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

Primary Purpose

Ovarian Cancer

Status
Recruiting
Phase
Phase 2
Locations
International
Study Type
Interventional
Intervention
Ipatasertib
Cobimetinib
Trastuzumab Emtansine
Atezolizumab
Bevacizumab
Paclitaxel
Giredestrant
Abemaciclib
Inavolisib
Palbociclib
Letrozole
Olaparib
Luteinizing Hormone-Releasing Hormone (LHRH) Agonists
Cyclophosphamide
Inavolisib
Sponsored by
Hoffmann-La Roche
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Ovarian Cancer

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)FemaleDoes not accept healthy volunteers

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

Sites / Locations

  • Arizona Oncology - HOPE WilmotRecruiting
  • Kaiser Permanente - IrvineRecruiting
  • UCSF Helen Diller Family CCCRecruiting
  • Minnesota Oncology HematologyRecruiting
  • Washington University School of Medicine; Dept of Medicine/Div of Medical OncologyRecruiting
  • Memorial Sloan Kettering Cancer Center
  • Levine Cancer InstituteRecruiting
  • Ohio State UniversityRecruiting
  • University of Oklahoma Health Sciences Center; Stephenson Cancer CenterRecruiting
  • Northwest Cancer Specialists, P.C.Recruiting
  • Pinnacle Health; Harrisburg Hospital PharmacyRecruiting
  • Magee-Woman's HospitalRecruiting
  • MD Anderson Cancer CenterRecruiting
  • Texas Oncology - Gulf CoastRecruiting
  • Huntsman Cancer InstituteRecruiting
  • Virginia Oncology AssociatesRecruiting
  • University of Washington - Seattle Cancer Care Alliance; Medical OncologyRecruiting
  • Cabrini Hospital; Cabrini FoundationRecruiting
  • UZ Leuven; Gyneacologische OncologieRecruiting
  • CHU Sart-TilmanRecruiting
  • Kingston General HospitalRecruiting
  • Princess Margaret Cancer CenterRecruiting
  • McGill University Health Centre - Glen SiteRecruiting
  • Fakultni nemocnice Brno BohuniceRecruiting
  • Gynekologicko-porodnicka klinikaRecruiting
  • CHU Besançon - Hôpital Jean Minjoz
  • Institut Bergonie; OncologieRecruiting
  • Centre Francois Baclesse; OncologieRecruiting
  • CENTRE LEON BERARD; Département d?Hématologie et d?OncologieRecruiting
  • Institut Régional du Cancer de MontpellierRecruiting
  • Groupe Hospitalier DiaconessesRecruiting
  • Centre Eugène MarquisRecruiting
  • ICO - Site René GauducheauRecruiting
  • Institut Claudius Regaud; Departement Oncologie MedicaleRecruiting
  • Gustave RoussyRecruiting
  • Universitätsklinikum "Carl Gustav Carus"; Frauenheilkunde und GeburtshilfeRecruiting
  • Kliniken Essen-Mitte Evang. Huyssens-Stiftung, Klinik für Gynäkologie und gynäkologische Onkologie
  • Universitätsklinikum Mannheim; FrauenklinikRecruiting
  • Klinikum der Universität München; Campus Großhadern; Klinik und Poliklinik für FrauenheilkundeRecruiting
  • Istituto Tumori Napoli;Unità Operativa Oncologia Medica Uro-GinecologicaRecruiting
  • Policlinico Universitario Agostino GemelliRecruiting
  • IRCCS S. Raffaele; Ginecologia OncologicaRecruiting
  • Irccs Istituto Europeo Di Oncologia (IEO); Oncologia MedicaRecruiting
  • I.R.C.C. Candiolo; Oncologia Medica e EmatologiaRecruiting
  • A.O. U. Consorziale Policlinico di Bari; Oncologia Ginecologica
  • Seoul National University HospitalRecruiting
  • Severance Hospital, Yonsei University Health SystemRecruiting
  • Asan Medical CenterRecruiting
  • Samsung Medical CenterRecruiting
  • LLC MedscanRecruiting
  • FSBI "Federal Medical Research Center n.a. V.A.Almazov"
  • Chelyabisnk regional clinical center for oncology and nuclear medicineRecruiting
  • Institutio Catalan De OncologiaRecruiting
  • Hospital Universitario 12 de Octubre; Servicio de OncologiaRecruiting
  • Hospital Universitario La Paz; Servicio de OncologiaRecruiting
  • Hospital Clinico Universitario Virgen de la Victoria; Servicio de Oncologia
  • Hôpitaux Universitaires de Genève; Département d'oncologieRecruiting
  • Adana Baskent University Medical Faculty; Oncology
  • Baskent Universitesi Ankara Hastanesi; Tıbbi Onkoloji BölümüRecruiting
  • Koc University Medical Faculty; Department of Gynecology & ObstetricsRecruiting
  • Western General Hospital; Edinburgh Cancer CenterRecruiting
  • University College London Hospitals NHS Foundation Trust - University College HospitalRecruiting

