NCT04931342

A Study Evaluating the Efficacy and Safety of Biomarker-Driven Therapies in Patients With Persistent or Recurrent Rare Epithelial Ovarian Tumors

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

• Status: Active Not Recruiting
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 176 (actual)
• Sponsor: Hoffmann-La Roche · Industry
• Sex: Female
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

This study will evaluate the efficacy and safety of multiple biomarker-selected treatments in patients with persistent or recurrent rare epithelial ovarian, fallopian tube, or primary peritoneal tumors. Enrollment will take place in two phases: a preliminary phase followed by a potential expansion phase.

Conditions

• Ovarian Cancer

Interventions

Type	Name	Description
DRUG	Ipatasertib	Ipatasertib will be administered by mouth once a day on Days 1-21 of each cycle. (Cycle length = 28 days)
DRUG	Cobimetinib	Cobimetinib will be administered by mouth once a day on Days 1-21 of each cycle. (Cycle length=28 days)
DRUG	Trastuzumab Emtansine	Trastuzumab Emtansine will be administered intravenously on Day 1 of each cycle. (Cycle length=21 days)
DRUG	Atezolizumab	Atezolizumab will be administered intravenously on Day 1 of each cycle. (Cycle length=21 days)
DRUG	Bevacizumab	Bevacizumab will be administered intravenously on Day 1 of each cycle. (Cycle length=21 days)
DRUG	Paclitaxel	Paclitaxel will be administered intravenously on Days 1, 8, and 15 of each cycle. (Cycle length=28 days)
DRUG	Giredestrant	Giredestrant will be administered by mouth once a day on Days 1-28 of each cycle (Cycle length=28 days)
DRUG	Abemaciclib	Abemaciclib will be administered by mouth twice a day during each 28-day cycle
DRUG	Inavolisib	Inavolisib will be administered by mouth once a day on Days 1-28 of each 28-day cycle
DRUG	Palbociclib	Palbociclib will be administered by mouth once a day on Days 1-21 of each 28-day cycle
DRUG	Letrozole	Letrozole will be administered by mouth once a day on Days 1-28 of each 28-day cycle
DRUG	Olaparib	Olaparib will be administered by mouth twice a day on Days 1-28 of each 28-day cycle
DRUG	Luteinizing Hormone-Releasing Hormone (LHRH) Agonists	LHRH agonists are required beginning at least 2 weeks prior to initiation of study treatment for premenopausal or perimenopausal women. Acceptable agents include goserelin or leuprolide; triptorelin is also acceptable. Monthly injections of LHRH agonist are preferred.
DRUG	Cyclophosphamide	Cyclophosphamide will be administered by mouth once a day on Days 1-21 of each cycle. (Cycle length = 21 days)
DRUG	Inavolisib	Inavolisib will be administered by mouth once a day on Days 1-21 of each 21-day cycle

Timeline

• Start date: 2021-10-07
• Primary completion: 2028-02-28
• Completion: 2028-05-30
• First posted: 2021-06-18
• Last updated: 2026-03-10

Locations

41 sites across 13 countries: United States, Australia, Canada, Czechia, France, Germany, Italy, Russia, South Korea, Spain, Switzerland, Turkey (Türkiye), United Kingdom

Regulatory

• FDA-regulated drug study