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Closed (no longer recruiting)Last updated: 1 February 2024

PIVOT-10: This phase II trial is testing an experimental immunotherapy (NKTR-214) in combination with another standard type of immunotherapy (Nivolumab) in patients with advanced urothelial cancer that have low PD-L1 expressionA 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

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 patients with urothelial cancer.

Cancer

Urinary System Cancers Genitourinary

Age

People18+

Phase

II

Trial Acronym

PIVOT-10

More information

Trial Identifiers

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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

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.

Exclusion

  • You have certain types of non-cancer medical conditions.
  • You have had certain treatments, surgical procedures or drugs.
Message

Clinical trials have complex eligibility criteria.

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