Expanded Access Program With Nivolumab to Treat Melanoma

Description

The primary purpose of this study is to provide treatment with Nivolumab to subjects with histologically confirmed stage III (unresectable) or stage IV advanced melanoma who have progressed on or after prior treatment with an anti-CTLA4-containing therapy and for subjects with known BRAF mutation, also progressed on or after treatment with a BRAF inhibitor.

Study Start Date

June 2014

Estimated Completion Date

May 2018

Interventions

  • Drug: Nivolumab

Specialties

  • Oncology: Dermatologic Oncology,Pharmacology/Therapy
  • Pharmacy: Chemotherapy/Oncology
  • Dermatology: Dermatologic Oncology
  • Physician Assistant: Clinical Pharmacology,Dermatology,Hematology/Oncology

MeSH Terms

  • Melanoma
  • Nivolumab

Study ID

Bristol-Myers Squibb -- CA209-168

Status

Available

Trial ID

NCT02142218

Study Type

Expanded Access

Trial Phase

N/A

Enrollment Quota

Not Listed

Sponsor

Bristol-Myers Squibb

For more information regarding BMS clinical trial participation, please visit www.BMSStudyConnect.com

Inclusion Criteria

  • ? 18 years of age
  • Histologically confirmed malignant melanoma, Including mucosal melanoma
  • Previously treated unresectable med stage III or stage IV melanoma, as per American Joint Committee on Cancer staging system
  • Eastern Cooperative Oncology Group (ECOG) perform status (PS) 0-1
  • Progressed on or after prior treatment with an anti-CTLA4-containing therapy and, for subjects with known BRAF mutation, also progressed on or after treatment with a BRAF inhibitor

Exclusion Criteria

  • Active brain metastases or leptomeningeal metastases
  • Life expectancy <6 weeks
  • Subjects with active, known or suspected autoimmune disease
  • Subjects with a known history of anti-CTLA-4 therapy related adverse reactions based on the CTCAE v criteria
  • Any treatment in a Nivolumab clinical trial

Gender

Both

Ages

18 Years and older

Accepts Healthy Volunteers

Not Listed

Study Locations and Contact Information (35)

Study Location Distance Name Phone Email
North Shore HematologyOncology Associates PC - East Setauket, New York 21.2 miles Jeffrey Vacirca Site 0023 None None
North Shore HematologyOncology Associates PC - East Setauket, New York 21.2 miles None None None
Icahn School Of Medicine At Mount Sinai - New York, New York 46.8 miles None None None
Icahn School Of Medicine At Mount Sinai - New York, New York 46.8 miles Philip Friedlander Site 0038 None None
St LukeS Hospital - Bethlehem, Pennsylvania 118.7 miles None None None
St LukeS Hospital - Bethlehem, Pennsylvania 118.7 miles Sanjiv Agarwala Site 0046 None None
Lehigh Valley Health Network - Allentown, Pennsylvania 124.2 miles Suresh Nair Site 0001 None None
Sidney Kimmel Comprehensive Cancer Center At Johns Hopkins - Lutherville, Maryland 218.1 miles William Sharfman Site 0003 None None
Local Institution - Washington, District of Columbia 258.2 miles Site 0028 None None
Local Institution - Washington, District of Columbia 258.2 miles None None None
Mid Ohio OncologyHematology IncDba - Columbus, Ohio 515.7 miles Timothy D Moore Site 0008 614-383-6000 None
Oncology Specialists SC - Park Ridge, Illinois 756.1 miles Sigrun Hallmeyer Site 0004 None None
Summit Cancer Care - Savannah, Georgia 769.1 miles Mark Taylor Site 0011 None None
Waukesha Memorial Hospital - Waukesha, Wisconsin 780.4 miles Laura Raftery Site 0039 None None
Waukesha Memorial Hospital - Waukesha, Wisconsin 780.4 miles None None None
Oncology Hematology Associates Of Sw In - Newburgh, Indiana 784.8 miles Edward Fox Site 0007 None None
Oncology Hematology Associates Of Sw In - Newburgh, Indiana 784.8 miles None None None
Winship Cancer Institute - Atlanta, Georgia 795.6 miles Ragini Kudchadkar Site 0013 None None
Tennessee Oncology PLLC - Nashville, Tennessee 810.5 miles Jeffrey Infante Site 0002 None None
Cancer Specialists Of North Florida - Jacksonville, Florida 892.6 miles Suprith Badarinath Site 0012 None None
Florida Hospital - Orlando, Florida 989.4 miles Lee Zehngebot Site 0005 None None
Florida Hospital - Orlando, Florida 989.4 miles None None None
The Jones Clinic Pc - Germantown, Tennessee 999.8 miles C Michael Jones Site 0006 None None
Lynn Cancer Institute At Boca Raton Regional Hospital - Boca Raton, Florida 1,102.6 miles Lloyd Berkowitz Site 0048 None None
Lynn Cancer Institute At Boca Raton Regional Hospital - Boca Raton, Florida 1,102.6 miles None None None
Local Institution - Mobile, Alabama 1,103.2 miles None None None
Local Institution - Mobile, Alabama 1,103.2 miles Site 0040 None None
Southern Cancer Center Pc - Mobile, Alabama 1,107.8 miles Michael W Meshad Site 0035 None None
Southern Cancer Center Pc - Mobile, Alabama 1,107.8 miles None None None
Mount Sinai Comprehensive Cancer Center - Miami Beach, Florida 1,137.7 miles Jose Lutzky Site 0009 305-535-3300 None
Nebraska Cancer Specialists - Omaha, Nebraska 1,190.7 miles None None None
Nebraska Cancer Specialists - Omaha, Nebraska 1,190.7 miles Ralph Hauke Site 0010 None None
Comprehensive Cancer Centers Of Nevada - Las Vegas, Nevada 2,281.7 miles None None None
Comprehensive Cancer Centers Of Nevada - Las Vegas, Nevada 2,281.7 miles Wolfram Samlowski Site 0030 None None
Local Institution - Encinitas, California 2,468.2 miles Site 0047 None None

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