Trials / Active Not Recruiting
Active Not RecruitingNCT06132958
Sacituzumab Tirumotecan (MK-2870) in Post Platinum and Post Immunotherapy Endometrial Cancer (MK-2870-005)
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 in Participants With Endometrial Cancer Who Have Received Prior Platinum-based Chemotherapy and Immunotherapy (MK-2870-005/ENGOT-en23/GOG-3095)
- Status
- Active Not Recruiting
- Phase
- Phase 3
- Study type
- Interventional
- Enrollment
- 710 (estimated)
- Sponsor
- Merck Sharp & Dohme LLC · Industry
- Sex
- Female
- Age
- 18 Years
- Healthy volunteers
- Not accepted
Summary
Researchers are looking for new ways to treat people with endometrial cancer (EC) who have previously received treatment with platinum based therapy (a type of chemotherapy) and immunotherapy. Immunotherapy is a treatment that helps the immune system fight cancer. This clinical study will compare sacituzumab tirumotecan to chemotherapy. The goal of the study is to learn if people who receive sacituzumab tirumotecan live longer overall and without the cancer getting worse compared to people who receive chemotherapy.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| BIOLOGICAL | Sacituzumab tirumotecan | 4 mg/kg of sacituzumab tirumotecan by IV infusion |
| DRUG | Doxorubicin | 60 mg/m\^2 of doxorubicin by IV Infusion |
| DRUG | Paclitaxel | 80 mg/m\^2 of paclitaxel by IV infusion |
| DRUG | Nab-paclitaxel | 100 mg/m\^2 of nab-paclitaxel by IV infusion |
| DRUG | Rescue medications | Participants will receive the following rescue medications per approved product label before sacituzumab tirumotecan infusion: Histamine-1 (H1) receptor antagonist, histamine-2 (H2) receptor antagonist, acetaminophen or equivalent, dexamethasone or equivalent, and steroid mouthwash (dexamethasone or equivalent). |
Timeline
- Start date
- 2023-12-06
- Primary completion
- 2028-01-10
- Completion
- 2028-01-10
- First posted
- 2023-11-15
- Last updated
- 2026-04-03
Locations
241 sites across 31 countries: United States, Argentina, Australia, Austria, Belgium, Brazil, Canada, Chile, China, Czechia, Denmark, Finland, France, Germany, Greece, Ireland, Israel, Italy, Japan, Malaysia, Mexico, Netherlands, Norway, Poland, Puerto Rico, Singapore, South Korea, Spain, Sweden, Switzerland, United Kingdom
Regulatory
- FDA-regulated drug study
Source: ClinicalTrials.gov record NCT06132958. Inclusion in this directory is not an endorsement.