A Phase 3, Randomized, Open-label, Multicenter Study to Evaluate the Efficacy and Safety of Sacituzumab Tirumotecan (MK-2870) in Combination With Pembrolizumab With or Without Bevacizumab Compared With Standard of Care as Firstline Maintenance Treatment for Participants With Persistent, Recurrent, or Newly Diagnosed Metastatic Cervical Cancer With PD-L1 CPS Greater Than or Equal to 1 (TroFuse-036/GOG-3123/ENGOT-cx22)
Summary
Researchers are looking for new ways to treat metastatic cervical cancer. Cervical cancer is cancer in the cervix, the lower part of the uterus (womb). Metastatic means the cancer has spread to other parts of the body. Researchers want to learn about giving the study medicine sacituzumab tirumotecan (also called sac-TMT or MK-2870) along with pembrolizumab and bevacizumab treatments. Sac-TMT is an antibody drug conjugate, which is a type of medicine that attaches to specific targets on cancer cells and delivers treatment to destroy those cells. The goals of this study are to learn: * About the safety of sac-TMT with pembrolizumab and bevacizumab, and if people tolerate them when given together, and * If people who receive sac-TMT and pembrolizumab, with or without bevacizumab, live longer overall or without their cancer getting worse as compared to those who receive standard treatment
Detailed description
This is a 2-part study. In Part 1 Safety Run-in, eligible participants will be allocated to treatment with sac-TMT + pembrolizumab + bevacizumab. In Part 2, all participants receive standard of care induction treatment. Eligible participants whose cancer does not progress then begin maintenance treatment and are randomized to receive pembrolizumab or sac-TMT + pembrolizumab. All participants in Part 2 maintenance treatment may also receive bevacizumab at the investigator's discretion.
Arms & interventions
- BiologicalPembrolizumab
Intravenous (IV) Infusion
- BiologicalSacituzumab Tirumotecan
IV Infusion
- BiologicalBevacizumab
IV Infusion
- DrugPaclitaxel
IV Infusion
- DrugCisplatin
IV Infusion
- DrugCarboplatin
IV Infusion
- DrugRescue Medications
Participants will receive the following rescue medications prior to sac-TMT infusion, per approved product label: histamine-1 receptor antagonist, histamine-2 receptor antagonist, acetaminophen or equivalent, and dexamethasone or equivalent, prophylactic steroid mouthwash (dexamethasone or equivalent), and granulocyte colony-stimulating factor (G-CSF).
Outcome measures
Primary
Part 1 Safety Run-in: Number of Participants Who Experience 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.
Time frame: Up to approximately 69 months
Part 1 Safety Run-in: Number of Participants Who Discontinue Study Treatment 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.
Time frame: Up to approximately 66 months
Part 2 Maintenance Treatment: Progression-free Survival (PFS) per Response Evaluation Criteria in Solid Tumors Version 1.1 (RECIST 1.1) as Assessed by Blinded Independent Central Review (BICR)
PFS is defined as the time from randomization to the first documented progressive disease (PD) or death due to any cause, whichever occurs first, as assessed by RECIST 1.1 as evaluated by BICR. PD is defined as ≥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 ≥5 mm. The appearance of one or more new lesions is also considered PD. PFS as assessed by BICR will be presented.
Time frame: Up to approximately 48 months
Part 2 Maintenance Treatment: Overall Survival (OS)
OS is defined as time from randomization to death due to any cause. OS will be presented.
Time frame: Up to approximately 60 months
Secondary
Part 2 Maintenance Treatment: Progression-free Survival 2 (PFS2) as Assessed by the Investigator
Time frame: Up to approximately 60 months
Part 2 Maintenance Treatment: Number of Participants Who Experience One or More AEs
Time frame: Up to approximately 64 months
Part 2 Maintenance Treatment: Number of Participants Who Discontinue Study Treatment Due to an AE
Time frame: Up to approximately 61 months
Part 2 Maintenance Treatment: Change from Baseline in European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire-Core 30 (EORTC QLQ-C30) Global Health Status and Quality of Life Combined Score
Time frame: Baseline and up to approximately 58 months
Part 2 Maintenance Treatment: Change from Baseline in EORTC QLQ-C30 Physical Functioning Combined Score
Time frame: Baseline and up to approximately 58 months
Part 2 Maintenance Treatment: Change from Baseline in EORTC QLQ-C30 Role Functioning Combined Score
Time frame: Baseline and up to approximately 58 months
Part 2 Maintenance Treatment: Change from Baseline in EORTC Quality of Life Questionnaire-Cervical Cancer Module (QLQ-CX24) Combined Score
Time frame: Baseline and up to approximately 58 months
Eligibility criteria
Study locations (16)
Mount Sinai Comprehensive Cancer Center ( Site 6000)
Miami Beach, Florida, 33140
Florida Cancer Specialists - East ( Site 7000)
West Palm Beach, Florida, 33401
Winship Cancer Institute of Emory University ( Site 5005)
Atlanta, Georgia, 30308
Nancy N. & J.C. Lewis Cancer and Research Pavillion - Research Department ( Site 6005)
Savannah, Georgia, 31405
TRIALS 365 ( Site 6008)
Shreveport, Louisiana, 71103
Minnesota Oncology Hematology, PA ( Site 8003)
Edina, Minnesota, 55435
Women's Cancer Center of Nevada ( Site 6011)
Las Vegas, Nevada, 89106
Laura and Isaac Perlmutter Cancer Center at NYU Langone ( Site 6009)
New York, New York, 10016
Oklahoma Cancer Specialists and Research Institute, LLC ( Site 6001)
Tulsa, Oklahoma, 74146
Oncology Associates of Oregon, P.C.(Willamette Valley Cancer Institute) (WVCI) ( Site 8007)
Eugene, Oregon, 97401
Women & Infants Hospital ( Site 6003)
Providence, Rhode Island, 02905
University of Tennessee Medical Center ( Site 6012)
Knoxville, Tennessee, 37920
Texas Oncology - DFW ( Site 8005)
Fort Worth, Texas, 76104
Texas Oncology-The Woodlands ( Site 8000)
The Woodlands, Texas, 77380
Texas Oncology - Northeast Texas ( Site 8002)
Tyler, Texas, 75702
University of Virginia Cancer Center ( Site 6014)
Charlottesville, Virginia, 22908