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:

Criteria that apply to all groups:

• Adults between 18 and 80 years old, any gender
• People who have liver tumours that can be treated with ablation (a procedure that destroys tumour tissue), where all liver tumours are smaller than 5 cm across
• People with an expected survival of at least 3 months
• People who are generally able to carry out normal daily activities with little to no limitation (confirm with trial site for exact definition)
• People whose blood test results taken within 14 days before starting the trial show that the blood, liver, kidney, and clotting functions meet specific minimum levels set by the trial (confirm with trial site for exact values)

Additional criteria for the colorectal cancer group:

• People with colorectal cancer that has spread to the liver, where the liver tumours cannot be surgically removed, or where the person cannot tolerate or does not wish to have surgery
• People whose cancer has not responded to standard second-line drug treatment

Additional criteria for the triple-negative breast cancer group:

• People with a confirmed diagnosis of triple-negative breast cancer, meaning the cancer tests negative for certain hormone receptors and a protein called HER2
• People whose cancer has not responded to standard second-line drug treatment, including those who have previously received a specific type of immunotherapy drug (PD-1 antibody therapy)

Additional criteria for the melanoma group:

• People with confirmed melanoma that has spread to the liver, where the liver tumours cannot be or have not been surgically removed
• People whose cancer has not responded to standard first-line drug treatment

Who may not be able to join:

Criteria that apply to all groups:

• People with a known or suspected allergy to the study drugs or similar drugs
• People who have taken part in another clinical trial and received at least one treatment within the 4 weeks before enrolling
• People with a history of, or currently having, another type of cancer (with some exceptions, such as certain cured skin, bladder, cervical, or thyroid cancers)
• People with immune system disorders within the 7 days before starting the trial, or those currently taking steroid medications above a certain dose, or other drugs that suppress the immune system
• People with active or uncontrolled spread of cancer to the brain or nervous system
• People who have previously had an organ or bone marrow transplant
• People with uncontrolled fluid build-up around the lungs, heart, or abdomen that is causing significant breathing difficulties
• People who have had bleeding from ruptured veins in the oesophagus or stomach area within the past month
• People currently receiving other anti-cancer treatments such as radiotherapy or chemotherapy outside of what this trial provides
• People with significant abnormalities in their body's salt and mineral balance, as assessed by the trial team
• People with major organ failure
• People who have received systemic drug treatment, radiotherapy, or local liver treatment within 1 month before enrolling
• People who previously had a severe immune-related reaction (grade 3 or higher) to immunotherapy, except for thyroid or blood sugar-related side effects
• People with active or uncontrolled serious infections
• People with any other medical condition, abnormal test result, or other circumstance that the trial team considers would make participation unsafe or affect the trial results
• Women who are pregnant, breastfeeding, or who test positive for pregnancy at the start of the trial
• People with HIV infection, active hepatitis B (with detectable virus levels above a certain threshold), active hepatitis C (with detectable virus levels above a certain threshold), or other forms of hepatitis or liver cirrhosis
• People with severe heart, lung, liver, or kidney problems, uncontrolled clotting disorders, uncontrolled high blood pressure or diabetes, active infections, or mental health or social circumstances that may affect ability to participate
• People with any other factor that the trial team considers may affect safety or the ability to complete the trial

Additional exclusion criteria for the colorectal cancer group:

• People with high blood pressure that cannot be controlled with a single blood pressure medication, or who require two or more blood pressure medications
• People with significant levels of protein detected in their urine (above specific thresholds set by the trial)
• People with active stomach or bowel conditions such as ulcers, ulcerative colitis, active tumour bleeding, or other conditions the trial team considers a risk for gastrointestinal bleeding or perforation
• People with a significant history of bleeding (such as vomiting blood, blood in stools, or coughing up blood) within the past 3 to 4 months, or a blood clot, stroke, or mini-stroke within the past 12 months
• People who have had a heart attack, severe chest pain, or heart bypass surgery within the 6 months before enrolling
• People with a certain level of heart failure, irregular heartbeat requiring medication, or a specific abnormality on a heart tracing test (ECG)
• People who are unable to swallow oral medication (specifically fruquintinib tablets)

Additional exclusion criteria for the triple-negative breast cancer group:

• People who have previously received a specific immunotherapy drug called pucotenlimab

Additional exclusion criteria for the melanoma group:

• People who have previously received specific immunotherapy drugs called pembrolizumab or toripalimab
• People with high blood pressure that cannot be controlled with a single blood pressure medication, or who require two or more blood pressure medications
• People with significant levels of protein detected in their urine (above specific thresholds set by the trial)
• People who have had a heart attack, severe chest pain, or heart bypass surgery within the 6 months before enrolling
• People with a certain level of heart failure, irregular heartbeat requiring medication, or a specific abnormality on a heart tracing test (ECG)

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