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

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.

Study Overview

• Status: Active, not recruiting
• Conditions: Ovarian Cancer
• Intervention / Treatment: Drug: Ipatasertib; Drug: Paclitaxel; Drug: Cobimetinib; Drug: Trastuzumab Emtansine; Drug: Atezolizumab; Drug: Bevacizumab; Drug: Abemaciclib; Drug: Luteinizing Hormone-Releasing Hormone (LHRH) Agonists; Drug: Inavolisib; Drug: Palbociclib; Drug: Letrozole; Drug: Olaparib; Drug: Giredestrant; Drug: Inavolisib; Drug: Cyclophosphamide

• Study Type: Interventional
• Enrollment (Actual): 176
• Phase: Phase 2

Contacts and Locations

Study Locations

• Australia
  • Victoria
    • Malvern, Victoria, Australia, 3144
      • Cabrini Hospital
• Canada
  • Ontario
    • Toronto, Ontario, Canada, M5G 1Z5
      • Princess Margaret Cancer Center
  • Quebec
    • Montreal, Quebec, Canada, H4A 3J1
      • McGill University Health Centre - Glen Site
• Czechia
  • Prague, Czechia, 120 00
    • Gynekologicko-porodnicka klinika
• France
  • Besançon, France, 25030
    • CHU Besançon - Hôpital Jean Minjoz
  • Caen, France, 14076
    • Centre Francois Baclesse
  • Lyon, France, 69373
    • Centre Leon Berard
  • Paris, France, 75020
    • Groupe Hospitalier Diaconesses
  • Rennes, France, 35042
    • Centre Eugène Marquis
  • Saint-Herblain, France, 44805
    • ICO - Site René Gauducheau
  • Toulouse, France, 31059
    • Institut Claudius Regaud
  • Villejuif, France, 94800
    • Gustave Roussy
• Germany
  • Essen, Germany, 45136
    • Kliniken Essen-Mitte Evang. Huyssens-Stiftung, Klinik für Gynäkologie und gynäkologische Onkologie
  • Mannheim, Germany, 68167
    • Universitätsklinikum Mannheim
• Italy
  • Apulia
    • Bari, Apulia, Italy, 70124
      • A.O. U. Consorziale Policlinico di Bari
  • Campania
    • Naples, Campania, Italy, 80131
      • Istituto Tumori Napoli
  • Lazio
    • Rome, Lazio, Italy, 00168
      • Policlinico Universitario Agostino Gemelli
  • Lombardy
    • Milan, Lombardy, Italy, 20132
      • IRCCS S. Raffaele
• Russia
  • Moscow Oblast
    • Moskva, Moscow Oblast, Russia, 119421
      • LLC Medscan
• South Korea
  • Seoul, South Korea, 03080
    • Seoul National University Hospital
  • Seoul, South Korea, 05505
    • Asan Medical Center
  • Seoul, South Korea, 03722
    • Severance Hospital, Yonsei University Health System
  • Seoul, South Korea, (0)6351
    • Samsung Medical Center
• Spain
  • Barcelona, Spain, 08908
    • Institutio Catalan De Oncologia
  • Madrid, Spain, 28041
    • Hospital Universitario 12 de Octubre
  • Madrid, Spain, 28046
    • Hospital Universitario La Paz
  • Málaga, Spain, 29010
    • Hospital Clinico Universitario Virgen de La Victoria
• Switzerland
  • Geneva, Switzerland, 1205
    • Hopitaux universitaires de Geneve
• Turkey (Türkiye)
  • Adana, Turkey (Türkiye), 01220
    • Adana Baskent University Medical Faculty; Oncology
  • Ankara, Turkey (Türkiye), 06490
    • Baskent Universitesi Ankara Hastanesi; Tıbbi Onkoloji Bölümü
  • Istanbul, Turkey (Türkiye), 34010
    • Koc University Medical Faculty; Department of Gynecology & Obstetrics
• United Kingdom
  • Edinburgh, United Kingdom, EH4 2XU
    • Western General Hospital
  • London, United Kingdom, NW1 2PG
    • University College London Hospitals NHS Foundation Trust - University College Hospital
• United States
  • California
    • San Francisco, California, United States, 94158
      • UCSF Helen Diller Family CCC
  • Missouri
    • St Louis, Missouri, United States, 63108
      • Washington University School of Medicine
  • North Carolina
    • Charlotte, North Carolina, United States, 28204
      • Levine Cancer Institute
  • Ohio
    • Columbus, Ohio, United States, 43210
      • Ohio State University
  • Oklahoma
    • Oklahoma City, Oklahoma, United States, 73104
      • University of Oklahoma Health Sciences Center
  • Texas
    • The Woodlands, Texas, United States, 77380
      • Texas Oncology - Gulf Coast
  • Virginia
    • Norfolk, Virginia, United States, 23502
      • Virginia Oncology Associates
  • Washington
    • Seattle, Washington, United States, 98109
      • University of Washington - Seattle Cancer Care Alliance

