Phase 2 Head and Neck Cancer Trial, Recruiting NCT05317000 Sponsor: Barbara Burtness Condition: Head and Neck Cancer
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Phase 2 Head and Neck Cancer Trial, Recruiting

NCT05317000
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:

  • People diagnosed with a specific type of throat cancer (squamous cell carcinoma of the oropharynx) that can be surgically removed, confirmed by a tissue or cell sample from the tumor or a nearby lymph node.
  • People whose cancer is at an early-to-moderate stage (T1-T3, N0-N2, M0 based on a standard cancer staging system), and where the cancer is linked to the HPV virus.
  • People whose cancer has been confirmed as suitable for surgery by a surgeon involved in the trial, which may include a scope examination of the throat and airways.
  • People who are able to provide additional small tissue samples (biopsies) for research purposes, either in a clinic or during a scope procedure.
  • People whose cancer has tested positive for HPV using a specific laboratory test (called p16 testing) that shows a particular staining pattern in at least 70% of the tumor cells.
  • People aged 18 or older, with no upper age limit, provided general health is adequate.
  • People who are in good general health and able to carry out normal daily activities, with only minor limitations at most (as measured by a standard medical health scale called ECOG 0 or 1).
  • People whose blood counts, liver function, kidney function, and protein levels fall within acceptable ranges as measured by standard blood tests (confirm specific values with the trial site).
  • Women who could become pregnant must have a negative pregnancy test taken within 24 hours before starting treatment (or up to 72 hours before in certain circumstances).
  • People who are willing and able to sign a written consent form agreeing to take part in the trial.

Who may not be able to join:

  • People for whom throat surgery performed through the mouth would be medically unsafe.
  • People who are taking full-dose blood-thinning (anticoagulant) medication.
  • People who currently have another active cancer, or who have had another cancer within the past two years — though some exceptions may apply, such as certain hormone-sensitive breast or prostate cancers, previously removed non-melanoma skin cancers, previously removed cervical cancer, or a type of brain covering tumour called a meningioma (confirm with trial site).
  • People who are unable to give informed consent.
  • People who have already received chemotherapy, radiation therapy, or major surgery for the cancer being studied in this trial.
  • Women who are pregnant or breastfeeding.
  • People with an active autoimmune disease (where the immune system attacks the body), those who have taken high-dose steroid medications within the past 7 days, or those who have known allergies or medical reasons to avoid the drugs used in this trial.

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 23 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: Barbara Burtness, MD, Yale University

Phone: (203) 785-4095

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
Sponsor
Barbara Burtness
Registry
ClinicalTrials.gov
Start date
23 March 2023
Est. completion
30 June 2028

Where this trial is recruiting

🇺🇸 United States

Primary endpoints

Increased response for combination therapy compared with either monotherapy

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: 23 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