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm 5

Arm 6

Arm 7

Arm 8

Arm 9

Arm 10

Arm 11

Arm Type

Experimental

Experimental

Experimental

Experimental

Experimental

Experimental

Experimental

Experimental

Experimental

Experimental

Experimental

Arm Label

Ipatasertib + Paclitaxel (PIK3CA/AKT1/PTEN-altered tumors)

Cobimetinib (BRAF/NRAS/KRAS/NF1-altered tumors)

Trastuzumab Emtansine (ERBB2-amplified/mutant tumors)

Atezolizumab + Bevacizumab (Non-matched)

Giredestrant + Abemaciclib (ER+ tumors)

Inavolisib + Palbociclib (PIK3CA-altered tumors)

Inavolisib + Palbociclib + Letrozole (ER+ and PIK3CA-altered tumors)

Inavolisib + Olaparib (Non-matched)

Inavolisib + Giredestrant (ER+ and PIK3CA-altered tumors)

Inavolisib + Bevacizumab (PIK3CA-altered tumors)

Atezolizumab + Bevacizumab + Cyclophosphamide (Non-matched)

Arm Description

Participants in the Ipatasertib + Paclitaxel arm will receive treatment until unacceptable toxicity or disease progression per RECIST v1.1.

Participants in the Cobimetinib arm will receive treatment until unacceptable toxicity or disease progression per RECIST v1.1.

Participants in the Trastuzumab Emtansine arm will receive treatment until unacceptable toxicity or disease progression per RECIST v1.1.

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.

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.

Participants in the Inavolisib + Palbociclib arm will receive treatment until unacceptable toxicity or disease progression per RECIST v1.1.

Participants in the Inavolisib + Palbociclib + Letrozole arm will receive treatment until unacceptable toxicity or disease progression per RECIST v1.1.

Participants in the Inavolisib + Olaparib arm will receive treatment until unacceptable toxicity or disease progression per RECIST v1.1.

Participants in the Inavolisib + Giredestrant arm will receive treatment until unacceptable toxicity or disease progression per RECIST v1.1.

Participants in the Inavolisib + Bevacizumab arm will receive treatment until unacceptable toxicity or disease progression per RECIST v1.1.

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.

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

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.
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.
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.
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.
Overall Survival (OS)
OS after start of treatment is defined as the time from start of treatment to death from any cause.
Confirmed ORR as Determined by IRC (Independent Review Committee)
Confirmed ORR, as determined by the IRC according to RECIST v1.1.
DOR as Determined by IRC
DOR, as determined by the IRC according to RECIST v1.1
DCR as Determined by IRC
DCR, as determined by the IRC according to RECIST v1.1
PFS as Determined by IRC
PFS, as determined by the IRC according to RECIST v1.1
Percentage of Participants With Adverse Events
Percentage of participants with adverse events.

