Phase 1 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:

Safety Cohort (for people with various solid tumours):

• People who have advanced, spread, or inoperable solid tumours that have continued to grow despite standard treatments (people with melanoma and kidney cancer will make up roughly 30% of this group)
• People who have between 1 and 4 tumour sites that doctors believe can be safely treated with radiation
• People aged 18 or older
• People who are in good general health and able to carry out normal daily activities with little or no limitation (confirmed by a doctor using a standard health scale)
• People whose blood counts and organ function (including white blood cells, platelets, liver enzymes, bilirubin, and kidney function) fall within acceptable ranges as determined by blood tests
• People who have at least one tumour that can be clearly measured (at least 1 cm) using a CT scan, MRI, or physical examination
• People who are able to understand and are willing to sign a consent form
• Women who could become pregnant must have a negative pregnancy test within 24 hours before starting treatment, must not be breastfeeding, and must agree to use contraception for around 155 days after treatment ends
• Men who are sexually active with women who could become pregnant must agree to use contraception and avoid donating sperm for around 215 days after treatment ends

Efficacy Cohort (for people with melanoma that has stopped responding to certain immunotherapy):

• People with melanoma whose cancer has stopped responding to treatments that target the PD-1 or PD-L1 pathways (a type of immunotherapy)
• People who have between 1 and 4 tumour sites that doctors believe can be safely treated with radiation
• People aged 18 or older
• People who are in good general health and able to carry out normal daily activities with little or no limitation
• People whose blood counts and organ function fall within acceptable ranges, as described above for the Safety Cohort
• People who have at least one tumour that can be clearly measured (at least 1 cm) using a CT scan, MRI, or physical examination
• People who are able to understand and are willing to sign a consent form

Who may not be able to join:

• People with cancer that has spread to the brain or spinal cord, unless the brain metastases have been treated (with radiation or surgery) and have been stable for at least 4 weeks, and the person has been off steroid medications for at least 2 weeks (confirm with trial site)
• People currently taking part in another clinical trial involving an experimental treatment
• People who have had a serious allergic reaction to medications similar to the study drugs (nivolumab or BMS-986253)
• People with an active autoimmune disease (conditions where the immune system attacks the body), although some exceptions apply — for example, people with type 1 diabetes, an underactive thyroid managed with hormone replacement, or mild skin conditions like vitiligo may still be considered
• People with serious or uncontrolled heart conditions, including a heart attack or stroke within the past 6 months, uncontrolled chest pain within the past 3 months, certain irregular heart rhythms, a history of heart muscle disease or severe heart failure, or a history of heart inflammation (myocarditis)
• People who have had encephalitis (brain inflammation), meningitis (infection around the brain), or uncontrolled seizures within the past year
• People who have previously had a life-threatening reaction to immunotherapy, unless the reaction is unlikely to happen again with appropriate medical management
• People who have received chemotherapy or immunotherapy without enough recovery time, or radiation therapy within the past 4 weeks, or who are still experiencing significant side effects from previous treatments (some exceptions may apply — confirm with trial site)
• People who have not sufficiently recovered from a recent major surgery
• People with another active cancer that is growing or currently being treated (some skin cancers or early-stage cervical cancer that has been treated may be exceptions)
• People with an underlying health condition that, in the doctor's opinion, would make the study treatment unsafe or make it difficult to participate
• Women who are pregnant or breastfeeding
• People who are unable to tolerate blood draws or intravenous access
• People who have an active infection currently being treated with antibiotics, antiviral, or antifungal medications within 7 days before starting the study
• People taking immune-suppressing medications, including steroid tablets at doses of 10 mg or more per day
• People who are in prison or are being held involuntarily
• People who are being held against their will for treatment of a psychiatric or physical illness
• People who are unable to follow the rules and restrictions of the trial

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