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:

• Adults aged 18 or older
• People whose doctors estimate they have more than 12 weeks to live
• People who are willing and able to attend scheduled visits, follow the treatment plan, and complete required tests throughout the study
• People who have been diagnosed with malignant melanoma (confirmed by laboratory testing of tissue) that has spread to the brain, with at least one measurable brain tumour spot that is 0.5 cm or larger
• People who have at least one brain tumour spot that has never been treated with targeted radiation (stereotactic radiosurgery), measuring between 0.5 cm and 3 cm, visible on a contrast MRI scan
• People who can provide a stored tumour tissue sample, or who are able to have a tissue biopsy taken during the screening period (note: fine needle aspiration samples are not acceptable; if no tissue is available and a repeat biopsy is not possible, enrolment may still be considered)
• People who have previously had targeted radiation or surgical removal of up to 5 brain tumour spots, as long as they have fully recovered with no lasting nerve-related effects, and untreated measurable spots remain
• People who have had radiation to areas of the body outside the brain (no waiting period required before starting this trial)
• People who have no current neurological symptoms related to their brain tumours, and who have not needed or received steroid medications (taken by mouth or injection) in the 5 days before starting the trial
• People whose general physical health and ability to carry out daily activities meets the study's fitness standard (confirm with trial site)
• People whose organ function — including kidneys, liver, and blood — meets the study's required levels (confirm with trial site)
• Women who could potentially become pregnant must have a negative pregnancy test within 3 days before starting treatment, must not be breastfeeding, and must agree to use an approved method of contraception during treatment and for 5 months after treatment ends
• People whose side effects from any previous cancer treatment have largely resolved before starting this trial (minor or stable ongoing conditions such as hormone replacement for thyroid or other gland problems are generally acceptable)
• People who require low-dose steroids only as a replacement for normal hormone levels the body cannot produce on its own

Who may not be able to join:

• People with a known history of cancer spread to the lining surrounding the brain and spinal cord (leptomeningeal disease)
• People who have had targeted or highly focused brain radiation within 1 week before starting the trial
• People who have previously had targeted radiation to more than 5 brain tumour spots, or who have had whole-brain radiation at any time
• People with any brain tumour spot larger than 3 cm
• People who have previously received checkpoint inhibitor therapy (a type of immunotherapy) for melanoma that had already spread — although people who received certain immunotherapy drugs (ipilimumab and/or anti-PD1) before surgery or after surgery as a preventive treatment may be eligible if at least 6 months have passed since that treatment ended
• People with an active autoimmune disease (conditions where the immune system attacks the body), with some exceptions such as type 1 diabetes, thyroid conditions managed with hormone replacement only, or mild skin conditions not requiring systemic treatment
• People with serious medical, neurological, or psychiatric conditions that the treating team judges would prevent them from safely following the study requirements
• People with a history of a second cancer, unless treatment for that cancer was completed with no signs of return for at least 2 years (some early-stage or surface-level cancers are exempt from this requirement; common skin cancers such as basal cell or squamous cell carcinoma do not need to be removed before starting the trial)
• People with a known history of hepatitis B or hepatitis C, or who test positive for these infections during screening
• People with a known history of HIV infection
• People who have used corticosteroid medications (steroids) within 10 days before starting the trial, unless taken only as a low-dose hormone replacement — other steroid types may require a waiting period (confirm with trial site)
• People who require ongoing treatment with steroids or other immune-suppressing medications at more than a low daily dose within 14 days before starting the trial (inhaled or topical steroids, and low-dose replacement steroids, are generally permitted if there is no active autoimmune disease)
• People who have had a major surgical procedure or significant injury within 14 days before starting the trial, or who are expected to need major surgery during the study (unless wounds have fully healed)
• People with wounds, ulcers, or bone fractures that are not healing
• Women who are pregnant or breastfeeding
• People with an uncontrolled serious illness, such as an active significant infection, or any other ongoing condition that the treating doctor believes could interfere with the study
• People with significant heart disease, heart failure above a mild level, unstable chest pain, new-onset chest pain within the last 3 months, a heart attack within the past 6 months, or a history of heart muscle inflammation (myocarditis)
• People with certain elevated heart-related blood test results (troponin levels), depending on how high they are and whether they remain elevated on repeat testing — a heart specialist may need to review the case before a decision is made (confirm with trial site)
• People who have used another experimental drug within 14 days (or 5 half-lives of that drug, whichever is longer) before starting the trial medications
• People with a history of lung inflammation (pneumonitis) not caused by infection that required steroid treatment, or who currently have pneumonitis

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