Ignite Creation Date:
2025-12-25 @ 12:45 AM
Ignite Modification Date:
2026-01-07 @ 4:51 AM
Study NCT ID:
NCT03228667
Status:
ACTIVE_NOT_RECRUITING
Last Update Posted:
2025-10-17
First Post:
2017-07-21
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
QUILT-3.055: A Study of Combination Immunotherapies in Patients Who Have Previously Received Treatment With Immune Checkpoint Inhibitors
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D002289', 'term': 'Carcinoma, Non-Small-Cell Lung'}, {'id': 'D055752', 'term': 'Small Cell Lung Carcinoma'}, {'id': 'D002295', 'term': 'Carcinoma, Transitional Cell'}, {'id': 'D000077195', 'term': 'Squamous Cell Carcinoma of Head and Neck'}, {'id': 'D015266', 'term': 'Carcinoma, Merkel Cell'}, {'id': 'D008545', 'term': 'Melanoma'}, {'id': 'D002292', 'term': 'Carcinoma, Renal Cell'}, {'id': 'D013274', 'term': 'Stomach Neoplasms'}, {'id': 'D002583', 'term': 'Uterine Cervical Neoplasms'}, {'id': 'D006528', 'term': 'Carcinoma, Hepatocellular'}, {'id': 'D053842', 'term': 'Microsatellite Instability'}, {'id': 'C536928', 'term': 'Turcot syndrome'}, {'id': 'D015179', 'term': 'Colorectal Neoplasms'}], 'ancestors': [{'id': 'D002283', 'term': 'Carcinoma, Bronchogenic'}, {'id': 'D001984', 'term': 'Bronchial Neoplasms'}, {'id': 'D008175', 'term': 'Lung Neoplasms'}, {'id': 'D012142', 'term': 'Respiratory Tract Neoplasms'}, {'id': 'D013899', 'term': 'Thoracic Neoplasms'}, {'id': 'D009371', 'term': 'Neoplasms by Site'}, {'id': 'D009369', 'term': 'Neoplasms'}, {'id': 'D008171', 'term': 'Lung Diseases'}, {'id': 'D012140', 'term': 'Respiratory Tract Diseases'}, {'id': 'D002277', 'term': 'Carcinoma'}, {'id': 'D009375', 'term': 'Neoplasms, Glandular and Epithelial'}, {'id': 'D009370', 'term': 'Neoplasms by Histologic Type'}, {'id': 'D002294', 'term': 'Carcinoma, Squamous Cell'}, {'id': 'D006258', 'term': 'Head and Neck Neoplasms'}, {'id': 'D027601', 'term': 'Polyomavirus Infections'}, {'id': 'D004266', 'term': 'DNA Virus Infections'}, {'id': 'D014777', 'term': 'Virus Diseases'}, {'id': 'D007239', 'term': 'Infections'}, {'id': 'D014412', 'term': 'Tumor Virus Infections'}, {'id': 'D018278', 'term': 'Carcinoma, Neuroendocrine'}, {'id': 'D018358', 'term': 'Neuroendocrine Tumors'}, {'id': 'D017599', 'term': 'Neuroectodermal Tumors'}, {'id': 'D009373', 'term': 'Neoplasms, Germ Cell and Embryonal'}, {'id': 'D000230', 'term': 'Adenocarcinoma'}, {'id': 'D009380', 'term': 'Neoplasms, Nerve Tissue'}, {'id': 'D018326', 'term': 'Nevi and Melanomas'}, {'id': 'D012878', 'term': 'Skin Neoplasms'}, {'id': 'D012871', 'term': 'Skin Diseases'}, {'id': 'D017437', 'term': 'Skin and Connective Tissue Diseases'}, {'id': 'D007680', 'term': 'Kidney Neoplasms'}, {'id': 'D014571', 'term': 'Urologic Neoplasms'}, {'id': 'D014565', 'term': 'Urogenital Neoplasms'}, {'id': 'D052776', 'term': 'Female Urogenital Diseases'}, {'id': 'D005261', 'term': 'Female Urogenital Diseases and Pregnancy Complications'}, {'id': 'D000091642', 'term': 'Urogenital Diseases'}, {'id': 'D007674', 'term': 'Kidney Diseases'}, {'id': 'D014570', 'term': 'Urologic Diseases'}, {'id': 'D052801', 'term': 'Male Urogenital Diseases'}, {'id': 'D005770', 'term': 'Gastrointestinal Neoplasms'}, {'id': 'D004067', 'term': 'Digestive System Neoplasms'}, {'id': 'D004066', 'term': 'Digestive System Diseases'}, {'id': 'D005767', 'term': 'Gastrointestinal Diseases'}, {'id': 'D013272', 'term': 'Stomach Diseases'}, {'id': 'D014594', 'term': 'Uterine Neoplasms'}, {'id': 'D005833', 'term': 'Genital Neoplasms, Female'}, {'id': 'D002577', 'term': 'Uterine Cervical Diseases'}, {'id': 'D014591', 