Biomarker-Driven Therapy for Ovarian Cancer
(BOUQUET Trial)

Recruiting in Palo Alto (17 mi)

+83 other locations

Age: 18+

Sex: Female

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Phase 2

Waitlist Available

Sponsor: Hoffmann-La Roche

No Placebo Group

Prior Safety Data

Breakthrough Therapy

Trial Summary

What is the purpose of this trial?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.

Eligibility Criteria

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.

Inclusion Criteria

You have a disease that can be measured using a specific set of guidelines.

Agreement to remain abstinent or use contraception, and refrain from donating eggs for women of childbearing potential

My blood and organs are functioning well.

+5 more

Exclusion Criteria

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

My current diagnosis is a borderline ovarian tumor.

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

+9 more

Participant Groups

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.

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.

Abemaciclib is already approved in United States, European Union for the following indications:

🇺🇸 Approved in United States as Verzenio for:

Hormone receptor-positive (HR+), human epidermal growth factor receptor 2 (HER2)-negative advanced or metastatic breast cancer
HR+, HER2- node-positive early breast cancer

🇪🇺 Approved in European Union as Verzenio for: