Trial record 1 of 2 for:
nivolumab melanoma | Expanded Access Studies
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 July 2014 by Bristol-Myers Squibb
Information provided by (Responsible Party):
First received: July 8, 2014
Last updated: NA
Last verified: July 2014
History: No changes posted
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.
What is Expanded Access?
||Expanded Access Program With Nivolumab (BMS-936558) in Combination With Ipilimumab (Yervoy®) in Anti-CTLA-4 Treatment-Naïve Subjects With Unresectable or Metastatic Melanoma
|Ages Eligible for Study:
||18 Years and older
|Genders Eligible for Study:
For more information regarding BMS clinical trial participation, please visit www.BMSStudyConnect.com
- 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
- 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)
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
No publications provided
History of Changes
|Other Study ID Numbers:
|Study First Received:
||July 8, 2014
||July 8, 2014
||United States: Food and Drug Administration
United States: Institutional Review Board
Additional relevant MeSH terms:
ClinicalTrials.gov processed this record on August 28, 2014
Neoplasms, Germ Cell and Embryonal
Neoplasms by Histologic Type
Neoplasms, Nerve Tissue
Nevi and Melanomas