Feb 3rd, 2023 - PRIMARY OBJECTIVE: I. To compare bladder intact event-free survival (BI-EFS) for concurrent chemoradiation therapy (CRT) with and without atezolizumab in localized muscle invasive bladder cancer (MIBC). SECONDARY OBJECTIVES: I. To compare overall survival between the two arms. II. To compare modified bladder intact event-free survival including cancer related death between arms. III. To compare...

Feb 3rd, 2023 - The purpose of this study is to evaluate if the combination of nivolumab and a CCR2/CCR5 dual antagonist (BMS-813160) with GVAX is safe in patients with locally advanced pancreatic cancer (LAPC) who have received chemotherapy and radiotherapy, and to see if this combination therapy enhances the infiltration of CD8+CD137+ cells in PDACs .

Feb 3rd, 2023 - This is a local, non-interventional, multi-center, single-cohort study using primary data of patients treated with Xofigo for the indication of castration resistant prostate cancer (CRPC) with bone metastases. A total of 300 patients (valid for safety analysis) are enrolled within 18 months. During the observation period (i.e. up to 6 months), safety and effectiveness information is collected. ...

Feb 3rd, 2023 - PRIMARY OBJECTIVE: I. To compare the invasive disease-free survival (IDFS) of patients with inflammatory breast cancer receiving concurrent administration of olaparib with standard doses of radiotherapy to the chest wall and regional lymph nodes compared to standard doses of radiotherapy alone to the chest wall and regional lymph nodes. SECONDARY OBJECTIVE: I. To compare the effect of concurren...

Feb 3rd, 2023 - The purpose of this study is to compare overall survival (OS) and progression free survival (PFS) per Response Evaluation Criteria in Solid Tumors Version 1.1 (RECIST 1.1) as assessed by blinded independent central review (BICR). Hypothesis (H1): Concurrent chemoradiation therapy with pembrolizumab followed by pembrolizumab plus olaparib is superior to concurrent chemoradiation therapy alone wi...

Feb 3rd, 2023 - This is a 114-week,randomized, multicenter, double-blind, parallel-group, active-control study with an open-label extension period of up to 156 weeks, for a total duration of up to 270 weeks in patients with IgAN who have persistent overt proteinuria and remain at high risk of disease progression despite being on a stable dose (or doses) of an angiotensin-converting enzyme inhibitor (ACEI) and/...

Feb 3rd, 2023 - PRIMARY OBJECTIVE: I. To compare the overall survival (OS) in patients with metastatic renal cell cancer (RCC) treated with ipilimumab-nivolumab followed by either nivolumab versus cabozantinib-nivolumab. SECONDARY OBJECTIVES: I. To determine progression free survival (PFS) of patients treated with nivolumab versus nivolumab-cabozantinib. II. To evaluate the 12-month complete response rate in p...

Feb 3rd, 2023 - Sixty patients will be included in this prospective randomized study. The patients will be allocated into two groups: the ESPB group (group E, n = 30) and the tramal group (group T, n =30). All patients will receive standard general anesthesia. Ultrasound-guided ESPB will be performed to group erector spinae plane block

Feb 3rd, 2023 - The purpose of the study is to assess the efficacy of rozanolixizumab as measured by seizure freedom, change in cognitive function, use of rescue medication, onset of seizure freedom and to assess safety and tolerability.

Feb 3rd, 2023 - There are 5 parts to this study for which the primary objectives are to evaluate safety, tolerability, and pharmacokinetics (PK) of navitoclax when administered alone (Part 1) or when administered in combination with ruxolitinib (Part 2). In Part 2, participants must have been receiving a stable dose of ruxolitinib therapy for at least 12 weeks prior to study enrollment. In Part 3, all eligible...

Feb 3rd, 2023 - This is a phase 2/3, global, multicenter, open-label, multi-cohort study designed to evaluate the safety and efficacy of targeted therapies or immunotherapy as single agents or in combination in participants with unresectable, advanced or metastatic NSCLC determined to harbor oncogenic somatic mutations or positive by tumor mutational burden (TMB) assay as identified by two blood-based next-gen...

Feb 3rd, 2023 - Participants will be randomized (3:1) to receive tedizolid phosphate at a weight-based dose ≤200 mg/day, intravenous (IV) and/or oral suspension for 6 to 10 days, or comparator IV and/or oral per local standard of care for 10 to 14 days. The switch from IV to oral administration can be made at any time based on 1) no worsening of the primary skin lesion, 2) last temperature <37.7 °C, and 3) pri...

Feb 3rd, 2023 - This Phase 3 multinational, randomized, double-blind study is designed to compare the efficacy and safety of the combination of ibrutinib and venetoclax vs. ibrutinib and placebo in subjects with MCL.

Feb 3rd, 2023 - After being informed about the study and potential risks, all patients diagnosed with idopathic sudden sensorineural hearing loss who do not meet the exclusion criteria and do meet the inclusion criteria, and who give written informed consent will be enrolled in the trial. A standard treatment for ISSNHL (oral methyprednisolone) will be given to half of the patients and the other half of the pa...

Feb 3rd, 2023 - A prospective, multi-centre, phase IV clinical trial of Acalabrutinib capsules in Indian adult patients with chronic lymphocytic leukaemia (CLL) and relapsed and refractory mantle cell lymphoma (MCL). As per recommendation from Indian health authority, the current phase-IV study is planned with the aim to assess the safety and efficacy profile of Acalabrutinib in Indian patients with CLL/SLL, a...

Feb 3rd, 2023 - To estimate the clinical benefit of cemiplimab monotherapy versus cemiplimab in combination with RP1 for patients with locally advanced or metastatic CSCC, as assessed by overall response rate (ORR) and complete response rate (CRR) according to blinded independent review.

Feb 3rd, 2023 - Chronic lymphocytic leukemia (CLL) is the most common leukemia (cancer of blood cells). The purpose of this study is to assess how well venetoclax + obinutuzumab (VenG) works and how safe they are in adult participants with CLL who were previously treated with VenG. Adverse events and change in disease activity will be assessed. Venetoclax is an approved drug for the treatment of CLL. Study doc...

Feb 3rd, 2023 - Study RIN-PF-302 is a Phase 3, multicenter, open-label extension (OLE) study for eligible subjects who completed Study RIN-PF-301 or Study RIN-PF-303 to evaluate the long-term safety and tolerability of inhaled treprostinil in subjects with idiopathic pulmonary fibrosis (IPF). Following OLE entry, subjects will return at Week 4, Week 12, and every 12 weeks thereafter for up to 6 years or until ...

Feb 3rd, 2023 - Study Description: Individuals undergoing cisplatin-based chemoradiation therapy are at risk for developing significant, permanent hearing loss. The cholesterol-lowering drug atorvastatin has the potential to reduce the incidence and severity of hearing loss, as evidenced by our preclinical data in mice and our retrospective data in humans.Here we will compare hearing changes between subjects o...

Feb 3rd, 2023 - This study will compare the safety and effects of HAI floxuridine and dexamethasone combined with the standard chemotherapy drugs gemcitabine and oxaliplatin (GemOx) with those of GemOx alone in people with untreated cholangiocarcinoma that cannot be removed with surgery. The researchers want to find out whether the study treatment works better than the standard chemotherapy to delay progressio...