Phase 2 Head and Neck Cancer Trial, Recruiting NCT07392580 Sponsor: University of Miami Condition: Head and Neck Cancer
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Phase 2 Head and Neck Cancer Trial, Recruiting

NCT07392580
Recruiting Phase 2

Who may be able to join

AI generated eligibility summary. Written by an AI model from the official source data and checked on a sample basis. It can contain mistakes, so confirm anything important against the original source. How we use AI

Who might be able to join this trial:

  • Adults aged 18 or older, of any gender
  • People who have previously been treated for squamous cell cancer of the voice box (larynx) with radiation therapy
  • People who have cancer that has come back, confirmed by a tissue sample (biopsy) — if no stored tissue sample is available, a new biopsy may be taken as part of standard care to confirm the diagnosis
  • People who are willing to receive 3 weekly rounds of chemotherapy given under local anaesthetic before surgery
  • People whose blood, liver, and kidney function test results fall within the acceptable ranges required by the trial, tested within 6 weeks before treatment starts (confirm specific values with the trial site)
  • Women who are not able to become pregnant (due to surgical removal of the uterus and/or ovaries, or who are at least 45 years old with no menstrual period for 12 or more months)
  • Women who could potentially become pregnant, provided a pregnancy test at the start of the trial is negative, and a highly effective method of contraception (at least 99% effective) is used from the start of the trial through to at least 14 months after the last dose of trial treatment

Who may not be able to join:

  • People who are unable to tolerate being awake and without sedation during procedures on the voice box (a mild sedative tablet may be offered beforehand)
  • People who are unable to receive contrast dye (used in certain scans)
  • People currently receiving other cancer treatments, such as chemotherapy, radiation, immunotherapy, or other investigational therapies
  • People who have received certain cancer treatments too recently before the trial start date — the required waiting periods vary by treatment type (confirm specific timeframes with the trial site)
  • People who have not adequately recovered from a major surgery or its complications
  • People who have had another cancer within the last 3 years, unless it was a type considered fully cured and low-risk (such as certain skin cancers or early-stage cervical changes — confirm with the trial site)
  • People with significant uncontrolled medical conditions affecting the kidneys, liver, blood, digestive system, hormones, lungs, nerves, or mental health
  • People with an ongoing serious infection currently requiring antibiotic, antifungal, or antiviral treatment, or who have received a live vaccine within 30 days of the trial dosing date
  • People with a known HIV infection or a positive HIV test result (note: HIV testing for this trial is optional)
  • People with moderate to severe heart failure (New York Heart Association Class II to IV)
  • People with uncontrolled or symptomatic irregular heart rhythm, a stroke within the last 6 months, liver cirrhosis, or an autoimmune condition requiring immune-suppressing medications or long-term steroid use above a certain dose
  • People who are currently pregnant or breastfeeding
  • People whose overall condition, in the view of the trial doctor, would interfere with safe participation, attending required visits, or the reliability of trial results
  • People who do not have the capacity to make informed decisions about their own participation

Important: Always verify eligibility with the trial site directly before applying.

Based on publicly available eligibility criteria from ClinicalTrials.gov. Verify directly with the trial site before acting. This is not medical advice.

This is a simplified plain English summary of the eligibility criteria. Full criteria are set by the trial investigators and may include additional requirements not shown here. Never self-exclude from a trial based on this summary. Contact the trial site directly to confirm your eligibility.
Last synced 26 July 2026
Phase 2: approximately ~30% of drugs entering this phase reach regulatory approval, based on published industry-wide historical data. This is not specific to this trial.
Phase success rates shown are historical industry-wide averages based on published data. They are not a prediction for this specific trial or your individual situation.

Contact this trial

Principal Investigator: David Rosow, MD, University of Miami

Phone: +1 (305) 2432587

Contact details sourced from ClinicalTrials.gov. Verify directly with the trial site before attending.

GP referral letter

Print a one-page summary to share with your doctor.

Trial details

Status
Recruiting
Phase
Phase 2
Registry
ClinicalTrials.gov
Start date
1 September 2026
Est. completion
1 September 2031

Where this trial is recruiting

🇺🇸 United States

Primary endpoints

Overall Pathologic Response Rate (OPRR)

Can't join this trial?

Expanded access pathways

If this trial is not available to you, other access pathways may exist. In Australia, the TGA Special Access Scheme allows access to unapproved therapeutic goods for individual patients.

TGA Special Access Scheme information

Find other recruiting trials on ClinicalTrials.gov

Data last synced from ClinicalTrials.gov: 26 July 2026. Trial status can change. Always verify current status directly with the trial site before making any decision.

Trial recruitment status can change without notice between our nightly data updates. Always contact the trial site directly to confirm current recruitment status before making any decisions or travel arrangements.

View original record on ClinicalTrials.gov