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Ovarian CancerPhase 2BOUQUETNCT04931342

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

A Phase 2 study testing Ipatasertib, Cobimetinib and Trastuzumab Emtansine in people with Ovarian Cancer, run by Hoffmann-La Roche at 41 sites in 13 countries.

Active, not recruiting

Under way, not looking for participants. Everyone needed has enrolled. The study is still running.

Official record
Search all trials

Trial 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. Read more about this study

Who is it for?
Ages 18 years and older, women only
Conditions the study is for
Ovarian Cancer
What is being tested?
Ipatasertib, Cobimetinib and Trastuzumab Emtansine
Could I receive a placebo?
No, everyone receives an active treatment
How many people
176 participants
Where
41 sitesin 13 countries
Study dates
7 Oct 2021to 30 May 2028
Phase
Phase 2
Are there results?
Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • Women only
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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)
Show all 24Show fewer
  • 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

Who cannot join

None listed.

Trial locations and contacts

41 sites in 13 countries.

41 sites in 13 countries

United States8 sites

  • Levine Cancer Institute

    Charlotte, North Carolina, 28204

  • Ohio State University

    Columbus, Ohio, 43210

  • Virginia Oncology Associates

    Norfolk, Virginia, 23502

  • University of Oklahoma Health Sciences Center

    Oklahoma City, Oklahoma, 73104

  • UCSF Helen Diller Family CCC

    San Francisco, California, 94158

  • University of Washington - Seattle Cancer Care Alliance

    Seattle, Washington, 98109

  • Washington University School of Medicine

    St Louis, Missouri, 63108

  • Texas Oncology - Gulf Coast

    The Woodlands, Texas, 77380

Other trials in United States

France8 sites

  • CHU Besançon - Hôpital Jean Minjoz

    Besançon, 25030

  • Centre Francois Baclesse

    Caen, 14076

  • Centre Leon Berard

    Lyon, 69373

  • Groupe Hospitalier Diaconesses

    Paris, 75020

  • Centre Eugène Marquis

    Rennes, 35042

  • ICO - Site René Gauducheau

    Saint-Herblain, 44805

  • Institut Claudius Regaud

    Toulouse, 31059

  • Gustave Roussy

    Villejuif, 94800

Other trials in France

Italy4 sites

  • A.O. U. Consorziale Policlinico di Bari

    Bari, Apulia, 70124

  • IRCCS S. Raffaele

    Milan, Lombardy, 20132

  • Istituto Tumori Napoli

    Naples, Campania, 80131

  • Policlinico Universitario Agostino Gemelli

    Rome, Lazio, 00168

Other trials in Italy

South Korea4 sites

  • Samsung Medical Center

    Seoul, (0)6351

  • Seoul National University Hospital

    Seoul, 03080

  • Severance Hospital, Yonsei University Health System

    Seoul, 03722

  • Asan Medical Center

    Seoul, 05505

Other trials in South Korea

Spain4 sites

  • Institutio Catalan De Oncologia

    Barcelona, 08908

  • Hospital Universitario 12 de Octubre

    Madrid, 28041

  • Hospital Universitario La Paz

    Madrid, 28046

  • Hospital Clinico Universitario Virgen de la Victoria

    Málaga, 29010

Other trials in Spain

Turkey (Türkiye)3 sites

  • Adana Baskent University Medical Faculty; Oncology

    Adana, 01220

  • Baskent Universitesi Ankara Hastanesi; Tıbbi Onkoloji Bölümü

    Ankara, 06490

  • Koc University Medical Faculty; Department of Gynecology & Obstetrics

    Istanbul, 34010

Other trials in Turkey (Türkiye)

Canada2 sites

  • McGill University Health Centre - Glen Site

    Montreal, Quebec, H4A 3J1

  • Princess Margaret Cancer Center

    Toronto, Ontario, M5G 1Z5

Other trials in Canada

Germany2 sites

  • Kliniken Essen-Mitte Evang. Huyssens-Stiftung, Klinik für Gynäkologie und gynäkologische Onkologie

    Essen, 45136

  • Universitätsklinikum Mannheim

    Mannheim, 68167

Other trials in Germany

United Kingdom2 sites

  • Western General Hospital

    Edinburgh, EH4 2XU

  • University College London Hospitals NHS Foundation Trust - University College Hospital

