Window-of-opportunity proof-of-concept, non-randomized, open-label phase II trial of Olaparib given alone (cohort A) or in combination with Durvalumab (cohort B) prior to primary debulking surgery in histologically proven high-grade epithelial ovarian cancer (EOC)

Patients with presumed and previously untreated advanced stage ovarian cancer planned to undergo laparoscopy for histologic diagnosis and treatment planning.

Feasibility of WoO procedure defined as the successful completion of the WoO therapy: Relative dose intensity (RDI) of ≥80%. No treatment-related surgical delays. Adherence to therapeutic strategy. Lack of clinical progression prior to primary debulking surgery. No treatment-related toxicities of any grade that in the judgment of the investigator or surgeon significantly interfered with the subject’s optimal perioperative management

Safety of the WoO procedure. Evaluated by the proportion of patients who experience any adverse event (CTCAE v5.0), of a grade ≥3., Proportion of ctDNA mutation positive patients at baseline above a predefined a cut-off (copies/ml)., Circulating DNA ratio at day 21 (CDR21) defined as the ratio of mutation abundance at day 21 relative to baseline of the mutant ctDNA allele with the highest abundance (mutant copies/ml) at baseline., Progression free survival (PFS). Defined as the time from registration into the trial (PIC2) until progression defined as progressive disease according to RECIST or GCIG criteria or death without progression or clinical deterioration of performance status with associated signs of disease (e.g. bowel obstruction and non-measurable disease).

No related papers found yet.

Germany