Skip to content
DataLookout
Start free
Menu

NCT04852328

Three Schedules of CUE-101 Administered Before Surgery or Definitive Chemoradiation Therapy in HLA-A*0201 Positive Patients With Locally Advanced, HPV16-Positive Oropharyngeal Squamous-Cell Carcinoma

StatusActive, Not Recruiting
PhasePhase 2
Primary completion (estimated)
Track this trial

Free. We email you which fields changed when ClinicalTrials.gov updates this record.

Record History

All 17 versions: 14 with changes below, 3 re-verified with no change. See every version on ClinicalTrials.gov ↗

  1. Eligibility criteria expanded, about 39 words Show 5 more changesShow less
    • Enrollment closed, study ongoing
    • Primary and study completion moved earlier from Oct 31, 2027 to Jul 6, 2027
    • Enrollment target: estimated 30 to confirmed 28
    • Secondary endpoints: details revised at 3 of 9 entries
    • Site details revised
  2. Site contact updatedv16
  3. Site contact updatedv15
  4. Eligibility criteria shortened, about 13 words
    • Primary endpoints: 6 to 8
    • Secondary endpoints: 5 to 9
    • Site contact updated
    v13
  5. Primary and study completion dates: Oct 31, 2025 to Oct 31, 2027v12
Show 8 earlier versionsHide 8 earlier versions
  1. Eligibility criteria shortened, about 2 wordsv9
  2. Primary and study completion dates: Oct 31, 2024 to Oct 31, 2025v8
  3. Eligibility criteria expanded, about 10 words
    • Site contact updated
    v7
  4. Trial status: Not Yet Recruiting to Recruiting
    • Primary and study completion dates: Sep 30, 2024 to Oct 31, 2024
    • Start date changed from estimate of Nov 30, 2021 to Dec 6, 2021
    • Site details revised
    v6
  5. Eligibility criteria revisedv5
  6. Start date: Sep 30, 2021 to Nov 30, 2021
    • Primary and study completion dates: Jul 31, 2024 to Sep 30, 2024
    v4
  7. Start date: Jul 31, 2021 to Sep 30, 2021
    • Primary and study completion dates: May 31, 2024 to Jul 31, 2024
    v3
  8. Eligibility criteria expanded, about 2 wordsv2
  1. Study First Submitted
  • Notable: the plan changed
  • Minor: routine updates

Endpoints

Primary

Number of treatment-related adverse events
Timeframe: From start of treatment through 12 months after the completion of standard of care treatment (estimated to be 15 months)
Number of adverse events
Timeframe: From start of treatment through 12 months after the completion of standard of care treatment (estimated to be 15 months
Treatment-related delays in start of standard of care therapy
Timeframe: From start of treatment through start of standard of care therapy (estimated to be 2 weeks)
Change in frequency of HPV16 E711-20-specific CD8+ T cells in peripheral blood samples
Timeframe: Through 12 month follow-up
Change in frequency of HPV16 E711-20 tetramer-positive cytotoxic T cell lymphocytes
Timeframe: Through 12 month follow-up
Change in frequency of HPV16 E711-20-specific CD8+ T cells in tumor samples
Timeframe: Baseline, day -2 or -1 before start of standard of care therapy
Activation markers of HPV16 E711-20 tetramer-positive cytotoxic T cell lymphocytes
Timeframe: Through 12 month follow-up
Proliferative status of HPV16 E711-20 tetramer-positive cytotoxic T cell lymphocytes
Timeframe: Through 12 month follow-up

Secondary (9)

Pathological tumor response
Objective response rate (ORR)
Change in area under the concentration-time curve (AUC) of serum PK parameters
Change in Cmax of serum PK parameters
Change in Terminal elimination half-life(t1/2) of serum PK parameters
Show 4 moreShow less
Number of participants who relapse
Number of participants who die summarized by cause of death
Progression-free survival (PFS)
Overall survival (OS)

Arms and interventions

Schedule A: CUE-101Experimental

* In Schedule A, CUE-101 will be administered during the neoadjuvant phase as a single dose given 14 days prior to initiation of standard of care (SOC) therapy. * Standard of care therapy consists of surgery and postoperative adjuvant (cisplatin) and radiation therapy or cisplatin and radiation therapy (definitive-chemoradiation therapy)

Schedule B: CUE-101Experimental

* In Schedule B, CUE-101 will be administered during the neoadjuvant phase as two doses: one dose given 14 days and one dose given 7 days prior to initiation of standard of care (SOC) therapy. * Standard of care therapy consists of surgery and postoperative adjuvant (cisplatin) and radiation therapy or cisplatin and radiation therapy (definitive-chemoradiation therapy)

Schedule C: CUE-101Experimental

* In Schedule C, CUE-101 will be administered during the neoadjuvant phase as a single dose given 7 days prior to initiation of standard of care (SOC) therapy. * Standard of care therapy consists of surgery and postoperative adjuvant (cisplatin) and radiation therapy or cisplatin and radiation therapy (definitive-chemoradiation therapy)

Drugs: CUE-101

Sites

1 site in 1 country

  • Washington University School of MedicineSt Louis, Missouri, United States