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DOstarlimab in Patients With Recurrent or dMMR/MSI-H Endometrial Cancer

NCT05728814 · Status: RECRUITING · Type: OBSERVATIONAL · Enrollment: 100

Last updated 2024-02-23

No results posted yet for this study

Summary

This is a multicenter, retrospective, observational (non-interventional) study, in patients treated in a real-world setting within the Spanish dostarlimab EAP. The study is planned to be conducted in the Medical Oncology departments at 50-60 Spanish GEICO-associated hospitals. Its multicenter nature aims to improve the representativeness of the study population in Spain. The study would include approximately 110 patients with dMMR/MSI-H recurrent or advanced EC, that have progressed on or following prior treatment with a platinum containing regimen, treated within the dostarlimab EAP, available in Spain from January 2021 to September 2022. The total number of participating centers and patients will be confirmed once the EAP is closed.

Patient's medical records will be screened by local clinical staff to assess for eligibility according to selection criteria. The study comprises a single study visit, in which the patient will give her informed consent to participate (when the patient is alive) and the physician will extract the study data from the patient's medical charts.

Alive patients who fulfill inclusion criteria and meet no exclusion criteria will be informed by a member of their care team about the purpose of the study, as well as about potential risks and benefits of study participation. The written informed consent form (ICF) should be signed prior to study initiation in alive patients in order to access their medical records. Deceased patients will be still included but their relatives will not be contacted. In these instances, data will be collected by members of the direct care team, unless there is a prior express order from the patient to preserve confidentiality. All eligible deceased and consenting living patients at the participating centers will be included. Data will be directly retrieved from hospital medical records and reported in the electronic Case Report Form (eCRF).

Conditions

Interventions

DRUG

Dostarlimab

The treatment under observation is dostarlimab administered on day 1 of each treatment cycle until disease progression, unacceptable toxicity or patient/doctor's decision. The recommended dose for dostarlimab is 4 cycles of 500 mg every 3 weeks followed by 1000 mg every 6 weeks for all subsequent cycles.

Sponsors & Collaborators

  • Grupo Español de Investigación en Cáncer de Ovario

    lead OTHER

Principal Investigators

  • Alejandro Gallego Martinez · Clinica Universitaria de Navarra

  • Marta Mendiola Sabio · Hospital Universitario La Paz

Eligibility

Min Age
18 Years
Max Age
100 Years
Sex
FEMALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2023-03-07
Primary Completion
2024-04-12
Completion
2024-09-12
FDA Drug
Yes

Countries

  • Spain

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05728814 on ClinicalTrials.gov