Clinical summary
Summary
Eligible participants will be assigned to one of eight experimental arms based on the biomarkers of their cancer. In Experimental Arm A (PIK3CA/AKT1/PTEN-altered cancers), participants will receive Ipatasertib (administered orally once a day on Days 1-21 of each 28-day cycle) + Paclitaxel (administered intravenously on Days 1, 8, and 15 of each 28-day cycle). In Experimental Am B (BRAF/NRAS/KRAS/NF1-altered cancers), participants will receive cobimetinib (administered orally once a day on Days 1-21 of each 28-day cycle). In Experimental Arm C (ERBB2-amplified/mutant cancers), participants will receive Trastuzumab Emtansine (administered intravenously on Day 1 of each 21-day cycle). In Experimental Arm D (non-matched), participants will receive Atezolizumab (administered intravenously on Day 1 of each 21-day cycle) + Bevacizumab (administered intravenously on Day 1 of each 21-day cycle). In Experimental Arm E (ER+ cancers), participants will receive Giredestrant (administered orally once a day during each 28-day cycle) + Abemaciclib (administered orally twice a day during each 28-day cycle) + (if applicable) Luteinizing Hormone-Releasing Hormone (LHRH) Agonists (required to begin at least 2 weeks prior to initiation of study treatment for premenopausal or perimenopausal women). In Experimental Arm F (PIK3CA-altered cancers), participants will receive Inavolisib (administered orally once a day on Days 1-28 of each 28-day cycle) + Palbociclib (administered orally once a day on Days 1-21 of each 28-day cycle). In Experimental Arm G (ER+ and PIK3CA-altered cancers), participants will receive Inavolisib (administered orally once a day on Days 1-21 of each 28-day cycle) + Palbociclib (administered orally once a day on Days 1-21 of each 28-day cycle) + Letrozole (administered orally once a day on Days 1-28 of each 28-day cycle) + (if applicable) Luteinizing Hormone-Releasing Hormone (LHRH) Agonists (required to begin at least 2 weeks prior to initiation of study treatment for premenopausal or perimenopausal women). In Experimental Arm H (non-matched), participants will receive Inavolisib (administered by mouth once a day on Days 1-28 of each 28-day cycle + Olaparib (administered by mouth twice a day on Days 1-28 of each 28-day cycle).Age
18+
More information
Trial Identifiers
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Commercial Sponsor
Hoffmann-La Roche, European Network of Gynaecological Oncological Trial Groups (ENGOT)
Scientific Title
A Phase II, Open-Label, Multicenter, Platform Study Evaluating the Efficacy and Safety of Biomarker-Driven Therapies in Patients With Persistent or Recurrent Rare Epithelial Ovarian Tumors