'term': 'Uterine Diseases'}, {'id': 'D005831', 'term': 'Genital Diseases, Female'}, {'id': 'D000091662', 'term': 'Genital Diseases'}, {'id': 'D008113', 'term': 'Liver Neoplasms'}, {'id': 'D008107', 'term': 'Liver Diseases'}, {'id': 'D042822', 'term': 'Genomic Instability'}, {'id': 'D010335', 'term': 'Pathologic Processes'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}, {'id': 'D007414', 'term': 'Intestinal Neoplasms'}, {'id': 'D003108', 'term': 'Colonic Diseases'}, {'id': 'D007410', 'term': 'Intestinal Diseases'}, {'id': 'D012002', 'term': 'Rectal Diseases'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'C582303', 'term': 'ALT-803'}, {'id': 'C582435', 'term': 'pembrolizumab'}, {'id': 'D000077594', 'term': 'Nivolumab'}, {'id': 'C000594389', 'term': 'atezolizumab'}, {'id': 'C000609138', 'term': 'avelumab'}, {'id': 'C000613593', 'term': 'durvalumab'}, {'id': 'D000077143', 'term': 'Docetaxel'}], 'ancestors': [{'id': 'D061067', 'term': 'Antibodies, Monoclonal, Humanized'}, {'id': 'D000911', 'term': 'Antibodies, Monoclonal'}, {'id': 'D000906', 'term': 'Antibodies'}, {'id': 'D007136', 'term': 'Immunoglobulins'}, {'id': 'D007162', 'term': 'Immunoproteins'}, {'id': 'D001798', 'term': 'Blood Proteins'}, {'id': 'D011506', 'term': 'Proteins'}, {'id': 'D000602', 'term': 'Amino Acids, Peptides, and Proteins'}, {'id': 'D012712', 'term': 'Serum Globulins'}, {'id': 'D005916', 'term': 'Globulins'}, {'id': 'D043823', 'term': 'Taxoids'}, {'id': 'D043822', 'term': 'Cyclodecanes'}, {'id': 'D003516', 'term': 'Cycloparaffins'}, {'id': 'D006840', 'term': 'Hydrocarbons, Alicyclic'}, {'id': 'D006844', 'term': 'Hydrocarbons, Cyclic'}, {'id': 'D006838', 'term': 'Hydrocarbons'}, {'id': 'D009930', 'term': 'Organic Chemicals'}, {'id': 'D004224', 'term': 'Diterpenes'}, {'id': 'D013729', 'term': 'Terpenes'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE2'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NON_RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 40}}, 'statusModule': {'overallStatus': 'ACTIVE_NOT_RECRUITING', 'startDateStruct': {'date': '2018-12-11', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2024-10', 'completionDateStruct': {'date': '2030-12-31', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2025-10-14', 'studyFirstSubmitDate': '2017-07-21', 'studyFirstSubmitQcDate': '2017-07-21', 'lastUpdatePostDateStruct': {'date': '2025-10-17', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2017-07-25', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2029-08-31', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Objective Response Rate', 'timeFrame': 'Through study completion, an average of 1 year', 'description': 'Assess ORR, defined as Investigator-assessed CR + PR, per RECIST 1.1.'}, {'measure': 'Prolongation of Overall Survival (OS) with NAI Therapy by ALC Response', 'timeFrame': 'Throughout the study completion.', 'description': 'Time from first study drug administration to death resulting from any cause in patients achieving a pre-specified Absolute Lymphocyte Count (ALC) response.'}], 'secondaryOutcomes': [{'measure': 'Disease-specific Survival', 'timeFrame': 'Through study completion, an average of 1 year', 'description': 'Assess time from first treatment to death resulting from cancer.'}, {'measure': 'PFS (Progression-Free Survival)', 'timeFrame': 'Through study completion, an average of 1 year', 'description': 'Time from first study drug administration to disease progression or death from any cause, whichever occurs first.'