A Phase 2 interventional study of N-803 + Pembrolizumab and N-803 + Nivolumab in Non-Small Cell Lung Cancer, Small Cell Lung Cancer and Urothelial Carcinoma, sponsored by ImmunityBio, Inc.. Active, not recruiting at 35 sites in United States. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-01-14.
Sponsored by ImmunityBio, Inc. · Phase 2, Interventional, and Treatment
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.
All cohorts are closed to enrollment
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.
a. For those participants who received neoadjuvant, adjuvant, and/or consolidation anti-PD-1 or anti-PD-L1 therapy for stage
I-III disease:
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.
EXCLUSION CRITERIA (Cohort 6 only)
Inadequate organ function, evidenced by the following laboratory results:
Have any of following:
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. 1a - Non-small cell lung cancer 1b - Small cell lung cancer 1c - Urothelial carcinoma 1d - Head and neck squamous cell carcinoma 1e - Merkel cell carcinoma 1f - Melanoma 1g - Renal cell carcinoma 1h - Gastric cancer 1i - Cervical cancer 1j - Hepatocellular carcinoma 1k - Microsatellite instability-high or mismatch repair deficient solid tumor cancer or colorectal cancer
Drug: N-803 + Pembrolizumab · Drug: N-803 + Nivolumab · Drug: N-803 + Atezolizumab · Drug: N-803 + Avelumab · Drug: N-803 + Durvalumab
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.
Drug: N-803 + Pembrolizumab · Drug: N-803 + Nivolumab
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.
Drug: N-803 + Pembrolizumab · Drug: N-803 + Nivolumab
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.
Drug: N-803 + Pembrolizumab · Drug: N-803 + Nivolumab · Drug: N-803 + Atezolizumab · Drug: N-803 + Avelumab · Drug: N-803 + Durvalumab
Patients that have experienced disease progression by Investigator-assessment per irRECIST while receiving treatment in Cohorts 1-4.
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
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).
Drug: N-803 + Docetaxel + Pembrolizumab · Drug: N-803 + Docetaxel + Nivolumab
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 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 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 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 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 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
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
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
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
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
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).
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.
ORR, defined as Investigator-assessed CR + PR per RECIST v1.1.
ORR reflects tumor shrinkage and is the key measure of antitumor activity.
Time frame: 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
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
OS is the gold-standard efficacy endpoint; the protocol explores whether an ALC rise predicts a survival benefit.
Time frame: 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
ALC response to NAI therapy
Defined as achieving a mean on-treatment absolute lymphocyte count (ALC) ≥ 1,000 cells/µL.
Time frame: From the date of first study-drug administration until the earlier of death or the planned end of follow-up, assessed up to 24 months.
Prolongation of therapy
Measured as the time on NAI treatment, analyzed according to whether the participant attained the ALC response described above.
Time frame: From the date of first study-drug administration until the earlier of death or the planned end of study follow-up, assessed up to 24 months after the last dose of study drug.
Overall survival (OS) for all patients and subgroups
Defined as the time from the first study-drug administration to death from any cause.
Time frame: From the date of first study-drug administration until the earlier of death or the planned end of study follow-up, assessed up to 24 months after the last dose of study drug.
Disease-specific survival (DSS)
Time from first study drug administration to death resulting from cancer.
Time frame: From the date of first study-drug administration until the earlier of death or the planned end of study follow-up, assessed up to 24 months after the last dose of study drug.
Progression-free survival (PFS)
Time from the first study-drug administration to either documented disease progression or death from any cause, whichever occurs first
Time frame: From the date of first study-drug administration until the earlier of death or the planned end of study follow-up, assessed up to 24 months after the last dose of study drug.
Time to response
The interval from the first dose of study drug to the first documented objective tumor response (CR or PR)
Time frame: From the date of first study-drug administration until the earlier of death or the planned end of study follow-up, assessed up to 24 months after the last dose of study drug.
Duration of response (DoR)
Time from the date of documented response (CR or PR) until disease progression or death.
Time frame: From the date of first study-drug administration until the earlier of death or the planned end of study follow-up, assessed up to 24 months after the last dose of study drug.
