Neoplasms

Respiratory Tract (Lung and Bronchial) Diseases

All Conditions

Rare Diseases

Lung Neoplasms

Mesothelioma

Mesothelioma, Malignant

Adenoma

Neoplasms, Glandular and Epithelial

Neoplasms by Histologic Type

Neoplasms, Mesothelial

Malignant Mesothelioma

Antineoplastic Agents

All Drugs and Chemicals

Niraparib

Dostarlimab

Poly(ADP-ribose) Polymerase Inhibitors

Enzyme Inhibitors

niraparib 300 mg/die and dostarlimab 500 mg day 1 Q3 weeks for the first 4 cycles followed by 1000 mg day 1 Q6 weeks

niraparib and dostarlimab

giorgio v scagliotti, medicine

Silvia Novello, MD

Giorgio V Scagliotti, Medicine

This is a single arm, prospective, interventional, multicenter phase 2 study of the combination of niraparib and dostarlimab in patients with advanced non-small cell lung cancer (NSCLC) and/or malignant pleural mesothelioma (MPM), and positive for PD-L1 expression (TPS ≥ 1%) and germline or somatic mutations in the DNA homologous recombination repair (HRR) genes.

This is a single arm, prospective, interventional, multicenter phase 2 study of the combination of niraparib and dostarlimab in patients with advanced non-small cell lung cancer (NSCLC) and/or malignant pleural mesothelioma (MPM), and positive for PD-L1 expression (TPS ≥ 1%) and germline or somatic mutations in the DNA homologous recombination repair (HRR) genes.

Approximately 70 eligible patients with previously treated advanced disease, not amenable for curative treatment will be included in this study and will be grouped as follows:

* Homologous recombination deficiency (HRd)-positive and PD-L1-positive advanced NSCLC referred to as Cohort A (n= 35)
* HRd-positive and PD-L1-positive advanced MPM referred to as Cohort B (n= 35)

HRd-positive and PD-L1-positive are defined as follows:

* HRd-positive: Tumors that harbor known or suspected deleterious germline or somatic mutations in the HRR genes, based on the HRd Assay.
* PD-L1-positive: Tumors with PD-L1 expression on at least 1% of tumor cells based on immunohistochemistry (IHC) analysis.

UNITO-001- Study in HRR/PDL1 Positive MPM/NSCLC

A Phase II, Open-Label, Single Arm, Prospective, Multicenter Study of Niraparib Plus Dostarlimab in Patients With Advanced NSCLC and/or MPM, and Positive for PD-L1 Expression and Germline or Somatic Mutations in the HRR Genes

the time from the date of the first treatment dose until either disease progression, as assessed by investigator's review according to RECIST v1.1criteria, or modified RECIST for assessment of response in malignant pleural mesothelioma version 1.1 (mRECIST v1.1), or death due to any cause, whichever occurs first.

the proportion of participants who have a best overall response of either complete response (CR) or partial responses (PR) as assessed by investigator's review according to RECIST v1.1, or modified RECIST for assessment of response in malignant pleural mesothelioma version 1.1 (mRECIST

the proportion of participants who have complete response (CR), partial responses (PR), or stable disease (SD) as assessed by investigator's review according to RECIST v1.1 or mRECIST v1.1

the time from the date a response was first documented until either disease progression or death due to any cause, whichever occurs first.

the time from the date of the first dose to death due to any cause

Spots Global Cancer Trial Database for niraparib and dostarlimab