Phase 2 Head and Neck Cancer Trial, Recruiting
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 been diagnosed (confirmed by laboratory testing of tissue) with stage IV Head and Neck Squamous Cell Carcinoma, Neuroendocrine Tumors, or Soft Tissue Sarcoma, and who have had surgery aimed at fully removing the cancer.
- People whose surgical tissue sample was successfully collected and sent to the specialist laboratory, and whose sample met all required quality standards.
- People who have no detectable cancer remaining, confirmed by a CT scan or MRI of the chest, abdomen, and pelvis done within 60 days before joining the trial.
- People who, after surgery, have no standard follow-up treatment available and would normally only be monitored by their doctors.
- People who have fully recovered from any side effects caused by their surgery.
- People aged 18 years or older.
- People who are generally well and able to carry out daily activities, as measured by a standard medical scale (ECOG score of 0 or 1 — meaning fully active or able to do light work).
- People whose blood counts, liver function, and kidney function all fall within acceptable ranges as determined by blood tests (confirm with trial site for specific values).
- People aged 70 or older whose heart is pumping at 55% efficiency or above, confirmed by an ultrasound of the heart.
- People who are willing and able to use a highly effective form of contraception from the time of signing consent until three months after the trial ends (this applies to women who could become pregnant and to all men). Complete abstinence may be acceptable if the treating doctor agrees this is reliably maintained.
- People who are willing and able to give written consent to participate in the study.
Who may not be able to join:
- People who still have detectable cancer remaining after surgery.
- People who had their surgery more than 90 days before enrolling in the trial.
- People who have had another type of cancer in the past 5 years, with the exception of certain treated skin cancers or cervical carcinoma in situ that was fully removed by surgery.
- People who have a history of immune system deficiency, whether present from birth or developed later, including anyone who has had an organ transplant.
- People who test positive for Hepatitis B (beyond vaccination markers), Hepatitis C, HIV, or syphilis, based on blood tests done within 30 days before any laboratory procedures for the trial.
- People who are pregnant or breastfeeding.
- People who have taken part in another clinical trial using an experimental treatment within the 30 days before screening for this trial.
- People who have an active inflammatory or autoimmune condition that requires or may require treatment with steroids or other immune-suppressing medicines.
- People for whom the blood collection procedure used in this trial (leukapheresis, where white blood cells are separated from the blood) is considered medically unsuitable. People aged 70 or older must also be cleared by a heart specialist before undergoing this procedure.
- People with any serious uncontrolled illness, including active infections, heart failure, unstable chest pain, heart rhythm problems, or significant mental health or personal circumstances that could affect their safety or ability to follow the trial requirements.
- People who do not wish to give written informed consent.
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.
Contact this trial
Principal Investigator: Laura Ridolfi, MD, Istituto Scientifico Romagnolo per lo Studio e la Cura dei Tumori (IRST)
Phone: +39 0543739266
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
Where this trial is recruiting
Primary endpoints
Incidence of Treatment-Emergent Adverse Events; Immunological efficacy
Can't join this trial?
Data last synced from ClinicalTrials.gov: 13 July 2026. Trial status can change. Always verify current status directly with the trial site before making any decision.