Full Information

First Posted
June 9, 2021
Last Updated
October 13, 2023
Sponsor
Hoffmann-La Roche
Collaborators
GOG Foundation, European Network of Gynaecological Oncological Trial Groups (ENGOT)
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1. Study Identification

Unique Protocol Identification Number
NCT04931342
Brief Title
A Study Evaluating the Efficacy and Safety of Biomarker-Driven Therapies in Patients With Persistent or Recurrent Rare Epithelial Ovarian Tumors
Acronym
BOUQUET
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
Study Type
Interventional

2. Study Status

Record Verification Date
October 2023
Overall Recruitment Status
Recruiting
Study Start Date
October 7, 2021 (Actual)
Primary Completion Date
May 30, 2028 (Anticipated)
Study Completion Date
December 31, 2028 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Hoffmann-La Roche
Collaborators
GOG Foundation, European Network of Gynaecological Oncological Trial Groups (ENGOT)

4. Oversight

Studies a U.S. FDA-regulated Drug Product
Yes
Studies a U.S. FDA-regulated Device Product
No

5. Study Description

Brief 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Ovarian Cancer

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
550 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Ipatasertib + Paclitaxel (PIK3CA/AKT1/PTEN-altered tumors)
Arm Type
Experimental
Arm Description
Participants in the Ipatasertib + Paclitaxel arm will receive treatment until unacceptable toxicity or disease progression per RECIST v1.1.
Arm Title
Cobimetinib (BRAF/NRAS/KRAS/NF1-altered tumors)
Arm Type
Experimental
Arm Description
Participants in the Cobimetinib arm will receive treatment until unacceptable toxicity or disease progression per RECIST v1.1.
Arm Title
Trastuzumab Emtansine (ERBB2-amplified/mutant tumors)
Arm Type
Experimental
Arm Description
Participants in the Trastuzumab Emtansine arm will receive treatment until unacceptable toxicity or disease progression per RECIST v1.1.
Arm Title
Atezolizumab + Bevacizumab (Non-matched)
Arm Type
Experimental
Arm Description
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.
Arm Title
Giredestrant + Abemaciclib (ER+ tumors)
Arm Type
Experimental
Arm Description
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.
Arm Title
Inavolisib + Palbociclib (PIK3CA-altered tumors)
Arm Type
Experimental
Arm Description
Participants in the Inavolisib + Palbociclib arm will receive treatment until unacceptable toxicity or disease progression per RECIST v1.1.
Arm Title
Inavolisib + Palbociclib + Letrozole (ER+ and PIK3CA-altered tumors)
Arm Type
Experimental
Arm Description
Participants in the Inavolisib + Palbociclib + Letrozole arm will receive treatment until unacceptable toxicity or disease progression per RECIST v1.1.
Arm Title
Inavolisib + Olaparib (Non-matched)
Arm Type
Experimental
Arm Description
Participants in the Inavolisib + Olaparib arm will receive treatment until unacceptable toxicity or disease progression per RECIST v1.1.
Arm Title
Inavolisib + Giredestrant (ER+ and PIK3CA-altered tumors)
Arm Type
Experimental
Arm Description
Participants in the Inavolisib + Giredestrant arm will receive treatment until unacceptable toxicity or disease progression per RECIST v1.1.
Arm Title
Inavolisib + Bevacizumab (PIK3CA-altered tumors)
Arm Type
Experimental
Arm Description
Participants in the Inavolisib + Bevacizumab arm will receive treatment until unacceptable toxicity or disease progression per RECIST v1.1.
Arm Title
Atezolizumab + Bevacizumab + Cyclophosphamide (Non-matched)
Arm Type
Experimental
Arm Description
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.
Intervention Type
Drug
Intervention Name(s)
Ipatasertib
Other Intervention Name(s)
RO5532961
Intervention Description
Ipatasertib will be administered by mouth once a day on Days 1-21 of each cycle. (Cycle length = 28 days)
Intervention Type
Drug
Intervention Name(s)
Cobimetinib
Other Intervention Name(s)
RO5514041
Intervention Description
Cobimetinib will be administered by mouth once a day on Days 1-21 of each cycle. (Cycle length=28 days)
