A Phase 3, Randomized, Open-label, Multicenter Study to Evaluate the Efficacy and Safety of Sacituzumab Tirumotecan Maintenance Treatment With or Without Bevacizumab Versus Standard of Care After Second-line Platinum-based Doublet Chemotherapy in Participants With Platinum-sensitive Recurrent Ovarian Cancer (TroFuse-022/ENGOT-ov84/GOG-3103)
Summary
The main goals of this study are to learn about the safety of sacituzumab tirumotecan with bevacizumab and if people tolerate it; and if people who take sacituzumab tirumotecan with or without bevacizumab live longer without the cancer getting worse than those who receive standard of care treatment.
Arms & interventions
- BiologicalSacituzumab tirumotecan
IV Infusion
- BiologicalBevacizumab
IV Infusion
- DrugH1 receptor antagonist
Rescue medication taken per approved product label before sacituzumab tirumotecan
- DrugH2 receptor antagonist
Rescue medication taken per approved product label before sacituzumab tirumotecan
- DrugAcetaminophen (or equivalent)
Rescue medication taken per approved product label before sacituzumab tirumotecan
- DrugDexamethasone (or equivalent)
Rescue medication taken per approved product label before sacituzumab tirumotecan
- DrugSteroid mouthwash (dexamethasone or equivalent)
Rescue medication taken orally 2-4 times daily
Outcome measures
Primary
Part 1: Number of participants with one or more adverse events (AEs)
An AE is any untoward medical occurrence in a clinical study participant, temporally associated with the use of study intervention, whether or not considered related to the study intervention. An AE can therefore be any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease (new or exacerbated) temporally associated with the use of a study intervention.
Time frame: Up to 6 weeks
Part 1: Number of participants who discontinue study intervention due to an AE
An AE is any untoward medical occurrence in a clinical study participant, temporally associated with the use of study intervention, whether or not considered related to the study intervention. An AE can therefore be any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease (new or exacerbated) temporally associated with the use of a study intervention.
Time frame: Up to 6 weeks
Part 2: Progression-free Survival (PFS)
PFS is defined as the time from randomization to the first documented progressive disease (PD) or death from any cause, whichever occurs first. Per RECIST 1.1, PD is defined as at least a 20% increase in the sum of diameters of target lesions. In addition to the relative increase of 20%, the sum must also demonstrate an absolute increase of at least 5 mm. The appearance of one or more new lesions is also considered PD. PFS as assessed by blinded independent central review (BICR) will be presented.
Time frame: Up to approximately 4 years
Secondary
Part 2: Overall Survival (OS)
Time frame: Up to approximately 4 years
Part 2: Number of participants with one or more AEs
Time frame: Up to approximately 4 years
Part 2: Number of participants who discontinue study intervention due to an AE
Time frame: Up to approximately 4 years
Part 2: Change from Baseline in European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire-Core 30 (EORTC QLQ-C30) Global Health Status-Quality of Life Score
Time frame: Baseline and up to approximately 4 years
Part 2: Change from Baseline in EORTC QLQ-C30 Physical Functioning Score
Time frame: Baseline and up to approximately 4 years
Part 2: Change from Baseline in EORTC QLQ-C30 Role Functioning Score
Time frame: Baseline and up to approximately 4 years
Part 2: Change from Baseline in EORTC Quality of Life Questionnaire-Ovarian Cancer Module 28 (QLQ-OV28) abdominal/gastrointestinal (GI) symptom scale
Time frame: Baseline and up to approximately 4 years
Eligibility criteria
Study locations (30)
University of Alabama at Birmingham ( Site 0006)
Birmingham, Alabama, 35249
Alaska Women's Cancer Care ( Site 0096)
Anchorage, Alaska, 99508
Yale-New Haven Hospital-Smilow Cancer Hospital at Yale-New Haven ( Site 0001)
New Haven, Connecticut, 06510
Mount Sinai Cancer Center ( Site 0078)
Miami Beach, Florida, 33140
Sarasota Memorial Hospital ( Site 0075)
Sarasota, Florida, 34239
Florida Cancer Specialists East ( Site 7000)
West Palm Beach, Florida, 33401
Winship Cancer Institute of Emory University ( Site 0086)
Atlanta, Georgia, 30322
Augusta University - Georgia Cancer Center ( Site 0066)
Augusta, Georgia, 30912
Parkview Research Center at Parkview Regional Medical Center ( Site 0003)
Fort Wayne, Indiana, 46845
Women's Cancer Care ( Site 0067)
Covington, Louisiana, 70433
Maine Medical Center Research Institute-MaineHealth/Maine Medical Partners - GynOnc ( Site 0008)
Scarborough, Maine, 04074
St. Dominic's Hospital ( Site 0064)
Jackson, Mississippi, 39216
Nebraska Methodist Hospital ( Site 0053)
Omaha, Nebraska, 68114
John Theurer Cancer Center at Hackensack University Medical Center ( Site 0081)
Hackensack, New Jersey, 07601
Rutgers Cancer Institute of New Jersey ( Site 0071)
New Brunswick, New Jersey, 08901
University of New Mexico Comprehensive Cancer Center ( Site 0055)
Albuquerque, New Mexico, 87131
NYU Langone Hospital - Long Island ( Site 0015)
Mineola, New York, 11501
Laura and Isaac Perlmutter Cancer Center ( Site 0076)
New York, New York, 10016
FirstHealth Cancer Center ( Site 0079)
Pinehurst, North Carolina, 28374
University of Cincinnati Medical Center ( Site 0090)
Cincinnati, Ohio, 45219
The James Cancer Hospital and Solove Research Institute at The Ohio State University Comprehensive C ( Site 0054)
Columbus, Ohio, 43210
Oklahoma Cancer Specialists and Research Institute, LLC ( Site 0056)
Tulsa, Oklahoma, 74146
Oncology Associates of Oregon, P.C.(Willamette Valley Cancer Institute) (WVCI) ( Site 8010)
Eugene, Oregon, 97401
Women & Infants Hospital ( Site 0050)
Providence, Rhode Island, 02905
Henry-Joyce Cancer Clinic ( Site 0060)
Nashville, Tennessee, 37232
Texas Oncology - Central/South Texas ( Site 8009)
Austin, Texas, 78758
Texas Oncology - DFW ( Site 8001)
Fort Worth, Texas, 76104
Texas Oncology - San Antonio ( Site 8005)
San Antonio, Texas, 78240
Texas Oncology - Gulf Coast ( Site 8003)
Webster, Texas, 77598
Virginia Cancer Specialists (VCS) ( Site 8011)
Fairfax, Virginia, 22031