GOG FOUNDATION - GOG-3123/MK2870-036

Official Title

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 First-line 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)

Study Purpose

To test the safety and efficacy of sacituzumab tirumotecan (sac-TMT) in people with cervical cancer that has returned or spread to other parts of the body during or after receiving treatment, or is not likely to be cured with surgery and/or radiation

Diagnosis

Persistent, recurrent, or newly diagnosed metastatic squamous cell carcinoma, adenocarcinoma, or adenosquamous carcinoma of the cervix.

Eligibility

Cancer is not amenable to curative treatment with surgery and/or radiation. Tissue sample required for biomarker testing. No prior immunotherapy.

Intervention

Study Part 1: (20 participants): After induction chemotherapy – Sac-TMT every 2 weeks + pembrolizumab every 6 weeks + bevacizumab every 3 weeks

Study Part 2: Induction chemotherapy with cisplatin + paclitaxel + pembrolizumab +/- bevacizumab every 3 weeks for 6 cycles, FOLLOWED BY Maintenance:
Arm 1 - sac-TMT every 2 weeks + pembrolizumab every 6 weeks +/- bevacizumab every 3 weeks.
Arm 2 - pembrolizumab every 6 weeks +/- bevacizumab every 3 weeks.