}, {'measure': 'Time to Response', 'timeFrame': 'Through study completion, an average of 1 year', 'description': 'Assess time to response'}, {'measure': 'Duration of Response', 'timeFrame': 'Through study completion, an average of 1 year', 'description': 'Assess duration of response'}, {'measure': 'Disease Control Rate (DCR):', 'timeFrame': 'Throughout the study completion, an average of 1 year', 'description': '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.'}, {'measure': 'Quality of life (QoL) - Assessed in cohorts 1-5 only.', 'timeFrame': 'To be assessed every 12 weeks, starting with Cycle 3.', 'description': 'Compare changes in QOL scores from baseline.'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': True, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Pembrolizumab', 'Nivolumab', 'Non-Small Cell Lung Cancer (NSCLC)', 'Immunotherapy', 'Interleukin-15', 'PD-1 Checkpoint Inhibitor', 'ALT-803', 'Atezolizumab', 'Avelumab', 'Small Cell Lung Cancer (SCLC)', 'Urothelial Carcinoma', 'Head and Neck Squamous Cell Carcinoma (HNSCC)', 'Merkel Cell Carcinoma (MCC)', 'Melanoma', 'Renal Cell Carcinoma (RCC)', 'Gastric Cancer', 'Cervical Cancer', 'Hepatocellular Carcinoma (HCC)', 'Microsatellite Instability-High (MSI-H)', 'PD-L1 Checkpoint Inhibitor', 'Mismatch Repair Deficient (dMMR) Solid Tumor Cancer', 'Colorectal Cancer (CRC)', 'Durvalumab', 'PD-L1 t-haNK', 'N-803', 'Keytruda', 'Opdivo', 'Imfinzi', 'Bavencio', 'Tecentriq'], 'conditions': ['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']}, 'descriptionModule': {'briefSummary': '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.', 'detailedDescription': 'All cohorts are closed to enrollment'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': "INCLUSION CRITERIA (Cohort 6 only)\n\n1. Age ≥ 18 years old.\n2. Able to understand and provide a signed informed consent that fulfills the relevant IRB/IEC guidelines.\n3. Pathologically confirmed stage IV NSCLC disease.\n4. Have received exactly 1 anti-PD-1 or anti-PD-L1 therapy (either pembrolizumab or nivolumab) for advanced disease (stage IV or recurrent disease, or stage I-III disease in certain circumstances) outlined below. Anti-PD-1 or anti-PD-L1 therapy may have been given alone or in combination with other therapy.\n\n a. For those participants who received neoadjuvant, adjuvant, and/or consolidation anti-PD-1 or anti-PD-L1 therapy for stage\n\n I-III disease:\n\n If they had disease progression within (≤) 365 days from initiation (cycle 1 day 1) of anti-PD-1 or anti-PD-L1 therapy, this counts as the single allowed anti-PD-1 or anti-PD-L1 therapy for advanced disease OR if they had disease progression more than (\\>) 365 days from initiation (cycle 1 day 1) of anti-PD-1 or anti-PD-L1 therapy, this is not considered anti-PD-1 or anti-PD-L1 therapy for advanced disease. These participants must have received anti-PD-1 or anti-PD-L1 therapy for stage IV or recurrent disease.\n5. Have reported disease progression (in the opinion of the treating physician) more than (\\>) 84 days following initiation (cycle 1 day 1) of their most recent anti-PD-1 or anti-PD-L1 therapy (either pembrolizumab or nivolumab).\n6. Participants who received anti-PD-1 or anti-PD-L1 therapy for stage IV or recurrent disease, must have had a best response of SD, PR or CR (in the opinion of the treating physician) on the anti- PD-1 or anti-PD-L1 therapy (either nivolumab or pembrolizumab) for stage IV or recurrent disease.