Tests niraparib with dostarlimab in pleural mesothelioma with certain gene changes
Tests niraparib plus dostarlimab in adults with pleural mesothelioma and specific gene changes.
Plain-language title generated from the registry record
Registry title: 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
Key facts
- Where
- Acquaviva delle Fonti, Aviano, Bari, Catania, Florence, Genoa, Lecce, Meldola, Messina, Monza, Naples, Orbassano, Padova, Pavia, Pesaro, Reggio Emilia, and Varese, ItalySee the 19 sites
- Phase
- Phase 2
Where in Italy
- IRCCS Istituti Fisioterapici Ospitalieri- Istituto Nazionale tumori Regina ElenaItalyNot yet recruiting
- Ente Ecclesiastico ospedale generale Regionale MiulliAcquaviva delle Fonti, ItalyNot yet recruiting
- Centro di Riferimento Oncologico di AvianoAviano, ItalyNot yet recruiting
- Istituto Tumori Bari Giovanni Paolo IIBari, ItalyNot yet recruiting
- A.O.U. Policlinico "G. Rodolicp-San Marco"Catania, ItalyNot yet recruiting
- Azienda USL Toscana CentroFlorence, ItalyNot yet recruiting
- Careggi University HospitalFlorence, ItalyNot yet recruiting
- IRCCS Ospedale Policlinico San MartinoGenoa, ItalyNot yet recruiting
- Ospedale Vito Fazzi LecceLecce, ItalyNot yet recruiting
- Istituto Romagnolo per lo Studio dei Tumori "Dino Amadori" - IRST S.r.lMeldola, ItalyNot yet recruiting
- Azienda Ospedaliera Universitaria Gaetano Martino MessinaMessina, ItalyNot yet recruiting
- Fondazione IRCCS San Gerardo dei TintoriMonza, ItalyNot yet recruiting
- Istituto Nazionale dei Tumori,Naples, ItalyNot yet recruiting
- Azienda Ospedaliero-Universitaria San Luigi GonzagaOrbassano, ItalyNot yet recruiting
- Istituto Oncologico VenetoPadova, ItalyNot yet recruiting
- Fondazione IRCCS Policlinico San MatteoPavia, ItalyNot yet recruiting
- Azienda Ospedaliera Ospedali Riuniti Marche NordPesaro, ItalyNot yet recruiting
- AUSL di Reggio Emilia IRCCS, Arcispedale Santa Maria Nuova di Reggio EmiliaReggio Emilia, ItalyNot yet recruiting
- Azienda Socio Sanitaria Territoriale Dei Sette LaghiVarese, ItalyNot yet recruiting
Questions to ask the study team
- How often do I need to come in, and for how long each time?
- Are travel costs paid?
- Can I keep my own doctor?
- What happens if I want to stop?
Trial details
- Who runs it
- Universita' Degli Studi Di Torino
- Trial code
- NCT04940637EU 2024-515555-38-01
- Record updated
- 22 May 2026
- Original description
To evaluate the progression free survival (PFS)Read full original descriptionShow less
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
To evaluate the progression free survival (PFS)
Inclusion: -Diagnosis (cyto or histological) of Mesothelioma or non-small cell lung cancer EGFR / ALK / ROS1 in advanced wild type - Disease progression to at least one previous systemic therapy line - Presence of germline and / or somatic mutations in DNA shelter genes and PD-L1 expression = 1% - Informed consent - Age over 18 and under 75 - Disease measurable according to RECIST criteria - Consent to biological material analysis (tissue biopsy) - Performance status 0-1 - Adequate organ functions.
Exclusion: Participation in other clinical studies - Presence of EGFR gene sensitizing mutations or ALK / ROS1 rearrangements - Immunodeficiency diagnosis - History of tuberculous infection - Known hypersensitivity to Niraparib or Dostarlimab, or excipients - Previous diagnosis of myelodysplastic syndrome or acute myeloid leukemia - Other known malignancy requiring active treatment - Diagnosis of autoimmune diseases Current or past non-infectious pneumonia treated with steroids or evidence of interstitial lung disease - Symptomatic cerebral or leptomeningeal metastases - Known medical conditions that may in some way preclude participation in the study because they confuse the results of the study itself or interfere with the participation of the subject, at the discretion of the researchers involved - Psychiatric comorbidities that preclude participation in the study / informed consent - Pregnancy / breastfeeding - Previous therapy with PARP inhibitors (poly-adenosine diphosphate-ribose) - Previous therapy with anti PD-1 or PD-L1 agents - HIV infection - Hepatitis B infection - Vaccinations within 30 days from the start of the experimental treatment.