An international multicentric randomized phase II evaluating dostarlimab in combination with niraparib versus niraparib alone compared to chemotherapy in the treatment of metastatic or recurrent endometrial or ovarian carcinosarcoma after at least one line of chemotherapy : ROCSAN study

Status

Not yet recruiting

Phases

Phase 2

Study type

Interventional

Source

EU CTIS

Registry ID

CTIS2024-516782-36-00

Acronym

GINECO-EN203b

Enrollment

135

Registered

2024-10-15

Start date

Unknown

Completion date

Unknown

Last updated

2025-12-10

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

Conditions

metastatic or recurrent endometrial or ovarian carcinosarcoma

Brief summary

Step 1 - Selection Phase : Response Rate at 4 months (W16-RR) as per RECIST 1.1, Step 2 – Extension phase :6-months Overall survival (OS) rate.

Detailed description

Progression-Free Survival (PFS), Time To Subsequent Treatment or Death, Progression-Free Survival 2 (PFS2), Overall Survival, Objective Response Rate (ORR), Disease Control Rate (DCR), Duration of response, Safety and Tolerability, QoL & symptom benefit evaluation

Interventions

DRUGZejula 100 mg hard capsules

DRUGJEMPERLI 500 mg concentrate for solution for infusion

Eligibility

Sex/Gender

All

Age

18 Years to No maximum

Design outcomes

Primary

Measure	Time frame
Step 1 - Selection Phase : Response Rate at 4 months (W16-RR) as per RECIST 1.1, Step 2 – Extension phase :6-months Overall survival (OS) rate.	—

Secondary

Measure	Time frame
Progression-Free Survival (PFS), Time To Subsequent Treatment or Death, Progression-Free Survival 2 (PFS2), Overall Survival, Objective Response Rate (ORR), Disease Control Rate (DCR), Duration of response, Safety and Tolerability, QoL & symptom benefit evaluation	—

Countries

France, Italy, Spain

Outcome results

None listed

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