Primary Outcome Measures Time from diagnosis of pleural mesothelioma to death of any cause as median overall survival time. [ Time Frame: 54 Months ] Secondary Outcome Measures Number of TTFields treatment-related SAEs, as assessed by the CEC, within total observation period, standardized to average annual incidences. [ Time Frame: 3 years + 18 months follow up ][…]
Clinical Trials
AMT-151 in Patients With Selected Advanced Solid Tumours
Primary Outcome Measures Recommended Phase 2 Dose (RP2D) [ Time Frame: Up to 24 months ] The RP2D will be determined using dose limiting toxicities (DLTs) and all other available study data Maximum Tolerated Dose (MTD) [ Time Frame: Up to 24 months ] The MTD will be determined using DLTs Incidence of Adverse Events [ Time Frame: Up to 24[…]
Oral AMXT 1501 Dicaprate in Combination With IV DFMO
Primary Outcome Measures Determine DLTs and RP2Ds in AMXT 1501 in combination with IV DFMO [ Time Frame: 1 year ] Indicate Number of patients with DLTs in AMXT1501 in combination with IV DFMO in patients with advanced cancer to determine the RP2D within the duration of the dose escalation period of the study[…]
Effect of HITHOC After Pleurectomy Decortication for Treatment of Malignant Pleural Mesothelioma
Primary Outcome Measures disease free survival or time to recurrence [ Time Frame: Through out the whole study with maximum of 2 years ] time from clearance of disease till onset of recurrence of same disease overall survival [ Time Frame: till mortality of the case or 2 years maximum ] survival of the cases till mortality Secondary[…]
A Phase 1/2 Trial of TC-510 In Patients With Advanced Mesothelin-Expressing Cancer
Primary Outcome Measures Phase 1 – Establish the recommended Phase 2 dose (RP2D) according to dose-limiting toxicity (DLT) of defined adverse events. [ Time Frame: DLTs within 28 days post-treatment ] Phase 1 -The number and percent of patients in the DLT evaluable set who experienced DLTs from the first administration of study drug[…]
Niraparib Efficacy in Patient With Unresectable Mesothelioma (NERO)
Primary Outcome Measures Progression-free survival [ Time Frame: From date of randomisation until the date of the first documented progression or date of death from any cause, whichever came first, assessed up to 18 months ] Progression-free survival is the determined by modified RECIST (pleural disease), RECIST 1.1 (for non-pleural disease), investigator reported progression[…]
Intraperitoneal Paclitaxel for Patients With Primary Malignant Peritoneal Mesothelioma (INTERACT MESO)
Primary Outcome Measures The maximum tolerable dose (MTD) [ Time Frame: After two completed cycles of therapy (each cycle is 1 week) ] The primary endpoint of the study is to determine the maximum tolerable dose (MTD) of intraperitoneal (IP) paclitaxel monotherapy, for patients with malignant peritoneal mesothelioma (MPM) who are not eligible to[…]
Immunological Variables Associated to ICI Toxicity in Cancer Patients
Primary Outcome Measures Modification(s) in the immune blood markers of treated subjects on treatment. [ Time Frame: Assessment: between week 4 and 6 after the first dose of the treatment ] Modification(s) in the immune blood markers including cytokines, immune cells and serum autoantibody level of treated subjects. Modification(s) in the immune blood markers[…]
OT-101 in Combination With Pembrolizumab in Subjects With Malignant Pleural Mesothelioma Failing to Respond to Checkpoint Inhibition
Primary Outcome Measures Determination of ORR for the combination of OT-101 and pembrolizumab in subjects [ Time Frame: approximately 24 months ] modified RECIST (mRECIST; v1.1) Secondary Outcome Measures PFS, DOR and 6-month and 12-month Overall Survival (OS) will be estimated in all subjects in the ITT population. [ Time Frame: approximately 18 months ] Progression-free Survival (PFS),[…]
Study of Safety, Pharmacokinetic and Efficacy of APG-5918 in Advanced Solid Tumors or Lymphomas
Primary Outcome Measures Dose-limiting Toxicity (DLT) [ Time Frame: 28 days ] DLTs will be assessed via CTCAE version 5.0 Inclusion Criteria Has an Eastern Cooperative Oncology Group (ECOG) performance status of 0 to 1 in dose escalation, 0 to 2 in dose expansion Has a life expectancy of >3 months Has a malignancy:[…]
