Mesothelioma
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:…
Studies show that durvalumab and tremelimumab work very well together while treating mesothelioma. A phase I clinical trial was performed at the Baylor College of Medicine in conjunction with Baylor St. Luke’s Medical Center. Durvalumab is an immunotherapy drug known as a PD-1/PD-L1 checkpoint inhibitor. It works by blocking the connection between T-cell receptors and…
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…
An immune system boosting therapy could potentially be used to treat mesothelioma. For a long period of time, chemotherapy drugs have been the standard drug to fight mesothelioma, but researchers believe bevacizumab could change this and be used alongside standard mesothelioma treatments. Chemotherapy is popular with doctors, but chemotherapy drugs are cytotoxic, which means they…
Italian researchers believe that lung sparing surgery can improve survival in mesothelioma patients, even when surgeries are more conservative. Pleurectomy and decortication is the surgery that spares the lungs. It is less comprehensive than the surgery that removes the lungs, which also makes it less dangerous to patients. Doctors at the Venice-Mestre hospital have found…
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)…
Mesothelioma, a cancer of the membrane that surrounds the lungs, abdomen, heart, and testicles is a very aggressive cancer. It spreads very quickly and when the tumors grow big enough, they crowd out organs and make it hard for people to breath. Mesothelioma sufferers can experience coughing, chest pain, and shortness of breath among other…
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…
