TroFuse-036/GOG-3123/ENGOT-cx22: A 2-part, phase 3, randomized study of sacituzumab tirumotecan (sac-TMT) + pembrolizumab (pembro) ± bevacizumab (bev) vs standard of care (SoC) as first-line maintenance therapy for PD-L1–positive cervical cancer.
Randomized trial evaluates maintenance therapy with sacituzumab tirumotecan + pembrolizumab in cervical cancer, suggesting enhanced treatment options.
Key Points
The study aims to evaluate the efficacy and safety of sacituzumab tirumotecan combined with pembrolizumab as a maintenance therapy for PD-L1–positive cervical cancer.
Phase 3, randomized, open-label design, enrolling patients aged ≥18 years with advanced cervical cancer.
Part 1 includes ~20 patients receiving induction therapy followed by maintenance with sac-TMT + pembro; Part 2 involves ~1003 patients randomized after induction therapy completion.
Primary endpoints include safety assessments in Part 1 and progression-free survival (PFS) in Part 2.
Preliminary phase 2 study indicated a 58% overall response rate (ORR) for the combination of sac-TMT and pembrolizumab.
Part 1 focuses on safety; Part 2 will measure PFS based on blinded independent assessments according to RECIST v1.1.
Secondary endpoints will include PFS2, safety, and patient-reported outcomes.