Phase 3 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 have signed and dated a consent form before any study-related checks begin.
• People aged 18 or older (or the minimum legal adult age in their country) at the time of signing the consent form.
• People with a confirmed diagnosis (through tissue or cell testing) of high-grade serous ovarian cancer, high-grade endometrioid ovarian cancer, primary peritoneal cancer, or fallopian tube cancer.
• For the Phase 2 part of the study only: People who have at least one tumour area that has not been previously treated with radiation and that can be safely biopsied, and who agree to provide tissue samples before and during treatment. In some cases, a recent archived tissue sample (taken within 6 months) may be accepted instead of a new biopsy.
• People who have received between 1 and 3 prior cancer treatments (Phase 2) or between 1 and 4 prior cancer treatments (Phase 3), counting treatments in specific ways as defined by the trial (confirm with trial site for how prior treatments are counted).
• People whose cancer stopped responding to platinum-based chemotherapy within a defined timeframe — the exact criteria depend on how many platinum treatments were received (confirm with trial site for specifics).
• People who have previously been treated with a drug called mirvetuximab soravtansine, if it is available locally and if their cancer showed high levels of a protein called folate receptor alpha — unless that treatment was not suitable for them or not available where they live.
• People who have at least one measurable tumour that can be assessed by CT or MRI scan, according to standard measurement guidelines.
• People with a good general level of physical functioning, scored as 0 or 1 on a standard scale used by doctors (meaning fully active or able to carry out light activity).
• People whose liver, kidneys, bone marrow, and other organs are functioning adequately, as confirmed by blood tests done within 14 days before starting the study drug.
• People who are willing and able to attend scheduled visits, follow the treatment plan, and complete all study requirements.
• For Phase 3 only: People whose health makes them suitable for at least one of the chemotherapy options available in the comparison treatment group.

Who may not be able to join:

• People whose ovarian cancer is of a clear cell, mucinous, sarcomatous, or mixed tumour type, or who have low-grade or borderline ovarian cancer (additional tumour types are also excluded in the Phase 3 part — confirm with trial site).
• People who have not waited long enough since their last cancer treatment, surgery, or radiation before joining the study (specific waiting periods apply for each type of prior treatment — confirm with trial site for details).
• People with active, symptomatic, or untreated cancer that has spread to the brain or spinal cord, or who need steroids or anti-seizure medication to manage these symptoms. People with treated, stable, and symptom-free brain metastases who no longer need steroids may still be considered, at the doctor's judgement.
• People who have had a stroke, mini-stroke, or other arterial blood clot event within the past 6 months.
• People with serious or uncontrolled heart conditions, including certain abnormal heart rhythms, recent heart attack, uncontrolled chest pain, severe heart failure, low heart pumping function, recent bypass surgery, uncontrolled high blood pressure, or certain electrical conduction problems in the heart (confirm with trial site for full details).
• People who have a history of lung inflammation (a condition called ILD or pneumonitis) that required steroid treatment, or who currently have this condition, or where it cannot be ruled out on scans.
• People with serious lung problems, including recent blood clots in the lungs, severe asthma, severe COPD, restricted lung function, or autoimmune conditions that affect the lungs, or people who have had a lung removed.
• People who regularly take steroid tablets at a dose above 10 mg per day, with some exceptions such as inhaled steroids for asthma, low-dose replacement steroids, or short-term use for treatment preparation (confirm with trial site for full list of exceptions).
• People who have had another cancer in the past 3 years, except for certain low-risk cancers that were treated with the expectation of a cure (such as early-stage cervical changes, non-melanoma skin cancer, or Stage 1 uterine cancer).
• People who still have significant side effects from previous cancer treatments that have not returned to a low or stable level (except hair loss, and with some exceptions for stable, well-managed long-term effects such as nerve pain, fatigue, or hormonal conditions).
• People who have previously received certain targeted treatments — specifically CDH6-targeted drugs or, depending on which part of the study, certain types of antibody-drug treatments (confirm with trial site for specifics based on Phase 2 or Phase 3).
• People who have had a severe allergic reaction to any ingredients in the study drug, or for whom the study drug is otherwise medically unsuitable.
• People with an active or uncontrolled HIV infection.
• People with serious uncontrolled illness, active infection, active bleeding problems, or substance use issues that the treating doctor believes would make participation unsafe or unreliable.
• People with active or uncontrolled hepatitis B or hepatitis C infection. People with a history of hepatitis B or C may still be considered if certain conditions are met (confirm with trial site for details).
• People who are pregnant, breastfeeding, or planning to become pregnant during the study.
• People whose personal, social, or geographic circumstances would make regular follow-up visits difficult or impossible.
• People with other significant medical, surgical, or laboratory findings that the treating doctor believes could affect safety or the reliability of the study results.
• People who have received a live-attenuated vaccine within 30 days before starting the study drug (note: mRNA vaccines and certain adenoviral vaccines are not considered live-attenuated for this purpose).
• For Phase 3 only: People with symptoms or scan evidence of a bowel blockage.
• For Phase 3 only: People who need fluid drained from their abdomen or chest more frequently than every 4 weeks.

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