Skip to content

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
Recruiting
Phases
Phase 2
Study type
Interventional
Source
EU CTIS
Registry ID
CTIS2024-512021-81-00
Acronym
GEICO 137-E
Enrollment
25
Registered
2025-08-06
Start date
2025-12-01
Completion date
Unknown
Last updated
2025-08-18

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

MMRd/MSI-H stage II-III endometrial cancer

Brief summary

cCR: Efficacy measured by the proportion of patients who did not undergo surgery due to cCR after neoadjuvant dostarlimab. cCR is defined as the absence of tumor persistence evaluated by MRI, CT, PET scan, pelvic exam, and review of surgical specimen.

Detailed description

pCR: Efficacy measured by the proportion of patients who had pCR having undergone surgery after neoadjuvant dostarlimab. pCR is defined as the absence of invasive tumor in the surgical specimen by local pathology review., ORR: Efficacy measured by ORR, which is defined as the number of patients with a best overall response (BOR) of complete response (CR) or partial response (PR) divided by the number of response evaluable patients (according to RECIST v1.1)., DFS: Efficacy measured by DFS, which is defined as the time in months from date of enrollment to date of local or distant recurrence (assessed radiologically by the investigator or by histopathologic confirmation), or death due to any cause, whichever occurs first., mOS: Efficacy measured by mOS, which is defined as the median of time in months from date of enrollment to date of death due to any cause. OS will be censored on the last date a patient was known to be alive., Toxicity will be assessed by adverse events related to study drugs, detected through physical examinations and laboratory tests, and graded according to CTCAE v5.0.

Interventions

DRUGJEMPERLI 500 mg concentrate for solution for infusion

Sponsors

Grupo Espanol De Investigacion En Cancer De Ovario
Lead SponsorOTHER

Eligibility

Sex/Gender
All
Age
18 Years to No maximum

Design outcomes

Primary

MeasureTime frame
cCR: Efficacy measured by the proportion of patients who did not undergo surgery due to cCR after neoadjuvant dostarlimab. cCR is defined as the absence of tumor persistence evaluated by MRI, CT, PET scan, pelvic exam, and review of surgical specimen.

Secondary

MeasureTime frame
pCR: Efficacy measured by the proportion of patients who had pCR having undergone surgery after neoadjuvant dostarlimab. pCR is defined as the absence of invasive tumor in the surgical specimen by local pathology review., ORR: Efficacy measured by ORR, which is defined as the number of patients with a best overall response (BOR) of complete response (CR) or partial response (PR) divided by the number of response evaluable patients (according to RECIST v1.1)., DFS: Efficacy measured by DFS, which is defined as the time in months from date of enrollment to date of local or distant recurrence (assessed radiologically by the investigator or by histopathologic confirmation), or death due to any cause, whichever occurs first., mOS: Efficacy measured by mOS, which is defined as the median of time in months from date of enrollment to date of death due to any cause. OS will be censored on the last date a patient was known to be alive., Toxicity will be assessed by adverse events related to stud

Countries

Spain

Outcome results

None listed

Source: EU CTIS · Data processed: Feb 4, 2026