A Phase IB Study to Determine the Safety and Tolerability of Canakinumab and Tislelizumab in Combination with Nab-Paclitaxel and Gemcitabine in the Neo-adjuvant Treatment of Patients with Pancreatic Cancer
Single Arm Phase Ib study at fixed dose of standard of care chemotherapy and anti PD1 and IL1b to evaluate the safety and preliminary toxicity of this quadruplet regimen prior to resection for pancreatic cancer.
A Phase Ib/II Open-Label Multicenter Study Evaluating the Safety Activity And Pharmacokinetics of Divarasib in Combination with Other Anti-Cancer Therapies in Patients with Previously Untreated Advanced or Metastatic Non-Small Cell Lung Cancer with a KRAS G12C Mutation
A Phase Ib/II, Open-Label, Multicenter Study Evaluating the Safety, Activity, And Pharmacokinetics of Divarasib in Combination with Other Anti-Cancer Therapies in Patients with Previously Untreated Advanced or Metastatic Non-Small Cell Lung Cancer with a KRAS G12C Mutation
A Phase II Clinical Trial to Study the Efficacy and Safety of Pembrolizumab (MK-3475) and Pembrolizumab in Combination with Other Investigational Agents in Subjects with High-risk Non-muscle-Invasive Bladder Cancer (NMIBC) Unresponsive to Bacillus Calmette-Guerin (BCG) Therapy
This is a single arm, multi-site, open-label trial of pembrolizumab (MK-3475) in subjects with high risk non-muscle-invasive bladder cancer (NMIBC) unresponsive to Bacillus Calmette Guerin (BCG), who are considered ineligible for radical cystectomy or have elected not to undergo the procedure, to be conducted in conformance with Good Clinical Practices.
A Phase II Multicenter Double-Blind Randomised Placebo-Controlled Study and Open-Label Long Term Extension to Evaluate the Safety and Efficacy of Elafibranor in Adult Participants with Primary Sclerosing Cholangitis (PSC)
The sponsor is conducting this phase II study to evaluate the safety and tolerability of 2 doses of elafibranor in participants with PSC, and its potential effect on the change in serum alkaline phosphatase (ALP) and other hepatic markers of PSC during 12 weeks of treatment in the double-blind period (DBP) compared to placebo. This will be followed by a 96-week open-label extension (OLE) period to assess long-term safety and maintenance of effects of elafibranor.
A PHASE II OPEN-LABEL MULTI-COHORT MULTICENTER STUDY IN PATIENTS WITH UNRESECTABLE HEPATOCELLULAR CARCINOMA AND CHILD-PUGH B7 AND B8 CIRRHOSIS
This is a Phase II, open-label, multicohort, multicenter study in patients with unresectable, locally advanced, or metastatic HCC who have Child-Pugh B7 or B8 liver cirrhosis who have received no prior systemic therapy in this treatment setting. The study is designed to non-comparatively evaluate the safety and efficacy of atezolizumab plus bevacizumab or atezolizumab monotherapy in this population.
A PHASE II OPEN-LABEL MULTICENTER RANDOMIZED STUDY OF THE EFFICACY AND SAFETY OF ADJUVANT AUTOGENE CEVUMERAN PLUS ATEZOLIZUMAB AND MFOLFIRINOX VERSUS MFOLFIRINOX ALONE IN PATIENTS WITH RESECTED PANCREATIC DUCTAL ADENOCARCINOMA (PDAC)
The purpose of this study is to evaluate the efficacy and safety of adjuvant autogene cevumeran plus atezolizumab and modified leucovorin, 5-fluorouracil (5-FU), irinotecan, and oxaliplatin (mFOLFIRINOX) versus mFOLFIRINOX alone in participants with resected pancreatic ductal adenocarcinoma (PDAC) who have not received prior systemic anti-cancer treatment for PDAC and have no evidence of disease after surgery.
A Phase II open label study of IMMU-132 in metastatic urothelial cancer after failure of platinum-based regimen or anti-PD-1/ PD-L1 based immunotherapy
This is an international, multi-center, open-label, Phase II study in patients with metastatic urothelial cancer after failure of platinum-based regimen or anti-PD-1 / PD-L1 based immunotherapy enrolling in two parallel cohorts.Cohort 1: Single-arm, open-label, two-stage design, phase II study of IMMU-132 in third-line therapy of urothelial cancers, after platinum-based and PD-1 / PD-L1 based therapies failure.Cohort 2: Single-arm, open-label, phase II study of IMMU-132 in second-line therapy of urothelial cancers, ineligible for platinum-based therapy.
A phase II randomized double-blind placebo-controlled multi-center study to assess the safety tolerability and preliminary efficacy of empagliflozin among patients with residual kidney function receiving hemodialysis for the treatment of end-stage kidney disease
This study is a randomized, 12-week pilot trial to investigate biologic efficacy and safety of empagliflozin in End Stage Kidney Disease (ESKD) patients on maintenance hemodialysis (HD). This pilot trial (via PAS-20-160) will provide critical data to inform the design of a larger multi-center study.
A PHASE II RANDOMIZED OPEN LABEL MULTI-CENTER STUDY OF THE EFFECTS OF ELCTRONIC CIGARETTES ON SMOKING HARM REDUCTION IN CIGARETTE SMOKERS WITH SERIOUS MENTAL ILLNESS.
This study will compare the feasibility and preliminary efficacy of telehealth motivational counseling + e-cigarettes versus telehealth motivational counseling + combination Nicotine replacement therapy (NRT; patch and lozenge) on reduction of cigarettes per day (CPD) and health outcomes among smokers diagnosed with Serious Mental Illness (SMI).
A Phase II Study of Biomarker Driven Early Discontinuation of Anti-PD-1 Therapy in Patients with Advanced Melanoma (PET-Stop) [EA6192]
This phase II trial investigates how well biomarkers on PET/CT imaging drive early discontinuation of anti-PD-1 therapy in patients with stage IIIB-IV melanoma that cannot be removed by surgery (unresectable). Anti-PD-1 therapy has become a standard therapy option for patients with unresectable melanoma. This trial is being done to determine if doctors can safely shorten the use of standard of care anti-PD1 therapy for melanoma by using biomarkers seen on PET/CT imaging and tumor biopsy.