    London, NW1 2PG

Other trials in United Kingdom

Australia1 site

  • Cabrini Hospital

    Malvern, Victoria, 3144

Other trials in Australia

Czechia1 site

  • Gynekologicko-porodnicka klinika

    Prague, 120 00

Other trials in Czechia

Russia1 site

  • LLC Medscan

    Moskva, Moscow Oblast, 119421

Other trials in Russia

Switzerland1 site

  • Hôpitaux Universitaires de Genève

    Geneva, 1205

Other trials in Switzerland

About this study

Official 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

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
Being tested
Ipatasertib, Cobimetinib, Trastuzumab Emtansine, Atezolizumab, Bevacizumab
Medical subject headings
Ovarian Neoplasms

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • IpatasertibDrug

    Also called RO5532961

    Ipatasertib will be administered by mouth once a day on Days 1-21 of each cycle. (Cycle length = 28 days)

  • CobimetinibDrug

    Also called RO5514041

    Cobimetinib will be administered by mouth once a day on Days 1-21 of each cycle. (Cycle length=28 days)

  • Trastuzumab EmtansineDrug

    Also called RO5304020

    Trastuzumab Emtansine will be administered intravenously on Day 1 of each cycle. (Cycle length=21 days)

  • AtezolizumabDrug

    Also called RO5541267, Tecentriq

    Atezolizumab will be administered intravenously on Day 1 of each cycle. (Cycle length=21 days)

  • BevacizumabDrug

    Also called RO4876646, Avastin

    Bevacizumab will be administered intravenously on Day 1 of each cycle. (Cycle length=21 days)

  • PaclitaxelDrug

    Paclitaxel will be administered intravenously on Days 1, 8, and 15 of each cycle. (Cycle length=28 days)

  • GiredestrantDrug

    Giredestrant will be administered by mouth once a day on Days 1-28 of each cycle (Cycle length=28 days)

  • AbemaciclibDrug

    Abemaciclib will be administered by mouth twice a day during each 28-day cycle

  • InavolisibDrug

    Inavolisib will be administered by mouth once a day on Days 1-28 of each 28-day cycle

  • PalbociclibDrug

    Palbociclib will be administered by mouth once a day on Days 1-21 of each 28-day cycle

  • LetrozoleDrug

    Letrozole will be administered by mouth once a day on Days 1-28 of each 28-day cycle

  • OlaparibDrug

    Olaparib will be administered by mouth twice a day on Days 1-28 of each 28-day cycle

  • Luteinizing Hormone-Releasing Hormone (LHRH) AgonistsDrug

    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.

  • CyclophosphamideDrug

    Cyclophosphamide will be administered by mouth once a day on Days 1-21 of each cycle. (Cycle length = 21 days)

  • InavolisibDrug

    Inavolisib will be administered by mouth once a day on Days 1-21 of each 21-day cycle

