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A Phase 2, Randomized, Non-Comparative, Open-Label Study of NKTR-214 in Combination With Nivolumab and of Chemotherapy in Cisplatin Ineligible, Locally Advanced or Metastatic Urothelial Cancer Patients With Low PD-L1 Expression

Status
Active
Cancer Type
Bladder Cancer
Kidney Cancer
Unknown Primary
Trial Phase
Phase II
Eligibility
18 Years and older, Male and Female
Study Type
Treatment
NCD ID
NCT03785925
Protocol IDs
18-214-10 (primary)
NCI-2019-01752
CA045-012
Study Sponsor
Nektar

Summary

The main purpose of this study is to evaluate the anti-tumor activity of NKTR-214 in combination with nivolumab by assessing the objective response rate (ORR) in cisplatin ineligible, locally advanced or metastatic urothelial cancer patients with low PD-L1 expression. The efficacy will be assessed within the experimental Arm A, while Arm B will serve as a reference arm.
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