A Phase 3, Open-label, Multicenter, Randomized Trial of Trastuzumab Deruxtecan With Bevacizumab Versus Bevacizumab Monotherapy as First-line Maintenance Therapy in HER2-Expressing Ovarian Cancer (DESTINY-Ovarian01/ENGOT-ov89/GEICO144- O/GOG-3112/APGOT-OV13)
Summary
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.
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.
Arms & interventions
- DrugTrastuzumab Deruxtecan
T-DXd will be administered at a dose of 5.4 mg/kg intravenously (IV) every 3 weeks (Q3W)
- DrugBevacizumab
Bevacizumab will be administered at a dose of 15/mg/kg IV Q3W
Outcome measures
Primary
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
Overall Survival in the HER2 IHC 3+/2+ population
Time frame: From date of randomization to death due to any cause, up to approximately 72 months
Progression Free Survival by BICR in the HER2 IHC 3+/2+/1+ population
Time frame: From date of randomization to radiographic disease progression or death due to any cause, up to approximately 35 months
Overall Survival in the HER2 IHC 3+/2+/1+ population
Time frame: From date of randomization to death due to any cause, up to approximately 72 months
Progression Free Survival by the investigator in HER2 IHC 3+/2+ population
Time frame: From date of randomization to radiographic disease progression or death due to any cause, up to approximately 35 months
Progression Free Survival by the investigator in HER2 IHC 3+/2+/1+ population
Time frame: From date of randomization to radiographic disease progression or death due to any cause, up to approximately 35 months
Eligibility criteria
Study locations (28)
Scripps Clinic
La Jolla, California, 92037
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
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