Trial purpose
Cancer treatment
Tumor type
Genitourinary
Age
18+
Clinical summary
Summary
Eligible patients will be randomised into either an experimental or reference arm. Patients in the experimental arm will receive NKTR-214 in combination with nivolumab. Patients in the reference arm will be used as a comparison and will receive a combination of two chemotherapy drugs, gemcitabine and carboplatin.
Conditions
This trial is treating people with urothelial cancer
Eligibility
Inclusion
- 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
- 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
- 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 pathway, 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 Cycle 1 Day 1
Additional protocol-defined inclusion/exclusion criteria applied
Inclusion
- You have been diagnosed with cancer, but have not received any treatment.
- Your cancer has spread to other parts of the body (metastatic) or has grown into nearby parts of the body (locally advanced).
Exclusion
- You have certain types of non-cancer medical conditions.
- You have had certain treatments, surgical procedures or drugs.
Clinical trials have complex eligibility criteria, and other criteria may apply for this trial. Ask your doctor about whether this trial could be right for you.
More information
Trial Identifiers
Information on this page is partially produced from ClinicalTrials.gov *. View further details about this trial on the registry via the links below:
Trial sponsor
Nektar Therapeutics
Scientific Title
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
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