Study groups in NCT04931342
Study groupRoleWhat they receive
Ipatasertib + Paclitaxel (PIK3CA/AKT1/PTEN-altered tumors)ExperimentalParticipants in the Ipatasertib + Paclitaxel arm will receive treatment until unacceptable toxicity or disease progression per RECIST v1.1.
Receives: Drug: Ipatasertib; Drug: Paclitaxel
Cobimetinib (BRAF/NRAS/KRAS/NF1-altered tumors)ExperimentalParticipants in the Cobimetinib arm will receive treatment until unacceptable toxicity or disease progression per RECIST v1.1.
Receives: Drug: Cobimetinib
Trastuzumab Emtansine (ERBB2-amplified/mutant tumors)ExperimentalParticipants in the Trastuzumab Emtansine arm will receive treatment until unacceptable toxicity or disease progression per RECIST v1.1.
Receives: Drug: Trastuzumab Emtansine
Atezolizumab + Bevacizumab (Non-matched)ExperimentalParticipants 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.
Receives: Drug: Atezolizumab; Drug: Bevacizumab
Giredestrant + Abemaciclib (ER+ tumors)ExperimentalParticipants in the Giredestrant + Abemaciclib arm will receive treatment until unacceptable toxicity or disease progression as determined by the investigator according to RECIST v1.1.
Receives: Drug: Giredestrant; Drug: Abemaciclib; Drug: Luteinizing Hormone-Releasing Hormone (LHRH) Agonists
Inavolisib + Palbociclib (PIK3CA-altered tumors)ExperimentalParticipants in the Inavolisib + Palbociclib arm will receive treatment until unacceptable toxicity or disease progression per RECIST v1.1.
Receives: Drug: Inavolisib; Drug: Palbociclib
Inavolisib + Palbociclib + Letrozole (ER+ and PIK3CA-altered tumors)ExperimentalParticipants in the Inavolisib + Palbociclib + Letrozole arm will receive treatment until unacceptable toxicity or disease progression per RECIST v1.1.
Receives: Drug: Inavolisib; Drug: Palbociclib; Drug: Letrozole; Drug: Luteinizing Hormone-Releasing Hormone (LHRH) Agonists
Inavolisib + Olaparib (Non-matched)ExperimentalParticipants in the Inavolisib + Olaparib arm will receive treatment until unacceptable toxicity or disease progression per RECIST v1.1.
Receives: Drug: Inavolisib; Drug: Olaparib
Inavolisib + Giredestrant (ER+ and PIK3CA-altered tumors)ExperimentalParticipants in the Inavolisib + Giredestrant arm will receive treatment until unacceptable toxicity or disease progression per RECIST v1.1.
Receives: Drug: Giredestrant; Drug: Inavolisib
Inavolisib + Bevacizumab (PIK3CA-altered tumors)ExperimentalParticipants in the Inavolisib + Bevacizumab arm will receive treatment until unacceptable toxicity or disease progression per RECIST v1.1.
Receives: Drug: Bevacizumab; Drug: Inavolisib
Atezolizumab + Bevacizumab + Cyclophosphamide (Non-matched)ExperimentalParticipants 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.
Receives: Drug: Atezolizumab; Drug: Bevacizumab; Drug: Cyclophosphamide

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. 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.

    Measured: Up to approximately 5 years

Secondary outcomes (10)

  1. 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.

    Measured: Up to approximately 5 years

  2. 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.

    Measured: Up to approximately 5 years

  3. 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.

    Measured: Up to approximately 5 years

  4. 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.

    Measured: Up to 6 month

  5. Overall Survival (OS)

    OS after start of treatment is defined as the time from start of treatment to death from any cause.

    Measured: Up to approximately 5 years

  6. Confirmed ORR as Determined by IRC (Independent Review Committee)

    Confirmed ORR, as determined by the IRC according to RECIST v1.1.

    Measured: Up to approximately 5 years

  7. DOR as Determined by IRC

    DOR, as determined by the IRC according to RECIST v1.1

    Measured: Up to approximately 5 years

  8. DCR as Determined by IRC

    DCR, as determined by the IRC according to RECIST v1.1

    Measured: Up to approximately 5 years

  9. PFS as Determined by IRC

    PFS, as determined by the IRC according to RECIST v1.1

    Measured: Up to approximately 5 years

  10. Percentage of Participants With Adverse Events

    Percentage of participants with adverse events.

    Measured: Up to approximately 5 years

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted18 Jun 2021
  2. Study start7 Oct 2021
  3. Primary completion28 Feb 2028 (estimated)
  4. Study completion30 May 2028 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 2
Primary purpose
Treatment
Allocation
Non-randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
176 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT04931342
Sponsor's protocol ID
WO42178
Other IDs
GOG-3051, ENGOT-GYN2
Acronym
BOUQUET
Status last verified
Sep 2026
First submitted
9 Jun 2021
Last updated
10 Sep 2026
Results posted
No
FDA-regulated drug
Yes
FDA-regulated device
No
Individual data sharing
Yes: 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

Publications

  • Ray-Coquard I, Ledermann J, DeFazio A, Okamoto A, Gershenson D. Controversies in the organization and structure of management for rare tumors. Int J Gynecol Cancer. 2025 Mar;35(3):101669. doi: 10.1016/j.ijgc.2025.101669. Epub 2025 Jan 29.

    PubMed 40022843

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing Ipatasertib, Cobimetinib and Trastuzumab Emtansine in people with Ovarian Cancer, run by Hoffmann-La Roche at 41 sites in 13 countries.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 24 inclusion and 0 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: under way, not looking for participants, as of the sponsor's last update on 10 Sep 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 41 sites in United States, France, Italy, South Korea, Spain and 8 more countries. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Confirmed Objective Response Rate (ORR) (time frame: Up to approximately 5 years). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT04931342, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 10 Sep 2026.

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