Bempegaldesleukin and Pembrolizumab With or Without Chemotherapy in Locally Advanced or Metastatic Solid Tumors

Part of paid clinical trials in Fayetteville, Arkansas.

Sponsor
Nektar Therapeutics
Study ID
NCT03138889
Phase
PHASE1/PHASE2
Status
Terminated

Conditions

Eligibility Criteria

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

Interventions

  • NKTR-214 — DRUG
    NKTR-214: The dose will be 0.008 mg/kg intravenous (IV) infusion administered over 30 (± 5) minutes q3w. The maximum dose of NKTR-214 will be 0.012 mg/kg. This will include a fixed 3+3 dose escalation followed by intra-patient step-up dose escalation based on tolerability.
  • Pembrolizumab — DRUG
    Pembrolizumab (anti-PD-1) will be dosed as per the pharmacy manual.
  • NKTR-214 — DRUG
    NKTR-214: The dose will be 0.006 mg/kg intravenous (IV) infusion.
  • NKTR-214 — DRUG
    NKTR-214: The dose will be 0.010 mg/kg intravenous (IV) infusion.
  • Cisplatin — DRUG
    Cisplatin will be dosed per the pharmacy manual
  • Carboplatin — DRUG
    Carboplatin will be dosed per the pharmacy manual
  • Nab paclitaxel — DRUG
    Nab-paclitaxel will be dosed per local practice and label
  • Paclitaxel — DRUG
    Paclitaxel will be dosed per local practice and label
  • Pemetrexed — DRUG
    Pemetrexed will be dosed per the pharmacy manual
  • Atezolizumab — DRUG
    Atezolizumab will be dosed per current label indication

Study Details

This study is to assess the safety and tolerability, and to assess the preliminary clinical benefit of NKTR-214 when combined with pembrolizumab (KEYTRUDA®) with or without chemotherapy. The study is comprised of two groups; dose optimization and dose expansion cohorts. Dose Optimization included first-line and second-line advanced or metastatic solid tumors including non-small cell lung cancer (NSCLC) The dose expansion cohort will include first-line NSCLC patients.

Key Dates

Start date
Jun 9, 2017
Status verified
Mar 2023
Primary completion
Jul 5, 2022
Completion
Aug 24, 2022

Study Design

Enrollment
162 participants (actual)
Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Experimental: Dose Optimization, Combo of NKTR-214 + Pembrolizumab(KEYTRUDA®)
    Cohort 1: NKTR-214 will be combined with pembrolizumab
  • Experimental: Dose Expansion, Combo of NKTR-214 + Pembrolizumab(KEYTRUDA®)
    Cohort 2: NKTR-214 will be combined with pembrolizumab
  • Experimental: Dose Expansion, Combo of NKTR-214 + Pembrolizumab (KEYTRUDA®)
    Cohort 3: NKTR-214 will be combined with pembrolizumab
  • Experimental: Dose Expansion, NKTR-214 + Pembrolizumab and either Cisplatin, or Carboplatin and Pemetrexed
    Cohort 4: NKTR-214 will be dosed in combination with pembrolizumab and either cisplatin, or carboplatin and pemetrexed, per investigator discretion
  • Experimental: Dose Expansion, NKTR-214 + Pembrolizumab and Carboplatin and either Nab-paclitaxel or Paclitaxel
    Cohort 5: NKTR-214 will be dosed in combination with pembrolizumab and carboplatin and either nab-paclitaxel or paclitaxel, per investigator discretion
  • Experimental: Combo of NKTR-214 + Pembrolizumab(KEYTRUDA®) or Atezolizumab (TECENTRIQ®)
    Cohort 0 (Before Protocol Amendment 5.0): NKTR-214 will be combined with pembrolizumab or atezolizumab

Primary Outcome Measure

Number of Participants Experiencing Dose-Limiting Toxicities in Dose Optimization Cohort 1a [ Time Frame: DLTs were assessed at 21 days from Cycle 1 ]

Locations (23)

FacilityCityStateZIPSite coordinators
Highlands Oncology Group, PA - North HillsFayettevilleArkansas72703-
California Pacific Medical CenterSan FranciscoCalifornia94115-
University of Colorado Anschutz Medical CampusAuroraColorado80045-
Augusta University - Augusta University Medical CenterAugustaGeorgia30912-
Ochsner Medical CenterNew OrleansLouisiana70816-
Henry Ford HospitalDetroitMichigan48202-
Park Nicollet - Frauenshuh Cancer CenterSaint Louis ParkMinnesota55426-
Washington University School of Medicine in St. LouisSt LouisMissouri63156-
St. Vincent Frontier Cancer CenterBillingsMontana59101-
University of Nebraska Medical CenterOmahaNebraska68198-
Comprehensive Cancer Centers of Nevada (CCCN) - Central ValleyLas VegasNevada89169-
Rutgers Cancer Institute of New JerseyNew BrunswickNew Jersey08901-
Columbia University Medical CenterNew YorkNew York10032-
New York University Langone Medical CenterNew YorkNew York10016-
Duke Clinical Research InstituteDurhamNorth Carolina27705-
Fox Chase Cancer CenterPhiladelphiaPennsylvania19111-
West Cancer CenterGermantownTennessee38138-
Sarah Cannon Research Institute (SCRI) (The SCRI Oncology Research Consortium)NashvilleTennessee37203-
The University of Texas MD Anderson Cancer CenterHoustonTexas77030-
Inova Melanoma and Skin Cancer CenterFairfaxVirginia22031-
Blue Ridge Cancer CareRoanokeVirginia24153-
Northwest Medical SpecialtiesTacomaWashington98405-
Froedtert & the Medical College of Wisconsin Froedtert HospitalMilwaukeeWisconsin53226-

Find similar trials in Fayetteville, AR

By condition
Lung cancer
By specialty
OncologyLung oncologyLung disease
By research site
Highlands Oncology Group, PA - North Hills· Fayetteville, ARCalifornia Pacific Medical Center· San Francisco, CAUniversity of Colorado Anschutz Medical Campus· Aurora, COAugusta University - Augusta University Medical Center· Augusta, GAOchsner Medical Center· New Orleans, LAHenry Ford Hospital· Detroit, MI

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