Phase 2 Head and Neck Cancer Trial, Recruiting NCT04166006 Sponsor: Istituto Romagnolo per lo Studio dei Tumori Dino Amadori IRST S.r.l. IRCCS Condition: Head and Neck Cancer
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Phase 2 Head and Neck Cancer Trial, Recruiting

NCT04166006
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 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.

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 13 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: 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

Status
Recruiting
Phase
Phase 2
Sponsor
Istituto Romagnolo per lo Studio dei Tumori Dino Amadori IRST S.r.l. IRCCS
Registry
ClinicalTrials.gov
Start date
12 December 2019
Est. completion
1 April 2027

Where this trial is recruiting

🇮🇹 Italy

Primary endpoints

Incidence of Treatment-Emergent Adverse Events; Immunological efficacy

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: 13 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