Phase 1 Head and Neck Cancer Trial, Recruiting NCT06589609 Sponsor: BlueSky Immunotherapies GmbH Condition: Head and Neck Cancer
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Phase 1 Head and Neck Cancer Trial, Recruiting

NCT06589609
Recruiting Phase 1

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 to 65 who have been newly diagnosed with a specific type of throat cancer (oropharyngeal squamous cell carcinoma) that has tested positive for both p16 and HPV16, and has reached an advanced but locally contained stage (confirm specific staging details with trial site)
  • People whose cancer has not spread to distant parts of the body (secondary HPV16-positive tumours are allowed)
  • People whose main tumour can be reached for a tissue sample and for direct injection as part of the treatment
  • People who are in reasonably good general health, able to carry out normal activity with only minor limitations (confirm with trial site)
  • People with a life expectancy of at least 6 months
  • People with a normal or near-normal heart tracing (ECG) at the screening stage
  • Women who could potentially become pregnant must have a negative blood pregnancy test at the start of the study
  • People who agree to use reliable contraception for the full duration of the study treatment
  • People who are willing and able to provide written consent to participate

Who may not be able to join:

  • People whose cancer has already spread to distant parts of the body
  • People who have another active cancer that is not related to HPV16
  • People with a history of any other cancer, unless it was fully cleared at least 2 years before joining and no further treatment for it is needed during the study
  • People with significantly abnormal blood, kidney, or liver test results that cannot be explained by their current illness
  • People who have had any vaccine within 1 week before the study start date
  • People who have had an active significant viral infection (such as flu, CMV, or EBV) within 4 weeks before starting the study treatment
  • People who have hepatitis B, hepatitis C, HIV, or any other condition that weakens the immune system
  • People who have had a flu-like illness within 4 weeks before the study start date
  • People with a known allergy or sensitivity to Tamiflu or any of its ingredients
  • People who are pregnant or breastfeeding
  • People with a serious ongoing illness, including an active infection requiring treatment
  • People with confirmed or suspected lupus, thyroid inflammation, inflammatory bowel disease (including Crohn's disease), or multiple sclerosis
  • People who are taking medications that suppress the immune system, including ongoing steroid tablets, certain anti-rheumatic drugs (such as azathioprine, methotrexate, or cyclosporine), or biological therapies (such as infliximab or adalimumab) — steroid eye drops or ear drops are allowed
  • People who have had major surgery within 4 weeks before the study start date
  • People with significant ongoing heart, liver, or kidney disease, or a history of serious unstable conditions such as heart failure, heart attack, or severe irregular heartbeat
  • People who have taken part in another clinical trial or used an experimental drug within 2 months before the study start date
  • People who, in the treating doctor's judgement, may not be able to participate safely or may affect the study results
  • People who are unable to follow the study's requirements

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 29 July 2026
Phase 1: approximately ~10% 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

Phone: +43140400

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 1
Sponsor
BlueSky Immunotherapies GmbH
Registry
ClinicalTrials.gov
Start date
23 August 2024
Est. completion
1 November 2027

Where this trial is recruiting

🇦🇹 Austria

Primary endpoints

Frequency and severity of adverse events (AEs)

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: 29 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