Phase 2 Head and Neck Cancer Trial, Recruiting NCT06385080 Sponsor: Janssen Research & Development, LLC Condition: Head and Neck Cancer
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Phase 2 Head and Neck Cancer Trial, Recruiting

NCT06385080
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:

  • You have been diagnosed with head and neck squamous cell carcinoma (a type of cancer in the throat, mouth, or voice box area) that has come back or spread, and cannot be cured with local treatments — OR (for one specific group) you have a locally advanced form of this cancer that doctors believe can be treated with surgery
  • Your cancer started in one of these areas: the oropharynx (back of the throat), oral cavity (mouth), hypopharynx (lower throat), or larynx (voice box), depending on which group of the trial you are being considered for
  • Depending on your group, your cancer may need to have been tested for p16 (a protein marker) and shown a negative result, OR tested positive for HPV (a virus linked to some cancers)
  • You may be asked to provide results of a PD-L1 test (a marker that can affect how cancer responds to certain treatments), if those results are available
  • For one specific group (Cohort 6), your cancer must be at Stage III or IVa and must be removable by surgery
  • Your cancer must be measurable or detectable on scans, depending on which group you are in
  • Any side effects from previous cancer treatments should have largely cleared up before starting this trial (with some exceptions, such as hair loss or mild nerve tingling)
  • You must be in reasonably good general health, able to carry out normal daily activities (confirm with trial site)
  • Your blood counts and organ function must meet minimum levels, including: hemoglobin (a measure of red blood cells) of at least 9 g/dL, a sufficient number of white blood cells, and platelets at an adequate level — and you must not have had a blood transfusion or certain blood-boosting treatments in the 7 days before your blood test

Who may not be able to join:

  • You have a serious lung condition such as interstitial lung disease, pneumonitis (lung inflammation), or pulmonary fibrosis (lung scarring), or these conditions cannot be ruled out from your scan results
  • You have cancer that has spread to the brain or spinal cord and has not been treated with surgery or radiation
  • You have a history of significant heart or cardiovascular (heart and blood vessel) disease
  • You have received chemotherapy, targeted therapy, immunotherapy, or any other experimental cancer treatment within the past 2 to 4 weeks before starting the trial (the exact timeframe depends on the treatment)
  • You have received radiation therapy for symptom relief within the 7 days before starting the 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 2 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.

GP referral letter

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Trial details

Status
Recruiting
Phase
Phase 2
Registry
ClinicalTrials.gov
Start date
22 April 2024
Est. completion
27 December 2027

Where this trial is recruiting

🇨🇳 China 🇫🇷 France 🇩🇪 Germany 🇯🇵 Japan 🇲🇾 Malaysia 🇵🇱 Poland 🇰🇷 South Korea 🇪🇸 Spain 🇹🇼 Taiwan 🇬🇧 United Kingdom 🇺🇸 United States

Primary endpoints

Cohorts 1, 2, 3B, 4 and 5: Objective Response Rate; Cohort 3A: Number of Participants With Dose-limiting Toxicities (DLT); Cohort 3A: Number of Participants With Treatment-emergent Adverse Events (TEAEs) as a Measure of Severity; Cohort 6: Major Pathologic Response (MPR)

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: 2 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