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BRIEF 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

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


  • Org Study ID: 18-214-10
  • Secondary ID: CA045-012
  • NCT ID: NCT03785925
  • NCT Alias:
  • Sponsor: Nektar Therapeutics - Industry
  • Source: Nektar Therapeutics

Brief 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.

Overal Status Start Date Phase Study Type
Recruiting April 29, 2019 Phase 2 Interventional

Primary Outcomes:

Primary Outcome 1 - Measure: Objective Response Rate (ORR) using Response Evaluation Criteria in Solid Tumors (RECIST) 1.1 per Blinded Independent Central Review (BICR) in patients with low programmed cell death ligand (PD-L1) expression

Primary Outcome 1 - Time Frame: Approximately 18 months

Condition:

  • Urinary Bladder Neoplasm
  • Neoplasm Metastasis

Eligibility

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
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Gender: All

Minimum Age: 18 Years

Maximum Age: N/A

Healthy Volunteers: No

Official Information

Name: Erin Karski, MD

Role: Study Director

Affiliation: Nektar Therapeutics

Overall Contact

Name: Nektar Recruitment

Phone: 855-482-8676

Email: StudyInquiry@nektar.com

Locations

Facility Status Contact
Investigator Site - Anchorage
Anchorage, Alaska 99503
United States
Recruiting
Investigator Site - Whittier
Whittier, California 90603
United States
Recruiting
Investigator Site - Peoria
Peoria, Illinois 61615
United States
Recruiting
Investigator Site - Billings
Billings, Montana 59102
United States
Recruiting
Local Institution - Houston
Houston, Texas 77030
United States
Recruiting
Investigator Site - Auchenflower
Auchenflower, Queensland 4066
Australia
Recruiting
Investigator Site - Kurralta Park
Kurralta Park, South Australia 5037
Australia
Recruiting