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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/study/NCT04931342




Registration number
NCT04931342
Ethics application status
Date submitted
9/06/2021
Date registered
18/06/2021

Titles & IDs
Public title
A Study Evaluating the Efficacy and Safety of Biomarker-Driven Therapies in Patients With Persistent or Recurrent Rare Epithelial Ovarian Tumors
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
Secondary ID [1] 0 0
GOG-3051
Secondary ID [2] 0 0
WO42178
Universal Trial Number (UTN)
Trial acronym
BOUQUET
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Ovarian Cancer 0 0
Condition category
Condition code
Cancer 0 0 0 0
Ovarian and primary peritoneal

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Treatment: Drugs - Ipatasertib
Treatment: Drugs - Cobimetinib
Treatment: Drugs - Trastuzumab Emtansine
Treatment: Drugs - Atezolizumab
Treatment: Drugs - Bevacizumab
Treatment: Drugs - Paclitaxel
Treatment: Drugs - Giredestrant
Treatment: Drugs - Abemaciclib
Treatment: Drugs - Inavolisib
Treatment: Drugs - Palbociclib
Treatment: Drugs - Letrozole
Treatment: Drugs - Olaparib
Treatment: Drugs - Luteinizing Hormone-Releasing Hormone (LHRH) Agonists
Treatment: Drugs - Cyclophosphamide
Treatment: Drugs - Inavolisib

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.

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.

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.

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.

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.

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.

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.

Experimental: Inavolisib + Olaparib (Non-matched) - Participants in the Inavolisib + Olaparib arm will receive treatment until unacceptable toxicity or disease progression per RECIST v1.1.

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.

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.

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.


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

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

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

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

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

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

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

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

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

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

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

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

Treatment: Drugs: 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.

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

Treatment: Drugs: Inavolisib
Inavolisib will be administered by mouth once a day on Days 1-21 of each 21-day cycle
Intervention code [1] 0 0
Treatment: Drugs
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Confirmed Objective Response Rate (ORR)
Timepoint [1] 0 0
Up to approximately 5 years
Secondary outcome [1] 0 0
Duration of Response (DOR)
Timepoint [1] 0 0
Up to approximately 5 years
Secondary outcome [2] 0 0
Disease Contral Rate (DCR)
Timepoint [2] 0 0
Up to approximately 5 years
Secondary outcome [3] 0 0
Progression Free Survival (PFS)
Timepoint [3] 0 0
Up to approximately 5 years
Secondary outcome [4] 0 0
6-Month PFS Rate
Timepoint [4] 0 0
Up to 6 month
Secondary outcome [5] 0 0
Overall Survival (OS)
Timepoint [5] 0 0
Up to approximately 5 years
Secondary outcome [6] 0 0
Confirmed ORR as Determined by IRC (Independent Review Committee)
Timepoint [6] 0 0
Up to approximately 5 years
Secondary outcome [7] 0 0
DOR as Determined by IRC
Timepoint [7] 0 0
Up to approximately 5 years
Secondary outcome [8] 0 0
DCR as Determined by IRC
Timepoint [8] 0 0
Up to approximately 5 years
Secondary outcome [9] 0 0
PFS as Determined by IRC
Timepoint [9] 0 0
Up to approximately 5 years
Secondary outcome [10] 0 0
Percentage of Participants With Adverse Events
Timepoint [10] 0 0
Up to approximately 5 years

