A Phase 3 Randomized Open-label Multicenter Study to Evaluate the Efficacy and Safety of Sacituzumab Tirumotecan (MK-2870) 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)

Brief description of study

This is a Phase 3 randomized (split into groups by chance) study designed to compare how well and how safely sacituzumab tirumotecan, with or without bevacizumab, works compared to the usual care after second-line carboplatin-based chemotherapy in patients with platinum-sensitive recurrent ovarian cancer (PSROC). This means their ovarian cancer came back, but it returned more than 180 days after finishing their first platinum-based chemotherapy treatment. The study is “open-label,” which means both the doctors and the patients know which treatment is being given. One group will get sacituzumab tirumotecan(an antibody-drug conjugate (ADC), either by itself or with bevacizumab(a monoclonal antibody). Sacituzumab tirumotecan finds and attaches to a protein called TROP2 on cancer cells and delivers the chemotherapy directly to the cancer cells while trying to spare normal cells. Bevacizumab is a type of medicine that works by blocking a protein called VEGF. Another group will get the usual treatment, called standard of care (SoC).

The study will randomly enroll patients into one of two groups:Arm 1 (sacituzumab tirumotecan) or Arm 2 (SoC). Participants in Arm 1 will receive sacituzumab tirumotecan by IV every 2 weeks. They may also receive bevacizumab by IV every 3 weeks. This treatment will continue until the cancer gets worse, side effects become too severe or another reason in the study rules requires stopping. Participants in Arm 2 will have observation (close monitoring without active treatment) and may also receive bevacizumab by IV every 3 weeks. This will also continue until the cancer gets worse, side effects become too severe or another reason in the study rules requires stopping. Bevacizumab can only be given to participants who have already received at least 2 full doses (15 mg/kg every 3 weeks, with no dose reductions) during their second round of chemotherapy. The study doctor can decide whether or not to continue bevacizumab. The main goal of the study (primary endpoint) is to measure progression-free survival (PFS). This means how long patients live without their cancer getting worse. Another important goal (key secondary endpoint) is overall survival (OS), which means how long patients live overall after starting the study. All patients will have frequent medical check ups and blood samples taken to see how their bodies are handling the study medicine. The study team will be monitoring the patients for potential side effects and safety concerns.


Clinical Study Identifier: s24-00407
ClinicalTrials.gov Identifier: NCT06824467
Principal Investigator: Bhavana Pothuri.
Other Investigators: Christina Grace Wilson, Rupal Bhana, Marina Stasenko, Kelly A Levine, Michelle Diane Swanson Lightfoot, Emeline Mariam Aviki, Kent Chan, Edward A Jimenez, Erin Annette Reese, Leslie R Boyd, Fabia Brisard Pierrot, Cindy Corbo, Whitfield B. Growdon, Sarah Saerohm Lee, Marilyn Huang, Anastasiya Apanasyuk, Sabrina Machado, Kathleen M Lutz, Olivia Richardson Khouri, Victoria Helen Dowd, Alexander A Hindenburg.


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