A Study Evaluating the Efficacy and Safety of Biomarker-Driven Therapies in Patients With Persistent or Recurrent Rare Epithelial Ovarian Tumors (BOUQUET)
|
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. |
| ClinicalTrials.gov Identifier: NCT04931342 |
|
Recruitment Status :
Active, not recruiting
First Posted : June 18, 2021
Last Update Posted : April 16, 2024
|
Sponsor:
Hoffmann-La Roche
Collaborators:
GOG Foundation
European Network of Gynaecological Oncological Trial Groups (ENGOT)
Information provided by (Responsible Party):
Hoffmann-La Roche
- Study Details
- Tabular View
- No Results Posted
- Disclaimer
- How to Read a Study Record
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.
| Condition or disease | Intervention/treatment | Phase |
|---|---|---|
| Ovarian Cancer | Drug: Ipatasertib Drug: Cobimetinib Drug: Trastuzumab Emtansine Drug: Atezolizumab Drug: Bevacizumab Drug: Paclitaxel Drug: Giredestrant Drug: Abemaciclib Drug: Inavolisib Drug: Palbociclib Drug: Letrozole Drug: Olaparib Drug: Luteinizing Hormone-Releasing Hormone (LHRH) Agonists Drug: Cyclophosphamide | Phase 2 |
| Study Type : | Interventional (Clinical Trial) |
| Estimated Enrollment : | 550 participants |
| Allocation: | Non-Randomized |
| Intervention Model: | Parallel Assignment |
| Masking: | None (Open Label) |
| Primary Purpose: | Treatment |
| 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 |
| Actual Study Start Date : | October 7, 2021 |
| Estimated Primary Completion Date : | May 30, 2028 |
| Estimated Study Completion Date : | December 31, 2028 |
Resource links provided by the National Library of Medicine
MedlinePlus Genetics related topics:
Ovarian cancer
MedlinePlus related topics:
Ovarian Cancer
| 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 Name: 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 Name: 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 Name: 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 Name: RO5541267, Tecentriq Drug: Bevacizumab Bevacizumab will be administered intravenously on Day 1 of each cycle. (Cycle length=21 days)
Other Name: 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: Giredestrant
Giredestrant will be administered by mouth once a day on Days 1-28 of each cycle (Cycle length=28 days) Drug: Abemaciclib Abemaciclib will be administered by mouth twice a day during each 28-day cycle Drug: 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. |
|
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 |
|
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: 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: 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. |
|
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 |
|
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: 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 1-28 of each 28-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 Name: RO4876646, Avastin 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 Name: RO5541267, Tecentriq Drug: Bevacizumab Bevacizumab will be administered intravenously on Day 1 of each cycle. (Cycle length=21 days)
Other Name: RO4876646, Avastin Drug: Cyclophosphamide Cyclophosphamide will be administered by mouth once a day on Days 1-21 of each cycle. (Cycle length = 21 days) |
Primary Outcome Measures :
- Confirmed Objective Response Rate (ORR) [ Time Frame: Up to approximately 5 years ]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) [ Time Frame: Up to approximately 5 years ]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) [ Time Frame: Up to approximately 5 years ]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) [ Time Frame: Up to approximately 5 years ]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 [ Time Frame: Up to 6 month ]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) [ Time Frame: Up to approximately 5 years ]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) [ Time Frame: Up to approximately 5 years ]Confirmed ORR, as determined by the IRC according to RECIST v1.1.
- DOR as Determined by IRC [ Time Frame: Up to approximately 5 years ]DOR, as determined by the IRC according to RECIST v1.1
- DCR as Determined by IRC [ Time Frame: Up to approximately 5 years ]DCR, as determined by the IRC according to RECIST v1.1
- PFS as Determined by IRC [ Time Frame: Up to approximately 5 years ]PFS, as determined by the IRC according to RECIST v1.1
- Percentage of Participants With Adverse Events [ Time Frame: Up to approximately 5 years ]Percentage of participants with adverse events.
Information from the National Library of Medicine
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.
| Ages Eligible for Study: | 18 Years and older (Adult, Older Adult) |
| Sexes Eligible for Study: | Female |
| Gender Based Eligibility: | Yes |
| Accepts Healthy Volunteers: | No |
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
Information from the National Library of Medicine
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04931342
Locations
Show 58 study locations
Sponsors and Collaborators
Hoffmann-La Roche
GOG Foundation
European Network of Gynaecological Oncological Trial Groups (ENGOT)
Investigators
| Study Director: | Clinical Trials | Hoffmann-La Roche |
| Responsible Party: | Hoffmann-La Roche |
| ClinicalTrials.gov Identifier: | NCT04931342 |
| Other Study ID Numbers: |
WO42178 GOG-3051 ( Other Identifier: GOG Foundation ) ENGOT-GYN2 ( Other Identifier: European Network of Gynaecological Oncological Trial Groups (ENGOT) ) |
| First Posted: | June 18, 2021 Key Record Dates |
| Last Update Posted: | April 16, 2024 |
| Last Verified: | April 2024 |
| Individual Participant Data (IPD) Sharing Statement: | |
| Plan to Share IPD: | Yes |
| 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). |
| Studies a U.S. FDA-regulated Drug Product: | Yes |
| Studies a U.S. FDA-regulated Device Product: | No |
Additional relevant MeSH terms:
|
Ovarian Neoplasms Endocrine Gland Neoplasms Neoplasms by Site Neoplasms Ovarian Diseases Adnexal Diseases Genital Diseases, Female Female Urogenital Diseases Female Urogenital Diseases and Pregnancy Complications Urogenital Diseases Genital Neoplasms, Female Urogenital Neoplasms Genital Diseases Endocrine System Diseases Gonadal Disorders |
Maytansine Ado-Trastuzumab Emtansine Cyclophosphamide Bevacizumab Trastuzumab Atezolizumab Letrozole Olaparib Palbociclib Ipatasertib Hormones Prolactin Release-Inhibiting Factors Inavolisib Antineoplastic Agents, Phytogenic Antineoplastic Agents |