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Purpose

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.

Condition

Eligibility

Eligible Ages
Over 18 Years
Eligible Sex
Female
Accepts Healthy Volunteers
No

Inclusion Criteria

  1. 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. *For participants in the safety run-in phase, a safety run-in ICF needs to be signed and dated prior to the start of any trial-specific qualification procedures. 2. 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. 3. 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). 4. Is newly diagnosed FIGO Stage III or IV. 5. Has HER2 expression per 2016 ASCO-CAP gastric cancer IHC scoring (3+/2+/1+) guidelines1 by prospective central testing. *For participants in the safety run-in phase, HER2 expression assessed by either local (require using ASCO-CAP gastric cancer IHC scoring [IHC 3+/2+/1+] guidelines) or central assessment (if available) is acceptable. Submission of the pathology report is required for participants enrolled based on local HER2 IHC results. 6. Has adequate tumor tissue sample available for assessment of HER2 by central laboratory. Tumor tissue block or sufficient tissue slides are required for HER2 testing and retrospective HRD status determination. *Participants in the safety run-in phase who are enrolled based on local HER2 IHC results are recommended to provide tumor tissue sample from the same specimen for central assessment. 7. Has a local HRD or BRCA test result available. Participants with BRCA-wildtype will have a local HRD test results, as applicable. 8. Has received up to 6 cycles of standard of care bevacizumab in combination with frontline platinum- based chemotherapy as per approved indication and clinical guidelines and is eligible to continue single agent bevacizumab maintenance per standard of care and investigator discretion.

Exclusion Criteria

  1. Has ovarian, fallopian tube, or peritoneal cancer of non-epithelial origin. 2. Has a known or suspected deleterious BRCA alteration as per local test that makes the patient eligible for PARP inhibitor. 3. Participant to receive PARP inhibitor as maintenance per standard of care and investigator discretion. Reasons for which the participant is not eligible for PARP inhibitor will be recorded in the eCRF as follows: - HRD negative - HRD positive with SD as best response after platinum - HRD positive non-serous histology Note: For participants enrolled from the Republic of Korea - HRD tested, but inconclusive - HRD positive but safety concern (safety concern to be specified). 4. Has a history of severe hypersensitivity reactions to either the drug substances or inactive ingredients in the drug products and other monoclonal antibodies. 5. Previous Cerebral-Vascular Accident, Transient Ischemic Attack or Sub- Arachnoids Hemorrhage within 6 months prior to randomization. *Note: For participants enrolled from the Republic of Korea, 6. Has evidence of bleeding diathesis or significant coagulopathy (in the absence of anticoagulation therapy). 7. Has a history of hemorrhagic disorders, abdominal fistula, gastrointestinal perforation, or active gastrointestinal bleeding within 6 months before randomization. 8. Evidence of active or ongoing bowel obstruction. 9. Has a medical history of myocardial infarction within 6 months before randomization, symptomatic congestive heart failure (New York Heart Association Class II to IV). Participants with troponin levels above the upper limit of normal at Screening (as defined by the manufacturer), and without any myocardial infarction related symptoms should have a cardiologic consultation during the Screening Period to rule out myocardial infarction. 10. Has a corrected QT interval prolongation to >480 msec based on average of the Screening triplicate 12-lead ECG. 11. Has a history of (non-infectious) ILD/pneumonitis that required steroids, has current ILD/pneumonitis, or where suspected ILD/pneumonitis cannot be ruled out by imaging at Screening.

Study Design

Phase
Phase 3
Study Type
Interventional
Allocation
Randomized
Intervention Model
Parallel Assignment
Primary Purpose
Treatment
Masking
None (Open Label)
Masking Description
This is an open-label study.

Arm Groups

ArmDescriptionAssigned Intervention
Experimental
Treatment Arm A 		Participants will receive T-DXd in combination with bevacizumab
  • Drug: Trastuzumab Deruxtecan
    T-DXd will be administered at a dose of 5.4 mg/kg intravenously (IV) every 3 weeks (Q3W)
    Other names:
    • T-DXd
    • ENHERTU®
  • Drug: Bevacizumab
    Bevacizumab will be administered at a dose of 15/mg/kg IV Q3W
Active Comparator
Treatment Arm B 		Participants will receive bevacizumab monotherapy
  • Drug: Bevacizumab
    Bevacizumab will be administered at a dose of 15/mg/kg IV Q3W

Recruiting Locations

Disney Family Cancer Center
Burbank, California 91505

Scripps Clinic
La Jolla, California 92037

Palo Alto Medical Foundation
Palo Alto, California 94301

Broward Health Medical Center
Fort Lauderdale, Florida 33316

Jupiter Medical Center
Jupiter, Florida 33458

Mount Sinai Medical Center
Miami Beach, Florida 33140

AdventHealth Cancer Institute
Orlando, Florida 32804

Woman's Care FL
St. Petersburg, Florida 33713

Nancy N. & J.C Lewis Cancer & Research Pavillion- St. Josephs/ Candler Health System
Savannah, Georgia 31405

Endeavor Health Evanston Kellogg Cancer Care Center
Evanston, Illinois 60201

Indiana University
Indianapolis, Indiana 46202

Trials365 LLC
Shreveport, Louisiana 71103

Greater Baltimore Medical Center
Towson, Maryland 21204

Massachusetts General Hospital
Boston, Massachusetts 02114

Dana-Farber Cancer Institute
Boston, Massachusetts 02215

Trinity Health St. Joseph Mercy Ann Arbor
Ann Arbor, Michigan 48106

Corewell Health
Grand Rapids, Michigan 49503

Minnesota Oncology Hematology PA
Minneapolis, Minnesota 55404

St. Vincent Gynecologic Oncology
Billings, Montana 59102

Valley Health System
Paramus, New Jersey 07652

Laura and Isaac Perlmutter Cancer Center at NYU Langone
New York, New York 10016

Icahn School of Medicine at Mount Sinai
New York, New York 10029

Columbia University
New York, New York 10032

UNC Hospital
Chapel Hill, North Carolina 27599

Miami Valley Hospital South
Centerville, Ohio 45459

Legacy Medical Group Gynecologic Oncology
Portland, Oregon 97210

Providence Cancer Center Oncology
Portland, Oregon 97213

St. Lukes University Health Network
Bethlehem, Pennsylvania 18015

Ann B Barshinger Cancer Institute
Lancaster, Pennsylvania 17601

Avera Medical Group Gynecologic
Sioux Falls, South Dakota 57105

Sarah Cannon Research Institute (Oncology Associates of Oregon PC)
Nashville, Tennessee 37203

Utah Cancer Specialists Network
Salt Lake City, Utah 84106

More Details

Status
Recruiting
Sponsor
Daiichi Sankyo

Study Contact

Contact for Trial Information
908-992-6400
CTRinfo_us@daiichisankyo.com

Detailed Description

A non-randomized safety run-in phase will be conducted prior to randomization phase to assess the safety of T-DXd in combination with bevacizumab.

Notice

Study information shown on this site is derived from ClinicalTrials.gov (a public registry operated by the National Institutes of Health). The listing of studies provided is not certain to be all studies for which you might be eligible. Furthermore, study eligibility requirements can be difficult to understand and may change over time, so it is wise to speak with your medical care provider and individual research study teams when making decisions related to participation.