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[…]
Clinical Trials
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[…]
First Line Sintilimab Combined With Anlotinib and Platinum Doublet Chemotherapy in Malignant Pleural Mesothelioma
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[…]
Assessment of Histologic Prognostic Factors in Peritoneal Malignant Mesothelioma
Primary Outcome Measures Assessment of pronostic impact of nuclear grade in comparison with combined grade in peritoneal malignant mesothelioma [ Time Frame: 3 months to 4 years ] Assessment by the review of pathologists Inclusion Criteria peritoneal malignant mesothelioma Exclusion Criteria opposition to reuse personnal data
A Study of Immunotherapy Drugs Nivolumab and Ipilimumab in Patients w/Resectable Malignant Peritoneal Mesothelioma
Primary Outcome Measures Major Pathologic (Disease) Response of Tumor to Nivolumab Combined with Ipilimumab Before Surgery [ Time Frame: 24 months ] The response of participant’s tumor to treatment with nivolumab and ipilimumab before surgery by analyzing tissue samples collected from participant during surgery for the presence of cancerous tumour cells. Major pathologic response[…]
Chemotherapy With or Without Immunotherapy for Peritoneal Mesothelioma
Primary Outcome Measures Response rate [ Time Frame: Up to 4 years after study activation ] Will be compared between arms. Secondary Outcome Measures Major pathologic response rate [ Time Frame: Up to 3 years ] The proportion of patients with a pathologic response will be calculated and compared between arms and 95% confidence intervals reported. The chi-square[…]
Atezolizumab Versus Placebo for the Adjuvant Treatment of Malignant Pleural Mesothelioma (Atezomeso) (AtezoMeso)
Primary Outcome Measures To evaluate the efficacy of atezolizumab in patients with MPM in terms of DFS [ Time Frame: 12 weeks ] DFS, defined as the time from initiation of study treatment to first recurrence of disease or death for any cause, whichever occurs first. Secondary Outcome Measures To evaluate the safety of[…]
Study of the Efficacy and Safety of the Bintrafusp Alfa in Previously Treated Advanced Malignant Pleural Mesothelioma (BIMES)
Primary Outcome Measures To evaluate the efficacy of the treatment [ Time Frame: From the date of randomization to the date of last follow up, assessed up to 24 months ] To determine the efficacy of M7824 in terms of the Progression Free Survival (PFS) assessed by the investigator according to the modified Response[…]
