Expanded Access Program With Nivolumab in Combination With Ipilimumab in Patients With Tumors Unable to be Removed by Surgery or Metastatic Melanoma (CheckMate218)

Study Description

Go to 

Study Description Study Design Interventions Eligibility Criteria Contacts and Locations More Information

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.

Condition or disease	Intervention/treatment
Malignant Melanoma	Drug: Nivolumab; Drug: Ipilimumab

Study Design

Go to 

Study Description Study Design Interventions Eligibility Criteria Contacts and Locations More Information

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

Interventions

Go to 

Study Description Study Design Interventions Eligibility Criteria Contacts and Locations More Information

Eligibility Criteria

Go to 

Study Description Study Design Interventions Eligibility Criteria Contacts and Locations More Information

Ages Eligible for Study:	18 Years and older (Adult, Senior)
Sexes Eligible for Study:	All

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

Go to 

Study Description Study Design Interventions Eligibility Criteria Contacts and Locations More Information

  Show 66 Study Locations

Sponsors and Collaborators

Bristol-Myers Squibb

Investigators

Study Director:	Bristol-Myers Squibb	Bristol-Myers Squibb

More Information

Go to 

Study Description Study Design Interventions Eligibility Criteria Contacts and Locations More Information

Additional Information:

BMS Clinical Trial Information 

BMS clinical trial educational resource 

EAP Investigator Requests 

FDA Safety Alerts and Recalls 

Responsible Party:	Bristol-Myers Squibb
ClinicalTrials.gov Identifier:	NCT02186249 History of Changes
Other Study ID Numbers:	CA209-218
First Posted:	July 10, 2014
Last Update Posted:	February 8, 2017
Last Verified:	February 2017

Additional relevant MeSH terms:

Melanoma; Nevi and Melanomas; Nivolumab; Neuroendocrine Tumors; Neuroectodermal Tumors; Neoplasms, Germ Cell and Embryonal; Neoplasms by Histologic Type	Neoplasms; Neoplasms, Nerve Tissue; Antibodies, Monoclonal; Antineoplastic Agents; Immunologic Factors; Physiological Effects of Drugs