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8110 Gatehouse Road, Falls Church, VA 22042

BMS CA045-001: A Phase 3, Randomized, Open-label Study of NKTR-214 Combined with Nivolumab versus Nivolumab Alone in Participants with Previously Untreated Unresectable or Metastatic Melanoma

General Information

Age Group

Adult

Status

Recruiting

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

For more information go to: https://clinicaltrials.gov/ct2/show/NCT03635983