Disease Control Rate (DCR):
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.
Time frame: Assessed at the end of each 6-week cycle (each cycle = 42 days) through 2 years (up to Cycle 17)
Quality of life (QoL) - Assessed in cohorts 1-5 only.
Assesses patient well-being using standardized questionnaires like EORTC QLQ-C30/LC13 or FACT PRO (module-specific), each with varying scales where higher scores generally indicate better functioning (but may also mean more symptoms).
Time frame: From the date of first study-drug administration until the earlier of death or the planned end of study follow-up, assessed up to 24 months after the last dose of study drug.
Physical examinations
A full physical exam is conducted to assess any new or worsening clinical findings.
Time frame: Baseline (screening), Day 1 (first dose), and prior to every subsequent NAI dose (e.g., every 2 weeks), then at each post-treatment safety visit (Week 12, Week 24, Week 36, Week 48, and at end-of-study visit)
Incidence of TEAEs and SAEs
All treatment-emergent adverse events and serious adverse events are recorded and graded using the NCI Common Terminology Criteria for Adverse Events version 5.0.
Time frame: Captured continuously from the first dose of study drug and monitored at every study visit throughout the treatment period and the post-treatment follow-up phase (until study closure, typically up to ~24 months after the last dose).
Laboratory tests
Routine hematology, chemistry, and other safety-related labs are performed to detect treatment-related abnormalities.
Time frame: Baseline, Day 1, on-treatment (prior to each dose; every 2 weeks), and at each post-treatment safety visit (Week 12, Week 24, Week 36, Week 48, and end-of-study)
Vital signs
Blood pressure, heart rate, respiratory rate, temperature, and weight are recorded.
Time frame: Baseline, Day 1, before each NAI infusion (typically every 2 weeks), and at all scheduled safety follow-up visits (Week 12, Week 24, Week 36, Week 48, and final study visit)
ORR (Objective Response Rate)
Cohorts 1-5 (irRECIST) Proportion of participants achieving a confirmed complete or partial response per immune-related RECIST.
Time frame: Assessed from the first dose onward at scheduled tumor-assessment visits (typically every 8-12 weeks) until progression, death, or study end (≈ 24 months).
PFS (Progression-Free Survival)
Cohorts 1-5 (irRECIST) Time from first dose to disease progression (per irRECIST) or death from any cause, whichever occurs first.
Time frame: From Day 1 of first study-drug administration to first documented disease progression (per irRECIST/iRECIST) or death from any cause, whichever occurs first, assessed up to 24 months.
Time to response
Cohorts 1-5 (irRECIST) Interval from first dose to the first documented objective response (CR or PR)
Time frame: From Day 1 of first study-drug administration to the date of first confirmed complete or partial response, assessed up to 24 months.
DCR (Disease-Control Rate)
Cohorts 1-5 (irRECIST) Proportion of participants achieving CR, PR, or stable disease per irRECIST.
Time frame: Assessed at each tumor-assessment visit (baseline, Week 8 ± 1, Week 16 ± 2, Week 24 ± 2, and thereafter every 12 weeks) through 24 months.
DoR (Duration of Response)
Cohorts 1-5 (irRECIST) Time from first documented response to disease progression or death.
Time frame: From the date of first confirmed response to subsequent disease progression or death, whichever occurs first, assessed up to 24 months.
Immunogenicity profile
Cohorts 1-5 (irRECIST) Detection of anti-drug antibodies or other immune responses to the investigational agents.
Time frame: Blood sampled at baseline, Day 1, Week 4, Week 12, and then every 12 weeks up to 24 months.
Cmax - Maximum plasma concentration of the investigational agent
The highest observed plasma concentration of the study drug after a single intravenous infusion, expressed in ng · mL-¹. Concentrations are measured using a validated LC-MS/MS assay (lower limit of quantitation = 1 ng · mL-¹).
