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

NO_LONGER_AVAILABLE

Conditions studied: Malignant Melanoma

In brief

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.

Key facts

Study ID

NCT02186249

Run by

Bristol-Myers Squibb

Last updated by the study team

2017-02-08

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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

You may not qualify if…

• 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

Where it is running

• Mayo Clinic Arizona — Phoenix, Arizona, United States
• 6501 Truxtun Avenue — Bakersfield, California, United States
• UC San Diego Moores Cancer Center — La Jolla, California, United States
• 100 UCLA Medical Plaza — Los Angeles, California, United States
• 514 North Prospect Ave — Redondo Beach, California, United States
• California Pacific Medical Center Research Institute — San Francisco, California, United States
• University of California San Francisco — San Francisco, California, United States
• Angeles Clinic and Research Institute — Santa Monica, California, United States
• 1325 East Church Street — Santa Monica, California, United States
• University of Colorado Hospital — Aurora, Colorado, United States
• Rocky Mountain Cancer Centers — Littleton, Colorado, United States
• Smilow Cancer Hospital at Yale University Cancer Center — New Haven, Connecticut, United States
• Georgetown-Lombardi Comprehensive Cancer Center — Washington D.C., District of Columbia, United States
• Memorial Regional Hospital — Hollywood, Florida, United States
• 4500 San Pablo Road South — Jacksonville, Florida, United States
• Cancer Specialists of North Florida — Jacksonville, Florida, United States
• UF Health Cancer Center at Orlando Health — Longwood, Florida, United States
• Mount Sinai Medical Center — Miami Beach, Florida, United States
• Florida Hospital Cancer Institute — Orlando, Florida, United States
• H. Lee Moffitt Cancer Center & Research Institute — Tampa, Florida, United States
• Winship Cancer Institute — Atlanta, Georgia, United States
• 600 Celebrate Life Parkway — Newnan, Georgia, United States
• Evanston Premier Healthcare Research LLC — Evanston, Illinois, United States
• Oncology Specialists, SC — Niles, Illinois, United States
• Banner MD Anderson Cancer Center — Gilbert, Arizona, United States

Full record on ClinicalTrials.gov

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