NCT07013851

Clinical Trial to Assess the Efficacy of Dostarlimab as Neoadjuvant Therapy in Patients With MMRd/MSI-H Stage II-III Endometrial Cancer

Phase II Clinical Trial to Assess the Efficacy of Dostarlimab as Neoadjuvant Therapy in Patients With MMRd/MSI-H Stage II-III Endometrial Cancer

• Status: Not Yet Recruiting
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 25 (estimated)
• Sponsor: Grupo Español de Investigación en Cáncer de Ovario · Academic / Other
• Sex: Female
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

The study for which participation is requested is a phase II clinical trial to assess the efficacy of dostarlimab as neoadjuvant therapy in patients with MMRd/MSI-H stage II-III endometrial cancer. The study is conducted in Spain with an estimated number of 25 patients for phase II. The main objective of this phase-II study is to evaluate the clinical complete response (cCR) after neoadjuvant therapy with dostarlimab.

Conditions

• MMRd/MSI-H Stage II-III Endometrial Cancer

Interventions

Type	Name	Description
DRUG	Dostarlimab	Patients will be treated in the neoadjuvant setting with dostarlima 500 mg (30') every 3 weeks for 4 cycles.All participants will undergo surgery within 6 weeks following the final dose of neoadjuvant dostarlimab. After surgery, adjuvant chemotherapy, including dostarlimab, will be administered as follows: Stage II EC: VBT/EBRT (completed within \>14 weeks after surgery) + Adjuvant dostarlimab 1000 mg Q6W x 9 cycles (54 weeks total). Stage III EC: 1. Concurrent EBRT+cisplatin followed by carboplatin + paclitaxel OR 2. Sequential: EBRT followed by carboplatin + paclitaxel OR 3. Chemotherapy alone: carboplatin + paclitaxel * Adjuvant dostarlimab 500 mg Q3W x 4-6 cycles (in combination with chemotherapy) plus 1000 mg Q6W x 6-7 cycles (54 weeks total).

Timeline

• Start date: 2025-10-01
• Primary completion: 2029-03-01
• Completion: 2029-10-01
• First posted: 2025-06-10
• Last updated: 2025-06-10

Locations

1 site across 1 country: Spain