Malignant Melanoma Clinical Trial
— CheckMate218Official title:
Expanded Access Program With Nivolumab (BMS-936558) in Combination With Ipilimumab (Yervoy®) in Subjects With Unresectable or Metastatic Melanoma
| NCT number | NCT02186249 |
| Other study ID # | CA209-218 |
| Secondary ID | |
| Status | No longer available |
| Phase | N/A |
| First received | July 8, 2014 |
| Last updated | February 6, 2017 |
| Verified date | February 2017 |
| Source | Bristol-Myers Squibb |
| Contact | n/a |
| Is FDA regulated | No |
| Health authority | |
| Study type | Expanded Access |
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.
| Status | No longer available |
| Enrollment | 0 |
| Est. completion date | |
| Est. primary completion date | |
| Accepts healthy volunteers | |
| Gender | All |
| Age group | 18 Years and older |
| Eligibility |
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 |
| Country | Name | City | State |
|---|---|---|---|
| Canada | Cross Cancer Institute | Edmonton | Alberta |
| Canada | Grand River Hospital | Kitchener | Ontario |
| Canada | London Health Sciences Centre | London | Ontario |
| Canada | McGill University Health Center | Montreal | Quebec |
| Canada | Lakeridge Health Oshawa | Oshawa | Ontario |
| Canada | Chuq Centre Hospitalier Universitaire de Quebec | Quebec | |
| Canada | Princess Margaret Hospital | Toronto | Ontario |
| Canada | Sunnybrook Health Science Centre | Toronto | Ontario |
| Canada | British Columbia Cancer Agency | Vancouver | British Columbia |
| United States | Lehigh Valley Health Network | Allentown | Pennsylvania |
| United States | University of Michigan Comprehensive Cancer Center | Ann Arbor | Michigan |
| United States | Winship Cancer Institute | Atlanta | Georgia |
| United States | University of Colorado Hospital | Aurora | Colorado |
| United States | Texas Oncology | Austin | Texas |
| United States | 6501 Truxtun Avenue | Bakersfield | California |
| United States | Johns Hopkins Sidney Kimmel Comprehensive Cancer Center | Baltimore | Maryland |
| United States | Medstar Health Research Institute | Baltimore | Maryland |
| United States | Center For Cancer and Blood Disorders | Bethesda | Maryland |
| United States | St Luke's Hospital | Bethlehem | Pennsylvania |
| United States | Beth Israel Deaconess Medical Center | Boston | Massachusetts |
| United States | Dana Farber Cancer Institute | Boston | Massachusetts |
| United States | Massachusetts General Hospital | Boston | Massachusetts |
| United States | Carolinas Healthcare System | Charlotte | North Carolina |
| United States | Karmanos Cancer Institute | Detroit | Michigan |
| United States | Greenville Health System | Easley | South Carolina |
| United States | Evanston Premier Healthcare Research LLC | Evanston | Illinois |
| United States | Banner MD Anderson Cancer Center | Gilbert | Arizona |
| United States | Cancer and Hematology Centers of Western Michigan | Grand Rapids | Michigan |
| United States | Memorial Regional Hospital | Hollywood | Florida |
| United States | MD Anderson Cancer Center | Houston | Texas |
| United States | 4500 San Pablo Road South | Jacksonville | Florida |
| United States | Cancer Specialists of North Florida | Jacksonville | Florida |
| United States | UC San Diego Moores Cancer Center | La Jolla | California |
| United States | Comprehensive Cancer Centers of Nevada | Las Vegas | Nevada |
| United States | Rocky Mountain Cancer Centers | Littleton | Colorado |
| United States | UF Health Cancer Center at Orlando Health | Longwood | Florida |
| United States | 100 UCLA Medical Plaza | Los Angeles | California |
| United States | Local Institution | Louisville | Kentucky |
| United States | University of Wisconsin | Madison | Wisconsin |
| United States | Mount Sinai Medical Center | Miami Beach | Florida |
| United States | Texas Oncology | Midland | Texas |
| United States | Atlantic Health System | Morristown | New Jersey |
| United States | Tennessee Oncology PLLC | Nashville | Tennessee |
| United States | Smilow Cancer Hospital at Yale University Cancer Center | New Haven | Connecticut |
| United States | Memorial Sloan-Kettering Cancer Center | New York | New York |
| United States | NYU Langone Medical Center | New York | New York |
| United States | 600 Celebrate Life Parkway | Newnan | Georgia |
| United States | Oncology Specialists, SC | Niles | Illinois |
| United States | Florida Hospital Cancer Institute | Orlando | Florida |
| United States | Texas Oncology | Paris | Texas |
| United States | Mayo Clinic Arizona | Phoenix | Arizona |
| United States | Northwest Cancer Specialists PC | Portland | Oregon |
| United States | 514 North Prospect Ave | Redondo Beach | California |
| United States | Virginia Cancer Institute | Richmond | Virginia |
| United States | Oncology and Hematology Associates of Southwest Virginia, Inc | Roanoke | Virginia |
| United States | Mayo Clinic | Rochester | Minnesota |
| United States | Washington University School of Medicine | Saint Louis | Missouri |
| United States | California Pacific Medical Center Research Institute | San Francisco | California |
| United States | University of California San Francisco | San Francisco | California |
| United States | 1325 East Church Street | Santa Monica | California |
| United States | Angeles Clinic and Research Institute | Santa Monica | California |
| United States | Seattle Cancer Care Alliance | Seattle | Washington |
| United States | H. Lee Moffitt Cancer Center & Research Institute | Tampa | Florida |
| United States | Tulsa Cancer Institute PLLC | Tulsa | Oklahoma |
| United States | Georgetown-Lombardi Comprehensive Cancer Center | Washington | District of Columbia |
| United States | Shenandoah Oncology Association | Winchester | Virginia |
| Lead Sponsor | Collaborator |
|---|---|
| Bristol-Myers Squibb |
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