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:

• People aged 18 or older who have been diagnosed with a locally advanced or metastatic cancer (confirmed by laboratory testing), where their treating specialist has determined that the immunotherapy drug atezolizumab — alone or combined with other approved drugs — is an appropriate treatment option for their cancer type.
• People whose cancer can be measured using standard imaging criteria (known as RECIST 1.1), meaning there are visible tumours that can be tracked over time.
• People who are reasonably functional in daily life — specifically, those whose physical ability level falls within a standard scale rating of 0 (fully active) to 2 (up and about more than half the day, capable of self-care).
• People whose blood and organ function meet minimum safety levels, including adequate white blood cell counts, red blood cell levels, platelet counts, liver function, kidney function, and protein levels in the blood (confirm specific numbers with the trial site).
• People who are able to become pregnant and who agree to use a highly effective form of contraception (such as hormonal methods, an intrauterine device, or surgical sterilisation) during treatment and for 5 months after the last dose — or who have not had and will not have vaginal heterosexual intercourse throughout that period.
• People who are able to father children and who agree to use an effective barrier or surgical contraception method from the start of the study until 5 months after the last dose.
• People who are currently breastfeeding and who are willing to stop breastfeeding from the start of treatment until 5 months after treatment ends.
• People living with HIV, provided they are on effective treatment and their viral load is undetectable.
• People with a history of chronic hepatitis B, provided they are on appropriate suppressive treatment (if needed) and their viral load is undetectable.
• People with a history of hepatitis C, provided their viral load is currently undetectable.
• People who previously had cancer spread to the brain that has already been treated, provided follow-up brain scans show no signs of the cancer growing back.
• People who have or previously had another separate cancer, as long as that cancer or its treatment is unlikely to interfere with how this trial measures safety or effectiveness.
• People who are able to understand the study information and are willing to sign a consent form.

Who may not be able to join:

• People who have received an experimental (non-FDA-approved) cancer treatment within the 28 days before starting the trial.
• People who have received immune-boosting drugs (such as interferon or interleukin-2), immune-suppressing medications, or any herbal medicines within 1 month before starting the trial (note: low-dose steroids or locally applied steroids may be permitted — confirm with trial site).
• People who have previously been treated with a type of drug called a CD137 agonist.
• People who have received certain immunotherapy drugs — including anti-CTLA-4, anti-PD-1, or anti-PD-L1 treatments (including atezolizumab itself) — within 28 days before starting the trial.
• People who have a history of, or are at risk of, autoimmune diseases (conditions where the body's immune system attacks itself), such as lupus, rheumatoid arthritis, multiple sclerosis, inflammatory bowel disease, or similar conditions — though some exceptions apply, including people with well-controlled underactive thyroid on stable medication, controlled Type 1 diabetes on stable insulin, or mild skin-only conditions such as eczema or psoriasis that meet specific criteria (confirm details with trial site).
• People who still have side effects from a previous cancer treatment that are moderate or severe in level, unless those effects are considered not clinically significant or are permanent/irreversible (mild hair loss or mild nerve-related sensory changes may be acceptable — confirm with trial site).
• People who have previously had a bone marrow transplant from a donor or an organ transplant.
• People who have had a severe allergic reaction to certain types of laboratory-made antibody treatments in the past.
• People who are known to be allergic to any ingredient in atezolizumab or to proteins produced using a specific cell line used in its manufacture.
• People who have received a live vaccine within 4 weeks before starting the trial.
• People who currently have active tuberculosis.
• People who have a history of certain lung conditions, including idiopathic pulmonary fibrosis, drug-related lung inflammation, or organising pneumonia — or who show signs of active lung inflammation on a chest scan at the time of screening (a history of radiation-related lung scarring in the treated area may be acceptable — confirm with trial site).
• People who have had significant heart or cardiovascular problems — such as a heart attack, stroke, unstable heart rhythm, or unstable chest pain — within the 3 months before starting the trial, or who have moderate-to-severe heart failure (confirm classification with trial site).
• People who are currently pregnant (a pregnancy test will be done at screening for those who could become pregnant).
• People with other uncontrolled health conditions or circumstances that would make it difficult to follow the trial requirements.

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