Treatment
Rinatabart Sesutecan (Rina-S) Plus Standard of Care versus Standard of Care as maintenance therapy.
Treatment duration
The treatment can continue until disease progression, unacceptable toxicity or withdrawal of consent.
Eligibility
Main inclusion criteria:
- Must have histologically or cytologically confirmed high-grade serous or endometrioid epithelial ovarian cancer (EOC), primary peritoneal cancer, or fallopian tube cancer.
- Must have PSOC defined as progressive disease > 6 months (ie, 183 days) from the last dose of primary (first-line [1L]) platinum therapy.
- Participants with known breast cancer (BRCA)-mutated (somatic or germline) or homologous recombination deficiency (HRD)-positive ovarian cancer who achieved complete response (CR)/no clinical evidence of disease (NED) or partial response (PR) following 1L platinum-based chemotherapy regimen must have previously received PARPi maintenance therapy as part of their 1L treatment.
- Must have completed platinum-based chemotherapy in the 2L treatment for recurrent PSOC.
- Must be randomized no later than 8 weeks from the last dose of the 2L platinum-based therapy.
- Participants must have achieved a CR/NED, PR; or SD permitted only if bevacizumab was given in 2L in combination with platinum-based chemotherapy, as assessed by the investigator, following completion of 2L platinum-based chemotherapy.
Main exclusion criteria:
- Participants with clear cell, mucinous, or sarcomatous histology, mixed tumors containing any of the above histologies, or low-grade/borderline ovarian tumors
- More than 2 prior lines of systemic therapy.
- Progression while on or following 2L platinum-based regimen prior to randomization.
- Participants who receive an intervening systemic anticancer treatment (excluding bevacizumab) after the last dose of 2L platinum-based chemotherapy and prior to randomization.
Disclaimer: This is an overview of the main in- and exclusion criteria which can also be found on clinicaltrials.gov (NCT07225270). Criteria might change during the course of the study due to amendments. Inclusion in the trial remains the responsibility of the principal investigator of the trial and will depend on patient eligibility and slot availability.
Contact
In case you feel your patient might be eligible for this trial or in case you want to have more information about this trial, please feel free to contact us via: lgog@uzleuven.be