Clinical trials are an important way to improve treatment for people with cancer. While most are continuing during the COVID-19 pandemic, the period of time that clinical trials are available and recruiting may change quickly. If you would like to get involved in a clinical trial, speak to your treatment team or the health service where the clinical trial is being undertaken, to confirm it is open and appropriate for you. For cancer information and support, call Cancer Council's experienced cancer nurses on 13 11 20 Monday to Friday from 9am-5pm.

BOUQUET : 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

Female<br/>OnlyGender Female
Only

RecruitingStatus Recruiting

Systemic<br/>Therapy TrialTypeSystemic
Therapy Trial

TwoPhase Two

18+Age Over 18

Female Reproductive<br/>System CancersCancer LocationFemale Reproductive
System Cancers

Systemic therapy | Female reproductive organsEpithelial,Fallopian tube,Ovary,Peritoneal

Trial Overview Read MoreRead more

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..
 

This trial is treating patients with epithelial ovarian, fallopian tube, or primary peritoneal cancer.

This is a systemic therapy trial.

You may be able to join this trial if:

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

You may be excluded from this trial if:

  • You have a certain disease or psychological condition.
  • You have had certain treatments, surgical procedures or drugs.

Clinical trials have complex eligibility criteria - talk to your doctor about your interest in this trial.

Clinical Summary Read MoreRead more

Trial Identifiers

Use the hyperlinks, where available to access additional clinical trial information.

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

Cooperative Group

European Network of Gynaecological Oncological Trial Groups (ENGOT)

Commercial Sponsor

Hoffmann-La Roche

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).

Recruiting Hospitals Read MoreRead more

Cabrini Education and Research Precinct
Malvern
Micheleine Uhe
muhe@cabrini.com.au
(03) 9508 3481

Trial Overview: General information about a clinical trial. This section provides an overview of who might be able to join this trial and what type of treatment is involved.

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