Perlmutter Cancer Center

This is a Phase 3 study testing a new experimental drug called sacituzumab tirumotecan (sac-TMT, also known as MK-2870) to see if it can help people with advanced cervical cancer live longer or keep their cancer under control longer. It is for patients with cervical cancer that: has come back (recurred) after treatment, or has spread to other parts of the body (metastatic), or is unlikely to be cured with surgery or radiation. All patients will first receive 18 weeks of standard chemotherapy for advanced cervical cancer. This may happen before joining the study, or as part of the study. After or alongside chemotherapy, participants will receive: Sac-TMT, given together with Pembrolizumab (also called pembro), with or without Bevacizumab. Sac-TMT is designed to deliver chemotherapy directly to cancer cells. Pembrolizumab (an immunotherapy drug) helps the immune system attack cancer. Bevacizumab blocks blood supply that tumors need to grow. This study aims to see if using these new treatments together is more effective at controlling the cancer than the standard treatment alone.

In this study, there are two parts: Part 1 and Part 2. To take part in Part 1 (Safety Run-In), participants must have completed 6 cycles of standard first-line treatment before joining the study. Once they meet this requirement, they can be enrolled in Part 1 to test the safety of the three-drug combination:sac-TMT + pembrolizumab + bevacizumab. In Part 2 (Induction and Maintenance Phase), patients will first recieve standard induction treatment: chemotherapy + pembrolizumab + bevacizumab. After induction, patients whose cancer has completely disappeared, shrunk or remained stable will be randomly assigned to one of two groups:Arm A and Arm B. The patients in Arm A will receive sac-TMT every 2 weeks, Pembrolizumab every 6 weeks and Bevacizumab may or may not be added, depending on the doctor's choice. This group is being studied to see if adding sac-TMT to standard therapy helps keep the cancer from growing longer and helps patients live longer. The patients in Arm B will receive the usual maintenance treatment for cervical cancer:Pembrolizumab every 6 weeks and Bevacizumab may or may not be added, depending on the doctor's choice. The goal of this group is to compare Arm B to Arm A (new treatment with sac-TMT) to see if adding sac-TMT improves outcomes. The study will look at two main goals: how long the cancer stays under control (Progression-Free Survival - PFS) and how long patients live (Overall Survival - OS). 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 have special scans done for all patients to see how the cancer is responding to the study medicines. The study team will be monitoring the patients for potential side effects and safety concerns.