Bempegaldesleukin and Pembrolizumab With or Without Chemotherapy in Locally Advanced or Metastatic Solid Tumors
NCT ID: NCT03138889
Last Updated: 2023-03-10
Study Results
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View full resultsBasic Information
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TERMINATED
PHASE1/PHASE2
162 participants
INTERVENTIONAL
2017-06-09
2022-08-24
Brief Summary
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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.
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Detailed Description
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The study will evaluate the clinical benefit, safety and tolerability of combining NKTR-214 with pembrolizumab with or without chemotherapy. Each dose expansion cohort will enroll approximately 100 new patients.
Dose Optimization evaluated an every three-week dose regimen (q3w) of NKTR-214 in combination with pembrolizumab given that the optimal dose and dosing schedule of NKTR-214 in combination with pembrolizumab remains unknown. The previously established recommended Phase 2 dose (0.006 mg/kg) of NKTR-214 was studied in combination with nivolumab.
Dose Expansion: NKTR-214 in combination with pembrolizumab will be evaluated in first-line non-small cell lung cancer (NSCLC). The NKTR-214 dose to be studied is 0.006 mg/kg q3w. This dose is based on the recommended phase 2 dose noted in the monotherapy trial with NKTR-214 (Study 15-214-01, NCT02869295) and an ongoing combination trial (16-214-02, NCT02983045). Pembrolizumab will be administered at a dose of 200mg q3w. Following data review for safety and efficacy, additional patients may be dosed using the findings from the dose optimization cohorts.
Conditions
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Study Design
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NON_RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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Dose Optimization, Combo of NKTR-214 + Pembrolizumab(KEYTRUDA®)
Cohort 1: NKTR-214 will be combined with pembrolizumab
NKTR-214
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
Pembrolizumab (anti-PD-1) will be dosed as per the pharmacy manual.
Dose Expansion, Combo of NKTR-214 + Pembrolizumab(KEYTRUDA®)
Cohort 2: NKTR-214 will be combined with pembrolizumab
Pembrolizumab
Pembrolizumab (anti-PD-1) will be dosed as per the pharmacy manual.
NKTR-214
NKTR-214: The dose will be 0.006 mg/kg intravenous (IV) infusion.
Dose Expansion, Combo of NKTR-214 + Pembrolizumab (KEYTRUDA®)
Cohort 3: NKTR-214 will be combined with pembrolizumab
NKTR-214
NKTR-214: The dose will be 0.010 mg/kg intravenous (IV) infusion.
Pembrolizumab
Pembrolizumab (anti-PD-1) will be dosed as per the pharmacy manual.
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
Cisplatin
Cisplatin will be dosed per the pharmacy manual
Carboplatin
Carboplatin will be dosed per the pharmacy manual
Pembrolizumab
Pembrolizumab (anti-PD-1) will be dosed as per the pharmacy manual.
NKTR-214
NKTR-214: The dose will be 0.006 mg/kg intravenous (IV) infusion.
Pemetrexed
Pemetrexed will be dosed per the pharmacy manual
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
Carboplatin
Carboplatin will be dosed per the pharmacy manual
Pembrolizumab
Pembrolizumab (anti-PD-1) will be dosed as per the pharmacy manual.
NKTR-214
NKTR-214: The dose will be 0.006 mg/kg intravenous (IV) infusion.
Nab paclitaxel
Nab-paclitaxel will be dosed per local practice and label
Paclitaxel
Paclitaxel will be dosed per local practice and label
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
Pembrolizumab
Pembrolizumab (anti-PD-1) will be dosed as per the pharmacy manual.
NKTR-214
NKTR-214: The dose will be 0.006 mg/kg intravenous (IV) infusion.
Atezolizumab
Atezolizumab will be dosed per current label indication
Interventions
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NKTR-214
NKTR-214: The dose will be 0.010 mg/kg intravenous (IV) infusion.
Cisplatin
Cisplatin will be dosed per the pharmacy manual
Carboplatin
Carboplatin will be dosed per the pharmacy manual
NKTR-214
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
Pembrolizumab (anti-PD-1) will be dosed as per the pharmacy manual.
NKTR-214
NKTR-214: The dose will be 0.006 mg/kg intravenous (IV) infusion.
Nab paclitaxel
Nab-paclitaxel will be dosed per local practice and label
Paclitaxel
Paclitaxel will be dosed per local practice and label
Pemetrexed
Pemetrexed will be dosed per the pharmacy manual
Atezolizumab
Atezolizumab will be dosed per current label indication
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* Male or female patients, age 18 years or older at the time of signing the informed consent form (ICF).
* Life expectancy \> 12 weeks from the time of enrollment as determined by the Investigator.
