Call us 24/7

PIVOT-10: 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

Description

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 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.

Status

Accepting new patients

Primary Study Objective(s)

The primary objective is to achieve an Objective Response Rate (ORR) in patients with low programmed cell death ligand (PD-L1) expression.

Core eligibility

Note: This is only a partial list of eligibility criteria.

Including patients who have:

  • Provided 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 that is 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)
  • Had a fresh biopsy or archival tissue
  • Had no prior systemic chemotherapy or investigational agent for inoperable locally advanced or mUC
  • Been deemed ineligible for cisplatin

Excluding patients who:

  • Have an active, known or suspected autoimmune disease
  • Have received prior IL-2 therapy
  • Had 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
  • Have hypertension unless they are on a stable anti-hypertensive regimen for the 14 days prior to randomization

Other protocol-defined inclusion/exclusion criteria could apply.