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CDK4/6 Inhibitor
Biomarker-Driven Therapy for Ovarian Cancer (BOUQUET Trial)
Phase 2
Waitlist Available
Research Sponsored by Hoffmann-La Roche
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
ECOG Performance Status of 0 or 1
Persistent or recurrent EOC that meets specific histological criteria and is not amenable to curative surgery
Timeline
Screening 3 weeks
Treatment Varies
Follow Up up to approximately 5 years
Awards & highlights
BOUQUET Trial Summary
This trial will test different treatments for ovarian, fallopian tube, or primary peritoneal tumors, selected based on biomarkers. Enrollment will happen in two phases, with the possibility of expanding in the second phase.
Who is the study for?
This trial is for patients with rare epithelial ovarian tumors that have come back or didn't go away after treatment. They must have had 1-4 previous treatments including platinum-based therapy, be in good physical condition, and agree to use birth control. It's not for those who are pregnant, breastfeeding, or have certain other cancers or severe infections.Check my eligibility
What is being tested?
The study tests how well different drugs work based on tumor markers in patients with persistent/recurrent ovarian tumors. Drugs like Abemaciclib and Trastuzumab Emtansine among others will be used. The trial includes initial and potential expansion phases to assess safety and effectiveness.See study design
What are the potential side effects?
Possible side effects include fatigue, nausea, hair loss from chemotherapy drugs like Paclitaxel; high blood pressure from Bevacizumab; diarrhea from Cobimetinib; low white blood cell counts from Abemaciclib; liver issues from Ipatasertib; bleeding risks associated with anticoagulants.
BOUQUET Trial Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
I am fully active or can carry out light work.
Select...
My ovarian cancer has come back or hasn't gone away and can't be removed with surgery.
Select...
I've had 1-4 treatments for my condition, including one with platinum.
BOUQUET Trial Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ up to approximately 5 years
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~up to approximately 5 years
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Confirmed Objective Response Rate (ORR)
Secondary outcome measures
6-Month PFS Rate
Confirmed ORR as Determined by IRC (Independent Review Committee)
DCR as Determined by IRC
+7 moreBOUQUET Trial Design
11Treatment groups
Experimental Treatment
Group I: Trastuzumab Emtansine (ERBB2-amplified/mutant tumors)Experimental Treatment1 Intervention
Participants in the Trastuzumab Emtansine arm will receive treatment until unacceptable toxicity or disease progression per RECIST v1.1.
Group II: Ipatasertib + Paclitaxel (PIK3CA/AKT1/PTEN-altered tumors)Experimental Treatment2 Interventions
Participants in the Ipatasertib + Paclitaxel arm will receive treatment until unacceptable toxicity or disease progression per RECIST v1.1.
Group III: Inavolisib + Palbociclib + Letrozole (ER+ and PIK3CA-altered tumors)Experimental Treatment4 Interventions
Participants in the Inavolisib + Palbociclib + Letrozole arm will receive treatment until unacceptable toxicity or disease progression per RECIST v1.1.
Group IV: Inavolisib + Palbociclib (PIK3CA-altered tumors)Experimental Treatment2 Interventions
Participants in the Inavolisib + Palbociclib arm will receive treatment until unacceptable toxicity or disease progression per RECIST v1.1.
Group V: Inavolisib + Olaparib (Non-matched)Experimental Treatment2 Interventions
Participants in the Inavolisib + Olaparib arm will receive treatment until unacceptable toxicity or disease progression per RECIST v1.1.
Group VI: Inavolisib + Giredestrant (ER+ and PIK3CA-altered tumors)Experimental Treatment2 Interventions
Participants in the Inavolisib + Giredestrant arm will receive treatment until unacceptable toxicity or disease progression per RECIST v1.1.
Group VII: Inavolisib + Bevacizumab (PIK3CA-altered tumors)Experimental Treatment2 Interventions
Participants in the Inavolisib + Bevacizumab arm will receive treatment until unacceptable toxicity or disease progression per RECIST v1.1.
Group VIII: Giredestrant + Abemaciclib (ER+ tumors)Experimental Treatment3 Interventions
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.
Group IX: Cobimetinib (BRAF/NRAS/KRAS/NF1-altered tumors)Experimental Treatment1 Intervention
Participants in the Cobimetinib arm will receive treatment until unacceptable toxicity or disease progression per RECIST v1.1.
Group X: Atezolizumab + Bevacizumab + Cyclophosphamide (Non-matched)Experimental Treatment3 Interventions
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.