\n7. Participants with a known sensitizing mutation for which an - approved targeted therapy for NSCLC exists (e.g., EGFR, ALK, ROS1, BRAF, RET, NTRK, KRAS, HER2 and MET sensitizing mutations), must have previously received at least 1 of the approved therapy(s). Prior targeted therapy for participants with targetable alterations is allowed if all other eligibility criteria are also met.\n8. ECOG performance status of 0 to 2.\n9. Measurable tumor lesions according to RECIST v1.1.\n10. Ability to attend required study visits and return for adequate follow-up, as required by this protocol.\n11. Agreement to practice effective contraception for female participants of child-bearing potential and non-sterile males. Female participants of child-bearing potential must agree to use effective contraception for up 7 months after completion of therapy, and non-sterile male participants must agree to use a condom for up to 7 months after treatment. Effective contraception includes surgical sterilization (eg, vasectomy, tubal ligation), orals, injectables, 2 forms of barrier methods (eg, condom, diaphragm) used with spermicide, intrauterine devices (IUDs), and hormonal therapy.\n\nEXCLUSION CRITERIA (Cohort 6 only)\n\n1. Systemic autoimmune disease currently requiring treatment (e.g., lupus erythematosus, rheumatoid arthritis, Addison's disease, or autoimmune disease associated with lymphoma). The participant must have been off treatment for 180 days.\n2. History of organ transplant requiring immunosuppression; or history of pneumonitis or interstitial lung disease requiring treatment with systemic steroids; or a history of receiving systemic steroid therapy or any other immunosuppressive medication ≤ 3 days prior to study initiation. Daily steroid replacement therapy (eg, prednisone or hydrocortisone) and corticosteroids used to manage AEs are permitted.\n3. History of known active hepatitis B or C infection.\n4. Active infection requiring antibiotic therapy.\n5. History of or active inflammatory bowel disease (e.g., Crohn's disease, ulcerative colitis).\n6. Had major surgery within 28 days prior to study enrollment. Participants must have fully recovered from the effects of prior surgery in the opinion of the treating Investigator.\n7. Inadequate organ function, evidenced by the following laboratory results:\n\n 1. Absolute lymphocyte count \\< institutional ULN.\n 2. Absolute neutrophil count (ANC) \\< 1,500 cells/mm3.\n 3. Platelet count \\< 100,000 cells/mm3.\n 4. Total bilirubin greater than the upper limit of normal (ULN; unless the participant has documented Gilbert's syndrome).\n 5. Aspartate aminotransferase (AST \\[SGOT\\]) or ALT (SGPT) \\> 1.5 × ULN.\n 6. Alkaline phosphatase (ALP) levels \\> 2.5 × ULN.\n 7. Hemoglobin \\< 9.0 g/dL.\n 8. Serum creatinine \\> 2.0 mg/dL or 177 μmol/L or creatinine clearance \\< 40 mL/min (using the Cockcroft-Gault formula below): Female = \\[(140 - age in years) × weight in kg × 0.85\\] / \\[72 × serum creatinine in mg/dL\\] Male = \\[(140 - age in years) × weight in kg × 1.00\\] / \\[72 × serum creatinine in mg/dL\\]\n8. Have any of following:\n\n 1. Cirrhosis at a level of Child-Pugh B (or worse);\n 2. Cirrhosis (any degree) and a history of hepatic encephalopathy; or\n 3. Clinically meaningful ascites resulting from cirrhosis. Clinically meaningful ascites is defined as ascites from cirrhosis requiring diuretics or paracentesis.\n9. Participation in an investigational drug study or history of receiving any investigational treatment within 30 days prior to the start of treatment on this study, except for hormone lowering therapy in participants with hormone-sensitive cancer.\n10. Assessed by the Investigator to be unable or unwilling to comply with the requirements of the protocol.