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Randomized phase III trial in MMR deficient endometrial cancer patients comparing chemotherapy alone versus Dostarlimab in first line advanced/metastatic setting: DOMENICA STUDY (GINECO-EN105b/ENGOT-en13 study)

Status
Active, not recruiting
Phases
Phase 3
Study type
Interventional
Source
EU CTIS
Registry ID
CTIS2023-510097-14-00
Acronym
GINECO-EN105b
Enrollment
217
Registered
2024-02-23
Start date
2022-04-15
Completion date
Unknown
Last updated
2025-12-18

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

Conditions

Patients with MMR deficient relapse or advanced / metastatic endometrial cancer

Brief summary

Progression Free Survival (PFS) assessed per BICR (Blinded Independent Central Review)

Detailed description

Overall survival (OS), Progression Free Survival 2 (PFS2), Quality of Life (QoL), Best objective Response Rate (ORR), Disease control rate (DCR), Duration of Response Rate (DoR), PFS, DoR as per investigator assessment, Safety and tolerability, Time to first and second Subsequent Treatment, Efficacy of second systemic therapies, To describe the pharmacokinetics of dostarlimab, To determine the immunogenicity of dostarlimab

Interventions

DRUGCARBOPLATIN
DRUGPACLITAXEL
DRUGDOSTARLIMAB

Sponsors

Arcagy Gineco
Lead SponsorOTHER

Eligibility

Sex/Gender
All
Age
18 Years to 64 Years

Design outcomes

Primary

MeasureTime frame
Progression Free Survival (PFS) assessed per BICR (Blinded Independent Central Review)

Secondary

MeasureTime frame
Overall survival (OS), Progression Free Survival 2 (PFS2), Quality of Life (QoL), Best objective Response Rate (ORR), Disease control rate (DCR), Duration of Response Rate (DoR), PFS, DoR as per investigator assessment, Safety and tolerability, Time to first and second Subsequent Treatment, Efficacy of second systemic therapies, To describe the pharmacokinetics of dostarlimab, To determine the immunogenicity of dostarlimab

Countries

France, Italy, Romania, Spain

Outcome results

None listed

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