Phase 3 Randomized Open-label Multicenter Study to Compare the Efficacy and Safety of Sacituzumab Tirumotecan in Combination with Pembrolizumab Versus Pembrolizumab Alone as First-line Maintenance Treatment in Participants with Mismatch Repair Proficient Endometrial Cancer (TroFuse-033/GOG-3119/ENGOT-en29)

Brief description of study

This is a Phase 3 trial testing whether the study medicine sacituzumab tirumotecan (an antibody-drug conjugate, also known as sac-TMT, or MK-2870), when given in combination with another medicine called pembrolizumab (an immunotherapy medicine), is effective and a better treatment in patients with a specific type of endometrial cancer called proficient (pMMR) endometrial cancer. This trial will compare treatment with sac-TMT plus pembrolizumab to pembrolizumab alone.

This study has two parts- Part 1 is the Induction phase, where patients will receive pembrolizumab and chemotherapy, and Part 2 is the Maintenance phase, where patients whose cancer has not progressed, as shown by the CT scans, will be divided into two groups to receive either sac-TMT plus pembrolizumab or pembrolizumab alone. Patients will undergo CT scans during the study to see how their cancer is changing in response to the study treatment. Blood samples will be taken from all patients to see how their bodies are handling the study medicine. All patients will be closely monitored for any side effects and safety concerns.


Clinical Study Identifier: s24-01985
ClinicalTrials.gov Identifier: NCT06952504
Principal Investigator: Bhavana Pothuri.
Other Investigators: Caitlin Elizabeth Ordonez Ferri, Kathleen M Lutz, Kelly A Levine, Rupal Bhana, Marina Stasenko, Michelle Diane Swanson Lightfoot, Emeline Mariam Aviki, Kent Chan, Edward A Jimenez, Erin Annette Reese, Fabia Brisard Pierrot, Cindy Corbo, Whitfield B. Growdon, Christina Grace Wilson, Sarah Saerohm Lee, Anastasiya Apanasyuk, Sabrina Machado, Leslie R Boyd, Olivia Richardson Khouri, Victoria Helen Dowd, Alexander A Hindenburg.


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