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[…]
Status
Observational Study in Patients With Previously Unresectable Malignant Pleural Mesothelioma Treated With Nivolumab and Ipilimumab (MESO-IMMUNE) (MESO-IMMUNE)
Primary Outcome Measures Progression Free Survival assessed locally [ Time Frame: time from first dose of combination Nivolumab-Ipilimumab to first documentation of disease progression or to death from any cause evaluated through the total duration of the study (up to 48 months) ] Progression free survival as assessed by the investigator, defined as the[…]
DENDRITIC Cell Therapy Combined With SURGERY in Mesothelioma (ENSURE)
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[…]
Study of RSO-021 in Patients With Malignant Pleural Effusion Due to Advanced/Metastatic Solid Tumors Including Mesothelioma
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[…]
Safety and Tolerability of TNG908 in Patients With MTAP-deleted Solid Tumors
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[…]
Oral TEAD Inhibitor Targeting the Hippo Pathway in Subjects With Advanced Solid Tumors
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 ][…]
Phase 1/2 Study of MRTX1719 in Solid Tumors With MTAP Deletion
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[…]
A Study of HFB200301 in Adult Patients With Advanced Solid Tumors
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[…]
Study of NGM831 as Monotherapy and in Combination With Pembrolizumab in Advanced or Metastatic Solid Tumors
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[…]
ERAS® Guidelines Validation of CRS With or Without HIPEC
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[…]
