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

Stopped early · Phase 1/Phase 2

Conditions studied: Non-Small Cell Lung Cancer

In brief

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 facts

Study ID

NCT03138889

Run by

Nektar Therapeutics

People needed

162

Starts

2017-06-09

Expected to finish

2022-08-24

Last updated by the study team

2023-03-10

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Dose Optimization and Dose Expansion Inclusion Criteria:
• Willing and able to provide written informed consent.
• 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
• Dose Expansion Inclusion Criteria (Non-Small Cell Lung Cancer):
• 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

You may not qualify if…

• Use of an investigational agent or an investigational device within 28 days before administration of first dose of study drug(s).
• 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
• NOTE: Other protocol defined Inclusion/Exclusion criteria may apply

Where it is running

• 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

Full record on ClinicalTrials.gov

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