Eligibility
Key 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
Minimum age
18 Years
Maximum age
No limit
Sex
Females
Can healthy volunteers participate?
No
Key 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 design
Purpose of the study
Treatment
Allocation to intervention
Non-randomised trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Parallel
Other design features
Phase
Phase 2
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Active, not recruiting
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
7/10/2021
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
30/05/2028
Actual
Sample size
Target
Accrual to date
Final
176
Recruitment in Australia
Recruitment state(s)
VIC
Recruitment hospital [1] 0 0
Cabrini Hospital; Cabrini Foundation - Malvern
Recruitment postcode(s) [1] 0 0
3144 - Malvern
Recruitment outside Australia
Country [1] 0 0
United States of America
State/province [1] 0 0
Arizona
Country [2] 0 0
United States of America
State/province [2] 0 0
California
Country [3] 0 0
United States of America
State/province [3] 0 0
Missouri
Country [4] 0 0
United States of America
State/province [4] 0 0
New York
Country [5] 0 0
United States of America
State/province [5] 0 0
North Carolina
Country [6] 0 0
United States of America
State/province [6] 0 0
Ohio
Country [7] 0 0
United States of America
State/province [7] 0 0
Oklahoma
Country [8] 0 0
United States of America
State/province [8] 0 0
Texas
Country [9] 0 0
United States of America
State/province [9] 0 0
Utah
Country [10] 0 0
United States of America
State/province [10] 0 0
Virginia
Country [11] 0 0
United States of America
State/province [11] 0 0
Washington
Country [12] 0 0
Canada
State/province [12] 0 0
Ontario
Country [13] 0 0
Canada
State/province [13] 0 0
Quebec
Country [14] 0 0
Czechia
State/province [14] 0 0
Brno
Country [15] 0 0
Czechia
State/province [15] 0 0
Prague
Country [16] 0 0
France
State/province [16] 0 0
Besançon Cedex
Country [17] 0 0
France
State/province [17] 0 0
Bordeaux
Country [18] 0 0
France
State/province [18] 0 0
Caen
Country [19] 0 0
France
State/province [19] 0 0
Lyon
Country [20] 0 0
France
State/province [20] 0 0
Montpellier
Country [21] 0 0
France
State/province [21] 0 0
Paris
Country [22] 0 0
France
State/province [22] 0 0
Rennes
Country [23] 0 0
France
State/province [23] 0 0
Saint Herblain
Country [24] 0 0
France
State/province [24] 0 0
Toulouse
Country [25] 0 0
France
State/province [25] 0 0
Villejuif
Country [26] 0 0
Germany
State/province [26] 0 0
Berlin
Country [27] 0 0
Germany
State/province [27] 0 0
Dresden
Country [28] 0 0
Germany
State/province [28] 0 0
Essen
Country [29] 0 0
Germany
State/province [29] 0 0
Mannheim
Country [30] 0 0
Germany
State/province [30] 0 0
Muenchen
Country [31] 0 0
Italy
State/province [31] 0 0
Campania
Country [32] 0 0
Italy
State/province [32] 0 0
Lazio
Country [33] 0 0
Italy
State/province [33] 0 0
Lombardia
Country [34] 0 0
Italy
State/province [34] 0 0
Puglia
Country [35] 0 0
Korea, Republic of
State/province [35] 0 0
Seoul
Country [36] 0 0
Russian Federation
State/province [36] 0 0
Moskovskaja Oblast
Country [37] 0 0
Russian Federation
State/province [37] 0 0
Sankt Petersburg
Country [38] 0 0
Russian Federation
State/province [38] 0 0
Sverdlovsk
Country [39] 0 0
Spain
State/province [39] 0 0
Barcelona
Country [40] 0 0
Spain
State/province [40] 0 0
Madrid
Country [41] 0 0
Spain
State/province [41] 0 0
Malaga
Country [42] 0 0
Switzerland
State/province [42] 0 0
Genève
Country [43] 0 0
Turkey
State/province [43] 0 0
Adana
Country [44] 0 0
Turkey
State/province [44] 0 0
Ankara
Country [45] 0 0
Turkey
State/province [45] 0 0
Istanbul
Country [46] 0 0
United Kingdom
State/province [46] 0 0
Edinburgh
Country [47] 0 0
United Kingdom
State/province [47] 0 0
London

Funding & Sponsors
Primary sponsor type
Commercial sector/industry
Name
Hoffmann-La Roche
Address
Country
Other collaborator category [1] 0 0
Other
Name [1] 0 0
GOG Foundation
Address [1] 0 0
Country [1] 0 0
Other collaborator category [2] 0 0
Other
Name [2] 0 0
European Network of Gynaecological Oncological Trial Groups (ENGOT)
Address [2] 0 0
Country [2] 0 0

Ethics approval
Ethics application status

Summary
Brief summary
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
Clinical Trials
Address 0 0
Hoffmann-La Roche
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Address 0 0
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for scientific queries

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
Yes
What data in particular will be shared?
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
When will data be available (start and end dates)?
Available to whom?
Available for what types of analyses?
How or where can data be obtained?


What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents

No documents have been uploaded by study researchers.


Results not provided in https://clinicaltrials.gov/study/NCT04931342