QUILT-3.055: A Study of Combination Immunotherapies in Patients Who Have Previously Received Treatment With Immune Checkpoint Inhibitors
Phase 2
Active, not recruiting
- Conditions
- Merkel Cell CarcinomaCervical CancerMismatch Repair DeficiencyMelanomaColorectal CancerUrothelial CarcinomaGastric CancerMicrosatellite InstabilityNon-Small Cell Lung CancerSmall Cell Lung Cancer
- Interventions
- Drug: N-803 + NivolumabDrug: N-803 + Nivolumab + PD-L1 t-haNKDrug: N-803 + Docetaxel + Nivolumab
- Registration Number
- NCT03228667
- Lead Sponsor
- ImmunityBio, Inc.
- Brief Summary
QUILT-3.055 is a Phase 2b, open-label, multicohort study investigating combination immunotherapies in patients with advanced solid tumors who have previously been treated with PD-1/PD-L1 checkpoint inhibitors. The study aims to evaluate the safety and efficacy of NAI (nogapendekin alfa inbakicept) in combination with other agents like checkpoint inhibitors and cell therapies across various cancer types and treatment settings. The study includes multiple cohorts based on prior therapies and cancer types, with a focus on assessing overall response rate (ORR), overall survival (OS), and other measures of anti-tumor activity and immune response.
- Detailed Description
All cohorts are closed to enrollment
Recruitment & Eligibility
- Status
- ACTIVE_NOT_RECRUITING
- Sex
- All
- Target Recruitment
- 40
Inclusion Criteria
Not provided
Exclusion Criteria
Not provided
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Cohort 1 N-803 + Atezolizumab Patients with any of the cancers listed below who have progressed on or after single-agent checkpoint inhibitor therapy after experiencing an initial complete response (CR) or partial response (PR) while taking a checkpoint inhibitor. 1a - Non-small cell lung cancer 1b - Small cell lung cancer 1c - Urothelial carcinoma 1d - Head and neck squamous cell carcinoma 1e - Merkel cell carcinoma 1f - Melanoma 1g - Renal cell carcinoma 1h - Gastric cancer 1i - Cervical cancer 1j - Hepatocellular carcinoma 1k - Microsatellite instability-high or mismatch repair deficient solid tumor cancer or colorectal cancer Cohort 1 N-803 + Avelumab Patients with any of the cancers listed below who have progressed on or after single-agent checkpoint inhibitor therapy after experiencing an initial complete response (CR) or partial response (PR) while taking a checkpoint inhibitor. 1a - Non-small cell lung cancer 1b - Small cell lung cancer 1c - Urothelial carcinoma 1d - Head and neck squamous cell carcinoma 1e - Merkel cell carcinoma 1f - Melanoma 1g - Renal cell carcinoma 1h - Gastric cancer 1i - Cervical cancer 1j - Hepatocellular carcinoma 1k - Microsatellite instability-high or mismatch repair deficient solid tumor cancer or colorectal cancer Cohort 1 N-803 + Durvalumab Patients with any of the cancers listed below who have progressed on or after single-agent checkpoint inhibitor therapy after experiencing an initial complete response (CR) or partial response (PR) while taking a checkpoint inhibitor. 1a - Non-small cell lung cancer 1b - Small cell lung cancer 1c - Urothelial carcinoma 1d - Head and neck squamous cell carcinoma 1e - Merkel cell carcinoma 1f - Melanoma 1g - Renal cell carcinoma 1h - Gastric cancer 1i - Cervical cancer 1j - Hepatocellular carcinoma 1k - Microsatellite instability-high or mismatch repair deficient solid tumor cancer or colorectal cancer Cohort 4 N-803 + Atezolizumab Patients who are currently receiving PD-1/PD-L1 checkpoint inhibitor therapy and have disease progression after experiencing stable disease (SD) for at least 6 months during their previous treatment with PD-1/PD-L1 checkpoint inhibitor therapy. Cohort 4 N-803 + Avelumab Patients who are currently receiving PD-1/PD-L1 checkpoint inhibitor therapy and have disease progression after experiencing stable disease (SD) for at least 6 months during their previous treatment with PD-1/PD-L1 checkpoint inhibitor therapy. Cohort 4 N-803 + Durvalumab Patients who are currently receiving PD-1/PD-L1 checkpoint inhibitor therapy and have disease progression after experiencing stable disease (SD) for at least 6 months during their previous treatment with PD-1/PD-L1 checkpoint inhibitor therapy. Cohort 5 N-803 + Atezolizumab + PD-L1 t-haNK Patients that have experienced disease progression by Investigator-assessment per irRECIST while receiving treatment in Cohorts 1-4. Cohort 5 N-803 + Avelumab + PD-L1 t-haNK Patients that have experienced disease progression by Investigator-assessment per irRECIST while receiving treatment in Cohorts 1-4. Cohort 5 N-803 + Durvalumab + PD-L1 t-haNK Patients that have experienced disease progression by Investigator-assessment per irRECIST while receiving treatment in Cohorts 1-4. Cohort 1 N-803 + Pembrolizumab Patients with any of the cancers listed below who have progressed on or after single-agent checkpoint inhibitor therapy after experiencing an initial complete response (CR) or partial response (PR) while taking a checkpoint inhibitor. 1a - Non-small cell lung cancer 1b - Small cell lung cancer 1c - Urothelial carcinoma 1d - Head and neck squamous cell carcinoma 1e - Merkel cell carcinoma 1f - Melanoma 1g - Renal cell carcinoma 1h - Gastric cancer 1i - Cervical cancer 1j - Hepatocellular carcinoma 1k - Microsatellite instability-high or mismatch repair deficient solid tumor cancer or colorectal cancer Cohort 1 N-803 + Nivolumab Patients with any of the cancers listed below who have progressed on or after single-agent checkpoint inhibitor therapy after experiencing an initial complete response (CR) or partial response (PR) while taking a checkpoint inhibitor. 