Intervention Type
Drug
Intervention Name(s)
Trastuzumab Emtansine
Other Intervention Name(s)
RO5304020
Intervention Description
Trastuzumab Emtansine will be administered intravenously on Day 1 of each cycle. (Cycle length=21 days)
Intervention Type
Drug
Intervention Name(s)
Atezolizumab
Other Intervention Name(s)
RO5541267, Tecentriq
Intervention Description
Atezolizumab will be administered intravenously on Day 1 of each cycle. (Cycle length=21 days)
Intervention Type
Drug
Intervention Name(s)
Bevacizumab
Other Intervention Name(s)
RO4876646, Avastin
Intervention Description
Bevacizumab will be administered intravenously on Day 1 of each cycle. (Cycle length=21 days)
Intervention Type
Drug
Intervention Name(s)
Paclitaxel
Intervention Description
Paclitaxel will be administered intravenously on Days 1, 8, and 15 of each cycle. (Cycle length=28 days)
Intervention Type
Drug
Intervention Name(s)
Giredestrant
Intervention Description
Giredestrant will be administered by mouth once a day on Days 1-28 of each cycle (Cycle length=28 days)
Intervention Type
Drug
Intervention Name(s)
Abemaciclib
Intervention Description
Abemaciclib will be administered by mouth twice a day during each 28-day cycle
Intervention Type
Drug
Intervention Name(s)
Inavolisib
Intervention Description
Inavolisib will be administered by mouth once a day on Days 1-28 of each 28-day cycle
Intervention Type
Drug
Intervention Name(s)
Palbociclib
Intervention Description
Palbociclib will be administered by mouth once a day on Days 1-21 of each 28-day cycle
Intervention Type
Drug
Intervention Name(s)
Letrozole
Intervention Description
Letrozole will be administered by mouth once a day on Days 1-28 of each 28-day cycle
Intervention Type
Drug
Intervention Name(s)
Olaparib
Intervention Description
Olaparib will be administered by mouth twice a day on Days 1-28 of each 28-day cycle
Intervention Type
Drug
Intervention Name(s)
Luteinizing Hormone-Releasing Hormone (LHRH) Agonists
Intervention Description
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.
Intervention Type
Drug
Intervention Name(s)
Cyclophosphamide
Intervention Description
Cyclophosphamide will be administered by mouth once a day on Days 1-21 of each cycle. (Cycle length = 21 days)
Intervention Type
Drug
Intervention Name(s)
Inavolisib
Intervention Description
Inavolisib will be administered by mouth once a day on Days 1-21 of each 21-day cycle
Primary Outcome Measure Information:
Title
Confirmed Objective Response Rate (ORR)
Description
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.
Time Frame
Up to approximately 5 years
Secondary Outcome Measure Information:
Title
Duration of Response (DOR)
Description
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.
Time Frame
Up to approximately 5 years
Title
Disease Contral Rate (DCR)
Description
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.
Time Frame
Up to approximately 5 years
Title
Progression Free Survival (PFS)
Description
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.
Time Frame
Up to approximately 5 years
Title
6-Month PFS Rate
Description
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.
Time Frame
Up to 6 month
Title
Overall Survival (OS)
Description
OS after start of treatment is defined as the time from start of treatment to death from any cause.
Time Frame
Up to approximately 5 years
Title
Confirmed ORR as Determined by IRC (Independent Review Committee)
Description
Confirmed ORR, as determined by the IRC according to RECIST v1.1.
Time Frame
Up to approximately 5 years
Title
DOR as Determined by IRC
Description
DOR, as determined by the IRC according to RECIST v1.1
Time Frame
Up to approximately 5 years
Title
DCR as Determined by IRC
Description
DCR, as determined by the IRC according to RECIST v1.1
Time Frame
Up to approximately 5 years
Title
PFS as Determined by IRC
Description
PFS, as determined by the IRC according to RECIST v1.1
Time Frame
Up to approximately 5 years
Title
Percentage of Participants With Adverse Events
Description
Percentage of participants with adverse events.
Time Frame
Up to approximately 5 years

