Sacituzumab Tirumotecan for Cervical Cancer
What You Need to Know Before You Apply
What is the purpose of this trial?
This study will have two phases: a sacituzumab tirumotecan safety run-in and a Phase 3 portion. The safety run-in phase will be used to evaluate the efficacy and safety of sacituzumab tirumotecan at the dose for evaluation in the Phase 3 portion. The purpose of this study is to compare the efficacy and safety of sacituzumab tirumotecan versus treatment of physician's choice as second-line treatment for participants with recurrent or metastatic cervical cancer in the Phase 3 portion.The primary study hypotheses are that, in the Phase 3 portion, sacituzumab tirumotecan results in a superior overall survival compared to TPC in participants with high trophoblast cell surface antigen 2 (TROP2) expression level and in all participants.
Will I have to stop taking my current medications?
The trial information does not specify if you need to stop taking your current medications. However, if you are on certain treatments like live vaccines or have recently had radiotherapy, you may need to wait before starting the trial.
What is known about the safety of Sacituzumab Tirumotecan (also known as Sacituzumab Govitecan) in humans?
Sacituzumab Govitecan has been used in treating breast cancer and urothelial carcinoma, with common side effects including neutropenia (low white blood cell count), diarrhea, colitis (inflammation of the colon), and sepsis (a severe infection). These side effects often occur within 30 days of starting treatment, and close monitoring is recommended to manage these reactions.12345
What makes the drug Sacituzumab Tirumotecan unique for treating cervical cancer?
Sacituzumab Tirumotecan is unique because it targets the Trop-2 protein, which is often overexpressed in cervical cancer cells, and delivers a potent chemotherapy agent directly to these cells, potentially increasing effectiveness while reducing side effects compared to traditional chemotherapy.46789
What data supports the effectiveness of the drug Sacituzumab Tirumotecan for cervical cancer?
The research shows that similar drugs like irinotecan and topotecan, when used in combination with other treatments, have shown effectiveness in treating cervical cancer, with response rates up to 75% in some cases. This suggests that Sacituzumab Tirumotecan, which may have similar components, could potentially be effective as well.410111213
Who Is on the Research Team?
Medical Director
Principal Investigator
Merck Sharp & Dohme LLC
Are You a Good Fit for This Trial?
This trial is for adults assigned female at birth with recurrent or metastatic cervical cancer, including squamous cell carcinoma and adenocarcinoma. Participants must have measurable disease, controlled HIV on ART if applicable, undetectable HBV or HCV viral load if previously infected, adequate organ function, and an ECOG performance status of 0 or 1.Inclusion Criteria
Timeline for a Trial Participant
Screening
Participants are screened for eligibility to participate in the trial
Safety Run-in
Evaluate the efficacy and safety of sacituzumab tirumotecan at the dose for evaluation in the Phase 3 portion
Phase 3 Treatment
Participants receive sacituzumab tirumotecan or treatment of physician's choice as second-line treatment for recurrent or metastatic cervical cancer
Follow-up
Participants are monitored for safety and effectiveness after treatment
What Are the Treatments Tested in This Trial?
Interventions
- Sacituzumab Tirumotecan
Sacituzumab Tirumotecan is already approved in China for the following indications:
Find a Clinic Near You
Who Is Running the Clinical Trial?
Merck Sharp & Dohme LLC
Lead Sponsor
Chirfi Guindo
Merck Sharp & Dohme LLC
Chief Marketing Officer since 2022
Degree in Engineering from Ecole Centrale de Paris, MBA from New York University Stern School of Business
Robert M. Davis
Merck Sharp & Dohme LLC
Chief Executive Officer since 2021
JD from Northwestern University Pritzker School of Law, MBA from Northwestern University Kellogg Graduate School of Management, Bachelor's in Finance from Miami University
European Network of Gynaecological Oncological Trial Groups (ENGOT)
Collaborator
GOG Foundation
Collaborator