Group XI: Atezolizumab + Bevacizumab (Non-matched)Experimental Treatment2 Interventions
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.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Abemaciclib
2019
Completed Phase 2
~1710
Ipatasertib
2011
Completed Phase 3
~2320
Cobimetinib
2017
Completed Phase 3
~2660
Trastuzumab Emtansine
2016
Completed Phase 3
~5630
Atezolizumab
2017
Completed Phase 3
~5860
Bevacizumab
2013
Completed Phase 4
~5280
Paclitaxel
2011
Completed Phase 4
~5380
Giredestrant
2019
Completed Phase 2
~300
Palbociclib
2017
Completed Phase 3
~3760
Letrozole
2002
Completed Phase 4
~2770
Olaparib
2007
Completed Phase 4
~2140
Cyclophosphamide
1995
Completed Phase 3
~3770
Inavolisib
2021
Completed Phase 2
~260
Find a Location
Who is running the clinical trial?
Hoffmann-La RocheLead Sponsor
2,432 Previous Clinical Trials
1,089,336 Total Patients Enrolled
15 Trials studying Ovarian Cancer
5,052 Patients Enrolled for Ovarian Cancer
GOG FoundationNETWORK
42 Previous Clinical Trials
16,191 Total Patients Enrolled
7 Trials studying Ovarian Cancer
2,729 Patients Enrolled for Ovarian Cancer
European Network of Gynaecological Oncological Trial Groups (ENGOT)OTHER
36 Previous Clinical Trials
16,689 Total Patients Enrolled
10 Trials studying Ovarian Cancer
4,841 Patients Enrolled for Ovarian Cancer
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- I have been diagnosed with endometrial cancer at the same time as another primary cancer.You have a disease that can be measured using a specific set of guidelines.My current diagnosis is a borderline ovarian tumor.I have a specific type of advanced ovarian, fallopian tube, or peritoneal cancer.I had endometrial cancer but it meets certain conditions.My blood and organs are functioning well.I have not had a severe infection in the last 4 weeks.My cancer did not respond to initial platinum-based chemotherapy.I can provide a tumor sample for genetic testing and hormone receptor tests.I have not taken hormonal therapy in the last 14 days.My ovarian cancer is not of the epithelial type.I am fully active or can carry out light work.My ovarian cancer has come back or hasn't gone away and can't be removed with surgery.I've had 1-4 treatments for my condition, including one with platinum.I haven't had cancer treatments like chemotherapy or immunotherapy in the last 28 days.I have brain metastases that are untreated or getting worse.I frequently need procedures to remove excess fluid from my chest or abdomen.My condition did not improve with platinum-based treatment, but it wasn't initially resistant.
Research Study Groups:
This trial has the following groups:- Group 1: Inavolisib + Giredestrant (ER+ and PIK3CA-altered tumors)
- Group 2: Atezolizumab + Bevacizumab + Cyclophosphamide (Non-matched)
- Group 3: Ipatasertib + Paclitaxel (PIK3CA/AKT1/PTEN-altered tumors)
- Group 4: Cobimetinib (BRAF/NRAS/KRAS/NF1-altered tumors)
- Group 5: Trastuzumab Emtansine (ERBB2-amplified/mutant tumors)
- Group 6: Atezolizumab + Bevacizumab (Non-matched)
- Group 7: Giredestrant + Abemaciclib (ER+ tumors)
- Group 8: Inavolisib + Palbociclib (PIK3CA-altered tumors)
- Group 9: Inavolisib + Palbociclib + Letrozole (ER+ and PIK3CA-altered tumors)
- Group 10: Inavolisib + Olaparib (Non-matched)
- Group 11: Inavolisib + Bevacizumab (PIK3CA-altered tumors)
Awards:
This trial has 1 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
What potential risks does Bevacizumab pose to patients?
"We have rated bevacizumab as a 2 on the 1-3 scale due to the Phase 2 trial data available, which confirms its safety but provides no evidence of efficacy."
Answered by AI
Are there any other experiments that have assessed the effects of Bevacizumab?
"Presently, there are 1,424 clinical studies in progress for Bevacizumab with 344 of them being Phase 3 trials. Although Shanghai is the host city for multiple experiments involving this medication, 73,447 locations across the world are conducting research on it."
Answered by AI
What is the size of this research study's participant pool?
"The sponsor, Hoffmann-La Roche, must recruit 400 eligible participants to complete the study. To do so they will be using 3 distinct locations - Northwestern University Medical School, Drug Information Center (located in Chicago), and Kaiser Permanente - Irvine (in Irvine)."
Answered by AI
Is enrollment currently available for this investigation?
"Affirmative. Clinicaltrials.gov reveals that this research endeavour, which launched on October 7th 2021, is still in the recruitment phase. 400 test subjects are needed across 23 different locations."
Answered by AI
What diseases has Bevacizumab been proven beneficial in treating?
"The anti-neoplastic drug bevacizumab is effective in treating metastatic cancerous growths, such as recurrent platinum-sensitive epithelial ovarian cancer and malignant neoplasms. It has also been approved to treat metastatic urothelial carcinoma."
Answered by AI
Are there multiple venues in which this test is being conducted?
"The locations for this trial are scattered throughout the United States with 23 sites in total. Chicago, Irvine and Saint Louis hospitals are among them. Potential participants should select a clinic near to their residence so that travel demands can be reduced."
Answered by AI
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