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Study of Trastuzumab Deruxtecan With Bevacizumab Versus Bevacizumab Monotherapy for First-line Maintenance in HER2-Expressing Ovarian Cancer (DESTINY-Ovarian01)

ConditionOvarian Cancer
Trial statusRecruiting
Trial phasePhase 3
Trial typeInterventional
Biological sexFemale
Age18+
SponsorDaiichi Sankyo

About 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 does not accept healthy volunteers

Qualifiers

Sign and date the tissue prescreening ICF, prior to HER2 central testing. Sign and date the Main ICF, prior to the start of any trial- specific qualification procedures. Consent to optional PGx prior to any PGx procedures.

Adults ≥18 years of age on the day of signing the ICF. Follow local regulatory requirements if the legal age of consent for trial participation is >18 years old.

Has histologically confirmed diagnosis of epithelial high-grade ovarian, fallopian tube or primary peritoneal carcinoma per local assessment (including but not limiting to serous, endometrioid, clear cell, carcinosarcoma, mucinous).

Is newly diagnosed FIGO Stage III or IV.

Disqualifiers

Has ovarian, fallopian tube, or peritoneal cancer of non-epithelial origin.

Has a known or suspected deleterious BRCA alteration as per local test that makes the patient eligible for PARP inhibitor.

HRD negative

HRD positive with SD as best response after platinum

Trial design

Design model

Parallel

Treatments tested in this trial

  • Trastuzumab Deruxtecan

    Drug

    T-DXd will be administered at a dose of 5.4 mg/kg intravenously (IV) every 3 weeks (Q3W)

  • Bevacizumab

    Drug

    Bevacizumab will be administered at a dose of 15/mg/kg IV Q3W

Treatment groups

582 Participants
are divided into 2 treatment groups
Group A: Treatment Arm AExperimental treatment 2 interventions
Group B: Treatment Arm BActive comparator 1 intervention

Trial outcomes

Primary outcomes

1

Progression Free Survival by Blinded Independent Central Review (BICR) in the HER2 IHC 3+/2+ population

Time from randomization to time of objective radiographic disease progression as assessed by BICR based on RECIST v1.1 or death due to any cause.

Time frame
From date of randomization to radiographic disease progression or death due to any cause, up to approximately 35 months

Secondary outcomes

1

Overall Survival in the HER2 IHC 3+/2+ population

Time interval from the date of randomization to the date of death due to any cause.

Time frame
From date of randomization to death due to any cause, up to approximately 72 months
2

Progression Free Survival by BICR in the HER2 IHC 3+/2+/1+ population

Time from randomization to time of objective radiographic disease progression as assessed by BICR based on RECIST v1.1 or death due to any cause.

Time frame
From date of randomization to radiographic disease progression or death due to any cause, up to approximately 35 months
3

Overall Survival in the HER2 IHC 3+/2+/1+ population

Time interval from the date of randomization to the date of death due to any cause.

Time frame
From date of randomization to death due to any cause, up to approximately 72 months
4

Progression Free Survival by the investigator in HER2 IHC 3+/2+ population

Time from randomization to time of objective radiographic disease progression as assessed by the investigator based on RECIST v1.1 or death due to any cause.

Time frame
From date of randomization to radiographic disease progression or death due to any cause, up to approximately 35 months

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Daiichi Sankyo

Lead sponsor

Source ClinicalTrials.gov
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