Lung Cancer Clinical Trial

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

Summary

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.

View Full Description

Full Description

NKTR-214 is a cytokine (investigational agent) that is designed to target CD122, a protein which is found on certain immune cells (known as CD8+ T Cells and Natural Killer Cells) to expand these cells to promote their anti-tumor effects. Pembrolizumab is a programmed death receptor -1 (PD-1) blocking, fully humanized, engineered monoclonal antibody of IgG1 isotype that promotes anti-tumor effects.

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.

View Eligibility Criteria

Eligibility Criteria

Inclusion Criteria:

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

Exclusion Criteria:

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

Study is for people with:

Lung Cancer

Phase:

Phase 1

Estimated Enrollment:

162

Study ID:

NCT03138889

Recruitment Status:

Terminated

Sponsor:

Nektar Therapeutics

Check Your Eligibility

Let’s see if you might be eligible for this study.

What is your age and gender ?

Submit

There are 37 Locations for this study

See Locations Near You

Highlands Oncology Group, PA - North Hills
Fayetteville Arkansas, 72703, United States
California Pacific Medical Center
San Francisco California, 94115, United States
University of Colorado Anschutz Medical Campus
Aurora Colorado, 80045, United States
Augusta University - Augusta University Medical Center
Augusta Georgia, 30912, United States
Ochsner Medical Center
New Orleans Louisiana, 70816, United States
Henry Ford Hospital
Detroit Michigan, 48202, United States
Park Nicollet - Frauenshuh Cancer Center
Saint Louis Park Minnesota, 55426, United States
Washington University School of Medicine in St. Louis
Saint Louis Missouri, 63156, United States
St. Vincent Frontier Cancer Center
Billings Montana, 59101, United States
University of Nebraska Medical Center
Omaha Nebraska, 68198, United States
Comprehensive Cancer Centers of Nevada (CCCN) - Central Valley
Las Vegas Nevada, 89169, United States
Rutgers Cancer Institute of New Jersey
New Brunswick New Jersey, 08901, United States
New York University Langone Medical Center
New York New York, 10016, United States
Columbia University Medical Center
New York New York, 10032, United States
Duke Clinical Research Institute
Durham North Carolina, 27705, United States
Fox Chase Cancer Center
Philadelphia Pennsylvania, 19111, United States
West Cancer Center
Germantown Tennessee, 38138, United States
Sarah Cannon Research Institute (SCRI) (The SCRI Oncology Research Consortium)
Nashville Tennessee, 37203, United States
The University of Texas MD Anderson Cancer Center
Houston Texas, 77030, United States
Inova Melanoma and Skin Cancer Center
Fairfax Virginia, 22031, United States
Blue Ridge Cancer Care
Roanoke Virginia, 24153, United States
Northwest Medical Specialties
Tacoma Washington, 98405, United States
Froedtert & the Medical College of Wisconsin Froedtert Hospital
Milwaukee Wisconsin, 53226, United States
Epworth HealthCare
Richmond Victoria, 3121, Australia
Centre Hospitalier de Saint-Quentin
Saint Quentin , 2100, France
Vivantes Klinikum Spandau
Berlin , 13585, Germany
Asklepios Fachkliniken München-Gauting
Gauting , 82131, Germany
LungenClinic Grosshansdorf
Grosshansdorf , 22927, Germany
Lungenklinik Hemer
Hemer , 58675, Germany
Universitätsklinikum Schleswig-Holstein
Lübeck , 23538, Germany
Robert-Bosch-Krankenhaus
Stuttgart , 70376, Germany
Hospital de la Santa Creu i Sant Pau
Barcelona , 08025, Spain
Hospital Universitario Vall d'Hebron
Barcelona , 08035, Spain
Hospital Universitario Insular de Gran Canaria
Las Palmas De Gran Canaria , 35016, Spain
Hospital Clínico San Carlos
Madrid , 28040, Spain
Hospital Universitario Fundacion Jimenez Diaz
Madrid , 28040, Spain
HM Universitario Sanchinarro
Madrid , 28050, Spain
Hospital Universitari i Politècnic La Fe
Valencia , 46026, Spain

How clear is this clinincal trial information?

Study is for people with:

Lung Cancer

Phase:

Phase 1

Estimated Enrollment:

162

Study ID:

NCT03138889

Recruitment Status:

Terminated

Sponsor:


Nektar Therapeutics

How clear is this clinincal trial information?

×

Introducing, the Journey Bar

Use this bar to access information about the steps in your cancer journey.