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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)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03785925
Recruitment Status : Active, not recruiting
First Posted : December 24, 2018
Last Update Posted : October 6, 2020
Sponsor:
Collaborator:
Bristol-Myers Squibb
Information provided by (Responsible Party):
Nektar Therapeutics

Tracking Information
First Submitted Date  ICMJE December 20, 2018
First Posted Date  ICMJE December 24, 2018
Last Update Posted Date October 6, 2020
Actual Study Start Date  ICMJE April 29, 2019
Estimated Primary Completion Date March 2021   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: August 5, 2019)
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 ]
Original Primary Outcome Measures  ICMJE
 (submitted: December 20, 2018)
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 ]
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: August 5, 2019)
  • ORR by RECIST 1.1 per BICR in all treated patients [ Time Frame: Approximately 6 months ]
  • 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 ]
  • 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 ]
  • Incidence of treatment-related Adverse Events (AEs) [ Time Frame: Up to 2 years ]
Original Secondary Outcome Measures  ICMJE
 (submitted: December 20, 2018)
  • Duration of Response (DOR) by RECIST 1.1 per BICR [ Time Frame: Up to 5 years ]
  • Incidence of treatment-related Adverse Events (AEs) [ Time Frame: Up to 2 years ]
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE A Single-Arm Study of Bempegaldesleukin (NKTR-214) Plus Nivolumab in Cisplatin Ineligible Patients Who Have Locally Advanced or Metastatic Urothelial Cancer
Official Title  ICMJE A Phase 2, Single-Arm Study of Bempegaldesleukin (NKTR-214) in Combination With Nivolumab in Cisplatin Ineligible, Locally Advanced or Metastatic Urothelial Cancer Patients
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.
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 2
Study Design  ICMJE Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE
  • Urinary Bladder Neoplasm
  • Neoplasm Metastasis
Intervention  ICMJE
  • 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
Study Arms  ICMJE Experimental: Combination of bempegaldesleukin (NKTR-214) + nivolumab
Participants will receive bempegaldesleukin (NKTR-214) in combination with nivolumab.
Interventions:
  • Biological: Bempegaldesleukin
  • Biological: Nivolumab
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Active, not recruiting
Actual Enrollment  ICMJE
 (submitted: August 4, 2020)
192
Original Estimated Enrollment  ICMJE
 (submitted: December 20, 2018)
165
Estimated Study Completion Date  ICMJE July 2022
Estimated Primary Completion Date March 2021   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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

Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Argentina,   Australia,   Austria,   Belgium,   Canada,   Denmark,   Finland,   France,   Germany,   Greece,   Israel,   Italy,   Mexico,   Netherlands,   Poland,   Portugal,   Russian Federation,   Spain,   Turkey,   United Kingdom,   United States
Removed Location Countries Brazil,   Puerto Rico
 
Administrative Information
NCT Number  ICMJE NCT03785925
Other Study ID Numbers  ICMJE 18-214-10
CA045-012 ( Other Identifier: Bristol-Myers Squibb Protocol ID )
2018-003636-79 ( EudraCT Number )
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE
Plan to Share IPD: Undecided
Responsible Party Nektar Therapeutics
Study Sponsor  ICMJE Nektar Therapeutics
Collaborators  ICMJE Bristol-Myers Squibb
Investigators  ICMJE
Study Director: David Chien, MD Nektar Therapeutics
PRS Account Nektar Therapeutics
Verification Date October 2020

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP