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

Conditions

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

Eligibility Criteria

Sex

FEMALE

Age

18 Years - N/A

Healthy Volunteers

Not accepted

Interventions

• Dostarlimab — DRUG
  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).

Study Details

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.

Key Dates

Start date

Oct 1, 2025

Status verified

Jun 2025

Primary completion

Mar 1, 2029

Completion

Oct 1, 2029

Study Design

Enrollment

25 participants (estimated)

Allocation

NA

Intervention model

SINGLE_GROUP

Primary purpose

TREATMENT

Arms

• Experimental: 1
  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).

Primary Outcome Measure

To evaluate the clinical complete response (cCR) after neoadjuvant dostarlimab. [ Time Frame: 43 months ]

Central Contacts

• Grupo Español de Investigación en Cáncer Ginecológico
  +34 910 09 72 58
  [email protected]