Phase 2 Melanoma 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:

• People who have been confirmed by biopsy to have stage III or IV melanoma (not uveal/eye melanoma) that cannot be surgically removed, has come back, or has spread to other parts of the body.
• People who have been confirmed by biopsy to have squamous cell cancer of the head and neck (in the oropharynx, mouth, hypopharynx, or larynx) that has either come back and cannot be cured with radiation or surgery, or has spread to other parts of the body. (Cancers originating in the nasopharynx or from an unknown primary site are not eligible.)
• For people with oropharyngeal (throat) cancer, HPV or p16 status must be known before joining.
• People whose cancer can be measured on scans at the time of starting treatment.
• People whose cancer got worse during or within 12 weeks after finishing a type of immunotherapy called a PD-1 checkpoint inhibitor, which they must have received for at least 6 weeks.
• People with HIV who are on anti-retroviral (HIV) medication and whose virus level was undetectable within the past 6 months.
• People with chronic hepatitis B whose virus level was undetectable within the past 28 days.
• People with a history of hepatitis C who have no detectable virus within the past 28 days.
• People who have recovered from side effects of any previous cancer treatment to a mild or baseline level.
• People aged 18 or older.
• People who are well enough to carry out light activity (rated 0 or 1 on a standard performance scale used by doctors).
• People with adequate heart function (rated class 2B or better on a standard heart health scale).
• People who are able to swallow capsules whole, without breaking, crushing, opening, chewing, or dissolving them.
• People who are not pregnant or breastfeeding, and people of reproductive potential who have agreed to use effective contraception throughout the study.
• People who have a suitable tumour tissue sample available from after their cancer stopped responding to immunotherapy, OR who are willing and able to have a tumour biopsy taken during the trial (under specific safety conditions).
• People who agree to provide a blood sample for genetic analysis.
• People who have been given the opportunity to participate in specimen banking.
• People who have been fully informed about the trial and have signed a consent form.
• People with reduced decision-making capacity may still be eligible, as long as their condition does not prevent them from safely taking part (for example, being able to track pill-taking and report side effects).

Who may not be able to join:

• People who have an active infection that requires treatment with systemic (whole-body) medication (except for managed HIV, hepatitis B, or hepatitis C as described above).
• People who have had a heart attack or a blood clot requiring blood thinners within the past 90 days, unless their condition is now stable and being managed medically.
• People who have received more than one prior course of radiotherapy (given with curative or preventative intent) to the head and neck mucosal area; specific waiting periods between finishing radiotherapy and joining the trial also apply.
• People who have previously received anti-VEGF therapies (a specific type of targeted cancer treatment) for any reason.
• People with known significant organ problems that, in the treating doctor's opinion, may make the combination treatment unsuitable.
• People with a malabsorption syndrome (a condition that prevents the body from properly absorbing nutrients and medications from food).
• People with an active autoimmune disease being treated with high-dose steroids or other immune-suppressing drugs (certain exceptions apply, such as type 1 diabetes, hormone-only conditions, or skin conditions not needing systemic treatment).
• People who have received an organ transplant from a donor.
• People who have coughed up significant amounts of bright red blood, or had tumour-related bleeding, within the past 90 days.
• People whose cancer invades major blood vessels (such as the carotid artery), as confirmed by imaging.
• People with cavitary (hollow) lung metastases located near the centre of the lung, as confirmed by imaging.
• People with any prior history of bleeding related to their current head and neck cancer.
• People who have had prior carotid artery bleeding.
• People who currently require certain blood-thinning medications such as warfarin, dabigatran, betrixaban, or clopidogrel. (Some lower-risk blood thinners may be permitted — confirm with the trial site.)
• People with uncontrolled high blood pressure in the 28 days before joining (specifically, systolic blood pressure above 150 mmHg and/or diastolic above 90 mmHg). People with controlled blood pressure on medication may still be eligible.
• People with another cancer whose history or treatment could interfere with assessing the safety or effectiveness of this trial, in the treating doctor's opinion.
• People (at the treatment registration step) who have received experimental drugs or certain antibody treatments within the past 28 days.
• People (at the treatment registration step) who have received surgery, chemotherapy, radiation, biological agents, or steroids within the past 14 days.
• People (at the treatment registration step) who have received a live, attenuated vaccine within the past 30 days. (mRNA or viral vector COVID-19 vaccines are permitted.)
• People (at the treatment registration step) who have taken certain strong medications that interact with the study drug (CYP3A4 inducers such as rifampin, carbamazepine, St. John's wort, or strong CYP3A4 inhibitors such as ketoconazole or grapefruit juice) within a defined period before starting treatment.
• People (at the treatment registration step) whose blood test results do not meet the required levels for white blood cells, platelets, liver function, or kidney function.

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