Primary Outcome Measures Dose limiting toxicity (DLT) of PRT3645 [ Time Frame: Baseline through Day 28 ] Dose limiting toxicity will be evaluated over the 28-day observation period Safety and tolerability of PRT3645: AEs, CTCAE Assessments [ Time Frame: Baseline through approximately 2 years ] Safety and tolerability will be evaluated by incidence of DLTs, laboratory measurements, severity[…]
Upcoming
TTFields in General Routine Clinical Care in Patients With Pleural Mesothelioma Study (TIGER Meso)
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 ][…]
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[…]
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[…]
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:[…]
Phase I Evaluation of Immunotoxin LMB-100 Administered by Normothermic, Intrapleural Perfusion Following Cytoreductive Surgery in Participants With Pleural Mesotheliomas, or Pleural Effusions From Cancers Expressing Mesothelin
Primary Outcome Measures Identify maximum tolerated dose (MTD) and evaluate the toxicities of LMB-100 administered by 90-minute normothermic, intrapleural perfusion in participants with mesothelin-positive MPM, or MPE from cancers that express mesothelin [ Time Frame: 21 days ] List of adverse event frequency, type, and grade Safety data based on toxicity grades and types[…]
A Phase II Clinical Trial to Evaluate Safety and Efficacy of XmAb20717 in Advanced Rare Cancers
Primary Objective Efficacy of XmAb20717 as defined by objective response (defined as a complete response [CR] or partial response [PR] on two consecutive occasions ≥4 weeks apart) as determined by an independent radiologist according to RECIST v1.1 (modified RECIST for pleural mesothelioma) Secondary Objective Objective response as determined by an[…]
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[…]