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

• Persistent or recurrent EOC that meets the following criteria: Histologically confirmed non-high-grade serous, non-high-grade endometrioid epithelial ovarian, fallopian tube, or primary peritoneal cancer, including but not limited to low-grade serous ovarian carcinoma, clear cell carcinoma, mucinous carcinoma, carcinosarcoma, undifferentiated carcinoma, seromucinous carcinoma, malignant Brenner tumors, Grades 1 or 2 endometrioid carcinoma, mesonephric-like adenocarcinoma and small cell carcinoma of the ovary, hypercalcemic type (SCCOHT). Disease that is not amenable to curative surgery
• Measurable disease (at least one target lesion) according to RECIST v1.1
• Previous treatment with one to four lines of therapy, at least one of which was platinum-based. Hormonal therapy does not count as a line of therapy.
• Platinum-resistant disease, defined as disease progression during or within 6 months of last platinum therapy, with the following exception: Participants with primary platinum-refractory disease are excluded.
• Submission of a representative tumor specimen that is suitable for next-generation sequencing (NGS) testing and estrogen receptor immunohistochemistry (ER IHC) to determine treatment arm assignment and for central pathology review.
• Submission of the local pathology report and, if available, any associated stained slides that supported the local diagnosis of the histology (to be used for central pathology review)
• Eastern Cooperative Oncology Group (ECOG) Performance Status of 0 or 1
• Adequate hematologic and end-organ function
• For women of childbearing potential: agreement to remain abstinent or use contraception, and agreement to refrain from donating eggs (if applicable)
• In addition to the general inclusion criteria above, participants must meet all of the arm-specific inclusion criteria for the respective arm

General Exclusion Criteria:

• Pregnant or breastfeeding, or intending to become pregnant or breastfeed during the study
• Primary platinum-refractory disease, defined as progression during or within 4 weeks after the last dose of the first-line platinum treatment
• Histologic diagnosis of high-grade serous or high-grade endometrioid ovarian, fallopian tube, or primary peritoneal cancer
• Current diagnosis of solely borderline epithelial ovarian tumor
• Current diagnosis of non-epithelial ovarian tumors
• Current diagnosis of synchronous primary endometrial cancer
• Prior history of primary endometrial cancer, with the following exception: a prior diagnosis of primary endometrial cancer is permitted if it meets all of the following conditions: Stage IA, no lymphovascular invasion, International Federation of Gynecology and Obstetrics Grade 1 or 2, not a high-grade subtype.
• Uncontrolled pleural effusion, pericardial effusion, or ascites requiring recurrent drainage procedures
• Symptomatic, untreated, or actively progressing CNS metastases
• Severe infection within 4 weeks prior to initiation of study treatment
• Treatment with chemotherapy, radiotherapy, antibody therapy or other immunotherapy, gene therapy, vaccine therapy, or investigational therapy within 28 days prior to initiation of study treatment
• Treatment with hormonal therapy within 14 days prior to initiation of study treatment
• In addition to the general exclusion criteria above, participants can not meet any of the arm-specific exclusion criteria for the respective arm

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Non-Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

