A Randomized Study of NKTR-214 Plus Nivolumab and of Reference Chemotherapy in Cisplatin Ineligible Patients Who Have Locally Advanced or Metastatic Urothelial Cancer With Low PD-L1 Expression



Status:Recruiting
Conditions:Cancer
Therapuetic Areas:Oncology
Healthy:No
Age Range:18 - Any
Updated:3/2/2019
Start Date:March 2019
End Date:May 2022
Contact:Nektar Recruitment
Email:StudyInquiry@nektar.com
Phone:855-482-8676

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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

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.


Inclusion Criteria:

- Provide written, informed consent to participate in the study and follow the study
procedures

- Eastern Cooperative Oncology Group (ECOG) performance status of ≤ 2

- Measurable disease per RECIST 1.1 criteria

- Tumor must be PD-L1 low defined by a Combined Positive Score (CPS) of < 10 utilizing
the Dako PD-L1 immunohistochemistry (IHC) 22C3 pharmDx assay

- Histologically or cytologically documented inoperable, locally advanced or metastatic
urothelial cell carcinoma (also termed TCC)

- Fresh biopsy or archival tissue

- No prior systemic chemotherapy or investigational agent for inoperable locally
advanced or mUC

- Ineligible for cisplatin

Exclusion Criteria:

- Patients who have an active, known or suspected autoimmune disease

- Patients must not have received prior IL-2 therapy

- Prior treatment with an anti PD-1, anti PD-L1, or anti cytotoxic T lymphocyte
associated protein 4 (anti CTLA-4) antibody, agents that target IL-2, or any other
antibody or drug specifically targeting T cell co-stimulation or immune checkpoint
pathways

- Patients with hypertension must be on a stable antihypertensive regimen for the 14
days prior to randomization

Other protocol-defined inclusion/exclusion criteria could apply
We found this trial at
3
sites
Anchorage, Alaska 99501
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Houston, Texas 77030
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Houston, TX
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Whittier, California 90603
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Whittier, CA
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