NCT05728814

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

A Retrospective, Real-world Multicenter Study of DOstarlimab in Patients With Recurrent or Advanced DNA Mismatch Repair Deficient/Microsatellite Instability-high (dMMR/MSI-H) Endometrial Cancer (DORA Study)

• Status: Unknown
• Phase: —
• Study type: Observational
• Enrollment: 100 (estimated)
• Sponsor: Grupo Español de Investigación en Cáncer de Ovario · Academic / Other
• Sex: Female
• Age: 18 Years – 100 Years
• Healthy volunteers: Not accepted

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).

Detailed description

1.1.1. Primary Clinical Objective • To assess the antitumor activity of dostarlimab in patients with recurrent or advanced mismatch repair deficient (dMMR)/microsatellite instability-high (MSI-H) endometrial cancer, in terms of objective response rate (ORR) and duration of response (DOR) based on investigators' assessment using Response Evaluation Criteria in Solid Tumors (RECIST) v1.1. 1.1.2. Secondary Clinical Objectives * To assess the effectiveness of dostarlimab in terms of investigator-assessed progression-free survival (PFS) and overall survival (OS). * To analyze the PFS rate at 6, 12, 18 and 24 months. * To assess the disease control rate (DCR) based on investigators' assessment using RECIST 1.1. * To evaluate duration of treatment with dostarlimab. * To describe the time to response to dostarlimab. * To evaluate the safety and tolerability of dostarlimab in patients with dMMR/MSI-H endometrial advanced cancer, including immune-related adverse events of interest (irAEI). * To evaluate Neutrophil-to-lymphocyte ratio as a potential predictive biomarker for treatment with dostarlimab. 1.1.3. Translational Objectives * To compare centralized immunohistochemistry (IHC) re-testing with local testing. * To compare centralized IHC re-testing results with two PCR-based techniques (Promega® and Idylla®) and with possible MMR gene alterations (genetic and epigenetic). * To analyze the overall response rate and progression-free survival of the dMMR/MSI population selected by each biomarker technique: IHC, Polymerase chain reaction (PCR) Promega®, PCR Idylla®, or gene alteration (next generation sequencing (NGS)/hypermethylation). 1.1.4. Population The study population consists of adult female patients with diagnosis of dMMR/MSI-H recurrent or advanced endometrial cancer with progression to a previous platinum regimen, who were treated within the Spanish dostarlimab Expanded Access Program (EAP) 1.1.5. Treatment Under Observation In this study, 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.

Conditions

• Endometrial Cancer

Interventions

Type	Name	Description
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.

Timeline

• Start date: 2023-03-07
• Primary completion: 2024-04-12
• Completion: 2024-09-12
• First posted: 2023-02-15
• Last updated: 2024-02-23

Locations

1 site across 1 country: Spain

Regulatory

• FDA-regulated drug study