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QUILT-3.055: A Study of Combination Immunotherapies in Patients Who Have Previously Received Treatment With Immune Checkpoint Inhibitors
NCT03228667 · View on ClinicalTrials.gov ↗
Study 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.
Conditions Studied
Interventions
- DRUG N-803 + Pembrolizumab
- DRUG N-803 + Nivolumab
- DRUG N-803 + Atezolizumab
- DRUG N-803 + Avelumab
- DRUG N-803 + Durvalumab
Study Locations (20)
California
- Chan Soon-Shiong Institute for Medicine — El Segundo
- MemorialCare Health System — Fountain Valley
- Glendale Adventist Medical Center — Glendale
- University of Southern California Norris Comprehensive Cancer Center — Los Angeles
- Desert Hematology Oncology Medical Group, Inc. — Rancho Mirage
Florida
- Memorial Healthcare System — Hollywood
- Miami Cancer Institute (Baptist Health South Florida) — Miami
- University of Miami — Miami
Missouri
- Mercy Research Joplin — Joplin
- Mercy Clinic Cancer & Hematology - Chub O'Reilly Cancer Center — Springfield
- Washington University School of Medicine — St Louis
Kentucky
- Baptist Health - Lexington — Lexington
- Baptist Health- Louisville — Louisville
Alaska
- Alaska Clinical Research Center — Anchorage
Arkansas
- Genesis Cancer Center — Hot Springs
Indiana
- Horizon Oncology Associates — Lafayette
Iowa
- University of Iowa Holden Comprehensive Cancer Center — Iowa City
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 40 participants |
| Start Date | 2018-12-11 |
| Est. Completion | 2030-12-31 |
| Phase | Phase 2 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT03228667
The ClinicalTrials.gov registry entry for NCT03228667 describes a study currently listed as active not recruiting. It is categorized as Phase 2, which is the standard way researchers label where a study sits along the investigational pathway from early safety work through later efficacy and post-marketing evaluation. The registered enrollment target is 40 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is ImmunityBio, which has 48 total studies on file at ClinicalTrials.gov, and sponsors are the parties responsible for study design, oversight, and regulatory filings.
The record links to 10 conditions, with Melanoma appearing as the primary indexed condition, and to 5 interventions — of which N-803 + Pembrolizumab is the first listed. Interventions can include drugs, devices, procedures, behavioral programs, or observational arms, and each is tracked as a separate registry field so that downstream queries can filter accurately. When a trial lists multiple interventions, it usually reflects a multi-arm design or a comparison protocol rather than a single treatment being tested in isolation. The brief summary published in the registry is the clearest source of protocol intent and should be read before drawing conclusions from any sidebar tags.
Geographic footprint matters for practical reasons: NCT03228667 reports 20 study locations spanning 11 distinct geographic areas — top geographies include California, Florida, Missouri. A larger site network tends to correlate with broader recruitment capacity, but it does not imply anything about study quality, and site-level enrollment status can diverge from the overall registry status shown above. Every data point on this page comes from the public ClinicalTrials.gov dataset and is reproduced here for reference only; it is not a medical recommendation, an endorsement of the sponsor, or an invitation to enroll. Verify current status, eligibility criteria, and contact details directly at ClinicalTrials.gov, and discuss any participation decision with your own healthcare provider.
Frequently Asked Questions
What is clinical trial NCT03228667 about?
NCT03228667 is a clinical study titled "QUILT-3.055: A Study of Combination Immunotherapies in Patients Who Have Previously Received Treatment With Immune Checkpoint Inhibitors". 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) i...
What is the current status of trial NCT03228667?
This trial is currently active not recruiting. It is a Phase 2 study. The enrollment target is 40 participants. The study started on 2018-12-11. Estimated completion is 2030-12-31.
What conditions does trial NCT03228667 study?
This clinical trial studies the following conditions: Melanoma, Gastric Cancer, Cervical Cancer, Hepatocellular Carcinoma, Non-Small Cell Lung Cancer. These conditions were identified from the trial registry and reflect the primary focus areas of the research.
What interventions are being tested in trial NCT03228667?
The interventions under investigation include: N-803 + Pembrolizumab (DRUG), N-803 + Nivolumab (DRUG), N-803 + Atezolizumab (DRUG), N-803 + Avelumab (DRUG), N-803 + Durvalumab (DRUG). Each intervention is being evaluated for safety and efficacy as part of this clinical study.
Who is sponsoring clinical trial NCT03228667?
This trial is sponsored by ImmunityBio, which has 48 total clinical trials registered on ClinicalTrials.gov. The sponsor is responsible for the study's design, funding, and regulatory compliance.
Where is trial NCT03228667 being conducted?
This trial has 20 study locations across Alaska, Arkansas, California, Florida, Indiana. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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