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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

Must not have

Current diagnosis of synchronous primary endometrial cancer

Current diagnosis of solely borderline epithelial ovarian tumor

Timeline

Screening 3 weeks

Treatment Varies

Follow Up up to approximately 5 years

Awards & highlights

No Placebo-Only Group

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.

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.

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.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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I am fully active or can carry out light work.

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My ovarian cancer has come back or hasn't gone away and can't be removed with surgery.

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I've had 1-4 treatments for my condition, including one with platinum.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

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I have been diagnosed with endometrial cancer at the same time as another primary cancer.

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My current diagnosis is a borderline ovarian tumor.

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I have a specific type of advanced ovarian, fallopian tube, or peritoneal cancer.

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My cancer did not respond to initial platinum-based chemotherapy.

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My ovarian cancer is not of the epithelial type.

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I haven't had cancer treatments like chemotherapy or immunotherapy in the last 28 days.

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I have brain metastases that are untreated or getting worse.

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I frequently need procedures to remove excess fluid from my chest or abdomen.

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

This trial's timeline: 3 weeks for screening, Varies for treatment, and up to approximately 5 years for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Confirmed Objective Response Rate (ORR)

Secondary study objectives

6-Month PFS Rate

Confirmed ORR as Determined by IRC (Independent Review Committee)

DCR as Determined by IRC

+7 more

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

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

~1890

Ipatasertib

2017

Completed Phase 3

~3630