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Trial record 1 of 1 for:    NCT03785925
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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 (PIVOT-10)

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ClinicalTrials.gov Identifier: NCT03785925
Recruitment Status : Recruiting
First Posted : December 24, 2018
Last Update Posted : February 28, 2019
Sponsor:
Collaborator:
Bristol-Myers Squibb
Information provided by (Responsible Party):
Nektar Therapeutics

Study Description
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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.

Condition or disease Intervention/treatment Phase
Urinary Bladder Neoplasm Neoplasm Metastasis Biological: NKTR-214 Biological: Nivolumab Drug: Reference Gemcitabine Drug: Reference Carboplatin Phase 2

Study Design
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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 165 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official 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
Estimated Study Start Date : March 2019
Estimated Primary Completion Date : June 2020
Estimated Study Completion Date : May 2022

Resource links provided by the National Library of Medicine


Arms and Interventions
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Arm Intervention/treatment
Experimental: Combination of NKTR-214 + nivolumab
Participants in Arm A will receive NKTR-214 in combination with nivolumab.
 Biological: NKTR-214
Specified dose on specified days
Other Names:
  • CD122-Biased Agonist
  • BMS-986321

Biological: Nivolumab
Specified dose on specified days
Other Names:
  • Opdivo®
  • BMS-936658
Combination of gemcitabine + carboplatin
Participants in the reference Arm B will receive a combination of gemcitabine and carboplatin.
 Drug: Reference Gemcitabine
Specified dose on specified days
Other Name: Gemzar®

Drug: Reference Carboplatin
Specified dose on specified days
Other Name: Paraplatin®


Outcome Measures
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Primary Outcome Measures :
  1. 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 [ Time Frame: Approximately 18 months ]

Secondary Outcome Measures :
  1. Duration of Response (DOR) by RECIST 1.1 per BICR [ Time Frame: Up to 5 years ]
  2. Incidence of treatment-related Adverse Events (AEs) [ Time Frame: Up to 2 years ]

Eligibility Criteria
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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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

Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03785925


Contacts
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Contact: Nektar Recruitment 855-482-8676 StudyInquiry@nektar.com

Locations
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United States, Alaska
Investigator Site - Anchorage Recruiting
Anchorage, Alaska, United States, 99503
United States, California
Investigator Site - Whittier Recruiting
Whittier, California, United States, 90603
United States, Texas
Local Institution - Houston Not yet recruiting
Houston, Texas, United States, 77030
Sponsors and Collaborators
Nektar Therapeutics
Bristol-Myers Squibb
Investigators
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Study Director: Erin Karski, MD Nektar Therapeutics
More Information
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Responsible Party: Nektar Therapeutics
ClinicalTrials.gov Identifier: NCT03785925     History of Changes
Other Study ID Numbers: 18-214-10
CA045-012 ( Other Identifier: Bristol-Myers Squibb )
First Posted: December 24, 2018    Key Record Dates
Last Update Posted: February 28, 2019
Last Verified: February 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No

Keywords provided by Nektar Therapeutics:
Bladder
Bladder Cancer
CD122
Cisplatin Ineligible
Immuno-oncology
Immunotherapy
Locally Advanced Urothelial Cancer
Metastatic Urothelial Cancer
mUC
Natural Killer Cells
Nivolumab
 NKTR-214
Opdivo®
PD-L1
Urothelial Cancer
Urothelial
Carboplatin
Gemcitabine
Paraplatin®
Gemzar®
GemCarbo

Additional relevant MeSH terms:
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Neoplasms
Neoplasm Metastasis
Urinary Bladder Neoplasms
Neoplastic Processes
Pathologic Processes
Urologic Neoplasms
Urogenital Neoplasms
Neoplasms by Site
Urinary Bladder Diseases
Urologic Diseases
Cisplatin
Gemcitabine
Carboplatin
 Nivolumab
Antineoplastic Agents
Antimetabolites, Antineoplastic
Antimetabolites
Molecular Mechanisms of Pharmacological Action
Antiviral Agents
Anti-Infective Agents
Enzyme Inhibitors
Immunosuppressive Agents
Immunologic Factors
Physiological Effects of Drugs
Antineoplastic Agents, Immunological