Clinical Trial

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

Active, Not Recruiting Phase 2
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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.
Protocol Amendment History 32 amendments
This ClinicalTrials.gov record has been amended 32 times since 2017-07-21; most recent amendment 2026-01-13.
Status change: Recruiting → Active, Not Recruiting 2025-09-16
Status change: Active, Not Recruiting → Recruiting 2024-12-11
Status change: Recruiting → Active, Not Recruiting 2021-05-28
Status change: Not Yet Recruiting → Recruiting 2018-05-07
Status change: Recruiting → Not Yet Recruiting 2018-01-19
Status change: Not Yet Recruiting → Recruiting 2017-10-19
Trial Details
NCT Number NCT03228667
Lead Sponsor ImmunityBio, Inc.
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 +5 more
Enrollment 40 participants
Start Date 2018-12-11
Primary Completion 2029-08-31 (estimated)
Study Completion 2030-12-31 (estimated)
Updated on ClinicalTrials.gov 2026-01-14