A Phase II Clinical Trial of Candida Therapeutic Vaccine in Head and Neck Cancer Patients to Reduce Recurrence
This study is designed to test a treatment called STK-012 for patients with advanced solid tumors. It is an open-label trial, meaning both the researchers and patients know what treatment is being given. The study has six parts: Phase 1a includes Part A, where STK-012 is given weekly, Part B, where it’s given every three weeks, Part C, where STK-012 is combined with another drug called pembrolizumab, and Part E, where it’s combined with pembrolizumab, pemetrexed, and carboplatin. Phase 1b includes Part D and Part F, which look at how effective these combinations are in a larger group of patients. The patients in the study have cancers that didn’t get better with standard treatments or can’t be treated with standard options. The study focuses on specific types of cancer, such as non-small cell lung cancer and kidney cancer. Each part of the study will carefully increase the doses to see how well the treatment works and to collect information about how it affects the body. There are also special groups to study how the treatment interacts with certain markers in the body.
A Phase II multicenter open-label trial of tagraxofusp (Tag) in combination with venetoclax and azacitidine (Ven/Aza) in adults with previously untreated CD123+ acute myeloid leukemia (AML) who are ineligible for intensive chemotherapy
This study looks at how safe and effective a medicine called Tag is when combined with Ven and Aza for people with CD123+ acute myeloid leukemia (AML) who can’t have intense chemotherapy. The study has two parts. In Part 1, two doses of Tag (9 µg/kg/day and 12 µg/kg/day for three days) will be tested, along with the same doses of Ven and Aza. Patients will be randomly split into two groups to try one of the doses. Doctors will check for side effects, especially serious ones, to decide which dose is safest to use in Part 2. Patients in each group will be studied, and doses with too many side effects won’t be used. In Part 2, the safest dose will be tested to see how well it works using a method to predict how successful it might be. If it doesn’t seem to work, the study might stop early.
A Phase II multisite open-label single arm trial of BNT327 in combination with docetaxel in second-line stage IV non-small cell lung cancer (NSCLC) following chemoimmunotherapy
This is a phase 2 study testing a new medicine, BNT327 (an investigational antibody), together with another medicine called docetaxel (standard chemotherapy treatment) to find the dose that works well and with fewer side effects for patients with advanced lung cancer that has spread to other parts of the body and who have received standard chemotherapy treatment before. This study has two parts. In the first part, the study team will find out the most effective dose of the combination of BNT327 and docetaxel that is safe and has fewer side effects. In the second part, more patients will be included to get the most effective dose found in the first part of the study. All patients will have their blood samples taken to see how the body is handling the study medicine and how the medicine changes the tumor. Patients will have special scans taken at different time points. Doctors will evaluate all the results to learn how medicine changes the tumor and make sure the patients are doing well. The study team will closely watch all patients for side effects and follow up to 90 days after their last dose.
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 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 Double-Blind Placebo-Controlled Study of Ensifentrine in Subjects with Non-Cystic Fibrosis Bronchiectasis
The purpose of this study is to evaluate the effect and safety of the treatment Ensifentrine on the occurrence of pulmonary exacerbations and on patient-reported symptoms in subjects with non-cystic fibrosis bronchiectasis (NCFBE).
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 Single-Arm Study of Craniospinal Irradiation with Linac Based Volumetric Modulated Arc Therapy (VMAT) for Patients with Leptomeningeal Metastasis
This study is a non-randomized phase II single-institution trial in which patients who consent to the trial will be treated with linac based VMAT CSI. The primary objective is to determine if linac based VMAT CSI for leptomeningeal metastases improves CNS progression free survival compared to historical control treated with IFRT. The investigators include doctors with expertise in treating leptomeningeal metastases both with radiation and systemic therapy.
A Phase II Study of Gemcitabine Plus Cisplatin Chemotherapy in Patients with Muscle-Invasive Bladder Cancer with Bladder Preservation for Those Patients Whose Tumors Harbor Deleterious DNA Damage Response (DDR) Gene Alterations
This is a study that looks at whether it's safe to treat patients with bladder cancer who have certain gene changes (called DDR gene alterations) in their tumor. These patients have had a procedurecalled TURBT (a way to remove part of the tumor) before treatment. They will get chemotherapy with gemcitabine and cisplatin. The study will check if the treatment works well by looking at how many patients are still cancer-free three years after they start treatment. If more than 80% of the patients are cancer-free at that time, the treatment will be considered safe. The patients will also be watched for five years to see how many stay cancer-free. If patients' tumors do not have these gene changes, or if the tumor shrinks but not enough, they will have their bladder removed (called cystectomy) and will be followed for five years to see if the cancercomes back or if they survive longer. If patients who could have had bladder-preserving treatment end up having their bladder removed, they will also be watched for five years to see how they do.
A Phase II Study of Ribociclib And Endocrine Treatment of Physician s Choice for Locoregional Recurrent Resected Hormone Receptor Positive HER2 Negative Breast Cancer (RaPhLRR Study)
Primary Objective: To estimate subsequent recurrence-free survival (RFS) at 3 years for ribociclib when administered with ET (AIs or fulvestrant), in patients with Hormone Receptor (HR) positive, HER2 negative breast cancer with adequately resected local recurrence of early breast cancer (EBC). Secondary Objectives:To estimate distant metastasis-free survivalTo estimate overall survival (OS).To evaluate safety and tolerabilityTo identify predictors of loco-regional recurrence.