MMRd/MSI-H stage II-III endometrial cancer
Conditions
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
Sponsors
Eligibility
Design outcomes
Primary
| Measure | Time 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
| Measure | Time 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