Recruiting
Primary Outcome Measures Incidence of Adverse Events (AEs) [ Time Frame: Up to 6 Months ] Time to onset of serious adverse events (SAEs) [ Time Frame: Up to 6 Months ] Time to onset of AEs [ Time Frame: Up to 6 Months ] Time to resolution of AEs [ Time Frame: Up to 6 Months ] Time to resolution of SAEs [ Time Frame: Up to 6 Months ] Incidence of physician seriousness…
Primary Outcome Measures Number of participant who are alive and have completed (neo)adjuvant DCT (5 administrations) and surgery at week 15 (+4 weeks) without extended treatment-related delay, persisting grade 3-4 treatment side-effects or evidence of progression [Feasibility] [ Time Frame: 2 years ] To determine the feasibility of DCT with Mesopher performed before and after eP/D in patients with…
Primary Outcome Measures Dose-limiting Toxicity [ Time Frame: First 21 days of treatment. ] The incidence of DLTs during the DLT assessment period. Frequency and Severity of Adverse Events (AE) [ Time Frame: Screening to 90 days from last dose. ] The incidences and percentages of patients experiencing AEs summarized by NCI CTCAE version 5.0 grade and by causality. Dose Finding [ Time Frame: Screening to…
Primary Outcome Measures Safety and tolerability of IK-930 [ Time Frame: Through study completion, an average of 36 months ] The frequency and severity, incidence of treatment-emergent and treatment-related adverse events using NCI-CTCAE v5.0 Occurrence of Dose Limiting Toxicity during first treatment cycle [ Time Frame: Approximately 1 year ] RP2D and/or MTD of IK-930 [ Time Frame: Approximately 1 year ] Define the recommended phase 2…
Primary Outcome Measures Phase 1: Number of Patients who Experience Dose-Limiting Toxicity [ Time Frame: 21 days ] Phase 1/1B: Number of patients who experience a treatment-related adverse event [ Time Frame: Up to 2 years ] Phase 2: Objective response rate (ORR) [ Time Frame: 2 years ] Phase 2: Duration of response (DOR) [ Time Frame: 2 years ] Phase 2: Progression free survival (PFS) [ Time Frame: 2 years ] Phase 2:…
Primary outcome Measures evaluate the immunohistochemical expression of Glypican-1 in pleural epitheloid mesothelioma, lung adenocarcinoma and lung SCC [ Time Frame: 1 month ] Immunohistochemical study to correlate its expression with some known clinico-pathological parameters, to evaluate its diagnostic and prognostic role. [ Time Frame: 1 month ] Statistical analysis Inclusion Criteria Patients with pleural epithelioid mesothelioma and lung adenocarcinoma and SCC who…
Primary Outcome Measures Compliance of ERAS® guidelines [ Time Frame: 3 months ] Post-ERAS® implementation phase: compliance rate towards the relevant core items from ERAS guidelines Secondary Outcome Measures Acceptance and feasibility of ERAS® guidelines [ Time Frame: 3 months ] Pre-ERAS® phase (current clinical practice): current compliance rate towards the ERAS guidelines Inclusion Criteria Adults female and male patients (> 18 year-old)…
Primary Outcome Measures Assessment of pronostic impact of nuclear grade in comparison with combined grade in peritoneal malignant mesothelioma [ Time Frame: 3 months to 4 years ] Assessment by the review of pathologists Inclusion Criteria peritoneal malignant mesothelioma Exclusion Criteria opposition to reuse personnal data
Primary Outcome Measures Major Pathologic (Disease) Response of Tumor to Nivolumab Combined with Ipilimumab Before Surgery [ Time Frame: 24 months ] The response of participant’s tumor to treatment with nivolumab and ipilimumab before surgery by analyzing tissue samples collected from participant during surgery for the presence of cancerous tumour cells. Major pathologic response will be defined as tissue…
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…
