A Phase 3 Randomized Active-controlled Open-label Multicenter Study to Compare the Efficacy and Safety of MK-2870 Monotherapy Versus Treatment of Physician s Choice as Second-line Treatment for Participants with Recurrent or Metastatic Cervical Cancer (TroFuse-020/GOG-3101/ENGOT-cx20)

Brief description of study

This is a Phase 3 study testing whether the study medicine MK-2870 is safer and more effective compared to the doctor's choice of other standard chemotherapy medication in patients with cervical cancer that has spread from the primary site (metastatic) or has come back after previous treatment (recurrent). MK-2870 is an antibody-drug conjugate that attacks and kills cancer cells more specifically than traditional chemotherapy.

The study will be done in two parts. In Part 1, called Run-in, a small number of patients will be enrolled to test whether MK-2870 at a dose of 4 mg/kg is safe and effective in patients with metastatic cervical cancer. In Part 2, called Phase 3, a larger number of patients will be randomly divided into two groups. Group 1 will receive the study medication, MK-2870, at 4 mg/kg. Group 2 will receive the doctor’s chosen treatment, which will be one of the following: Pemetrexed, Tisotumab vedotin, Topotecan, Vinorelbine, Gemcitabine, or Irinotecan.

All patients will have regular study visits throughout the study duration. Blood samples will be collected to check how patients are doing and learn how their bodies are handling the study medications. Specialized blood testing to monitor changes in DNA, RNA, and proteins (biomarkers) and ctDNA (circulating tumor DNA, which are small pieces of DNA shed by tumor cells in the blood) will be done to learn more about patients’ cancer and further help them with treatment. Special scans will be done for all patients to see how their tumors are changing in response to the study medication. All patients will be closely monitored for potential side effects and safety concerns.


Clinical Study Identifier: s25-01222
ClinicalTrials.gov Identifier: NCT06459180
Principal Investigator: Leslie R Boyd.
Other Investigators: Laura Palazzolo, Christina Grace Wilson, Rupal Bhana, Kent Chan, Michelle Diane Swanson Lightfoot, Emeline Mariam Aviki, Marina Stasenko, Edward A Jimenez, Erin Annette Reese, Bhavana Pothuri, Fabia Brisard Pierrot, Cindy Corbo, Whitfield B. Growdon, Sarah Saerohm Lee, Alexander A Hindenburg, Anastasiya Apanasyuk, Kelly A Levine, Olivia Richardson Khouri, Victoria Helen Dowd, Kathleen M Lutz.


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