Trastuzumab Deruxtecan + Bevacizumab for Ovarian Cancer

(DO-01 Trial)

Recruiting at 94 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

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests a new combination treatment for advanced ovarian cancer that expresses a specific protein called HER2. It compares the effectiveness and safety of trastuzumab deruxtecan (a targeted therapy) combined with bevacizumab against bevacizumab alone. The goal is to determine if the combination can better maintain health after initial treatment. Suitable participants have advanced high-grade epithelial ovarian cancer and have previously received standard treatment, including bevacizumab. As a Phase 3 trial, this study represents the final step before FDA approval, offering participants an opportunity to contribute to potentially groundbreaking treatment advancements.

Will I have to stop taking my current medications?

The trial information does not specify if you need to stop taking your current medications. It's best to discuss this with the trial coordinators or your doctor.

Is there any evidence suggesting that this trial's treatments are likely to be safe?

Research has shown that the combination of trastuzumab deruxtecan (T-DXd) and bevacizumab may effectively treat certain cancers. In earlier studies, patients generally tolerated this combination well. A preliminary phase with about 20 patients found that receiving the treatment every three weeks was manageable. Some side effects occurred, but they were similar to those expected with cancer treatments.

Bevacizumab is already approved for other uses and is usually well-tolerated on its own. When combined with T-DXd, the aim is to enhance the treatment's effectiveness while managing side effects. For those considering joining the trial, this combination has demonstrated reasonable safety in earlier research. However, discussing any potential risks with a healthcare provider is important. ^{1 2 3 4 5}

Why do researchers think this study treatment might be promising for ovarian cancer?

Trastuzumab Deruxtecan is unique for treating ovarian cancer because it combines an antibody-drug conjugate (ADC) with bevacizumab, an anti-angiogenic agent. This combination targets cancer cells more precisely and disrupts the blood supply they need to grow, potentially increasing its effectiveness compared to standard chemotherapy and targeted therapies like PARP inhibitors. Researchers are excited because this approach not only promises a more targeted attack on cancer cells but also aims to improve outcomes by leveraging the synergistic effects of the two drugs.

What evidence suggests that this trial's treatments could be effective for ovarian cancer?

Research has shown that combining trastuzumab deruxtecan and bevacizumab may effectively treat ovarian cancer with the HER2 protein. In this trial, participants in Treatment Arm A will receive this combination. Previous studies indicated that 37.1% of patients with HER2-positive tumors responded to this treatment, with some groups achieving even better results. For tumors with a specific level of HER2, the response rate was 26.5%, and the effects lasted about 9.8 months on average. These findings suggest that this drug combination might help shrink tumors and control the disease for a significant time. Meanwhile, participants in Treatment Arm B will receive bevacizumab monotherapy. The goal is to use both drugs together in Treatment Arm A to target and attack the cancer more effectively. ^{2 3 6 7 8}

Are You a Good Fit for This Trial?

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 for a Trial Participant

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

What Are the Treatments Tested in This Trial?

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.

How Is the Trial Designed?

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

Citations

1. clinicaltrials.gov clinicaltrials.gov/study/NCT06819007

NCT06819007 | Study of Trastuzumab Deruxtecan With ... This clinical trial is designed to evaluate the efficacy and safety of T-DXd in combination with bevacizumab versus bevacizumab monotherapy as first-line ...

2. datasourcebydaiichisankyo.com datasourcebydaiichisankyo.com/documents/d/datahub/esmo-gyn-2025_t-dxd_gonzalez-martin_poster_final

An open-label, randomized, multicenter, phase 3 study of ... Why are we performing this research? • Many patients with ovarian cancer have tumors that express the human epidermal growth factor receptor 2 (HER2) protein1-5.

3. esmoopen.com esmoopen.com/article/S2059-7029(25)01122-6/fulltext

DESTINY-Ovarian01 (DO 01) An open-label, randomized, multicenter, phase III study of trastuzumab deruxtecan (T-DXd) with bevacizumab (BEV) vs BEV monotherapy as first-line (1L) ...

4. ascopubs.org ascopubs.org/doi/pdf/10.1200/PO.23.00686

Exceptional Response to Trastuzumab Deruxtecan in a ... Preliminary results are promising across all tumor types and correlate with HER2 expression with an ORR of 37.1% for all participants and 45% in ...

5. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC11480158/

Efficacy of Trastuzumab Deruxtecan in HER2-Expressing ... In patients with IHC 2+ tumors, investigator-assessed ORR was 26.5% (95% CI 19.6, 34.3), and median DOR was 9.8 months (95% CI 4.5, 12.6).

6. clinicaltrials.gov clinicaltrials.gov/study/NCT06819007

NCT06819007 | Study of Trastuzumab Deruxtecan With ... This clinical trial is designed to evaluate the efficacy and safety of T-DXd in combination with bevacizumab versus bevacizumab monotherapy as first-line ...

7. connect.careboxhealth.com connect.careboxhealth.com/en-US/trial/listing/574499

Study of Trastuzumab Deruxtecan With Bevacizumab Versus ... This clinical trial is designed to evaluate the efficacy and safety of T-DXd in combination with bevacizumab versus bevacizumab monotherapy as first-line ...

8. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC11371105/

Exceptional Response to Trastuzumab Deruxtecan in a ... The exceptional clinical response we observed suggests that this agent deserves further study in this subtype of ovarian cancer.