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

Sponsor
University of Turin, Italy
Study ID
NCT04940637
Phase
PHASE2
Status
Unknown

Conditions

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • niraparib and dostarlimab — DRUG
    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

Study Details

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.

Key Dates

Start date
Dec 23, 2020
Status verified
May 2023
Primary completion
Jun 30, 2024
Completion
Jun 30, 2025

Study Design

Enrollment
70 participants (estimated)
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT

Arms

  • Experimental: Niraparib and Dostarlimab
    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

Primary Outcome Measure

PFS [ Time Frame: From date of randomization until the date of first documented progression or date of death from any cause, whichever came first, assessed up to 36 months ]

Central Contacts

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