Phase 2 Head and Neck Cancer Trial, Recruiting

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

Who might be able to join this trial:

• Adults aged 18 or older of any gender
• People who have given written consent to participate in the study
• People diagnosed with a specific type of mouth or throat cancer (squamous cell carcinoma of the oral cavity, oropharynx, hypopharynx, or larynx) that has been confirmed by a tissue test, is not related to HPV (p16 negative), and can be treated with surgery aimed at a cure
• People whose cancer is at stage III or IV but has not spread to distant parts of the body, according to a standard cancer staging system
• People whose general health and ability to carry out daily activities meets a standard medical fitness score (ECOG 0–1), meaning they are fully active or have only minor limitations
• People who are able to provide a fresh tissue sample from the tumour for study testing
• People who are willing to provide blood and saliva samples for the study
• People with no other current cancer (with some exceptions for certain minor or early-stage cancers, or cancers that went into complete remission at least 2 years ago and require no further treatment during the study)
• People whose blood counts, liver, kidney, and other organ function meet specific healthy thresholds set by the trial (confirm with trial site for exact values)
• People who are able to swallow the study medication
• People who agree not to donate blood during the study or for 90 days after the last dose of treatment
• People who agree not to breastfeed during the study or for 90 days after the last dose of treatment
• Women who could become pregnant must have a negative pregnancy test within 72 hours before starting treatment and must agree to use an adequate method of contraception from the screening stage through to 180 days after the last dose of treatment; women who cannot become pregnant (due to age, surgical procedure, or other defined reasons) meet this requirement without needing contraception (confirm specific definitions with trial site)
• Male participants must agree to use an adequate method of contraception from the first dose of treatment through to 180 days after the last dose (note: abstinence is acceptable if that is the person's established and preferred method)
• People who are able to understand the study procedures and are willing to participate

Who may not be able to join:

• People whose cancer has come back or spread to other parts of the body (recurrent or metastatic disease)
• People with locally advanced cancer that cannot be treated with surgery aimed at a cure
• People who have already received any local or systemic treatment for this type of head and neck cancer
• People whose cancer tests positive for HPV (p16 positive)
• People with cancer of the sinuses, nasal cavity, or nasopharynx
• People with squamous cell carcinoma found in neck lymph nodes where the original tumour site is unknown
• People who are already enrolled in another interventional clinical trial
• People who have had major surgery within 3 weeks before starting the study treatment, or who have not yet recovered from surgery
• People who have received an experimental treatment within 4 weeks (or within a certain time period based on how long that treatment stays in the body) before starting study treatment
• People who have had radiation therapy covering more than 20% of the bone marrow within 2 weeks, or any radiation therapy within 1 week, before the study start date
• People with a known allergic reaction to the study drugs (niraparib or TSR-042) or their ingredients
• People who have received a blood transfusion (platelets or red blood cells) within 4 weeks before starting study treatment
• People who have received certain blood cell–stimulating medications within 4 weeks before starting study treatment
• People who have had severe (Grade 3 or 4) low blood counts related to prior chemotherapy that lasted more than 4 weeks
• People with a history of certain serious blood or bone marrow disorders (myelodysplastic syndrome or acute myeloid leukaemia)
• People with a serious uncontrolled medical condition, uncontrolled infection, or certain serious heart, nerve, or psychiatric conditions that are not well managed
• People with known, symptomatic cancer that has spread to the brain or the lining of the brain or spinal cord
• People who had a severe immune-related side effect (Grade 3 or higher) from a previous immunotherapy treatment
• People who have a diagnosed immune system deficiency, or who have taken steroid or other immune-suppressing medications within 7 days before starting study treatment
• People who are currently receiving other cancer treatments, including chemotherapy, experimental drugs, biological therapies, or hormonal therapies
• People with a previous cancer history (with some exceptions for certain minor or early-stage cancers, or cancers fully resolved at least 2 years ago requiring no further treatment)
• People with an active or suspected autoimmune disease (some well-controlled conditions such as type 1 diabetes, thyroid conditions requiring only hormone replacement, or certain skin conditions not needing systemic treatment may still be eligible — confirm with trial site)
• People who require ongoing systemic treatment with corticosteroids above a certain dose, or other immune-suppressing medications, within 14 days of enrolment (inhaled or topical steroids may be permitted — confirm with trial site)
• People with a symptomatic lung condition called interstitial lung disease that could interfere with monitoring for drug-related lung side effects
• People with a known psychiatric condition or substance use disorder that would prevent them from following the study requirements
• People with a known active hepatitis B or hepatitis C infection, or HIV (note: people with HIV who have a normal immune cell count and undetectable viral load may not be excluded — confirm with trial site)
• People who are pregnant or breastfeeding
• People with any other medical condition that, in the treating doctor's opinion, would increase risks or interfere with the study
• People with any condition or history that, in the treating doctor's opinion, might prevent full participation in the trial
• People who have received a live vaccine within 14 days before starting study treatment

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