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

StatusActive, Not Recruiting
PhasePhase 2
Started
View on ClinicalTrials.gov ↗

Record History

  1. Primary endpoints revised (2) Secondary endpoints: 6 to 10v33 Show 1 more changeShow less
    • Secondary endpoints: 6 to 10

    See this version in full on ClinicalTrials.gov ↗

  2. Primary endpoints: 1 to 2 Secondary endpoints: 7 to 6v32 Show 1 more changeShow less
    • Secondary endpoints: 7 to 6

    See this version in full on ClinicalTrials.gov ↗

  3. Trial status: Recruiting to Active, Not Recruiting Site details revised at 35 of 35 sites · Study description expanded, about 1 wordv31 Show 2 more changesShow less
    • Site details revised at 35 of 35 sites
    • Study description expanded, about 1 word

    See this version in full on ClinicalTrials.gov ↗

  4. Re-verified, no change to tracked fieldsv30
  5. Study description revised Site contacts updated at 4 of 35 sitesv29 Show 1 more changeShow less
    • Site contacts updated at 4 of 35 sites

    See this version in full on ClinicalTrials.gov ↗

Show 27 earlier versionsHide 27 earlier versions
  1. Trial status: Active, Not Recruiting to Recruiting Enrollment target: 147 to 40 · Interventions: N-803 + Atezolizumab (Drug), N-803 + Atezolizumab + PD-L1 t-haNK (Drug), N-803 + Avelumab (Drug), N-803 + Avelumab + PD-L1 t-haNK (Drug)… to N-803 + Atezolizumab (Drug), N-803 + Atezolizumab + PD-L1 t-haNK (Drug), N-803 + Avelumab (Drug), N-803 + Avelumab + PD-L1 t-haNK (Drug)… · Eligibility criteria shortened, about 1,254 words · 4 morev28 Show 7 more changesShow less
    • Enrollment target: 147 to 40
    • Interventions: N-803 + Atezolizumab (Drug), N-803 + Atezolizumab + PD-L1 t-haNK (Drug), N-803 + Avelumab (Drug), N-803 + Avelumab + PD-L1 t-haNK (Drug)… to N-803 + Atezolizumab (Drug), N-803 + Atezolizumab + PD-L1 t-haNK (Drug), N-803 + Avelumab (Drug), N-803 + Avelumab + PD-L1 t-haNK (Drug)…
    • Eligibility criteria shortened, about 1,254 words
    • Secondary endpoints revised (7)
    • Site details revised at 35 of 35 sites
    • Study arms: 5 to 6
    • Study description expanded, about 5 words

    See this version in full on ClinicalTrials.gov ↗

  2. Re-verified, no change to tracked fieldsv27
  3. Primary completion date: May 2024 to Aug 31, 2029 Completion date: Dec 2024 to Dec 31, 2030v26 Show 1 more changeShow less
    • Completion date: Dec 2024 to Dec 31, 2030
  4. Primary completion date: May 2023 to May 2024 Completion date: Dec 2023 to Dec 2024v25 Show 1 more changeShow less
    • Completion date: Dec 2023 to Dec 2024
  5. Enrollment target: 145 to 147v24
  6. Re-verified, no change to tracked fieldsv23
  7. Primary completion date: Jun 2021 to May 2023 Completion date: Aug 2021 to Dec 2023v22 Show 1 more changeShow less
    • Completion date: Aug 2021 to Dec 2023
  8. Trial status: Recruiting to Active, Not Recruiting Enrollment target: estimated 636 to confirmed 145 · Site details revised at 35 of 35 sitesv21 Show 2 more changesShow less
    • Enrollment target: estimated 636 to confirmed 145
    • Site details revised at 35 of 35 sites
  9. Lead sponsor: Altor BioScience to ImmunityBio, Inc.v20
  10. Study sites: 34 to 35v19
  11. Re-verified, no change to tracked fieldsv18
  12. Enrollment target: 611 to 636 Interventions: ALT-803 + Atezolizumab (Drug), ALT-803 + Avelumab (Drug), ALT-803 + Nivolumab (Drug), ALT-803 + Pembrolizumab (Drug) to N-803 + Atezolizumab (Drug), N-803 + Atezolizumab + PD-L1 t-haNK (Drug), N-803 + Avelumab (Drug), N-803 + Avelumab + PD-L1 t-haNK (Drug)… · Eligibility criteria expanded, about 201 words · Secondary endpoints revised (7) · 3 morev17 Show 6 more changesShow less
    • Interventions: ALT-803 + Atezolizumab (Drug), ALT-803 + Avelumab (Drug), ALT-803 + Nivolumab (Drug), ALT-803 + Pembrolizumab (Drug) to N-803 + Atezolizumab (Drug), N-803 + Atezolizumab + PD-L1 t-haNK (Drug), N-803 + Avelumab (Drug), N-803 + Avelumab + PD-L1 t-haNK (Drug)…
    • Eligibility criteria expanded, about 201 words
    • Secondary endpoints revised (7)
    • Site details revised at 2 of 34 sites
    • Study arms: 4 to 5
    • Study title expanded, about 1 word