1a - Non-small cell lung cancer 1b - Small cell lung cancer 1c - Urothelial carcinoma 1d - Head and neck squamous cell carcinoma 1e - Merkel cell carcinoma 1f - Melanoma 1g - Renal cell carcinoma 1h - Gastric cancer 1i - Cervical cancer 1j - Hepatocellular carcinoma 1k - Microsatellite instability-high or mismatch repair deficient solid tumor cancer or colorectal cancer Cohort 2 N-803 + Pembrolizumab Patients with NSCLC whose tumors have high PD-L1 expression (TPS ≥ 50%) and who relapsed on a PD-1 checkpoint inhibitor after experiencing an initial CR or PR when they received checkpoint inhibitor as a single-agent for first-line treatment. Cohort 2 N-803 + Nivolumab Patients with NSCLC whose tumors have high PD-L1 expression (TPS ≥ 50%) and who relapsed on a PD-1 checkpoint inhibitor after experiencing an initial CR or PR when they received checkpoint inhibitor as a single-agent for first-line treatment. Cohort 3 N-803 + Pembrolizumab Patients with NSCLC who had an initial CR or PR but subsequently relapsed on maintenance PD-1 checkpoint inhibitor therapy when they initially received checkpoint inhibitor therapy in combination with chemotherapy as first-line treatment. Cohort 3 N-803 + Nivolumab Patients with NSCLC who had an initial CR or PR but subsequently relapsed on maintenance PD-1 checkpoint inhibitor therapy when they initially received checkpoint inhibitor therapy in combination with chemotherapy as first-line treatment. Cohort 4 N-803 + Pembrolizumab Patients who are currently receiving PD-1/PD-L1 checkpoint inhibitor therapy and have disease progression after experiencing stable disease (SD) for at least 6 months during their previous treatment with PD-1/PD-L1 checkpoint inhibitor therapy. Cohort 4 N-803 + Nivolumab Patients who are currently receiving PD-1/PD-L1 checkpoint inhibitor therapy and have disease progression after experiencing stable disease (SD) for at least 6 months during their previous treatment with PD-1/PD-L1 checkpoint inhibitor therapy. Cohort 5 N-803 + Pembrolizumab + PD-L1 t-haNK Patients that have experienced disease progression by Investigator-assessment per irRECIST while receiving treatment in Cohorts 1-4. Cohort 5 N-803 + Nivolumab + PD-L1 t-haNK Patients that have experienced disease progression by Investigator-assessment per irRECIST while receiving treatment in Cohorts 1-4. Cohort 6 N-803 + Docetaxel + Pembrolizumab Patients who have progressed after an initial response (CR or PR) to a PD-1/PD-L1 checkpoint inhibitor but now exhibit acquired resistance. They have received exactly one line of anti-PD-1 or anti-PD-L1 therapy (either pembrolizumab or nivolumab) for advanced NSCLC (Stage IV or recurrent). Cohort 6 N-803 + Docetaxel + Nivolumab Patients who have progressed after an initial response (CR or PR) to a PD-1/PD-L1 checkpoint inhibitor but now exhibit acquired resistance. They have received exactly one line of anti-PD-1 or anti-PD-L1 therapy (either pembrolizumab or nivolumab) for advanced NSCLC (Stage IV or recurrent).
- Primary Outcome Measures
Name Time Method Objective Response Rate Through study completion, an average of 1 year Assess ORR, defined as Investigator-assessed CR + PR, per RECIST 1.1.
Prolongation of Overall Survival (OS) with NAI Therapy by ALC Response Throughout the study completion. Time from first study drug administration to death resulting from any cause in patients achieving a pre-specified Absolute Lymphocyte Count (ALC) response.
- Secondary Outcome Measures
Name Time Method Disease-specific Survival Through study completion, an average of 1 year Assess time from first treatment to death resulting from cancer.
PFS (Progression-Free Survival) Through study completion, an average of 1 year Time from first study drug administration to disease progression or death from any cause, whichever occurs first.
Time to Response Through study completion, an average of 1 year Assess time to response
Duration of Response Through study completion, an average of 1 year Assess duration of response
Disease Control Rate (DCR): Throughout the study completion, an average of 1 year measures the percentage of patients with stable disease (SD), partial response (PR), or complete response (CR). It indicates the proportion of patients who experience benefit from the treatment in terms of disease stabilization or tumor shrinkage.
Quality of life (QoL) - Assessed in cohorts 1-5 only. To be assessed every 12 weeks, starting with Cycle 3. Compare changes in QOL scores from baseline.
Trial Locations
- Locations (35)
Alaska Clinical Research Center
🇺🇸Anchorage, Alaska, United States
Genesis Cancer Center
🇺🇸Hot Springs, Arkansas, United States
Chan Soon-Shiong Institute for Medicine
🇺🇸El Segundo, California, United States
MemorialCare Health System
🇺🇸Fountain Valley, California, United States
Glendale Adventist Medical Center
🇺🇸Glendale, California, United States
University of Southern California Norris Comprehensive Cancer Center
🇺🇸Los Angeles, California, United States
Desert Hematology Oncology Medical Group, Inc.
🇺🇸Rancho Mirage, California, United States
Memorial Healthcare System
🇺🇸Hollywood, Florida, United States
Miami Cancer Institute (Baptist Health South Florida)
🇺🇸Miami, Florida, United States
University of Miami
🇺🇸Miami, Florida, United States
Scroll for more (25 remaining)Alaska Clinical Research Center🇺🇸Anchorage, Alaska, United States