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Melanoma / Skin
General Information
Study Name:
BMS CA045-001: A Phase 3, Randomized, Open-label Study of NKTR-214 Combined with Nivolumab versus Nivolumab in Participants with Previously Untreated Unresectable or Metastatic Melanoma
Age Group:
Adult
Protocol Number:
NCT03635983
Background Information:
The purpose of the study is to test the effectiveness (how well the drug works), safety, and tolerability of the investigational drug called NKTR-214 , when combined with nivolumab versus nivolumab given alone in participants with previously untreated melanoma skin cancer that is either unable to be surgically removed or has spread. NKTR-214 and nivolumab in this informed consent may also be referred to as study medication(s) or treatment.
Offered at:
Inova Schar Cancer Institute
8081 Innovation Park Drive
Fairfax, VA 22031
A department of Inova Fairfax Hospital
Eligibility Information
Histologically confirmed stage III (unresectable) or stage IV melanoma.
Treatment-naïve participants (ie, no prior systemic anticancer therapy for unresectable or metastatic melanoma) with the exception of prior adjuvant treatment for melanoma with approved agents (eg, BRAF/MEK inhibitors, ipilimumab, nivolumab, pembrolizumab or Interferon.
Additional eligibility in protocol.
Ineligibility Information
Participants who have had recurrence within the 6 months of completing adjuvant treatment are not eligible.
Additional eligibility in protocol
Contact Information
Contact Name:
Kelly Jeffords, CCRP
Contact Phone:
571-472-0631
Contact Email:
kelly.jeffords@inova.org