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drugset / Trial / NCT03228667

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

NCT03228667 ↗

Phase 2 Active not recruiting 40 enrolled ImmunityBio, Inc.
Non-randomizedParallel-groupOpen-labelTreatment

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.

Timeline

Start
2018-12-11
Primary completion
2029-08-31
Completion
2030-12-31

Drugs

EvaluationDrugModalityDoseRoute
Subject Atezolizumab Monoclonal antibody 1200 mg Intravenous
Subject Avelumab Monoclonal antibody 800 mg Intravenous
Subject Docetaxel Small molecule 75 mg/m2 Intravenous
Subject Durvalumab Monoclonal antibody 10 mg/kg Intravenous
Subject N-803 Protein / enzyme biologic 15 ug/kg Subcutaneous
Subject N-803 Protein / enzyme biologic 1.2 mg Subcutaneous
Subject Nivolumab Monoclonal antibody 240 mg Intravenous
Subject Nivolumab Monoclonal antibody 480 mg Intravenous
Subject PD-L1 t-haNK Cell therapy 2e+09 cells Intravenous
Subject Pembrolizumab Monoclonal antibody 200 mg Intravenous

Indications

cervical cancer colorectal cancer cutaneous neuroendocrine carcinoma gastric cancer head and neck squamous cell carcinoma hepatocellular carcinoma melanoma mismatch repair cancer syndrome non-small cell lung carcinoma renal cell carcinoma small cell lung carcinoma urothelial carcinoma