Time frame: Assessed on Cycle 1 Day 1 (each cycle = 28 days) and Cycle 2 Day 1. Sampling schedule on each study day: pre-dose, end-of-infusion, 0.5 hour, 1 hour, 2 hours, 4 hours, 8 hours, and 24 hours post-dose
Tmax - Time to maximum plasma concentration of the investigational agent
Time elapsed from the start of the infusion to the occurrence of Cmax, expressed in hours. Determined from the same plasma-sampling schedule used for Cmax.
Time frame: Assessed on Cycle 1 Day 1 (each cycle = 28 days) and Cycle 2 Day 1. Sampling schedule on each study day: pre-dose, end-of-infusion, 0.5 hour, 1 hour, 2 hours, 4 hours, 8 hours, and 24 hours post-dose
AUC₀-t - Exposure (area under the plasma-concentration-time curve) from time 0 to the last quantifiable concentration
Calculated using the linear-trapezoidal method applied to the concentration-time data obtained from the intensive sampling schedule (pre-dose through 24 h) on Cycle 1 Day 1. Units are ng · h · mL-¹.
Time frame: Assessed on Cycle 1 Day 1 (each cycle = 28 days) and Cycle 2 Day 1. Sampling schedule on each study day: pre-dose, end-of-infusion, 0.5 hour, 1 hour, 2 hours, 4 hours, 8 hours, and 24 hours post-dose
AUC₀-τ - Steady-state exposure over one dosing interval
Area under the plasma-concentration-time curve over a full dosing interval (τ) at steady state, calculated by the linear-trapezoidal method using pre-dose and post-dose samples collected on Cycle 2 Day 1 (or the first cycle where steady state is confirmed). Units: ng · h · mL-¹.
Time frame: Assessed on Cycle 2 Day 1 (each cycle = 42 days). Intensive sampling: pre-dose, end-of-infusion, 0.5 hour, 1 hour, 2 hours, 4 hours, 8 hours, 24 hours post-dose. Sparse samples at weeks 12, 24, 36, 48, 60, 72, 84 (up to 24 months).
t½ - Terminal elimination half-life of the investigational agent
The time required for the plasma concentration to decline by 50 % during the terminal phase, calculated by log-linear regression of the last ≥3 measurable concentrations from the intensive sampling (typically 4 h, 8 h, 24 h) on Cycle 1 Day 1. Reported in hours.
Time frame: Determined from the same Cycle 1 Day 1 intensive sampling. No additional time points are required; the parameter is reported once per participant. The overall data-collection window for the participant is up to 24 months from first dose
ORR (Objective Response Rate)
Cohort 6 (iRECIST) Proportion of participants who achieve a confirmed complete response (CR) or partial response (PR) as assessed by the investigator using iRECIST criteria.
Time frame: Assessed from the first study-drug administration onward at scheduled tumor-assessment visits (typically every 8-12 weeks) and reported at the end of the follow-up period (up to the study's planned closure, e.g., ~24 months).
PFS (Progression-Free Survival)
Cohort 6 (iRECIST) Time from the first dose of study drug to the first occurrence of disease progression (per iRECIST) or death from any cause, whichever comes first.
Time frame: From Day 1 of first study-drug administration to first documented disease progression (per irRECIST/iRECIST) or death from any cause, whichever occurs first, assessed up to 24 months.
Time to response
Cohort 6 (iRECIST) - Interval between the first study-drug administration and the date of the first documented objective response (CR or PR) per iRECIST.
Time frame: From Day 1 of first study-drug administration to the date of first confirmed complete or partial response, assessed up to 24 months
DCR (Disease-Control Rate)
Cohort 6 (iRECIST) - Proportion of participants who achieve CR, PR, or stable disease (SD) according to iRECIST.
Time frame: Assessed at each tumor-assessment visit (baseline, Week 8 ± 1, Week 16 ± 2, Week 24 ± 2, and thereafter every 12 weeks) through 24 months
DoR (Duration of Response)
Cohort 6 (iRECIST) Time from the date of the first documented response (CR or PR) until disease progression (per iRECIST) or death, whichever occurs first.
Time frame: From the date of first confirmed response to subsequent disease progression or death, whichever occurs first, assessed up to 24 months.
Plan to share: No
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Carcinoma, Non-Small-Cell Lung→
ImmunityBio, Inc.