A Phase II, Open-Label, Single Arm, prospective, multicenter study of niraparib plus dostarlimab in patients with pleural mesothelioma positive for PD-L1 expression and germline or somatic mutations in the HRR genes

Status

Not yet recruiting

Phases

Phase 2

Study type

Interventional

Source

EU CTIS

Registry ID

CTIS2024-515555-38-01

Acronym

UNITO-001

Enrollment

Registered

2024-12-09

Start date

Unknown

Completion date

Unknown

Last updated

2025-07-28

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

Conditions

NON SMALL CELL LUNG CANCER, PLEURAL MESOTHELIOMA

Brief summary

To evaluate the progression free survival (PFS)

Detailed description

To evaluate the objective response rate (ORR) To evaluate the duration of response (DOR) To evaluate the disease control rate (DCR) To evaluate the overall survival (OS) To evaluate the safety and tolerability of the combination of Niraparib and dostarlimab

Interventions

DRUGJEMPERLI 500 mg concentrate for solution for infusion

DRUGNIRAPARIB

Eligibility

Sex/Gender

All

Age

18 Years to No maximum

Design outcomes

Primary

Measure	Time frame
To evaluate the progression free survival (PFS)	—

Secondary

Measure	Time frame
To evaluate the objective response rate (ORR) To evaluate the duration of response (DOR) To evaluate the disease control rate (DCR) To evaluate the overall survival (OS) To evaluate the safety and tolerability of the combination of Niraparib and dostarlimab	—

Countries

Italy

Outcome results

None listed

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