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Trial record 1 of 2 for:    nivolumab melanoma | Expanded Access Studies
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Expanded Access Program With Nivolumab (BMS-936558) in Combination With Ipilimumab (Yervoy®) in Anti-CTLA-4 Treatment-Naïve Subjects With Unresectable or Metastatic Melanoma (CheckMate 218)

Expanded access is currently available for this treatment.
Verified October 2014 by Bristol-Myers Squibb
Sponsor:
Information provided by (Responsible Party):
Bristol-Myers Squibb
ClinicalTrials.gov Identifier:
NCT02186249
First received: July 8, 2014
Last updated: October 27, 2014
Last verified: October 2014
  Purpose

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.


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 Anti-CTLA-4 Treatment-Naïve 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:

  • 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-naïve 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)
  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
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, Georgia
Winship Cancer Institute
Atlanta, Georgia, United States, 30322
Contact: Ragini Kudchadkar, Site 0006    813-745-8581      
United States, Pennsylvania
Lehigh Valley Health Network
Allentown, Pennsylvania, United States, 18103
Contact: Suresh Nair, Site 0001    610-402-7880      
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: October 27, 2014
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 November 24, 2014