11

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Ipatasertib + Paclitaxel (PIK3CA/AKT1/PTEN-altered tumors); Participants in the Ipatasertib + Paclitaxel arm will receive treatment until unacceptable toxicity or disease progression per RECIST v1.1.	Drug: Ipatasertib; Ipatasertib will be administered by mouth once a day on Days 1-21 of each cycle. (Cycle length = 28 days); Other Names: RO5532961; Drug: Paclitaxel; Paclitaxel will be administered intravenously on Days 1, 8, and 15 of each cycle. (Cycle length=28 days)
Experimental: Cobimetinib (BRAF/NRAS/KRAS/NF1-altered tumors); Participants in the Cobimetinib arm will receive treatment until unacceptable toxicity or disease progression per RECIST v1.1.	Drug: Cobimetinib; Cobimetinib will be administered by mouth once a day on Days 1-21 of each cycle. (Cycle length=28 days); Other Names: RO5514041
Experimental: Trastuzumab Emtansine (ERBB2-amplified/mutant tumors); Participants in the Trastuzumab Emtansine arm will receive treatment until unacceptable toxicity or disease progression per RECIST v1.1.	Drug: Trastuzumab Emtansine; Trastuzumab Emtansine will be administered intravenously on Day 1 of each cycle. (Cycle length=21 days); Other Names: RO5304020
Experimental: Atezolizumab + Bevacizumab (Non-matched); Participants in the Atezolizumab + Bevacizumab arm will receive treatment until unacceptable toxicity or loss of clinical benefit as determined by the investigator after an integrated assessment of radiographic and biochemical data, local biopsy results (if available), and clinical status.	Drug: Atezolizumab; Atezolizumab will be administered intravenously on Day 1 of each cycle. (Cycle length=21 days); Other Names: RO5541267, Tecentriq; Drug: Bevacizumab; Bevacizumab will be administered intravenously on Day 1 of each cycle. (Cycle length=21 days); Other Names: RO4876646, Avastin
Experimental: Giredestrant + Abemaciclib (ER+ tumors); Participants in the Giredestrant + Abemaciclib arm will receive treatment until unacceptable toxicity or disease progression as determined by the investigator according to RECIST v1.1.	Drug: Abemaciclib; Abemaciclib will be administered by mouth twice a day during 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: Giredestrant; Giredestrant will be administered by mouth once a day on Days 1-28 of each cycle (Cycle length=28 days)
Experimental: Inavolisib + Palbociclib (PIK3CA-altered tumors); Participants in the Inavolisib + Palbociclib arm will receive treatment until unacceptable toxicity or disease progression per RECIST v1.1.	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: Inavolisib; Inavolisib will be administered by mouth once a day on Days 1-21 of each 21-day cycle
Experimental: Inavolisib + Palbociclib + Letrozole (ER+ and PIK3CA-altered tumors); Participants in the Inavolisib + Palbociclib + Letrozole arm will receive treatment until unacceptable toxicity or disease progression per RECIST v1.1.	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: 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: Inavolisib; Inavolisib will be administered by mouth once a day on Days 1-21 of each 21-day cycle
Experimental: Inavolisib + Olaparib (Non-matched); Participants in the Inavolisib + Olaparib arm will receive treatment until unacceptable toxicity or disease progression per RECIST v1.1.	Drug: Inavolisib; Inavolisib 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: Inavolisib; Inavolisib will be administered by mouth once a day on Days 1-21 of each 21-day cycle
Experimental: Inavolisib + Giredestrant (ER+ and PIK3CA-altered tumors); Participants in the Inavolisib + Giredestrant arm will receive treatment until unacceptable toxicity or disease progression per RECIST v1.1.	Drug: Inavolisib; Inavolisib will be administered by mouth once a day on Days 1-28 of each 28-day cycle; Drug: Giredestrant; Giredestrant will be administered by mouth once a day on Days 1-28 of each cycle (Cycle length=28 days); Drug: Inavolisib; Inavolisib will be administered by mouth once a day on Days 1-21 of each 21-day cycle
Experimental: Inavolisib + Bevacizumab (PIK3CA-altered tumors); Participants in the Inavolisib + Bevacizumab arm will receive treatment until unacceptable toxicity or disease progression per RECIST v1.1.	Drug: Bevacizumab; Bevacizumab will be administered intravenously on Day 1 of each cycle. (Cycle length=21 days); Other Names: RO4876646, Avastin; Drug: Inavolisib; Inavolisib will be administered by mouth once a day on Days 1-28 of each 28-day cycle; Drug: Inavolisib; Inavolisib will be administered by mouth once a day on Days 1-21 of each 21-day cycle
Experimental: Atezolizumab + Bevacizumab + Cyclophosphamide (Non-matched); Participants in the Atezolizumab + Bevacizumab + Cyclophosphamide arm will receive treatment until unacceptable toxicity or loss of clinical benefit as determined by the investigator after an integrated assessment of radiographic and biochemical data, local biopsy results (if available), and clinical status.	Drug: Atezolizumab; Atezolizumab will be administered intravenously on Day 1 of each cycle. (Cycle length=21 days); Other Names: RO5541267, Tecentriq; Drug: Bevacizumab; Bevacizumab will be administered intravenously on Day 1 of each cycle. (Cycle length=21 days); Other Names: RO4876646, Avastin; Drug: Cyclophosphamide; Cyclophosphamide will be administered by mouth once a day on Days 1-21 of each cycle. (Cycle length = 21 days)

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Confirmed Objective Response Rate (ORR)	Confirmed ORR is defined as the proportion of participants with a confirmed complete response (CR) or partial response (PR) (demonstrated on two consecutive occasions >=4 weeks apart), as determined by the investigator according to RECIST v1.1.	Up to approximately 5 years

