This Phase 2b, multicohort, open-label clinical trial (QUILT-3.055) evaluates combination immunotherapies in patients with various advanced solid tumors who have progressed following prior PD-1/PD-L1 checkpoint inhibitor therapy. The trial includes six cohorts: Cohorts 1-4: Patients who progressed after an initial response (PR or CR) to prior PD-1/PD-L1 therapy, receiving combination therapy with N-803 and a PD-1/PD-L1 checkpoint inhibitor. (Closed to enrollment) Cohort 5: Patients who progressed while receiving treatment in cohorts 1-4; they receive combination therapy with N-803, a PD-1/PD-L1 checkpoint inhibitor, and PD-L1 t-haNK cells.(Closed to enrollment) Cohort 6A \& 6B: Patients with acquired resistance to prior PD-1/PD-L1 therapy; they receive combination therapy with N-803, docetaxel, and either pembrolizumab (6A) or nivolumab (6B). Treatment is administered for up to two years or until disease progression, and participants are closely monitored for adverse events (AEs), including immune-related AEs, with specific dose modifications outlined. The primary endpoint is objective response rate (ORR) assessed by RECIST v1.1. The study uses Simon's two-stage design for cohorts 1-3 to determine the optimal dose and further assesses safety and efficacy endpoints for all cohorts.
Non-Small Cell Lung Cancer, Small Cell Lung Cancer, Urothelial Carcinoma, Head and Neck Squamous Cell Carcinoma, Merkel Cell Carcinoma, Melanoma, Renal Cell Carcinoma, Gastric Cancer, Cervical Cancer, Hepatocellular Carcinoma, Microsatellite Instability, Mismatch Repair Deficiency, Colorectal Cancer
This Phase 2b, multicohort, open-label clinical trial (QUILT-3.055) evaluates combination immunotherapies in patients with various advanced solid tumors who have progressed following prior PD-1/PD-L1 checkpoint inhibitor therapy. The trial includes six cohorts: Cohorts 1-4: Patients who progressed after an initial response (PR or CR) to prior PD-1/PD-L1 therapy, receiving combination therapy with N-803 and a PD-1/PD-L1 checkpoint inhibitor. (Closed to enrollment) Cohort 5: Patients who progressed while receiving treatment in cohorts 1-4; they receive combination therapy with N-803, a PD-1/PD-L1 checkpoint inhibitor, and PD-L1 t-haNK cells.(Closed to enrollment) Cohort 6A \& 6B: Patients with acquired resistance to prior PD-1/PD-L1 therapy; they receive combination therapy with N-803, docetaxel, and either pembrolizumab (6A) or nivolumab (6B). Treatment is administered for up to two years or until disease progression, and participants are closely monitored for adverse events (AEs), including immune-related AEs, with specific dose modifications outlined. The primary endpoint is objective response rate (ORR) assessed by RECIST v1.1. The study uses Simon's two-stage design for cohorts 1-3 to determine the optimal dose and further assesses safety and efficacy endpoints for all cohorts.
QUILT-3.055: a Study of Combination Immunotherapies in Patients Who Have Previously Received Treatment with Immune Checkpoint Inhibitors
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Alaska Clinical Research Center, Anchorage, Alaska, United States, 99530
Genesis Cancer Center, Hot Springs, Arkansas, United States, 71913
Chan Soon-Shiong Institute for Medicine, El Segundo, California, United States, 90245
MemorialCare Health System, Fountain Valley, California, United States, 37846
Glendale Adventist Medical Center, Glendale, California, United States, 91206
University of Southern California Norris Comprehensive Cancer Center, Los Angeles, California, United States, 90033
Desert Hematology Oncology Medical Group, Inc., Rancho Mirage, California, United States, 92270
Memorial Healthcare System, Hollywood, Florida, United States, 33021
Miami Cancer Institute (Baptist Health South Florida), Miami, Florida, United States, 33176
University of Miami, Miami, Florida, United States, 33180
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
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18 Years to
ALL
No
ImmunityBio, Inc.,
2030-12-31