NCT03228667Phase 2Active not recruiting

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

Compare the available registry edits below. Primary completion is the date data collection ends for the main study measures; it does not tell you when results will be published.

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Primary completion2029-08-31Estimated

Enrollment · participants40Estimated

Source updated2026-01-14Last update listed in the registry record

Version history

Changes to this trial

Last 12 months

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Posted 2026-01-14 · 1 field changed

Primary outcomes · main study measures

Text edit · unverified significance

− Previous value

measure: Objective Response Rate; measure: Prolongation of Overall Survival (OS) with NAI Therapy by ALC Response

+ Updated value

measure: ORR, defined as Investigator-assessed CR + PR per RECIST v1.1.; measure: Prolongation of OS with NAI therapy by ALC response, where: - OS is defined as the time from first study drug administration to death resulting from any cause. - ALC response is defined as achievement or maintenance of an on-treatment ALC ≥ 1,000 cells/μ

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Posted 2025-10-20 · 1 field changed

Primary outcomes · main study measures

Text edit · unverified significance

− Previous value

measure: Objective Response Rate

+ Updated value

measure: Objective Response Rate; measure: Prolongation of Overall Survival (OS) with NAI Therapy by ALC Response

The saved outcome text may be shortened. Check the source for full wording.

Check registry source

Study details

Conditions studied

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

Treatments or interventions studied

N-803 + PembrolizumabDrug
N-803 + NivolumabDrug
N-803 + AtezolizumabDrug
N-803 + AvelumabDrug
N-803 + DurvalumabDrug
N-803 + Pembrolizumab + PD-L1 t-haNKDrug
N-803 + Nivolumab + PD-L1 t-haNKDrug
N-803 + Atezolizumab + PD-L1 t-haNKDrug
N-803 + Avelumab + PD-L1 t-haNKDrug
N-803 + Durvalumab + PD-L1 t-haNKDrug
N-803 + Docetaxel + PembrolizumabDrug
N-803 + Docetaxel + NivolumabDrug

Primary outcomes · main study measures

Read the study measures

measure: ORR, defined as Investigator-assessed CR + PR per RECIST v1.1.; description: ORR reflects tumor shrinkage and is the key measure of antitumor activity.; timeFrame: Evaluated from the first dose of study drug and repeated at each scheduled disease-assessment visit for up to 24 months (or until progression/death), with the time-to-response summarized using Kaplan-Meier methods; measure: Prolongation of OS with NAI therapy by ALC response, where: - OS is defined as the time from first study drug administration to death resulting from any cause. - ALC response is defined as achievement or maintenance of an on-treatment ALC ≥ 1,000 cells/μ; description: OS is the gold-standard efficacy endpoint; the protocol explores whether an ALC rise predicts a survival benefit.; timeFrame: Measured from the date of the first study-drug administration to the date of death (any cause) and followed for up to 24 months after the last dose (or until death), allowing the correlation with on-treatment ALC changes

History coverage

Research sample: selected versions from May 2023 onward plus a preceding baseline where available. Only selected fields were retained; endpoint measures were truncated to 300 characters. This is not complete trial or sponsor history. Daily snapshots begin when collection starts.

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