A Study of Bempegaldesleukin (NKTR-214: BEMPEG) in Combination With Nivolumab Compared With the Investigator's Choice of a Tyrosine Kinase Inhibitor (TKI) Therapy (Either Sunitinib or Cabozantinib Monotherapy) for Advanced Metastatic Renal Cell Carcinoma (RCC)

Part of paid clinical trials in Anchorage, Alaska.

Sponsor
Nektar Therapeutics
Study ID
NCT03729245
Phase
PHASE3
Status
Terminated

Conditions

Eligibility Criteria

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

Interventions

  • bempegaldesleukin — BIOLOGICAL
    Specified dose on specified days
  • sunitinib — DRUG
    Specified dose on specified days
  • nivolumab — BIOLOGICAL
    Specified dose on specified days
  • cabozantinib — DRUG
    Specified dose on specified days

Study Details

The main purpose of this study is to compare the objective response rate (ORR) and overall survival (OS) of bempegaldesleukin (NKTR-214: BEMPEG) combined with nivolumab to that of tyrosine kinase inhibitor (TKI) monotherapy (sunitinib or cabozantinib) in IMDC intermediate- or poor-risk patients and IMDC all-risk patients with previously untreated advanced renal cell carcinoma (RCC).

Key Dates

Start date
Dec 18, 2018
Status verified
Mar 2023
Primary completion
Jan 7, 2022
Completion
Oct 19, 2022

Study Design

Enrollment
623 participants (actual)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Experimental: Combination of bempegaldesleukin + nivolumab
    Patients in Arm A will receive bempegaldesleukin in combination with nivolumab.
  • Active Comparator: sunitinib or cabozantinib
    Patients in Arm B will receive the Investigator's choice of either one of two treatment options.

Primary Outcome Measure

Objective Response Rate (ORR) Per mRECIST 1.1 by BICR in IMDC All-risk Patients and Intermediate- or Poor (I/P)-Risk Patients With Previously Untreated Advanced RCC [ Time Frame: Approximately 32 months ]

Locations (20)

FacilityCityStateZIPSite coordinators
Alaska UrologicalAnchorageAlaska99503-
Western Regional Medical Center - CTCA - PPDSGoodyearArizona85338-
CARTI Cancer CenterLittle RockArkansas72205-
City of Hope National Medical CenterDuarteCalifornia91010-
University of California IrvineOrangeCalifornia92868-
Innovative Clinical Research InstituteWhittierCalifornia90603-
University of MiamiMiamiFlorida33136-
Winship Cancer Institute, Emory UniversityAtlantaGeorgia30322-
Tulane Medical CenterNew OrleansLouisiana70112-
University of Maryland Greenebaum Cancer CenterBaltimoreMaryland21201-
Comprehensive Cancer Centers of NevadaLas VegasNevada89106-
North Shore Hematology Oncology Association PCPort Jefferson StationNew York11776-
Kettering Medical CenterKetteringOhio45429-
Providence Cancer Institute, Franz ClinicPortlandOregon97213-
Lehigh Valley Physician Group (LVPG) - Hematology OncologyAllentownPennsylvania18103-
Penn State Milton S Hershey Medical CenterHersheyPennsylvania17033-
Eastern Regional Medical Center - CTCAPhiladelphiaPennsylvania19124-
Thomas Jefferson UniversityPhiladelphiaPennsylvania19107-
MD Anderson Cancer CenterHoustonTexas77030-
Huntsman Cancer Hospital - PPDSSalt Lake CityUtah84112-

Find similar trials in Anchorage, AK

By condition
Kidney cancer
By specialty
OncologyUrology
By research site
Alaska Urological· Anchorage, AKWestern Regional Medical Center - CTCA - PPDS· Goodyear, AZCARTI Cancer Center· Little Rock, ARCity of Hope National Medical Center· Duarte, CAUniversity of California Irvine· Orange, CAInnovative Clinical Research Institute· Whittier, CA

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