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

NCT05728814 | Recruiting FDA Drug

• 1 other identifier: GEICO 120-R & GEICO 120-T
• Study Type: observational
• Target: 100
• Locations: 1 country
• Sites: 1

Brief 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

Endometrial Cancer

Outcome Measures

Primary Outcomes (6)

• Dostarlimab Treatment

  End of treatment reason (toxicity, doctor's decision, patient's decision, progression or other)

  Month 4-6

• Dostarlimab Treatment

  Number of cycles Number of interruptions

  Month 4-6

• Dostarlimab Treatment

  Start date (first dose) End of treatment date

  Month 4-6

• Disease progression after dostarlimab

  Month 4-6

• Best Response Assessment

  Month 4-6

• Dostarlimab -Related Adverse Events

  Month 4-6

Secondary Outcomes (8)

• Demographics

  Month 4-6

• Medical History

  Month 4-6

• Endometrial Cancer History

  Month 4-6

• Endometrial Cancer Previous Treatments

  Month 4-6

• Baseline (pre-dostarlimab)

  Month 4-6

Study Arms (1)

Case-only

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).

Drug: Dostarlimab

Interventions

Dostarlimab DRUG

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.

Case-only

Eligibility Criteria

• Age: 18 Years - 100 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

The study population consists of adult female patients with diagnosis of dMMR/MSI-H recurrent or advanced endometrial cancer with recurrent disease to a previous platinum, treated within the Spanish dostarlimab EAP.

You may qualify if:

• At least 18 years of age, able to understand the program procedures and agree to participate by providing written informed consent.
• Histologically diagnosed endometrial cancer (note: all histologies are permitted except endometrial sarcoma \[including carcinosarcoma\]).
• Patient has evidence of tumor DNA damage repair dysfunction (dMMR/MSI-H) via locally available, validated methodology.
• Patient has progressed on or after platinum containing chemotherapy (and has received no more than 2 lines of anti-cancer therapy for recurrent or advanced (Stage ≥ IIIB) disease (first or second line)); prior treatment with hormone therapies is acceptable and does not count towards the number of lines of therapy.
• ECOG performance status of ≤ 2.
• Adequate organ and bone marrow function, as defined below:
• Absolute neutrophil count (ANC) ≥ 1,500/µL
• Platelets ≥ 100,000/µL
• Hemoglobin ≥ 9 g/dL
• Adequate liver and renal function:
• Serum creatinine ≤ 1.5 × upper limit of normal (ULN) or calculated creatinine clearance ≥ 50 mL/min using Cockcroft-Gault equation for patients with creatinine levels \> 1.5 × institutional ULN.
• Total bilirubin ≤ 1.5 × ULN AND direct bilirubin ≤ 1 × ULN.
• Aspartate aminotransferase (AST) and alanine aminotransferase (ALT) ≤ 2.5 × ULN unless liver metastases are present, in which case they must be ≤ 5 × ULN.
• Cannot be satisfactorily treated with available alternative treatments.
• Not eligible for a clinical trial with dostarlimab within the indication of the EAP (where access to the clinical trialsite is possible)

You may not qualify if:

• Has received prior therapy with an anti-programmed death-1 (anti-PD-1), anti-PD-1- ligand-1 (anti-PD-L1), or anti-PD-1 ligand-2 (anti-PD-L2) agent.
• Is considered a poor medical risk due to a serious, uncontrolled medical disorder, non malignant systemic disease, or active infection requiring antibiotic, antifungal or antiviral treatment.
• Has undergone major surgery 3 weeks prior to initiating dostarlimab (and not recovered from surgical effects).
• Has malignancies other than endometrial cancer (except for any other malignancy for which the patient is not being actively treated).
• Has a history of interstitial lung disease.
• Has an active autoimmune disease that required systemic treatment in the past 2 years (i.e., use of disease-modifying agents, corticosteroids, or immunosuppressive drugs); hormone replacement therapy (e.g., thyroxine, insulin, or physiologic corticosteroid replacement therapy for adrenal or pituitary insufficiency, etc.) is not considered a form of systemic treatment
• Has experienced ≥ Grade 3 immune related AE with prior immunotherapy, except for non-clinically significant laboratory abnormalities.
• Has known active hepatitis B (e.g., hepatitis B surface antigen \[HBsAg\] reactive) or hepatitis C (e.g., hepatitis C virus \[HCV\] ribonucleic acid \[qualitative\] is detected).
• Has received a live vaccine within 14 days of 1st dose of dostarlimab.
• Has a known hypersensitivity to dostarlimab components or excipients

Sponsors & Collaborators

• Grupo Español de Investigación en Cáncer de Ovario: lead

Study Sites (1)

Hospital Arnau de Vilanova

Valencia, Valencia, 46015, Spain

RECRUITING

MeSH Terms

Conditions

Endometrial Neoplasms

Interventions

dostarlimab

Condition Hierarchy (Ancestors)

Uterine Neoplasms; Genital Neoplasms, Female; Urogenital Neoplasms; Neoplasms by Site; Neoplasms; Uterine Diseases; Genital Diseases, Female; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Genital Diseases

Study Officials

• Alejandro Gallego Martinez

  Clinica Universitaria de Navarra

  PRINCIPAL INVESTIGATOR

• Marta Mendiola Sabio

  Hospital Universitario La Paz

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Patricio Ledesma

CONTACT

+34971439900; ensayos@sofpromed.com

Study Design

• Study Type: observational
• Observational Model: CASE ONLY
• Time Perspective: RETROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 21, 2022
• First Posted: February 15, 2023
• Study Start: March 7, 2023
• Primary Completion: April 12, 2024
• Study Completion: September 12, 2024
• Last Updated: February 23, 2024

Record last verified: 2024-02

Locations

ES (1)