Trastuzumab Deruxtecan + Bevacizumab for Ovarian Cancer

(DO-01 Trial)

Recruiting at 11 trial locations

Overseen By Contact for Trial Information

Age: 18+

Sex: Female

Trial Phase: Phase 3

Sponsor: Daiichi Sankyo

Must be taking: Bevacizumab

Must not be taking: PARP inhibitors

Disqualifiers: BRCA mutation, Non-epithelial cancer, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Pivotal Trial (Near Approval) This treatment is in the last trial phase before FDA approval

Prior Safety Data This treatment has passed at least one previous human trial

Compensation: Varies

Number of Visits: Unknown

Duration: Up to approximately 35 months

582 Participants Needed

Trial Summary

What is the purpose of this trial?

This clinical trial is designed to evaluate the efficacy and safety of T-DXd in combination with bevacizumab versus bevacizumab monotherapy as first-line maintenance therapy, in participants with human epidermal growth factor 2 (HER2)-expressing (immunohistochemistry \[IHC\] 3+/2+/1+) advanced high-grade epithelial ovarian cancer.

Eligibility Criteria

This trial is for individuals with advanced high-grade epithelial ovarian cancer that expresses HER2 (protein levels of 3+/2+/1+). Participants must have completed first-line chemotherapy with bevacizumab and are eligible for maintenance therapy. They need to provide a tissue sample for HER2 testing, consent to the study's procedures, and have results from local HRD or BRCA tests.

Inclusion Criteria

I have signed all required consent forms for the trial.

I have results for a BRCA or HRD test.

My cancer is at an advanced stage (Stage III or IV).

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Safety Run-in

A non-randomized safety run-in phase to assess the safety of T-DXd in combination with bevacizumab

Not specified

Treatment

Participants receive either T-DXd in combination with bevacizumab or bevacizumab monotherapy as first-line maintenance therapy

Up to approximately 35 months

Follow-up

Participants are monitored for safety and effectiveness after treatment

Up to approximately 72 months

Treatment Details

Interventions

• Bevacizumab
• Trastuzumab Deruxtecan

Trial Overview The trial is assessing the effectiveness and safety of combining Trastuzumab Deruxtecan (T-DXd) with bevacizumab versus using bevacizumab alone as a first-line maintenance treatment in patients whose tumors express certain levels of the HER2 protein.

Participant Groups

Group I: Treatment Arm A Experimental Treatment 2 Interventions

Participants will receive T-DXd in combination with bevacizumab

Group II: Treatment Arm B Active Control 1 Intervention

Participants will receive bevacizumab monotherapy

Who Is Running the Clinical Trial?

Daiichi Sankyo

Lead Sponsor

Trials

443

Recruited

493,000+

Hiroyuki Okuzawa

Daiichi Sankyo

Chief Executive Officer

Degree in Social Sciences from Hitotsubashi University

Yuki Abe

Daiichi Sankyo

Chief Medical Officer since 2023

MD