10. Eligibility

Sex
Female
Gender Based
Yes
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Reference Study ID Number: WO42178 https://forpatients.roche.com/
Phone
888-662-6728 (U.S. and Canada)
Email
global-roche-genentech-trials@gene.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Clinical Trials
Organizational Affiliation
Hoffmann-La Roche
Official's Role
Study Director
Facility Information:
Facility Name
Arizona Oncology - HOPE Wilmot
City
Tucson
State/Province
Arizona
ZIP/Postal Code
85710
Country
United States
Individual Site Status
Recruiting
Facility Name
Kaiser Permanente - Irvine
City
Irvine
State/Province
California
ZIP/Postal Code
92618
Country
United States
Individual Site Status
Recruiting
Facility Name
UCSF Helen Diller Family CCC
City
San Francisco
State/Province
California
ZIP/Postal Code
94158
Country
United States
Individual Site Status
Recruiting
Facility Name
Minnesota Oncology Hematology
City
Saint Paul
State/Province
Minnesota
ZIP/Postal Code
55102
Country
United States
Individual Site Status
Recruiting
Facility Name
Washington University School of Medicine; Dept of Medicine/Div of Medical Oncology
City
Saint Louis
State/Province
Missouri
ZIP/Postal Code
63108
Country
United States
Individual Site Status
Recruiting
Facility Name
Memorial Sloan Kettering Cancer Center
City
New York
State/Province
New York
ZIP/Postal Code
10065
Country
United States
Individual Site Status
Completed
Facility Name
Levine Cancer Institute
City
Charlotte
State/Province
North Carolina
ZIP/Postal Code
28204
Country
United States
Individual Site Status
Recruiting
Facility Name
Ohio State University
City
Columbus
State/Province
Ohio
ZIP/Postal Code
43212-3153
Country
United States
Individual Site Status
Recruiting
Facility Name
University of Oklahoma Health Sciences Center; Stephenson Cancer Center
City
Oklahoma City
State/Province
Oklahoma
ZIP/Postal Code
73104
Country
United States
Individual Site Status
Recruiting
Facility Name
Northwest Cancer Specialists, P.C.
City
Tigard
State/Province
Oregon
ZIP/Postal Code
97223
Country
United States
Individual Site Status
Recruiting
Facility Name
Pinnacle Health; Harrisburg Hospital Pharmacy
City
Harrisburg
State/Province
Pennsylvania
ZIP/Postal Code
17101
Country
United States
Individual Site Status
Recruiting
Facility Name
Magee-Woman's Hospital
City
Pittsburgh
State/Province
Pennsylvania
ZIP/Postal Code
15213
Country
United States
Individual Site Status
Recruiting
Facility Name
MD Anderson Cancer Center
City
Houston
State/Province
Texas
ZIP/Postal Code
77030
Country
United States
Individual Site Status
Recruiting
Facility Name
Texas Oncology - Gulf Coast
City
The Woodlands
State/Province
Texas
ZIP/Postal Code
77380
Country
United States
Individual Site Status
Recruiting
Facility Name
Huntsman Cancer Institute
City
Salt Lake City
State/Province
Utah
ZIP/Postal Code
84112
Country
United States
Individual Site Status
Recruiting
Facility Name
Virginia Oncology Associates
City
Norfolk
State/Province
Virginia
ZIP/Postal Code
23502
Country
United States
Individual Site Status
Recruiting
Facility Name
University of Washington - Seattle Cancer Care Alliance; Medical Oncology
City
Seattle
State/Province
Washington
ZIP/Postal Code
98109
Country
United States
Individual Site Status
Recruiting
Facility Name
Cabrini Hospital; Cabrini Foundation
City
Malvern
State/Province
Victoria
ZIP/Postal Code
3144
Country
Australia
Individual Site Status
Recruiting
Facility Name
UZ Leuven; Gyneacologische Oncologie
City
Leuven
ZIP/Postal Code
3000
Country
Belgium
Individual Site Status
Recruiting
Facility Name
CHU Sart-Tilman
City
Liège
ZIP/Postal Code
4000
Country
Belgium
Individual Site Status
Recruiting
Facility Name
Kingston General Hospital
City
Kingston
State/Province
Ontario
ZIP/Postal Code
K7L 2V7
Country
Canada
Individual Site Status
Recruiting
Facility Name
Princess Margaret Cancer Center
City
Toronto
State/Province
Ontario
ZIP/Postal Code
M5G 1Z5
Country
Canada
Individual Site Status
Recruiting
Facility Name
McGill University Health Centre - Glen Site
City
Montreal
State/Province
Quebec
ZIP/Postal Code
H4A 3J1
Country
Canada
Individual Site Status
Recruiting
Facility Name
Fakultni nemocnice Brno Bohunice
City
Brno
ZIP/Postal Code
625 00
Country
Czechia
Individual Site Status
Recruiting
Facility Name
Gynekologicko-porodnicka klinika
City
Prague
ZIP/Postal Code
120 00
Country
Czechia
Individual Site Status
Recruiting
Facility Name
CHU Besançon - Hôpital Jean Minjoz
City
Besançon Cedex
ZIP/Postal Code
25030
Country
France
Individual Site Status
Completed
Facility Name
Institut Bergonie; Oncologie
City
Bordeaux
ZIP/Postal Code
33076
Country
France
Individual Site Status
Recruiting
Facility Name
Centre Francois Baclesse; Oncologie
City
Caen
ZIP/Postal Code
14076
Country
France
Individual Site Status
Recruiting
Facility Name
CENTRE LEON BERARD; Département d?Hématologie et d?Oncologie
City
Lyon
ZIP/Postal Code
69373
Country
France
Individual Site Status
Recruiting
Facility Name
Institut Régional du Cancer de Montpellier
City
Montpellier
ZIP/Postal Code
34298
Country
France
Individual Site Status
Recruiting
Facility Name
Groupe Hospitalier Diaconesses
City
Paris
ZIP/Postal Code
75020
Country
France
Individual Site Status
Recruiting
Facility Name
Centre Eugène Marquis
City
Rennes
ZIP/Postal Code
35000
Country
France
Individual Site Status
Recruiting
Facility Name
ICO - Site René Gauducheau
City
Saint Herblain
ZIP/Postal Code
44805
Country
France
Individual Site Status
Recruiting
Facility Name
Institut Claudius Regaud; Departement Oncologie Medicale
City
Toulouse
ZIP/Postal Code
31059
Country
France
Individual Site Status
Recruiting
Facility Name
Gustave Roussy
City
Villejuif
ZIP/Postal Code
94805
Country
France
Individual Site Status
Recruiting
Facility Name
Universitätsklinikum "Carl Gustav Carus"; Frauenheilkunde und Geburtshilfe
City
Dresden
ZIP/Postal Code
01307
Country
Germany
Individual Site Status
Recruiting
Facility Name
Kliniken Essen-Mitte Evang. Huyssens-Stiftung, Klinik für Gynäkologie und gynäkologische Onkologie
City
Essen
ZIP/Postal Code
45136
Country
Germany
Individual Site Status
Active, not recruiting
Facility Name
Universitätsklinikum Mannheim; Frauenklinik
City
Mannheim
ZIP/Postal Code
68167
Country
Germany
Individual Site Status
Recruiting
Facility Name
Klinikum der Universität München; Campus Großhadern; Klinik und Poliklinik für Frauenheilkunde
City
Muenchen
ZIP/Postal Code
81377
Country
Germany
Individual Site Status
Recruiting
Facility Name
Istituto Tumori Napoli;Unità Operativa Oncologia Medica Uro-Ginecologica
City
Napoli
State/Province
Campania
ZIP/Postal Code
80131
Country
Italy
Individual Site Status
Recruiting
Facility Name
Policlinico Universitario Agostino Gemelli
City
Roma
State/Province
Lazio
ZIP/Postal Code
00168
Country
Italy
Individual Site Status
Recruiting
Facility Name
IRCCS S. Raffaele; Ginecologia Oncologica
City
Milano
State/Province
Lombardia
ZIP/Postal Code
20132
Country
Italy
Individual Site Status
Recruiting
Facility Name
Irccs Istituto Europeo Di Oncologia (IEO); Oncologia Medica
City
Milano
State/Province
Lombardia
ZIP/Postal Code
20141
Country
Italy
Individual Site Status
Recruiting
Facility Name
I.R.C.C. Candiolo; Oncologia Medica e Ematologia
City
Candiolo
State/Province
Piemonte
ZIP/Postal Code
10060
Country
Italy
Individual Site Status
Recruiting
Facility Name
A.O. U. Consorziale Policlinico di Bari; Oncologia Ginecologica
