Spots Global Cancer Trial Database for Bempegaldesleukin and Pembrolizumab With or Without Chemotherapy in Locally Advanced or Metastatic Solid Tumors
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Trial Identification
Brief Title: Bempegaldesleukin and Pembrolizumab With or Without Chemotherapy in Locally Advanced or Metastatic Solid Tumors
Official Title: A Phase 1/2, Open-Label, Multicenter Study to Investigate the Safety and Preliminary Efficacy of Combined Bempegaldesleukin (NKTR-214) and Pembrolizumab With or Without Chemotherapy in Patients With Locally Advanced or Metastatic Solid Tumors
Study ID: NCT03138889
Conditions
Study Description
Brief 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.
Detailed 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.
Eligibility
Minimum Age: 18 Years
Eligible Ages: ADULT, OLDER_ADULT
Sex: ALL
Healthy Volunteers: No
Locations
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, Saint 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
Contact Details
Name: Study Director
Affiliation: Nektar Therapeutics
Role: STUDY_DIRECTOR
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