Phase 2 Ovarian 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 diagnosed (confirmed by lab testing of tissue or cells) with one of these advanced cancers that cannot be removed by surgery with the aim of a cure: triple-negative breast cancer (TNBC), head and neck squamous cell cancer (of the mouth, throat, voice box, or related areas), high-grade ovarian, fallopian tube, or peritoneal cancer, or kidney cancer (RCC). People with head and neck cancer who are scheduled for surgery aimed at a cure may also be eligible.
• People whose cancer type meets specific prior treatment requirements — these vary depending on the cancer type and the treatment group being considered, and the trial site would be best placed to confirm which applies (confirm with trial site).
• People whose last cancer treatment was completed at least 4 weeks before the first planned dose of the trial treatment.
• People who have been fully vaccinated against COVID-19, with the final dose at least 14 days before the first trial treatment dose — though those who declined or were not eligible for COVID-19 vaccination may also be considered.
• People who have recovered from most side effects of previous cancer treatments, with any remaining effects being mild (Grade 1 or lower), not counting hair loss.
• People who have at least one tumour that can be measured on a CT or MRI scan (for most treatment groups).
• People who are willing to provide a tumour tissue sample before treatment, and ideally after treatment, where this is safely possible — those in the head and neck surgery group must provide a tissue sample before treatment and agree to have the removed tumour analysed.
• People who are 18 years of age or older.
• People who are expected to live for more than 6 months.
• People who are generally able to carry out daily activities with no or minimal limitation (as assessed by a standard performance scale used in cancer care).
• People whose blood test results show that the kidneys, liver, and blood cell counts are functioning within acceptable levels, as defined by the trial.
• People who are willing and able to give written consent to take part in the trial before any trial-related procedures begin.
• Women who could become pregnant must have a negative pregnancy test at the screening stage and again within 7 days before the first treatment, must not be breastfeeding, must not be planning to become pregnant during the trial, and must agree to use highly effective contraception before joining, throughout the trial, and for at least 4 months after stopping the trial vaccine alone, or 5 months after stopping if used with a checkpoint inhibitor (or longer if the product guidelines require it).
• Men who could father a child must agree to use highly effective contraception throughout the trial and for at least 4 months after stopping the trial vaccine alone, or 5 months if used with a checkpoint inhibitor (or longer if the product guidelines require it).
• People who are willing and able to attend scheduled visits and follow all trial procedures.
• People being considered for the checkpoint inhibitor (CPI) combination group must not have previously received CPI therapy, must have been assessed by a clinician as a suitable candidate, and the checkpoint inhibitor drug must be considered appropriate for their cancer according to the drug's approved guidelines.

Who may not be able to join:

• People whose cancer has spread to the brain and is causing symptoms, or who have cancer affecting the lining of the brain or spinal cord.
• People currently taking steroid medications at doses above 10 mg per day of prednisolone (or an equivalent), or taking any other immune-suppressing medications within 2 weeks before the first trial dose — low-dose steroids for conditions like adrenal insufficiency, asthma inhalers, or stable thyroid hormone replacement are generally permitted.
• People who have had a different cancer in the 2 years before screening, with some exceptions for certain low-risk cancers such as early-stage skin cancer, early cervical changes, or low-risk prostate cancer (confirm with trial site).
• People who are pregnant, breastfeeding, or planning to conceive or father a child during the trial period.
• People with serious uncontrolled health conditions, including uncontrolled infections, uncontrolled diabetes, significant lung disease, active liver disease, or uncontrolled bleeding risk.
• People with serious heart conditions, including moderate-to-severe heart failure, a heart attack or stroke within the past 6 months, significant abnormal heart rhythms, uncontrolled high blood pressure, or other significant heart or blood vessel problems.
• People whose blood shows equivocal or positive levels of anti-CCP antibodies (a marker sometimes associated with joint inflammation), or who have an active autoimmune disease that the trial doctor believes could interfere with the treatment.
• People who have received a live vaccine within 28 days, or a flu vaccine within 14 days, before the first trial treatment dose.
• People with a known history of HIV, active hepatitis B, or active hepatitis C.
• People who received a COVID-19 vaccine within 14 days before the first trial treatment dose.
• People with a known current or recent history (within the past year) of substance misuse, including illicit drugs or alcohol.
• People who have a history of severe skin reactions to a drug, or severe immune-related reactions that required dose changes (this applies specifically to the kidney cancer combination group).
• People who are known to be allergic to the trial treatment or any of its ingredients — and, where a checkpoint inhibitor is also planned, people with a known allergy to that drug or its ingredients.

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