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: Not yet recruiting
• Trial end date: 2022-05-01
• Target enrollment: 165
• Participant gender: All

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.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Nektar Therapeutics
• Collaborator: Bristol-Myers Squibb
• Treatments: Antibodies, Monoclonal; Carboplatin; Cisplatin; Gemcitabine; Nivolumab

Criteria

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