Phase 2 Prostate Cancer 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 who are able to understand and are willing to sign a consent form before the study begins.
• People aged 18 or older.
• People with advanced skin cancer (cutaneous squamous cell carcinoma, or cSCC) that cannot be removed by surgery and/or has spread to other parts of the body (Cohort 1).
• People with prostate cancer that has spread and continues to grow despite hormone-lowering treatment (castration-resistant prostate cancer, or CRPC), confirmed by laboratory or tissue testing, with rising PSA levels and very low testosterone levels below 50 ng/dL (Cohort 2).
• People in Cohort 1 who have previously received a type of immunotherapy called anti-PD-1 therapy, or who have never received it — any number of prior treatments is acceptable.
• People who are in good enough general health to carry out light daily activities (performance status score of 0 or 1 on a standard medical scale).
• People in Cohort 1 whose cancer can be measured using standard medical imaging or assessment tools.
• People whose blood test results show that the heart, liver, kidneys, and bone marrow are functioning well enough, tested within 28 days before starting treatment (confirm specific values with the trial site).
• People who have waited long enough since their last cancer treatment before starting this trial — the required waiting period depends on the type of treatment previously received (confirm specific timeframes with the trial site).
• People in Cohort 1 who have previously received a type of anti-cancer treatment that targets blood vessel growth (anti-VEGF therapy).
• People whose blood pressure is adequately controlled, at or below 150/100 mmHg, using no more than one blood pressure medication, with no changes to that medication in the 7 days before starting treatment.
• Women who could become pregnant must have a negative pregnancy test within 72 hours before starting treatment.
• Women who could become pregnant must agree to use reliable contraception during treatment and for 120 days after treatment ends.
• Men who could father a child must agree to use reliable contraception during treatment and for 120 days after treatment ends.

Who may not be able to join:

• People who previously had to permanently stop a PD-1/PD-L1 immunotherapy treatment, or needed long-term immune-suppressing medication, because of serious side effects from that treatment.
• People with a known history of serious allergic reactions to medicines chemically similar to the study drug, ivonescimab.
• People who are currently pregnant or breastfeeding.
• People with an active autoimmune disease (a condition where the immune system attacks the body), with some exceptions such as well-controlled Type 1 diabetes, thyroid conditions managed with medication only, or certain skin conditions not requiring systemic treatment (confirm with trial site).
• People with a known history of HIV infection or AIDS.
• People with a known history of hepatitis B or hepatitis C infection.
• People who have previously received a transplanted organ or bone marrow/stem cell transplant from another person.
• People with an active serious infection currently being treated with intravenous antibiotics, or any other serious uncontrolled illness requiring hospital care.
• People who still have unresolved side effects from previous cancer treatments that have not returned to mild or baseline levels, with some exceptions such as managed thyroid or diabetes conditions, hair loss, skin changes, or mild nerve-related symptoms (confirm with trial site).
• People with cancer that has grown into major blood vessels.
• People who have had major surgery or serious physical trauma within 4 weeks before starting treatment, or who plan to have major surgery within 4 weeks after the first dose.
• People who have experienced serious heart problems — such as unstable chest pain, a heart attack, significant heart failure, or dangerous blood vessel conditions — requiring hospitalisation within the past 12 months, or who have poorly controlled heart rhythm or blood supply problems.
• People with a history of bleeding from oesophageal or stomach veins, severe ulcers, non-healing wounds, abnormal connections between organs (fistulas), abdominal abscesses, or serious gastrointestinal bleeding within the past 6 months.
• People who have had a serious blood clot in an artery or vein, a mini-stroke (TIA), a stroke, or a dangerous spike in blood pressure causing brain symptoms within the past 6 months.
• People who have had a sudden worsening of a chronic lung disease (COPD) within the past 4 weeks.
• People with a history of a hole or tear in the digestive tract, a bowel blockage requiring special feeding, or major bowel removal surgery within the past 6 months.
• People who have received a live or weakened vaccine within 4 weeks before starting treatment, or who expect to need one during the study.
• People who have another cancer that is currently growing or requires active treatment, with some exceptions such as certain treated skin cancers or cervical pre-cancer (confirm with trial site).
• People with a known mental health condition or substance use disorder that would make it difficult to follow the study requirements.
• People who are unable to follow the study procedures and attend follow-up appointments.
• People who are currently taking part in another clinical trial using an investigational treatment.
• People whose personal or social circumstances would make it difficult to comply with study requirements.

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