Status
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 Phase 1: [ Time Frame: 28 days ] To determine the MTD and dosing schedule of TNG908 Phase 2: [ Time Frame: 16 weeks ] To assess anti-neoplastic activity of TNG908 in patients with MTAP-deleted advanced solid tumors by RECIST v1.1 Secondary outcome Measures Phase 1: [ Time Frame: 16 weeks ] To assess preliminary evidence of anti-neoplastic activity of TNG908 in patients with…
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 Number of participants with adverse events (AEs), serious AEs (SAEs), dose-limiting toxicities (DLTs), changes in laboratory values, vital signs and electrocardiogram (ECG) [ Time Frame: Cycle 1 Day 1 to 30 days after the last dose of HFB200301 (each cycle is 28 days), assessed up to 3 years ] To determine a Recommended Phase 2 Dose…
Primary Outcome Measures Number of Patients with Dose-limiting Toxicities [ Time Frame: Baseline up to 21 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 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 ORR [ Time Frame: 6 months after the final enrollment ] Objective Response Rate（ORR）according to mRECIST 1.1 standard Secondary Outcome Measures DOR [ Time Frame: 24 months ] Duration of remission DCR [ Time Frame: 24 months ] Disease Control Rate PFS [ Time Frame: 24 months ] Progression Free Survival OS [ Time Frame: 24 months ] Overall Survival AE [ Time Frame: 24 months ] Adverse event SAE [ Time Frame: 24 months ] Incidence and Severity of…
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…
