A Phase 1/2 Open-label Multicenter Study of the Combination of NKTR-214 and Nivolumab or the Combination of NKTR-214 Nivolumab and Ipilimumab in Patients With Select Locally Advanced or Metastatic Solid Tumor Malignancies

Are you eligible to participate in this study?

You may be eligible for this study if you meet the following criteria:

  • Conditions: triple-negative breast cancer | urothelial carcinoma | melanoma | renal cell carcinoma | non small cell lung cancer
  • Age: Between 18 - 100 Years
  • Gender: Male or Female

Inclusion Criteria
Histologically confirmed diagnosis of a locally advanced or metastatic melanoma, RCC, NSCLC, urothelial carcinoma, or TNBC
Life expectancy > 12 weeeks
Demonstrated adequate organ function
Exclusion Criteria
Use of an investigational agent or an investigational device within 28 days before administration of first dose of NKTR--214
Females who are pregnant or breastfeeding
Participants who have an active autoimmune disease requiring systemic treatment within the past 3 months or have a documented history of clinically severe autoimmune disease that requires systemic steroids or immunosuppressive agents
History of organ transplant that requires use of immune suppressive agents
History of allergy or hypersensitivity to study drug components
Active malignancy not related to the current diagnosed malignancy
Evidence of clinically significant interstitial lung disease or active, noninfectious pneumonitis
Prior surgery or radiotherapy within 14 days of therapy
Participants who have had 28 days since the last chemotherapy, biological therapy, or 14 days from approved tyrosine kinase inhibitor (TKI) therapy (sunitinib, sorafenib, vemurafenib, dabrafenib, cobimetinib, erlotinib, gefitinib, afatinib, osimertinib), or systemic or inhaled steroid therapy at doses greater than 10mg of prednisone or equivalent before administration of the first dose of study medication
Participant's inability to adhere to or tolerate protocol or study procedures
Additional criteria may apply

Recruitment Status

Closed

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