A Single-Arm Study of Bempegaldesleukin (NKTR-214) Plus Nivolumab in Cisplatin Ineligible Patients Who Have Locally Advanced or Metastatic Urothelial Cancer

Part of paid clinical trials in San Francisco, California.

Sponsor
Nektar Therapeutics
Study ID
NCT03785925
Phase
PHASE2
Status
Completed

Conditions

  • Neoplasm Metastasis
  • Urinary Bladder Neoplasm

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • Bempegaldesleukin — BIOLOGICAL
    Specified dose on specified days
  • Nivolumab — BIOLOGICAL
    Specified dose on specified days

Study Details

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.

Key Dates

Start date
Apr 29, 2019
Status verified
Mar 2023
Primary completion
Feb 9, 2022
Completion
Jun 30, 2022

Study Design

Enrollment
192 participants (actual)
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT

Arms

  • Experimental: Combination of bempegaldesleukin (NKTR-214) + nivolumab
    Participants will receive bempegaldesleukin (NKTR-214) in combination with nivolumab.

Primary Outcome Measure

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: Tumor assessments were performed at baseline and every 9 weeks from Cycle 1 Day 1 for the first 12 months, and then every 12 weeks as indicated in the Schedule of Events, up to approximately 27 months ]

Locations (8)

FacilityCityStateZIPSite coordinators
San Francisco VA Medical Center - NAVREF - PPDSSan FranciscoCalifornia94143-
Innovative Clinical Research Institute, LLCWhittierCalifornia90603-
Rocky Mountain Cancer CentersAuroraColorado80012-
Winship Cancer Institute, Emory UniversityAtlantaGeorgia30322-
Southeastern Regional Medical Center - CTCA - PPDSNewnanGeorgia30265-
Investigator Site - PeoriaPeoriaIllinois61615-
Laura And Isaac Perlmutter Cancer CenterNew YorkNew York10016-
MD Anderson Cancer CenterHoustonTexas77030-

Find similar trials in San Francisco, CA

By research site
San Francisco VA Medical Center - NAVREF - PPDS· San Francisco, CAInnovative Clinical Research Institute, LLC· Whittier, CARocky Mountain Cancer Centers· Aurora, COWinship Cancer Institute, Emory University· Atlanta, GASoutheastern Regional Medical Center - CTCA - PPDS· Newnan, GAInvestigator Site - Peoria· Peoria, IL

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