Sacituzumab Tirumotecan + Pembrolizumab for Endometrial Cancer
(TroFuse-033 Trial)
What You Need to Know Before You Apply
What is the purpose of this trial?
This trial tests new treatments for advanced or recurring endometrial cancer with specific proteins present in the cancer cells. The study examines whether combining sacituzumab tirumotecan, an antibody drug targeting cancer cells, with pembrolizumab, an immunotherapy, can help patients live longer without their cancer worsening, compared to pembrolizumab alone. Participants should have endometrial cancer that has returned or spread and should not have received previous treatments targeting the proteins involved in this study. As a Phase 3 trial, this study represents the final step before FDA approval, offering patients a chance to access potentially effective treatments earlier.
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, it mentions that prior hormonal therapy for endometrial carcinoma must be stopped at least one week before starting the trial treatment.
Is there any evidence suggesting that this trial's treatments are likely to be safe?
Research has shown that sacituzumab tirumotecan (sac-TMT) has a manageable safety profile for patients with endometrial and ovarian cancers. While some side effects occur, they are generally manageable.
Sac-TMT is an antibody drug conjugate (ADC), meaning it specifically targets cancer cells, helping to protect healthy cells. In past studies, most side effects were mild to moderate, such as fatigue or nausea.
Pembrolizumab, a well-known immunotherapy drug, is already approved for several types of cancer. It aids the immune system in fighting cancer cells. Most people tolerate it well, though some may experience fatigue or mild skin reactions.
Researchers are studying the combination of sac-TMT with pembrolizumab to determine if it improves treatment outcomes. Early results suggest that adding sac-TMT does not significantly increase severe side effects compared to pembrolizumab alone.
Prospective trial participants should discuss potential risks and benefits with their doctor. Current data supports that both treatments have been tolerable in past studies.12345Why are researchers excited about this trial's treatments?
Researchers are excited about Sacituzumab Tirumotecan + Pembrolizumab for endometrial cancer because these treatments offer a fresh approach compared to traditional therapies. Most current treatments involve surgery, radiation, and chemotherapy, which primarily attack rapidly dividing cells. Unlike these, Sacituzumab Tirumotecan targets a specific protein, Trop-2, found on cancer cells, allowing it to deliver chemotherapy directly to the tumor. Meanwhile, Pembrolizumab is an immunotherapy that helps the immune system recognize and fight cancer cells more effectively. Together, these treatments have the potential to enhance precision in targeting cancer cells, possibly leading to better outcomes with fewer side effects.
What evidence suggests that this trial's treatments could be effective for endometrial cancer?
Research has shown that sacituzumab tirumotecan (sac-TMT) holds promise in treating endometrial cancer, with patients experiencing an average of 5.7 months before the cancer worsens. The treatment shrinks tumors in about 31% to 34% of patients. In this trial, some participants will receive sac-TMT alone, while others will receive it with pembrolizumab. Adding pembrolizumab to standard treatment significantly slows cancer progression in advanced cases. This combination is considered an effective and safe option for managing this cancer. Together, sac-TMT and pembrolizumab have demonstrated lasting and encouraging results in studies, suggesting they could be a strong combination for treating advanced endometrial cancer.678910
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 advanced or recurrent endometrial cancer that still has certain normal proteins (pMMR). Participants must have a confirmed diagnosis, measurable disease according to specific criteria, and no prior systemic therapy for their cancer except under certain conditions like one round of platinum-based chemotherapy or hormonal therapy discontinued at least a week before.Inclusion Criteria
Timeline for a Trial Participant
Screening
Participants are screened for eligibility to participate in the trial
Induction
Participants receive pembrolizumab, carboplatin, and paclitaxel or docetaxel for 6 cycles
Maintenance Treatment
Participants receive pembrolizumab with or without sacituzumab tirumotecan for up to 14 cycles
Subsequent Treatment
Participants receive pembrolizumab with or without sacituzumab tirumotecan until discontinuation criteria are met
Follow-up
Participants are monitored for safety and effectiveness after treatment
What Are the Treatments Tested in This Trial?
Interventions
- Pembrolizumab
- Sacituzumab Tirumotecan
Trial Overview
The study compares the effectiveness of Sacituzumab Tirumotecan (sac-TMT) combined with Pembrolizumab versus Pembrolizumab alone in prolonging life without worsening of pMMR endometrial cancer. Sac-TMT is an antibody drug conjugate targeting and destroying cancer cells.
How Is the Trial Designed?
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Treatment groups
Experimental Treatment
Active Control
During the Induction Phase, participants receive pembrolizumab 200 mg, carboplatin AUC 5 (mg/mL/min), and paclitaxel 175 mg/m2 or docetaxel 75 mg/m2 on Day 1 of each 3-week cycle for 6 cycles (up to approximately 4 months). During the Subsequent Treatment Phase, participants receive sac-TMT 4 mg/kg on Days 1, 15, and 29 of each 6-week cycle until discontinuation criteria is met and pembrolizumab 400 mg on Day 1 of each 6-week cycle for up to 14 cycles (up to approximately 19 months).
During the Induction Phase, participants receive pembrolizumab 200 mg, carboplatin area under the curve (AUC) 5 (mg/mL/min), and paclitaxel 175 mg/m2 or docetaxel 75 mg/m2 on Day 1 of each 3-week cycle for 6 cycles (up to approximately 4 months). During the Maintenance Treatment Phase, participants receive sac-TMT 4 mg/kg on Days 1, 15, and 29 of each 6-week cycle and pembrolizumab 400 mg on Day 1 of each 6-week cycle for up to 14 cycles (up to approximately 19 months).
During the Induction Phase, participants receive pembrolizumab 200 mg, carboplatin AUC 5 (mg/mL/min), and paclitaxel 175 mg/m2 or docetaxel 75 mg/m2 on Day 1 of each 3-week cycle for 6 cycles (up to approximately 4 months). During the Maintenance Treatment Phase, participants receive pembrolizumab 400 mg on Day 1 of each 6-week cycle for up to 14 cycles (up to approximately 19 months).
During the Induction Phase, participants receive pembrolizumab 200 mg, carboplatin AUC 5 (mg/mL/min), and paclitaxel 175 mg/m2 or docetaxel 75 mg/m2 on Day 1 of each 3-week cycle for 6 cycles (up to approximately 4 months). During the Subsequent Treatment Phase, participants receive sac-TMT 4 mg/kg on Days 1, 15, and 29 of each 6-week cycle until discontinuation criteria is met.
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
Citations
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The goal of this study is to learn if people who receive sac-TMT with pembrolizumab live longer and without the cancer getting worse compared to people who ...
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The goal of this study is to learn if people who receive sac-TMT with pembrolizumab live longer and without the cancer getting worse compared to people who ...
716MO Efficacy and safety of sacituzumab tirumotecan ( ...
Here, we report the efficacy and safety results from the CC cohort in an ongoing Phase 2 basket study ... alpha (FRa) expression: Results from the ...
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clinicaltrials.med.nyu.edu
clinicaltrials.med.nyu.edu/cancer/clinicaltrial/2776/phase-3-randomized-open-label/Perlmutter Cancer Center - Clinical Research Studies
Phase 3 Randomized Open-label Multicenter Study to Compare the Efficacy and Safety of Sacituzumab Tirumotecan in Combination with Pembrolizumab Versus ...
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