Early Phase 1 Melanoma Trial, Recruiting

Written by an AI model from the 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 are 18 years of age or older.
• People who have been diagnosed with one of the following cancers that has come back or stopped responding to treatment, and has spread or cannot be removed by surgery: non-small cell lung cancer (NSCLC), small cell lung cancer (SCLC), triple-negative breast cancer (TNBC), skin melanoma, head and neck squamous cell cancer (HNSCC), endometrial cancer, or any cancer known to have a specific genetic marker called MMR-deficient or MSI-high.
• People whose cancer has continued to grow during or after their most recent cancer treatment, and who have either already tried standard treatments (including certain immunotherapy drugs), refused standard treatments, or have no suitable standard treatments available.
• People whose cancer tests positive for a protein called PD-L1 (testing can be done during a pre-screening step if the result is not already known).
• People who have at least one measurable area of cancer that can be tracked on scans, according to standard measurement guidelines.
• People who are well enough to carry out basic daily activities, based on a standard doctor-assessed scale (a score of 2 or lower on the ECOG scale).
• People who, in the treating doctor's opinion, have a life expectancy of at least 4 months.
• Women who could become pregnant must have a negative pregnancy test and must not be breastfeeding at the time of joining.
• Women who could become pregnant must agree to use a highly effective form of contraception during the study and for a set period after the last treatment dose (confirm specific timeframe with trial site).
• Men who could father a child must agree to use highly effective contraception and must not donate sperm during the study and for a set period after the last treatment dose (confirm specific timeframe with trial site).
• People who have previously been treated for cancer that has spread to the brain may be eligible, provided the brain metastases have been stable on scans for at least 28 days, no steroids are needed to manage brain-related symptoms, and there is no history of cancer spreading to the fluid around the brain or spine.
• For the Phase I part of the trial: people whose cancer lesions show up on a specific type of imaging scan using the trial's imaging agent (confirm details with trial site).

Who may not be able to join:

• People who have had an organ transplant in the past.
• People who currently have another active cancer (exceptions may be considered on a case-by-case basis for certain low-risk past cancers — confirm with trial site).
• People with a medical condition that, in the doctor's judgment, would prevent safe or full participation in the study (for example, severe claustrophobia, back pain that prevents lying still for scans, or difficulty remaining still during imaging procedures).
• People who still have side effects rated Grade 2 or higher from previous cancer treatment (hair loss is an exception).
• People with a history of severe allergic reactions, or who are known or expected to have a sensitivity to protein-based medicines or to the trial drug or its ingredients.
• People whose blood test results show that certain organs are not functioning well enough, including the kidneys, liver, or blood cell counts falling below required levels (confirm specific thresholds with trial site).
• People who have needed a blood transfusion within 4 weeks before starting the trial treatment.
• People with significant heart conditions, including unstable chest pain, a heart attack within the past 6 months, moderate-to-severe heart failure, certain abnormal heart rhythms, uncontrolled high blood pressure, reduced heart pumping function, or an abnormal heart electrical reading (ECG) (confirm specific details with trial site).
• People who are currently taking part in another clinical trial.
• People who are pregnant or breastfeeding.
• (Phase I only) People who have received any cancer treatment — including chemotherapy, immunotherapy, radiation, or other investigational therapies — within 28 days (or within 5 half-lives for certain drugs, whichever is shorter) before the first treatment dose.
• (Phase I only) People who previously stopped a type of immunotherapy drug (such as a PD-1, PD-L1, or PD-L2 inhibitor, or similar immune checkpoint therapy) because of a serious immune-related side effect rated Grade 3 or higher. Note: hormone-related immune side effects that are managed with replacement therapy may still be acceptable.
• (Phase I only) People who have had, or are scheduled to have, major surgery within 28 days before the first treatment dose (some minor procedures may be considered on a case-by-case basis — confirm with trial site).
• (Phase I only) People who test positive for HIV.
• (Phase I only) People with active or ongoing hepatitis B or C infection (those with well-controlled hepatitis B or C on stable treatment may be considered on a case-by-case basis — confirm with trial site).
• (Phase I only) People with any other medical condition that, in the doctor's opinion, would place them at unacceptably high risk of harm from the trial treatment.
• (Phase I only) People with any uncontrolled ongoing illness or serious uncontrolled condition, including active bacterial, fungal, or viral infections requiring systemic treatment.

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