City
Bari
State/Province
Puglia
ZIP/Postal Code
70124
Country
Italy
Individual Site Status
Terminated
Facility Name
Seoul National University Hospital
City
Seoul
ZIP/Postal Code
03080
Country
Korea, Republic of
Individual Site Status
Recruiting
Facility Name
Severance Hospital, Yonsei University Health System
City
Seoul
ZIP/Postal Code
03722
Country
Korea, Republic of
Individual Site Status
Recruiting
Facility Name
Asan Medical Center
City
Seoul
ZIP/Postal Code
05505
Country
Korea, Republic of
Individual Site Status
Recruiting
Facility Name
Samsung Medical Center
City
Seoul
ZIP/Postal Code
06351
Country
Korea, Republic of
Individual Site Status
Recruiting
Facility Name
LLC Medscan
City
Moskva
State/Province
Moskovskaja Oblast
ZIP/Postal Code
119421
Country
Russian Federation
Individual Site Status
Recruiting
Facility Name
FSBI "Federal Medical Research Center n.a. V.A.Almazov"
City
Sankt-peterburg
State/Province
Sankt Petersburg
ZIP/Postal Code
197341
Country
Russian Federation
Individual Site Status
Completed
Facility Name
Chelyabisnk regional clinical center for oncology and nuclear medicine
City
Chelyabinsk
State/Province
Sverdlovsk
ZIP/Postal Code
454087
Country
Russian Federation
Individual Site Status
Recruiting
Facility Name
Institutio Catalan De Oncologia
City
Badalona
State/Province
Barcelona
ZIP/Postal Code
08916
Country
Spain
Individual Site Status
Recruiting
Facility Name
Hospital Universitario 12 de Octubre; Servicio de Oncologia
City
Madrid
ZIP/Postal Code
28041
Country
Spain
Individual Site Status
Recruiting
Facility Name
Hospital Universitario La Paz; Servicio de Oncologia
City
Madrid
ZIP/Postal Code
28046
Country
Spain
Individual Site Status
Recruiting
Facility Name
Hospital Clinico Universitario Virgen de la Victoria; Servicio de Oncologia
City
Malaga
ZIP/Postal Code
29010
Country
Spain
Individual Site Status
Active, not recruiting
Facility Name
Hôpitaux Universitaires de Genève; Département d'oncologie
City
Genève
ZIP/Postal Code
1205
Country
Switzerland
Individual Site Status
Recruiting
Facility Name
Adana Baskent University Medical Faculty; Oncology
City
Adana
ZIP/Postal Code
01220
Country
Turkey
Individual Site Status
Active, not recruiting
Facility Name
Baskent Universitesi Ankara Hastanesi; Tıbbi Onkoloji Bölümü
City
Ankara
ZIP/Postal Code
06490
Country
Turkey
Individual Site Status
Recruiting
Facility Name
Koc University Medical Faculty; Department of Gynecology & Obstetrics
City
Istanbul
ZIP/Postal Code
34010
Country
Turkey
Individual Site Status
Recruiting
Facility Name
Western General Hospital; Edinburgh Cancer Center
City
Edinburgh
ZIP/Postal Code
EH4 2XU
Country
United Kingdom
Individual Site Status
Recruiting
Facility Name
University College London Hospitals NHS Foundation Trust - University College Hospital
City
London
ZIP/Postal Code
NW1 2PG
Country
United Kingdom
Individual Site Status
Recruiting

12. IPD Sharing Statement

Plan to Share IPD
Yes
IPD Sharing Plan Description
Qualified researchers may request access to individual patient level data through the clinical study data request platform (www.clinicalstudydatarequest.com). Further details on Roche's criteria for eligible studies are available here (https://clinicalstudydatarequest.com/Study-Sponsors/Study-Sponsors-Roche.aspx). For further details on Roche's Global Policy on Sharing of Clinical Study Information and how to request access to related clinical study documents, see here (https://www.roche.com/research_and_development/who_we_are_how_we_work/clinical_trials/our_commitment_to_data_sharing.htm).

Learn more about this trial

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

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