\n11. Pregnant and nursing women."}, 'identificationModule': {'nctId': 'NCT03228667', 'briefTitle': 'QUILT-3.055: A Study of Combination Immunotherapies in Patients Who Have Previously Received Treatment With Immune Checkpoint Inhibitors', 'organization': {'class': 'INDUSTRY', 'fullName': 'ImmunityBio, Inc.'}, 'officialTitle': 'QUILT-3.055: A Phase IIb, Multicohort, Open-Label Study of Combination Immunotherapies in Patients Who Have Previously Received Treatment With PD-1/PD-L1 Immune Checkpoint Inhibitors', 'orgStudyIdInfo': {'id': 'CA-ALT-803-02-17'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'OTHER', 'label': 'Cohort 1', 'description': '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.\n\n1a - Non-small cell lung cancer\n\n1b - Small cell lung cancer\n\n1c - Urothelial carcinoma\n\n1d - Head and neck squamous cell carcinoma\n\n1e - Merkel cell carcinoma\n\n1f - Melanoma\n\n1g - Renal cell carcinoma\n\n1h - Gastric cancer\n\n1i - Cervical cancer\n\n1j - Hepatocellular carcinoma\n\n1k - Microsatellite instability-high or mismatch repair deficient solid tumor cancer or colorectal cancer', 'interventionNames': ['Drug: N-803 + Pembrolizumab', 'Drug: N-803 + Nivolumab', 'Drug: N-803 + Atezolizumab', 'Drug: N-803 + Avelumab', 'Drug: N-803 + Durvalumab']}, {'type': 'OTHER', 'label': 'Cohort 2', 'description': '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.', 'interventionNames': ['Drug: N-803 + Pembrolizumab', 'Drug: N-803 + Nivolumab']}, {'type': 'OTHER', 'label': 'Cohort 3', 'description': '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.', 'interventionNames': ['Drug: N-803 + Pembrolizumab', 'Drug: N-803 + Nivolumab']}, {'type': 'EXPERIMENTAL', 'label': 'Cohort 4', 'description': '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.', 'interventionNames': ['Drug: N-803 + Pembrolizumab', 'Drug: N-803 + Nivolumab', 'Drug: N-803 + Atezolizumab', 'Drug: N-803 + Avelumab', 'Drug: N-803 + Durvalumab']}, {'type': 'EXPERIMENTAL', 'label': 'Cohort 5', 'description': 'Patients that have experienced disease progression by Investigator-assessment per irRECIST while receiving treatment in Cohorts 1-4.', 'interventionNames': ['Drug: N-803 + Pembrolizumab + PD-L1 t-haNK', 'Drug: N-803 + Nivolumab + PD-L1 t-haNK', 'Drug: N-803 + Atezolizumab + PD-L1 t-haNK', 'Drug: N-803 + Avelumab + PD-L1 t-haNK', 'Drug: N-803 + Durvalumab + PD-L1 t-haNK']}, {'type': 'EXPERIMENTAL', 'label': 'Cohort 6', 'description': '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).', 'interventionNames': ['Drug: N-803 + Docetaxel + Pembrolizumab', 'Drug: N-803 + Docetaxel + Nivolumab']}], 'interventions': [{'name': 'N-803 + Pembrolizumab', 'type': 'DRUG', 'description': '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.', 'armGroupLabels': ['Cohort 1', 'Cohort 2', 'Cohort 3', 'Cohort 4']}, {'name': 'N-803 + Nivolumab', 'type': 'DRUG', 'description': '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.', 'armGroupLabels': ['Cohort 1', 'Cohort 2', 'Cohort 3', 'Cohort 4']}, {'name': 'N-803 + Atezolizumab', 'type': 'DRUG', 'description': '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.', 'armGroupLabels': ['Cohort 1', 'Cohort 4']}, {'name': 'N-803 + Avelumab', 'type': 'DRUG', 'description': '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.', 'armGroupLabels': ['Cohort 1', 'Cohort 4']}, {'name': 'N-803 + Durvalumab', 'type': 'DRUG', 'description': '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.', 'armGroupLabels': ['Cohort 1', 'Cohort 4']}, {'name': 'N-803 + Pembrolizumab + PD-L1 t-haNK', 'type': 'DRUG', 