40
Participants
Start Date
December 11, 2018
Primary Completion Date
August 31, 2029
Study Completion Date
December 31, 2030
N-803 + Pembrolizumab
Patients will receive 200 mg pembrolizumab as an intravenous infusion over 30 minutes every three weeks. Patients will receive 15 µg/kg N-803 administered by subcutaneous injection every three weeks.
N-803 + Nivolumab
Patients will receive 240 mg nivolumab as an intravenous infusion over 30 minutes every two weeks. Patients will receive 15 µg/kg N-803 administered by subcutaneous injection every three weeks.
N-803 + Atezolizumab
Patients will receive 1200 mg atezolizumab as an intravenous infusion over 60 minutes every 3 weeks; if the first infusion is tolerated, subsequent infusions may be given over 30 minutes. Patients will receive 15 µg/kg N-803 administered by subcutaneous injection every three weeks.
N-803 + Avelumab
Patients will receive 800 mg avelumab as an intravenous infusion over 60 minutes every 2 weeks. Patients will receive 15 µg/kg N-803 administered by subcutaneous injection every three weeks.
N-803 + Durvalumab
Patients will receive 10 mg/kg durvalumab as an intravenous infusion over 60 minutes every 2 weeks. Patients will receive 15 µg/kg N-803 administered by subcutaneous injection every three weeks.
N-803 + Pembrolizumab + PD-L1 t-haNK
Patients will receive 200 mg pembrolizumab as an intravenous infusion over 30 minutes every three weeks. Patients will receive 15 µg/kg N-803 administered by subcutaneous injection every three weeks. Patients will receive PD-L1 t-haNK administered IV over 30 minutes at \~2 x 10\^9 cells/dose weekly
N-803 + Nivolumab + PD-L1 t-haNK
Patients will receive 240 mg nivolumab as an intravenous infusion over 30 minutes every two weeks. Patients will receive 15 µg/kg N-803 administered by subcutaneous injection every three weeks. Patients will receive PD-L1 t-haNK administered IV over 30 minutes at \~2 x 10\^9 cells/dose weekly
N-803 + Atezolizumab + PD-L1 t-haNK
Patients will receive 1200 mg atezolizumab as an intravenous infusion over 60 minutes every 3 weeks; if the first infusion is tolerated, subsequent infusions may be given over 30 minutes. Patients will receive 15 µg/kg N-803 administered by subcutaneous injection every three weeks. Patients will receive PD-L1 t-haNK administered IV over 30 minutes at \~2 x 10\^9 cells/dose weekly
N-803 + Avelumab + PD-L1 t-haNK
Patients will receive 800 mg avelumab as an intravenous infusion over 60 minutes every 2 weeks. Patients will receive 15 µg/kg N-803 administered by subcutaneous injection every three weeks. Patients will receive PD-L1 t-haNK administered IV over 30 minutes at \~2 x 10\^9 cells/dose weekly
N-803 + Durvalumab + PD-L1 t-haNK
Patients will receive 10 mg/kg durvalumab as an intravenous infusion over 60 minutes every 2 weeks. Patients will receive 15 µg/kg N-803 administered by subcutaneous injection every three weeks. Patients will receive PD-L1 t-haNK administered IV over 30 minutes at \~2 x 10\^9 cells/dose weekly
N-803 + Docetaxel + Pembrolizumab
The study employs a 6-week cycle combination of: N-803 (1.2 mg flat dose SC), docetaxel (75 mg/m² IV - first 2 cycles only), and pembrolizumab (200 mg IV).
N-803 + Docetaxel + Nivolumab
The study employs a 6-week cycle combination of:N-803 (1.2 mg flat dose SC), docetaxel (75 mg/m² IV - first 2 cycles only), and nivolumab (240 mg IV). Nivolumab dosing may be increased to 480mg every four weeks as per the investigator's discretion.
Roswell Park Cancer Institute, Buffalo
University of Rochester, Rochester
Gettysburg/Hanover Cancer Centers, Gettysburg
Bon Secours Richmond, Richmond
Spartanburg Medical Center, Spartanburg
Medical University of South Carolina, Charleston
St. Francis Cancer Center/Bon Secours St. Francis Health System, Greenville
Memorial Healthcare System, Hollywood
Miami Cancer Institute (Baptist Health South Florida), Miami
University of Miami, Miami
MemorialCare Health System, Fountain Valley
University of Tennessee Medical Center, Knoxville
Baptist Health- Louisville, Louisville
Baptist Health - Lexington, Lexington
Cleveland Clinic - Main Site, Cleveland
Horizon Oncology Associates, Lafayette
Henry Ford Hospital, Detroit
University of Iowa Holden Comprehensive Cancer Center, Iowa City
University of Minnesota - Masonic Cancer Center, Minneapolis
Sanford Clinical Research, Sioux Falls
St. Vincent Frontier Cancer Center (SCL), Billings
Washington University School of Medicine, St Louis
Mercy Research Joplin, Joplin
Mercy Clinic Cancer & Hematology - Chub O'Reilly Cancer Center, Springfield
Genesis Cancer Center, Hot Springs
Mercy Clinic Oklahoma City, Oklahoma City
Oncology Consultants of Houston, Houston
University of Southern California Norris Comprehensive Cancer Center, Los Angeles
Chan Soon-Shiong Institute for Medicine, El Segundo
Glendale Adventist Medical Center, Glendale
Desert Hematology Oncology Medical Group, Inc., Rancho Mirage
Providence Portland Medical Center, Portland
Alaska Clinical Research Center, Anchorage
Dana Farber Cancer Institute, Boston
Dartmouth-Hitchcock Medical Center, Lebanon
Lead Sponsor
ImmunityBio, Inc.
INDUSTRY