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

• Conditions: Malignant Melanoma

• Registration Number: NCT02186249
• Lead Sponsor: Bristol-Myers Squibb

Brief Summary

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2014-07-08
• Study First Submitted QC: 2014-07-08
• Study First Posted: 2014-07-10
• Status Verified: 2017-02
• Last Update Submitted: 2017-02-06
• Last Update Posted: 2017-02-08

Recruitment & Eligibility

• Status: NO_LONGER_AVAILABLE
• Sex: All
• Target Recruitment: Not specified

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

Study & Design

• Study Type: EXPANDED_ACCESS
• Study Design: Not specified

Trial Locations

Locations (64)

Banner MD Anderson Cancer Center; 🇺🇸 Gilbert, Arizona, United States

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

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