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 |
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.
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
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