Phase 2 Ovarian 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 at least 12 years old and have been diagnosed with a confirmed case of small cell carcinoma of the ovary (SCCOHT) that has not previously been treated (though joining after one cycle of chemotherapy may be possible, with treatment in the trial starting within 4 weeks of that first cycle).
• People whose cancer has been staged anywhere from Stage I to Stage IV.
• People who are generally well enough to carry out daily activities with little or no limitation (what doctors call ECOG performance status 0 or 1).
• People whose blood counts are at healthy enough levels — including white blood cells, neutrophils, platelets, and haemoglobin — without having needed recent growth factor support or blood transfusions to reach those levels.
• People whose liver, kidney, thyroid, and heart function are within acceptable ranges as measured by blood tests and heart scans.
• People who are willing to sign a consent form agreeing to take part in the trial, before any trial-related procedures begin.
• People who have health insurance coverage.
• People who are willing and able to follow all trial procedures and attend for the full duration of the study.
• Women who could become pregnant must have a negative pregnancy test (blood or urine) within 72 hours before being assigned to treatment.
• Women who could become pregnant must agree to use highly effective contraception throughout the trial, continuing for at least 120 days after the last dose of the study immunotherapy drug, and 180 days after the end of any chemotherapy or radiotherapy (if applicable).

Who may not be able to join:

• People who have previously received chemotherapy or certain immune-based treatments (such as anti-PD-1, anti-PD-L1, anti-PD-L2, or other similar therapies) for this condition.
• People who have received a live vaccine (such as measles, mumps, rubella, chickenpox, yellow fever, rabies, BCG, or typhoid) within 30 days before the first study treatment. Note: standard injected flu vaccines are generally allowed, but nasal spray flu vaccines are not.
• People who have had an organ or tissue transplant from another person.
• People who have already received more than one cycle of platinum-based chemotherapy, or any other systemic cancer treatment or experimental therapy for this disease.
• People with a known immune system deficiency, or who are currently taking high-dose steroid medication (more than 10 mg prednisone per day or equivalent) or other immune-suppressing treatments within 7 days before the first study dose.
• People who have another cancer that is still active or has required treatment within the past 5 years. (Note: certain skin cancers, superficial bladder cancer, or carcinomas in situ that have been treated with curative intent are generally not excluded — confirm with trial site.)
• People who have a medical reason that prevents them from taking any of the chemotherapy drugs used in this trial (cisplatin, adriamycin, etoposide, or cyclophosphamide).
• People who have had a severe allergic reaction (Grade 3 or higher) to pembrolizumab or any of its ingredients.
• People who have had a severe allergic reaction (Grade 3 or higher) to any of the chemotherapy drugs used in the trial or their ingredients.
• People with an active autoimmune disease that has required systemic medical treatment in the past 2 years. Note: hormone or other replacement therapies (such as thyroid medication or insulin) are generally not counted as systemic treatment and are usually allowed.
• People who have a history of serious lung inflammation (pneumonitis or interstitial lung disease) that required steroid treatment, or who currently have this condition.
• People who have an active infection that requires ongoing systemic treatment.
• People with a known history of HIV infection.
• People with a history of hepatitis B (with a reactive surface antigen test) or active hepatitis C infection.
• People with a known history of active tuberculosis (TB).
• People whose overall health, medical history, or other conditions — in the treating doctor's judgement — could affect the trial results or make participation unsafe or not in their best interest.
• People with a known psychiatric condition or substance use disorder that would make it difficult to meet the requirements of the trial.
• Women who are currently breastfeeding.
• People who have taken part in another clinical trial using an experimental treatment within 30 days before joining, during treatment, or within 30 days after treatment ends.

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