Phase 2 Head and Neck Cancer Trial, Recruiting

Written by an AI model from the ClinicalTrials.gov eligibility criteria and checked on a sample basis. Please confirm against the original criteria.

Who might be able to join this trial:

• People who have been confirmed (through laboratory testing of tissue or cells) to have squamous cell carcinoma of the oropharynx (throat/tonsil area), or a lump in the upper neck without a known origin that doctors suspect comes from the oropharynx.
• People whose cancer is classified as Stage I, II, or III according to current staging guidelines — but not those with the earliest-stage tumours classified as T1N0 or T2N0 (confirm with trial site).
• People whose treating doctor has determined them to be a candidate for standard treatment, either surgery followed by additional therapy, or a combination of chemotherapy and radiation.
• People who carry a specific genetic marker called HLA-A*0201, confirmed through a blood test at a certified laboratory.
• People whose tumour has tested positive for the HPV16 virus and a specific protein marker (p16INK4A), confirmed through certified laboratory testing.
• People who have a stored tumour tissue sample available, or who are able to provide a new tissue biopsy of adequate size and quality.
• People who are at least 18 years old.
• People who are in generally good physical condition and able to carry out daily activities with no more than mild limitations (as measured by a standard medical scale called ECOG, score of 0 or 1).
• People whose blood tests show healthy bone marrow and organ function, including adequate levels of platelets, haemoglobin, white blood cells, and normal kidney and liver function, as confirmed by laboratory results (confirm specific values with trial site).
• People who agree to use effective contraception (hormonal, barrier methods, or abstinence) before joining the trial and throughout participation. Men must continue contraception for 30 days after the trial ends. Anyone who becomes pregnant or suspects pregnancy during the trial must inform their treating doctor immediately.
• People who are able to understand the trial and are willing to sign an official consent form. A legally authorised representative may sign on behalf of someone who is unable to do so themselves.

Who may not be able to join:

• People who have previously had a bone marrow transplant, stem cell transplant, or solid organ transplant.
• People whose cancer has spread to distant parts of the body (metastases).
• People who have already received radiation therapy or systemic cancer treatment before starting the trial drug.
• People who have been taking corticosteroid medicines (such as prednisone) at doses above 10 mg per day, or other immune-suppressing medicines, within the 14 days before starting the trial drug. Low-dose topical, inhaled, eye, or nasal steroid treatments are generally permitted, as is a low-dose replacement hydrocortisone regimen (confirm with trial site).
• People who have had significant heart problems, including a heart attack or unstable chest pain within the past 16 weeks, serious irregular heart rhythms, uncontrolled high blood pressure, a blood clot, stroke, or mini-stroke within the past 16 weeks, a specific heart electrical abnormality (QTc prolongation), severe heart failure, inflammation around or of the heart muscle, or fluid around the heart.
• People who have serious breathing difficulties, such as a need for supplemental oxygen.
• People who have had significant digestive system problems, including a hole in the gut wall within the past year, serious gut bleeding within the past 3 months, acute pancreatitis within the past 3 months, significant diverticulitis flare-up within the past 4 weeks, or cirrhosis (scarring of the liver).
• People who have an active serious infection requiring intravenous treatment within 7 days before starting the trial drug, or who have not completed a course of treatment for an active infection at least one week before starting.
• People with a known history of hepatitis B or hepatitis C infection, or a positive test for these viruses — except those with fully treated hepatitis C who have been in complete remission and off treatment for more than one year.
• People who have had a second cancer that has not been in remission for more than 2 years. Some exceptions apply, such as certain skin cancers, early-stage cervical conditions, low-risk prostate cancer, or low-risk thyroid cancer (confirm with trial site).
• People who have previously had radiation therapy to the head or neck area.
• People who have had major surgery within 4 weeks before starting the trial drug. A diagnostic needle biopsy or tissue biopsy is not considered major surgery.
• People with a serious underlying health condition that would make it difficult to safely receive the planned treatment.
• People with a known allergy or sensitivity to the components of the trial drug (CUE-101), including recombinant proteins or polysorbate 80.
• People who have received a live virus vaccine within 4 weeks before starting the trial drug. Standard inactivated flu vaccines are generally permitted, and COVID-19 vaccines are permitted up to one week before starting (confirm with trial site).
• People with active or recent uncontrolled alcohol or substance misuse within the 3 months before starting the trial drug.
• People who are pregnant or breastfeeding. Women who could become pregnant must have a negative blood pregnancy test within 72 hours of joining the trial.

Important: Always verify eligibility with the trial site directly before applying.