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Duration of Response (DOR)	DOR is defined as the time from the first occurrence of a documented objective response to disease progression or death from any cause (whichever occurs first), as determined by the investigator according to RECIST v1.1.	Up to approximately 5 years
Disease Contral Rate (DCR)	DCR is defined as the proportion of participants with a confirmed CR or PR, or stable disease maintained for at least 16 weeks, as determined by the investigator according to RECIST v1.1.	Up to approximately 5 years
Progression Free Survival (PFS)	PFS after start of treatment is defined as the time from start of treatment to the first occurrence of disease progression or death from any cause (whichever occurs first), as determined by the investigator according to RECIST v1.1.	Up to approximately 5 years
6-Month PFS Rate	6-month PFS rate is defined as the proportion of participants who remained alive and progression-free at 6 months after start of treatment, as determined by the investigator according to RECIST v1.1.	Up to 6 month
Overall Survival (OS)	OS after start of treatment is defined as the time from start of treatment to death from any cause.	Up to approximately 5 years
Confirmed ORR as Determined by IRC (Independent Review Committee)	Confirmed ORR, as determined by the IRC according to RECIST v1.1.	Up to approximately 5 years
DOR as Determined by IRC	DOR, as determined by the IRC according to RECIST v1.1	Up to approximately 5 years
DCR as Determined by IRC	DCR, as determined by the IRC according to RECIST v1.1	Up to approximately 5 years
PFS as Determined by IRC	PFS, as determined by the IRC according to RECIST v1.1	Up to approximately 5 years
Percentage of Participants With Adverse Events	Percentage of participants with adverse events.	Up to approximately 5 years

Collaborators and Investigators

• Sponsor: Hoffmann-La Roche
• Collaborators: GOG Foundation; European Network of Gynaecological Oncological Trial Groups (ENGOT)
• Investigators: Study Director: Clinical Trials, Hoffmann-La Roche

Study record dates

Study Major Dates

• Study Start (Actual): October 7, 2021
• Primary Completion (Estimated): February 28, 2028
• Study Completion (Estimated): May 30, 2028

Study Registration Dates

• First Submitted: June 9, 2021
• First Submitted That Met QC Criteria: June 16, 2021
• First Posted (Actual): June 18, 2021

Study Record Updates

• Last Update Posted (Actual): June 8, 2026
• Last Update Submitted That Met QC Criteria: June 5, 2026
• Last Verified: June 1, 2026

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Urogenital Diseases; Genital Diseases; Endocrine System Diseases; Urogenital Neoplasms; Neoplasms by Site; Neoplasms; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Genital Diseases, Female; Endocrine Gland Neoplasms; Ovarian Diseases; Adnexal Diseases; Genital Neoplasms, Female; Gonadal Disorders; Ovarian Neoplasms; Hormones; Hormones, Hormone Substitutes, and Hormone Antagonists; Pituitary Hormone-Releasing Hormones; Hypothalamic Hormones; Peptide Hormones; Neuropeptides; Peptides; Amino Acids, Peptides, and Proteins; Oligopeptides; Nerve Tissue Proteins; Proteins; Organic Chemicals; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Azoles; Hydrocarbons; Cycloparaffins; Hydrocarbons, Alicyclic; Hydrocarbons, Cyclic; Terpenes; Polycyclic Compounds; Antibodies, Monoclonal, Humanized; Antibodies, Monoclonal; Antibodies; Immunoglobulins; Immunoproteins; Blood Proteins; Serum Globulins; Globulins; Taxoids; Cyclodecanes; Diterpenes; Nitriles; Macrolides; Lactones; Phosphoramide Mustards; Nitrogen Mustard Compounds; Mustard Compounds; Hydrocarbons, Halogenated; Phosphoramides; Organophosphorus Compounds; Lactams, Macrocyclic; Macrocyclic Compounds; Triazoles; Maytansine; Trastuzumab; Letrozole; Bevacizumab; Ado-Trastuzumab Emtansine; Cyclophosphamide; Paclitaxel; Gonadotropin-Releasing Hormone; giredestrant; abemaciclib; ipatasertib; atezolizumab; olaparib; palbociclib; cobimetinib; inavolisib
• Other Study ID Numbers: WO42178; GOG-3051 (Other Identifier: GOG Foundation); ENGOT-GYN2 (Other Identifier: European Network of Gynaecological Oncological Trial Groups (ENGOT))

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Plan Description: For eligible studies, qualified researchers may request access to individual patient level clinical data. See Roche's commitment to transparency of clinical study information here: https://go.roche.com/data_sharing

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: Yes
• Studies a U.S. FDA-regulated device product: No