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RecruitingLast updated:15 August 2023

BOUQUET: This phase II study is evaluating how safe and effective multiple biomarker-selected treatments are in people with persistent or recurrent rare epithelial ovarian, fallopian tube, or primary peritoneal cancer.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

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

People18+

Phase

II

Trial Acronym

BOUQUET

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

Eligibility

Inclusion

  • You have certain types of non-cancer medical conditions.
  • You have had certain treatments, surgical procedures or drugs.

Exclusion

  • You have had treatment but your cancer has gotten worse or has not responded to the treatment you have been given.
Message

Clinical trials have complex eligibility criteria.

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