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Trial record 1 of 1 for:    NCT03785925
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A Single-Arm Study of Bempegaldesleukin (NKTR-214) Plus Nivolumab in Cisplatin Ineligible Patients Who Have Locally Advanced or Metastatic Urothelial Cancer (PIVOT-10)

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ClinicalTrials.gov Identifier: NCT03785925
Recruitment Status : Recruiting
First Posted : December 24, 2018
Last Update Posted : June 2, 2020
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 bempegaldesleukin (NKTR-214) in combination with nivolumab by assessing the objective response rate (ORR) in cisplatin ineligible, locally advanced or metastatic urothelial cancer patients.

Condition or disease Intervention/treatment Phase
Urinary Bladder Neoplasm Neoplasm Metastasis Biological: Bempegaldesleukin Biological: Nivolumab Phase 2

Study Design
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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 190 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: A Phase 2, Single-Arm Study of Bempegaldesleukin (NKTR-214) in Combination With Nivolumab in Cisplatin Ineligible, Locally Advanced or Metastatic Urothelial Cancer Patients
Actual Study Start Date : April 29, 2019
Estimated Primary Completion Date : March 2021
Estimated Study Completion Date : July 2022

Resource links provided by the National Library of Medicine

Drug Information available for: Nivolumab

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

Biological: Nivolumab
Specified dose on specified days
Other Names:
  • Opdivo®
  • BMS-936658


Outcome Measures
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Primary Outcome Measures :
  1. Objective Response Rate (ORR) by Response Evaluation Criteria in Solid Tumors (RECIST) 1.1 per Blinded Independent Central Review (BICR) in patients whose tumors have low programmed cell death ligand (PD-L1) expression [ Time Frame: Approximately 6 months ]

Secondary Outcome Measures :
  1. ORR by RECIST 1.1 per BICR in all treated patients [ Time Frame: Approximately 6 months ]
  2. Duration of Response (DOR) by RECIST 1.1 per BICR in all treated patients and patients whose tumors have low PD-L1 expression [ Time Frame: Approximately 2 years ]
  3. ORR and DOR by RECIST 1.1 per Investigator assessment in all treated patients and in patients whose tumors have low PD-L1 expression [ Time Frame: Approximately 2 years ]
  4. 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

Key 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
  • 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

Key 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 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 will 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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Sponsors and Collaborators
Nektar Therapeutics
Bristol-Myers Squibb
Investigators
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Study Director: David Chien, MD Nektar Therapeutics
More Information
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Responsible Party: Nektar Therapeutics
ClinicalTrials.gov Identifier: NCT03785925    
Other Study ID Numbers: 18-214-10
CA045-012 ( Other Identifier: Bristol-Myers Squibb Protocol ID )
2018-003636-79 ( EudraCT Number )
First Posted: December 24, 2018    Key Record Dates
Last Update Posted: June 2, 2020
Last Verified: June 2020
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
Metastatic Urothelial Carcinoma
Urothelial Carcinoma
Bempegaldesleukin
BEMPEG
CPI Combination
IL-2
Additional relevant MeSH terms:
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Neoplasm Metastasis
Urinary Bladder Neoplasms
Neoplasms
Neoplastic Processes
Pathologic Processes
Urologic Neoplasms
Urogenital Neoplasms
 Neoplasms by Site
Urinary Bladder Diseases
Urologic Diseases
Nivolumab
Antineoplastic Agents, Immunological
Antineoplastic Agents