QUILT-3.055: A Study of Combination Immunotherapies in Patients Who Have Previously Received Treatment With Immune Checkpoint Inhibitors

PHASE2Active, not recruitingINTERVENTIONAL
Enrollment

40

Participants

Timeline

Start Date

December 11, 2018

Primary Completion Date

August 31, 2029

Study Completion Date

December 31, 2030

Conditions
Non-Small Cell Lung CancerSmall Cell Lung CancerUrothelial CarcinomaHead and Neck Squamous Cell CarcinomaMerkel Cell CarcinomaMelanomaRenal Cell CarcinomaGastric CancerCervical CancerHepatocellular CarcinomaMicrosatellite InstabilityMismatch Repair DeficiencyColorectal Cancer
Interventions
DRUG

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.

DRUG

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.

DRUG

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.

DRUG

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.

DRUG

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.

DRUG

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

DRUG

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

DRUG

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

DRUG

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

DRUG

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

DRUG

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).

DRUG

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.

Trial Locations (35)

14263

Roswell Park Cancer Institute, Buffalo

14642

University of Rochester, Rochester

17325

Gettysburg/Hanover Cancer Centers, Gettysburg

23114

Bon Secours Richmond, Richmond

29303

Spartanburg Medical Center, Spartanburg

29425

Medical University of South Carolina, Charleston

29607

St. Francis Cancer Center/Bon Secours St. Francis Health System, Greenville

33021

Memorial Healthcare System, Hollywood

33176

Miami Cancer Institute (Baptist Health South Florida), Miami

33180

University of Miami, Miami

37846

MemorialCare Health System, Fountain Valley

37920

University of Tennessee Medical Center, Knoxville

40207

Baptist Health- Louisville, Louisville

40503

Baptist Health - Lexington, Lexington

44195

Cleveland Clinic - Main Site, Cleveland

47905

Horizon Oncology Associates, Lafayette

48202

Henry Ford Hospital, Detroit

52242

University of Iowa Holden Comprehensive Cancer Center, Iowa City

55455

University of Minnesota - Masonic Cancer Center, Minneapolis

57104

Sanford Clinical Research, Sioux Falls

59102

St. Vincent Frontier Cancer Center (SCL), Billings

63110

Washington University School of Medicine, St Louis

64804

Mercy Research Joplin, Joplin

65804

Mercy Clinic Cancer & Hematology - Chub O'Reilly Cancer Center, Springfield

71913

Genesis Cancer Center, Hot Springs

73120

Mercy Clinic Oklahoma City, Oklahoma City

77024

Oncology Consultants of Houston, Houston

90033

University of Southern California Norris Comprehensive Cancer Center, Los Angeles

90245

Chan Soon-Shiong Institute for Medicine, El Segundo

91206

Glendale Adventist Medical Center, Glendale

92270

Desert Hematology Oncology Medical Group, Inc., Rancho Mirage

97213

Providence Portland Medical Center, Portland

99530

Alaska Clinical Research Center, Anchorage

02215

Dana Farber Cancer Institute, Boston

03756

Dartmouth-Hitchcock Medical Center, Lebanon

Sponsors

Lead Sponsor

All Listed Sponsors
lead

ImmunityBio, Inc.

INDUSTRY

NCT03228667 - QUILT-3.055: A Study of Combination Immunotherapies in Patients Who Have Previously Received Treatment With Immune Checkpoint Inhibitors | Biotech Hunter | Biotech Hunter