* Eastern Cooperative Oncology Group (ECOG) performance status 0 or 1.
* Oxygen saturation ≥ 92% on room air for all indications.
* Measurable disease per RECIST 1.1.
* Patients with brain metastases are eligible if certain criteria are met.
* Availability of fresh or archival tumor tissue
* Patients must have a minimum of 6 months of response to any nonpalliative cancer-directed treatment
* Histologically confirmed diagnosis of stage IV NSCLC.
* Patients must have a minimum of 6 months of response to any nonpalliative cancer-directed treatment.
* Patients with actionable mutations with approved targeted therapy in NSCLC are excluded. Testing for mutations should be performed per standard of care.
* Must not have received anti-cancer therapy for treatment of metastatic lung cancer
* Must not have received prior immunotherapy
Exclusion Criteria
* Females who are pregnant or breastfeeding.
* Patients who have an active autoimmune disease
* History of allergy or hypersensitivity to study drug components
* Evidence of clinically significant interstitial lung disease or active, noninfectious pneumonitis.
* Prior surgery or radiotherapy within 14 days of therapy.
* For Dose Optimization Cohort 1 only: Chemotherapy or biological therapy within 28 days of enrollment. Targeted therapy (e.g., tyrosine kinase inhibitors) within 14 days of enrollment. Patients with ongoing AEs related to prior cancer therapies will be excluded.
* Participant's inability to adhere to or tolerate protocol or study procedures
18 Years
ALL
No
Sponsors
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Nektar Therapeutics
INDUSTRY
Responsible Party
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Principal Investigators
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Study Director
Role: STUDY_DIRECTOR
Nektar Therapeutics
Locations
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Highlands Oncology Group, PA - North Hills
Fayetteville, Arkansas, United States
California Pacific Medical Center
San Francisco, California, United States
University of Colorado Anschutz Medical Campus
Aurora, Colorado, United States
Augusta University - Augusta University Medical Center
Augusta, Georgia, United States
Ochsner Medical Center
New Orleans, Louisiana, United States
Henry Ford Hospital
Detroit, Michigan, United States
Park Nicollet - Frauenshuh Cancer Center
Saint Louis Park, Minnesota, United States
Washington University School of Medicine in St. Louis
St Louis, Missouri, United States
St. Vincent Frontier Cancer Center
Billings, Montana, United States
University of Nebraska Medical Center
Omaha, Nebraska, United States
Comprehensive Cancer Centers of Nevada (CCCN) - Central Valley
Las Vegas, Nevada, United States
Rutgers Cancer Institute of New Jersey
New Brunswick, New Jersey, United States
New York University Langone Medical Center
New York, New York, United States
Columbia University Medical Center
New York, New York, United States
Duke Clinical Research Institute
Durham, North Carolina, United States
Fox Chase Cancer Center
Philadelphia, Pennsylvania, United States
West Cancer Center
Germantown, Tennessee, United States
Sarah Cannon Research Institute (SCRI) (The SCRI Oncology Research Consortium)
Nashville, Tennessee, United States
The University of Texas MD Anderson Cancer Center
Houston, Texas, United States
Inova Melanoma and Skin Cancer Center
Fairfax, Virginia, United States
Blue Ridge Cancer Care
Roanoke, Virginia, United States
Northwest Medical Specialties
Tacoma, Washington, United States
Froedtert & the Medical College of Wisconsin Froedtert Hospital
Milwaukee, Wisconsin, United States
Epworth HealthCare
Richmond, Victoria, Australia
Centre Hospitalier de Saint-Quentin
Saint-Quentin, , France
Vivantes Klinikum Spandau
Berlin, , Germany
Asklepios Fachkliniken München-Gauting
Gauting, , Germany
LungenClinic Grosshansdorf
Großhansdorf, , Germany
Lungenklinik Hemer
Hemer, , Germany
Universitätsklinikum Schleswig-Holstein
Lübeck, , Germany
Robert-Bosch-Krankenhaus
Stuttgart, , Germany
Hospital de la Santa Creu i Sant Pau
Barcelona, , Spain
Hospital Universitario Vall d'Hebron
Barcelona, , Spain
Hospital Universitario Insular de Gran Canaria
Las Palmas de Gran Canaria, , Spain
Hospital Clínico San Carlos
Madrid, , Spain
Hospital Universitario Fundacion Jimenez Diaz
Madrid, , Spain
HM Universitario Sanchinarro
Madrid, , Spain
Hospital Universitari i Politècnic La Fe
Valencia, , Spain
Countries
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Provided Documents
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Document Type: Study Protocol
Document Type: Statistical Analysis Plan
Other Identifiers
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16-214-05
Identifier Type: -
Identifier Source: org_study_id
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