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

Overview

Sponsor-declared trial summary

Key facts

Sponsor

Universita' Degli Studi Di Torino

Participant type

Patients

Age range

18-64 years, 65+ years

Gender

Male and Female

Therapeutic area

Diseases [C] - Neoplasms [C04], Diseases [C] - Respiratory Tract Diseases [C08]

Decision date (initial)

2024-12-09

Transition trial

Yes

Low-intervention

No

Rare-disease indication

No

Vulnerable population

No

External identifiers

EU CT number

2024-515555-38-01

EudraCT number

2020-000109-10

ClinicalTrials.gov

NCT04940637

Trial design

CTIS Part I — objectives, methods, condition coding

Main objective

Scope: Therapy, Efficacy

To evaluate the progression free survival (PFS)

Secondary objectives 1

1. 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

Conditions and MedDRA coding

NON SMALL CELL LUNG CANCER

Regulatory references

Plan to share IPD

No

Eligibility criteria

Principal inclusion / exclusion criteria as submitted by sponsor

Inclusion criteria 1

1. -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 criteria 1

1. - 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

Endpoints

Primary and secondary outcome measures (English text)

Primary endpoints 1

1. To evaluate the progression free survival (PFS)

Secondary endpoints 1

1. 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

Investigational products

Investigational medicinal products (IMPs), comparators, placebo, auxiliary

Test 2

Sponsors and contacts

Sponsor organisations, regulatory contacts, third parties

Universita' Degli Studi Di Torino

Sponsor organisation

Universita' Degli Studi Di Torino

Address

Regione Gonzole 10

City

Orbassano

Postcode

10043

Country

Italy

Scientific contact point

Organisation

Universita' Degli Studi Di Torino

Contact name

Francesco Passiglia

Public contact point

Organisation

Universita' Degli Studi Di Torino

Contact name

Francesco Passiglia

Third parties 1

Locations

1 EU/EEA country · 19 investigational sites

By country

Investigational sites

Results and documents

Annex IV summary of results, Annex V layperson summary, and all documents registered in CTIS for this trial

Documents 27 files

Public protocol annexes, IB summaries, regulatory submissions and post-authorisation documents registered in CTIS.

Application history

4 submissions — initial application plus substantial / non-substantial modifications