inovatyon - read-only.pdfit is my to invite you to the autumn nsgo-ctu investigator meeting on 1...
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Relapsed partially platinum sensitive Ovarian Cancer after end of 1st or
2nd-line platinum therapy
Group A:PLD 30 mg/m² + Carboplatin AUC 5 q4 wks
At PD, subsequent platinum rechallengeis mandatory
At PD, subsequent therapy at investigator discretion
Group B:PLD 30 mg/m2 +Trabectedin1.1 mg/m2
q3wks
R(1:1) Up to 6 cycles or PD
Primary Endpoint: Overall Survival
INOVATYONPhase III international, randomised study of Trabectedin plus Pegylated Liposomal
Doxorubicin (PLD) versus Carboplatin plus PLD in patients with relapsed ovarian cancer progressing within 6–12 months of last platinum
ENGOT model: aSponsor: Mario Negri Gynecologic Oncology Group; PI: Nicoletta Colombo
Accrual closed September 2017: 618 patients enrolled
Final Analysis planned for Q1 2020 (442 events )
2nd interim analysis at 2/3 of the events performed in Sept 2018 > green light to continue90% of planned OS events reached in October 2019