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[…]
Clinical Trials
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:[…]
Feasibility Trial of a Personalised Nutrition and Activity Programme for People With Lung Cancer Over 65 Years (CanBenefitII)
Primary Outcome Measures Recruitment Rate [ Time Frame: 24 weeks ] The Recruitment Rate will be assessed by the number of eligible patients approached vs the number of eligible patients consent for the study, providing a number of non-participations. This will be gathered as an aspect of feasibility. Retention Rate [ Time Frame: 24 weeks ] Retention rate[…]
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[…]
— SMARTEST Trial—
Primary Outcome Measures CD8 TILs density / gross tumor volume (GTV) [ Time Frame: Up to five years ] The primary objective of the study is to demonstrate that low dose cyclophosphamide in combination with sub-ablative radiation can enhance the anti-tumoral immune response compared to sub-ablative radiation alone Secondary Outcome Measures Survival [ Time Frame: Up to[…]
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[…]
A Study of Yervoy and Opdivo Combination Therapy in Participants With Unresectable Advanced/Recurrent Malignant Pleural Mesothelioma (MPM)
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[…]
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[…]