'description': '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', 'armGroupLabels': ['Cohort 5']}, {'name': 'N-803 + Nivolumab + PD-L1 t-haNK', 'type': 'DRUG', 'description': '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', 'armGroupLabels': ['Cohort 5']}, {'name': 'N-803 + Atezolizumab + PD-L1 t-haNK', 'type': 'DRUG', 'description': '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', 'armGroupLabels': ['Cohort 5']}, {'name': 'N-803 + Avelumab + PD-L1 t-haNK', 'type': 'DRUG', 'description': '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', 'armGroupLabels': ['Cohort 5']}, {'name': 'N-803 + Durvalumab + PD-L1 t-haNK', 'type': 'DRUG', 'description': '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', 'armGroupLabels': ['Cohort 5']}, {'name': 'N-803 + Docetaxel + Pembrolizumab', 'type': 'DRUG', 'description': '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).', 'armGroupLabels': ['Cohort 6']}, {'name': 'N-803 + Docetaxel + Nivolumab', 'type': 'DRUG', 'description': "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.", 'armGroupLabels': ['Cohort 6']}]}, 'contactsLocationsModule': {'locations': [{'zip': '99530', 'city': 'Anchorage', 'state': 'Alaska', 'country': 'United States', 'facility': 'Alaska Clinical Research Center', 'geoPoint': {'lat': 61.21806, 'lon': -149.90028}}, {'zip': '71913', 'city': 'Hot Springs', 'state': 'Arkansas', 'country': 'United States', 'facility': 'Genesis Cancer Center', 'geoPoint': {'lat': 34.5037, 'lon': -93.05518}}, {'zip': '90245', 'city': 'El Segundo', 'state': 'California', 'country': 'United States', 'facility': 'Chan Soon-Shiong Institute for Medicine', 'geoPoint': {'lat': 33.91918, 'lon': -118.41647}}, {'zip': '37846', 'city': 'Fountain Valley', 'state': 'California', 'country': 'United States', 'facility': 'MemorialCare Health System', 'geoPoint': {'lat': 33.70918, 'lon': -117.95367}}, {'zip': '91206', 'city': 'Glendale', 'state': 'California', 'country': 'United States', 'facility': 'Glendale Adventist Medical Center', 'geoPoint': {'lat': 34.14251, 'lon': -118.25508}}, {'zip': '90033', 'city': 'Los Angeles', 'state': 'California', 'country': 'United States', 'facility': 'University of Southern California Norris Comprehensive Cancer Center', 'geoPoint': {'lat': 34.05223, 'lon': -118.24368}}, {'zip': '92270', 'city': 'Rancho Mirage', 'state': 'California', 'country': 'United States', 'facility': 'Desert Hematology Oncology Medical Group, Inc.', 'geoPoint': {'lat': 33.73974, 'lon': -116.41279}}, {'zip': '33021', 'city': 'Hollywood', 'state': 'Florida', 'country': 'United States', 'facility': 'Memorial Healthcare System', 'geoPoint': {'lat': 26.0112, 'lon': -80.14949}}, {'zip': '33176', 'city': 'Miami', 'state': 'Florida', 'country': 'United States', 'facility': 'Miami Cancer Institute (Baptist Health South Florida)', 'geoPoint': {'lat': 25.77427, 'lon': -80.19366}}, {'zip': '33180', 'city': 'Miami', 'state': 'Florida', 'country': 'United States', 'facility': 'University of Miami', 'geoPoint': {'lat': 25.77427, 'lon': -80.19366}}, {'zip': '47905', 'city': 'Lafayette', 'state': 'Indiana', 'country': 'United States', 'facility': 'Horizon Oncology Associates', 'geoPoint': {'lat': 40.4167, 'lon': -86.87529}}, {'zip': '52242', 'city': 'Iowa City', 'state': 'Iowa', 'country': 'United States', 'facility': 'University of Iowa Holden Comprehensive Cancer Center', 'geoPoint': {'lat': 41.66113, 'lon': -91.53017}}, {'zip': '40503', 'city': 'Lexington', 'state': 'Kentucky', 'country': 'United States', 'facility': 'Baptist Health - 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