carolina 810.4 miles None None None
Local Institution - Louisville, Kentucky 823.2 miles None None None
Local Institution - Louisville, Kentucky 823.2 miles Site 0072 None None
Evanston Premier Healthcare Research LLC - Evanston, Illinois 850.4 miles Bruce Brockstein Site 0081 847-570-2515 None
Oncology Specialists SC - Niles, Illinois 856.2 miles Sigrun Hallmeyer Site 0024 847-268-8200 None
Winship Cancer Institute - Atlanta, Georgia 932.0 miles Ragini Kudchadkar Site 0006 813-745-8581 None
Winship Cancer Institute - Atlanta, Georgia 932.0 miles None None None
University of Wisconsin - Madison, Wisconsin 932.2 miles Mark Albertini Site 0036 608-263-0117 None
University of Wisconsin - Madison, Wisconsin 932.2 miles None None None
Tennessee Oncology PLLC - Nashville, Tennessee 942.8 miles Jeffrey Infante Site 0009 615-320-5090 None
Tennessee Oncology PLLC - Nashville, Tennessee 942.8 miles None None None
600 Celebrate Life Parkway - Newnan, Georgia 966.7 miles None None None
600 Celebrate Life Parkway - Newnan, Georgia 966.7 miles Navneet Dhillon Site 0025 770-400-6335 None
4500 San Pablo Road South - Jacksonville, Florida 1,015.8 miles Richard Joseph Site 0022 904-953-2000 None
4500 San Pablo Road South - Jacksonville, Florida 1,015.8 miles None None None
Cancer Specialists of North Florida - Jacksonville, Florida 1,021.9 miles Suprith Badarinath Site 0068 904-388-2619 None
Washington University School of Medicine - Saint Louis, Missouri 1,039.5 miles None None None
Washington University School of Medicine - Saint Louis, Missouri 1,039.5 miles Gerald Linette Site 0039 314-362-4819 None
Mayo Clinic - Rochester, Minnesota 1,083.1 miles Matthew Block Site 0071 507-289-5280 None
Mayo Clinic - Rochester, Minnesota 1,083.1 miles None None None
UF Health Cancer Center at Orlando Health - Longwood, Florida 1,107.2 miles None None None
UF Health Cancer Center at Orlando Health - Longwood, Florida 1,107.2 miles Sajeve Thomas Site 0067 855-265-4372 None
Florida Hospital Cancer Institute - Orlando, Florida 1,115.9 miles None None None
Florida Hospital Cancer Institute - Orlando, Florida 1,115.9 miles Lee Zehngebot Site 0027 407-303-2498 None
H Lee Moffitt Cancer Center Research Institute - Tampa, Florida 1,178.7 miles Weber Jeffrey Site 0018 813-449-8260 None
Memorial Regional Hospital - Hollywood, Florida 1,244.0 miles Atif Hussein Site 0032 954-986-6363 None
Memorial Regional Hospital - Hollywood, Florida 1,244.0 miles None None None
Mount Sinai Medical Center - Miami Beach, Florida 1,256.3 miles Jose Lutzky Site 0041 305-535-3300 None
Tulsa Cancer Institute PLLC - Tulsa, Oklahoma 1,391.1 miles None None None
Tulsa Cancer Institute PLLC - Tulsa, Oklahoma 1,391.1 miles Ali Moussa Site 0065 918-505-3200 None
Texas Oncology - Paris, Texas 1,456.9 miles Sucharu Prakash Site 0052 903-785-0031 None
MD Anderson Cancer Center - Houston, Texas 1,609.9 miles None None None
MD Anderson Cancer Center - Houston, Texas 1,609.9 miles Patel Sapna Site 0010 717-792-2921 None
Texas Oncology - Austin, Texas 1,694.2 miles None None None
Texas Oncology - Austin, Texas 1,694.2 miles Jeffrey Yorio Site 0046 512-427-9400 None
University of Colorado Hospital - Aurora, Colorado 1,759.8 miles Rene GonzalezCotarelo Site 0026 720-848-0564 None
Rocky Mountain Cancer Centers - Littleton, Colorado 1,771.5 miles Vibha Thomas Site 0049 303-388-4876 None
Texas Oncology - Midland, Texas 1,841.8 miles David Watkins Site 0047 303-388-4876 None
Mayo Clinic Arizona - Phoenix, Arizona 2,284.5 miles Alan Bryce Site 0056 480-301-8000 None
Banner MD Anderson Cancer Center - Gilbert, Arizona 2,285.1 miles Jade Homsi Site 0070 480-256-6444 None
Banner MD Anderson Cancer Center - Gilbert, Arizona 2,285.1 miles None None None
Comprehensive Cancer Centers of Nevada - Las Vegas, Nevada 2,385.6 miles Wolfram Samlowski Site 0045 702-822-5293 None
Seattle Cancer Care Alliance - Seattle, Washington 2,490.2 miles None None None
Seattle Cancer Care Alliance - Seattle, Washington 2,490.2 miles John Thompson Site 0012 206-288-1004 None
Northwest Cancer Specialists PC - Portland, Oregon 2,533.3 miles John Smith Site 0050 503-239-7767 None
UC San Diego Moores Cancer Center - La Jolla, California 2,581.5 miles Gregory Daniels Site 0005 858-822-6196 None
6501 Truxtun Avenue - Bakersfield, California 2,597.8 miles Ravindranath Patel Site 0035 661-862-7158 None
100 UCLA Medical Plaza - Los Angeles, California 2,605.2 miles John Glaspy Site 0040 818-271-2500 None
Angeles Clinic and Research Institute - Santa Monica, California 2,607.9 miles Omid Hamid Site 0043 310-231-2121 None
514 North Prospect Ave - Redondo Beach, California 2,609.2 miles Thomas Lowe Site 0033 310-750-3376 None
1325 East Church Street - Santa Monica, California 2,676.2 miles None None None
1325 East Church Street - Santa Monica, California 2,676.2 miles Robert Dichmann Site 0030 805-349-9393 None
University of California San Francisco - San Francisco, California 2,698.0 miles Adil Daud Site 0021 415-476-7710 None
California Pacific Medical Center Research Institute - San Francisco, California 2,698.0 miles Kevin Kim Site 0003 713-500-6799 None

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