Phase 2 Head and Neck Cancer Trial, Recruiting NCT05544136 Sponsor: Memorial Sloan Kettering Cancer Center Condition: Head and Neck Cancer
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Phase 2 Head and Neck Cancer Trial, Recruiting

NCT05544136
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 who have a confirmed diagnosis of squamous cell carcinoma (a type of cancer) in the head and neck area — but not cancers starting in the nasopharynx, nasal cavity or sinuses, mouth, salivary glands, thyroid, or skin
  • People whose cancer's original location is unknown, but who have visibly enlarged lymph nodes detected on scans, with tissue confirmation through biopsy
  • People whose cancer is in the oropharynx (throat area) or of unknown origin, where a specific protein marker called P16 has tested negative
  • People whose cancer is in the hypopharynx or voice box (larynx), regardless of their P16 test result
  • People whose cancer is at a certain stage — not too advanced and with no sign of spread to distant parts of the body, based on a specialised scan called a PET/CT (confirm with trial site for exact staging details)
  • People aged 18 or older
  • People who have not previously received radiation therapy or chemotherapy for this head and neck cancer
  • People whose primary tumour was surgically removed but who still have visibly enlarged lymph nodes detectable on scans
  • People with a reasonable level of general physical functioning, as measured by a standard performance scale (confirm with trial site)
  • People who have had a CT or MRI scan of the neck with contrast dye
  • People whose blood test results within the past 30 days show the bone marrow is producing enough blood cells (specific minimum levels apply — confirm with trial site)
  • People whose kidney function tests within the past 30 days meet the required minimum levels (specific thresholds apply — confirm with trial site; those with reduced kidney function may still be considered for a modified treatment approach)
  • People whose liver function tests within the past 30 days meet the required minimum levels (specific thresholds apply — confirm with trial site)
  • Women who could potentially become pregnant must have a negative blood pregnancy test within 14 days before joining
  • People (or their legal representative) who are willing and able to provide informed consent before joining the trial

Who may not be able to join:

  • People whose cancer originated in the nasopharynx, nasal cavity or sinuses, mouth, salivary glands, thyroid, or skin
  • People whose cancer is at a more advanced stage (T4 or N3 classification — confirm with trial site)
  • People who have previously had radiation therapy to the head or neck area
  • People who have previously received chemotherapy specifically for this head and neck cancer (prior chemotherapy for a completely different, unrelated cancer may be acceptable — confirm with trial site)
  • People who have had chemotherapy or radiation therapy of any kind within the past three years
  • People who have had surgery to remove the same cancer, other than a biopsy or removal of the primary tumour while enlarged lymph nodes are still present on scans
  • People who have had another type of invasive cancer in the past, unless they have been cancer-free for at least 3 years, or unless that previous cancer has a very high estimated cure rate (confirm with trial site)
  • People who have another cancer occurring at the same time, outside the throat area (exceptions may be considered by the trial doctors — confirm with trial site)
  • People who are pregnant or breastfeeding
  • People with serious active health conditions, including:
    • Unstable chest pain or heart failure that required hospitalisation in the last 6 months
    • A serious heart attack (affecting the full thickness of the heart wall) in the last 6 months
    • An active serious bacterial or fungal infection currently being treated with intravenous antibiotics
    • A flare-up of a chronic lung condition, or another breathing problem, that required hospitalisation or would prevent participation in the trial within the last 30 days
    • Serious liver disease causing visible yellowing of the skin or eyes, or blood clotting problems

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: Zeinab Abou Yehia, MD, Memorial Sloan Kettering Cancer Center

Phone: 212-639-3960

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
12 September 2022
Est. completion
12 March 2027

Where this trial is recruiting

🇺🇸 United States

Primary endpoints

Number of participants alive post-Chemo Radiation Therapy

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