Status
Primary Outcome Measures Response rate [ Time Frame: Up to 4 years after study activation ] Will be compared between arms. Secondary Outcome Measures Major pathologic response rate [ Time Frame: Up to 3 years ] The proportion of patients with a pathologic response will be calculated and compared between arms and 95% confidence intervals reported. The chi-square test will be used to…
Primary Outcome Measures To evaluate the efficacy of atezolizumab in patients with MPM in terms of DFS [ Time Frame: 12 weeks ] DFS, defined as the time from initiation of study treatment to first recurrence of disease or death for any cause, whichever occurs first. Secondary Outcome Measures To evaluate the safety of atezolizumab in patients with MPM…
Primary Outcome Measures To evaluate the efficacy of the treatment [ Time Frame: From the date of randomization to the date of last follow up, assessed up to 24 months ] To determine the efficacy of M7824 in terms of the Progression Free Survival (PFS) assessed by the investigator according to the modified Response Evaluation Criteria in Solid Tumors…
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 phase I trial studies the effect of stereotactic body radiation therapy and immunotherapy in treating patients with mesothelioma. Stereotactic body radiation therapy uses special equipment to position a patient and deliver radiation to tumors with high precision. This method may kill tumor cells with fewer doses over a shorter period and cause less damage to normal tissue. Giving stereotactic body radiation therapy and immunotherapy may improve the tumors response to the treatment and decrease side-effects.
Primary Outcome Measures Objective response rate (ORR) [ Time Frame: Baseline to the date of first documented progression or initiation of subsequent anticancer therapy or approximatively 9 months after the last participant receive first dose. ] Objective response rate (ORR), defined as the proportion of participants who have a confirmed complete response (CR) or partial response (PR), derived based…
Primary Outcome Measures Number of Patients with Dose-limiting Toxicities [ Time Frame: Baseline up to 28 Days ] A DLT is defined as an AE that meets at least one of the criteria listed in protocol, according to National Cancer Institute (NCI) common terminology criteria for AE (CTCAE) version 5.0, and is considered by the investigator to be clinically…
Primary Outcome Measures Number of patients with adverse events and serious adverse events [ Time Frame: 3 years ] Safety and tolerability of IAG933 Incidence of dose limiting toxicities during the first treatment cycle (dose escalation only) [ Time Frame: 1 year ] Safety, tolerability and the maximum tolerated dose or recommended dose of IAG933 Number of patients with dose interruptions and dose…
Primary Outcome Measures Pre-treatment Prognostic Algorithm Validation [ Time Frame: 4 years ] The primary objective is to utilize a novel prognostic algorithm to predict the outcome of MPM patients. This algorithm includes 4 different tests: molecular, radiological, and blood based. It will be performed on 240 prospectively-collected samples. A score of 0-4 will be assigned to each patient…
Malignant pleural mesothelioma (MPM) is a rare pleural cancer, which could be primary or secondary to an asbestos exposure. To enhance our knowledge of this rare disease, an exploration of genetic and tumor mechanism is mandatory. One of the principal difficulty is to harvest sufficient tumour pieces to perform multi-omics analysis. The goal of the SCITH-MESO study is to harvest larges pieces of tumour during a routine surgical procedure of MPM diagnosis by mean of pleural biopsies during VATS surgery. Operating samples will increase a tissue bank collection (CRB).
