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Expanded Access Program With Nivolumab (BMS-936558) in Combination With Ipilimumab (Yervoy®) in Subjects With Unresectable or Metastatic Melanoma (CheckMate 218)

Expanded access is currently available for this treatment.
Verified June 2015 by Bristol-Myers Squibb
Sponsor:
Information provided by (Responsible Party):
Bristol-Myers Squibb
ClinicalTrials.gov Identifier:
NCT02186249
First received: July 8, 2014
Last updated: June 16, 2015
Last verified: June 2015
  Purpose

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 Intervention
Malignant Melanoma
Drug: Nivolumab
Drug: Ipilimumab

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

Resource links provided by NLM:


Further study details as provided by Bristol-Myers Squibb:

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Criteria

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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT02186249

Contacts
Contact: Please Contact Clinical.Trials@bms.com

Locations
United States, California
UC San Diego Moores Cancer Center
La Jolla, California, United States, 92093
Contact: Gregory Daniels, Site 0005    858-822-6196      
California Pacific Medical Center Research Institute
San Francisco, California, United States, 94115
Contact: Kevin Kim, Site 0003    713-500-6799      
United States, Connecticut
Smilow Cancer Hospital at Yale University Cancer Center
New Haven, Connecticut, United States, 06519
Contact: Mario Sznol, Site 0002    203-785-6221      
United States, District of Columbia
Georgetown-Lombardi Comprehensive Cancer Center
Washington, District of Columbia, United States, 20007
Contact: Michael Atkins, Site 0008    202-444-4883      
United States, Florida
H. Lee Moffitt Cancer Center & Research Institute
Tampa, Florida, United States, 33612
Contact: Weber Jeffrey, Site 0018    813-449-8260      
United States, Georgia
Winship Cancer Institute
Atlanta, Georgia, United States, 30322
Contact: Ragini Kudchadkar, Site 0006    813-745-8581      
United States, Maryland
Johns Hopkins Sidney Kimmel Comprehensive Cancer Center
Baltimore, Maryland, United States, 21231
Contact: William Sharfman, Site 0007    410-583-2970      
Medstar Health Research Institute
Baltimore, Maryland, United States, 21204
Contact: Michael Atkins, Site 0020    443-777-7364      
United States, Massachusetts
Massachusetts General Hospital
Boston, Massachusetts, United States, 02214
Contact: F. Stephen Hodi, Site 0016    617-643-1540      
Dana Farber Cancer Institute
Boston, Massachusetts, United States, 02215
Contact: F. Stephen Hodi, Site 0015    617-632-4715      
Beth Israel Deaconess Medical Center
Boston, Massachusetts, United States, 02215
Contact: F. Stephen Hodi, Site 0017    617-632-9265      
United States, Michigan
University of Michigan Comprehensive Cancer Center
Ann Arbor, Michigan, United States, 48109
Contact: Christopher Lao, Site 0011    734-615-4762      
United States, New York
Memorial Sloan-Kettering Cancer Center
New York, New York, United States, 10017
Contact: Paul Chapman, Site 0004    646-888-4162      
NYU Langone Medical Center
New York, New York, United States, 10016
Contact: Anna Pavlick, Site 0014    212-731-5431      
United States, Pennsylvania
Lehigh Valley Health Network
Allentown, Pennsylvania, United States, 18103
Contact: Suresh Nair, Site 0001    610-402-7880      
St Luke's Hospital
Bethlehem, Pennsylvania, United States, 18015
Contact: Sanjiv Agarwala, Site 0013    610-954-4434      
United States, Tennessee
Tennessee Oncology PLLC
Nashville, Tennessee, United States, 37203
Contact: Jeffrey Infante, Site 0009    615-320-5090      
United States, Texas
MD Anderson Cancer Center
Houston, Texas, United States, 77030
Contact: Patel Sapna, Site 0010    717-792-2921      
United States, Washington
Seattle Cancer Care Alliance
Seattle, Washington, United States, 98109
Contact: John Thompson, Site 0012    206-288-1004      
Sponsors and Collaborators
Bristol-Myers Squibb
Investigators
Study Director: Bristol-Myers Squibb Bristol-Myers Squibb
  More Information

Additional Information:
No publications provided

Responsible Party: Bristol-Myers Squibb
ClinicalTrials.gov Identifier: NCT02186249     History of Changes
Other Study ID Numbers: CA209-218
Study First Received: July 8, 2014
Last Updated: June 16, 2015
Health Authority: United States: Food and Drug Administration
United States: Institutional Review Board

Additional relevant MeSH terms:
Melanoma
Neoplasms
Neoplasms by Histologic Type
Neoplasms, Germ Cell and Embryonal
Neoplasms, Nerve Tissue
Neuroectodermal Tumors
Neuroendocrine Tumors
Nevi and Melanomas

ClinicalTrials.gov processed this record on June 28, 2015