Sacituzumab Tirumotecan + Pembrolizumab for Cervical Cancer
What You Need to Know Before You Apply
What is the purpose of this trial?
This trial explores new ways to treat cervical cancer that has spread. It combines sacituzumab tirumotecan (a targeted cancer treatment) with pembrolizumab and bevacizumab to assess safety and effectiveness in extending patient survival or preventing cancer progression. Participants will join different groups to test these medicines together or against standard treatments. Individuals with recurrent or metastatic cervical cancer, who are not candidates for surgery or radiation, might be suitable for this study. As a Phase 3 trial, it represents the final step before FDA approval, offering participants a chance to contribute to potentially groundbreaking treatment advancements.
Will I have to stop taking my current medications?
The trial does not specify if you need to stop taking your current medications, but you cannot take strong inducers or inhibitors of cytochrome P450 3A4 during the treatment. It's best to discuss your current medications with the trial team.
Is there any evidence suggesting that this trial's treatments are likely to be safe?
Research has shown that sacituzumab tirumotecan (sac-TMT) is generally safe for patients with advanced cancers, though about 47.4% of patients experienced serious side effects. These side effects include low white blood cell counts (23.7%) and anemia (21.1%), which means having too few healthy red blood cells. This suggests that while the treatment is effective, it can cause significant issues for some people.
Studies indicate that pembrolizumab is mostly well-tolerated, with about 21% of patients with cervical cancer experiencing severe side effects. Pembrolizumab helps the immune system fight cancer.
These findings suggest that while both treatments can have serious side effects, they are considered manageable. Researchers are testing the treatments together to see if they can improve outcomes for patients with metastatic cervical cancer, which is cancer that has spread to other parts of the body.12345Why are researchers excited about this trial's treatments?
Researchers are excited about Sacituzumab Tirumotecan (Sac-TMT) combined with Pembrolizumab for cervical cancer because it offers a novel approach that differs from traditional treatments like chemoradiation or cisplatin-based therapies. Sac-TMT is an antibody-drug conjugate that specifically targets cancer cells, potentially improving efficacy and reducing side effects compared to non-targeted chemotherapy. Additionally, Pembrolizumab is an immunotherapy drug that helps the immune system recognize and attack cancer cells, offering a promising alternative for patients whose cancer has not responded well to standard treatments. This combination aims to enhance the body's natural defenses while directly targeting tumors, providing a dual mechanism of action that could lead to better outcomes for patients.
What evidence suggests that this trial's treatments could be effective for metastatic cervical cancer?
Studies have shown that sacituzumab tirumotecan (sac-TMT), a treatment in this trial, helps patients with metastatic cancer live longer without disease progression. This medicine targets and attacks cancer cells directly. Pembrolizumab, another treatment option in this trial, has proven effective in extending the lives of people with metastatic cervical cancer. Specifically, research indicates that patients treated with pembrolizumab lived longer without cancer worsening compared to those who received a placebo. These medicines boost the immune system to fight cancer and directly target tumors.13678
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 individuals with cervical cancer that has spread and can't be cured by surgery or radiation. Participants must have a specific type of cervical cancer, controlled HIV if infected, undetectable hepatitis B or C if previously infected, and be in good physical condition.Inclusion Criteria
Timeline for a Trial Participant
Screening
Participants are screened for eligibility to participate in the trial
Part 1 Safety Run-in
Participants receive sac-TMT, pembrolizumab, and bevacizumab to assess safety and tolerability
Part 2 Induction Treatment
Participants receive pembrolizumab, paclitaxel, and cisplatin (or carboplatin) with optional bevacizumab
Part 2 Maintenance Treatment
Participants receive sac-TMT and pembrolizumab, with optional bevacizumab, to evaluate efficacy and safety
Follow-up
Participants are monitored for overall survival and progression-free survival
What Are the Treatments Tested in This Trial?
Interventions
- Pembrolizumab
- Sacituzumab Tirumotecan
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