    See this version in full on ClinicalTrials.gov ↗

  13. Primary completion date: Jun 2020 to Jun 2021 Study sites: 31 to 34 · Completion date: Aug 2020 to Aug 2021v16 Show 2 more changesShow less
    • Study sites: 31 to 34
    • Completion date: Aug 2020 to Aug 2021
  14. Study sites: 27 to 31v15
  15. Study sites: 24 to 27v14
  16. Study sites: 21 to 24v13
  17. Study sites: 17 to 21v12
  18. Study sites: 13 to 17v11
  19. Enrollment target: 105 to 611 Start date: Jun 6, 2018 to Dec 11, 2018 · Study sites: 11 to 13 · Primary completion date: May 2021 to Jun 2020 · 6 morev10 Show 9 more changesShow less
    • Start date: Jun 6, 2018 to Dec 11, 2018
    • Study sites: 11 to 13
    • Primary completion date: May 2021 to Jun 2020
    • Completion date: Aug 2022 to Aug 2020
    • Interventions: ALT-803 + Nivolumab (Drug), ALT-803 + Pembrolizumab (Drug) to ALT-803 + Atezolizumab (Drug), ALT-803 + Avelumab (Drug), ALT-803 + Nivolumab (Drug), ALT-803 + Pembrolizumab (Drug)
    • Eligibility criteria expanded, about 1,203 words
    • Secondary endpoints: 6 to 7
    • Study arms: 2 to 4
    • Study title shortened, about 5 words

    See this version in full on ClinicalTrials.gov ↗

  20. Study sites: 7 to 11v9
  21. Study sites: 3 to 7 Start date changed from estimate of Jun 2018 to Jun 6, 2018v8 Show 1 more changeShow less
    • Start date changed from estimate of Jun 2018 to Jun 6, 2018
  22. Start date: May 2018 to Jun 2018v7
  23. Study sites: 2 to 3v6
  24. Trial status: Not Yet Recruiting to Recruiting Start date: Jan 2018 to May 2018 · Study sites: 1 to 2 · Primary completion date: Jan 2021 to May 2021 · 1 morev5 Show 4 more changesShow less
    • Start date: Jan 2018 to May 2018
    • Study sites: 1 to 2
    • Primary completion date: Jan 2021 to May 2021
    • Completion date: Apr 2022 to Aug 2022
  25. Start date: Oct 13, 2017 to Jan 2018 Trial status: Recruiting to Not Yet Recruiting · Primary completion date: Sep 2020 to Jan 2021 · Completion date: Dec 2020 to Apr 2022 · 2 morev4 Show 5 more changesShow less
    • Trial status: Recruiting to Not Yet Recruiting
    • Primary completion date: Sep 2020 to Jan 2021
    • Completion date: Dec 2020 to Apr 2022
    • Eligibility criteria expanded, about 97 words
    • Site details revised

    See this version in full on ClinicalTrials.gov ↗

  26. Trial status: Not Yet Recruiting to Recruiting Start date changed from estimate of Sep 2017 to Oct 13, 2017 · Site details revisedv3 Show 2 more changesShow less
    • Start date changed from estimate of Sep 2017 to Oct 13, 2017
    • Site details revised
  27. Secondary endpoints revised (6) Study title shortened, about 19 wordsv2 Show 1 more changeShow less
    • Study title shortened, about 19 words

    See this version in full on ClinicalTrials.gov ↗

  1. Study First Submitted
  • Stopped: an ongoing trial was terminated, suspended or withdrawn.
  • Notable: the trial’s plan changed such as a big move in its timeline or size, a new primary endpoint, sponsor or phase, or recruiting opened or resumed.
  • Minor: routine progress and housekeeping, such as sites added or enrollment closed.
ImmunityBio, Inc.
33 trials monitored
See 2 trials at risk
Lung Cancer
4,057 trials monitored
See 217 trials at risk
Non-Small Cell Lung Cancer (NSCLC)
2,932 trials monitored
See 157 trials at risk
Colorectal Cancer
2,920 trials monitored
See 132 trials at risk
and 8 more diseases
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.
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
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov