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 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.
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.
A Phase II Study of the Interleukin-6 Receptor Inhibitor Sarilumab in Combination with Ipilimumab Nivolumab and Relatlimab in Patients with Unresectable Stage III or Stage IV Melanoma
A Phase II Study of the Interleukin-6 Receptor Inhibitor Sarilumab in Combination with Ipilimumab, Nivolumab and Relatlimab in Patients with Unresectable Stage III or Stage IV Melanoma
A phase II/III Study of Paclitaxel/Carboplatin alone or Combined with either Trastuzumab and Hyaluronidase-oysk (HERCEPTIN HYLECTA) or Pertuzumab Trastuzumab and Hyaluronidase-zzfx (PHESGO) in HER2 Positive Stage I-IV Endometrial Serous Carcinoma or Carcinosarcoma
This study is being done to answer the following question: Can we lower the chance of your endometrial cancer coming back and causing death by adding a drug or drugs that target HER2 proteins in addition to the usual combination of chemotherapy drugs that target HER2 proteins in addition to the usual combination of chemotherapy drugs?
A Phase III Multi-center Open-label Sponsor-blinded Randomized Study of AZD0901 Monotherapy Compared with Investigator s Choice of Therapy in Second- or Later-Line Adult Participants with Advanced/Metastatic Gastric or Gastroesophageal Junction Adenocarcinoma Expressing Claudin18.2
This study is designed to test how effective a new treatment called AZD0901 is for patients with advanced stomach cancer or cancer that is at the junction of the stomach and esophagus (GEJ) that shows a specific marker called CLDN18.2. In this study, patients will be divided into three groups. One group will receive AZD0901 and the other group will get a treatment chosen by their doctor from a list of commonly used cancer therapies. Patients will continue with their treatment until it is no longer effective or safe for them.
A PHASE III MULTICENTER RANDOMIZED OPEN-LABEL STUDY COMPARING THE EFFICACY AND SAFETY OF GLOFITAMAB (RO7082859) IN COMBINATION WITH POLATUZUMAB VEDOTIN PLUS RITUXIMAB CYCLOPHOSPHAMIDE DOXORUBICIN AND PREDNISONE (POLA-R-CHP) VERSUS POLA-R-CHP IN PREVIOUSLY UNTREATED PATIENTS WITH LARGE B-CELL LYMPHOMA
This study is to see which treatment (glofitamab in combination with Pola-R-CHP or Pola-R-CHP alone) works better for a large B-Cell Lymphoma. It involves patients who haven't had treatment before for their type of cancer. They'll be split into two groups, and each group will get a different treatment. Doctors will look at things like how sick patients are and where they live to make sure the groups are fair. The treatment will start within a week of being chosen. One group will get one treatment for the first six rounds, then a different one for the next two rounds. The other group will get the same treatment for all eight rounds. Doctors will keep a close eye on any side effects and how well the treatment works. They'll use special tests to check. Another group of experts will also check the results to make sure they're accurate. If someone doesn't pass the first check, they might get another chance.
A Phase III Randomised Double -Blind Active-controlled Study to Assess the Efficacy Safety and Tolerability of Baxdrostat in Combination with Dapagliflozin Compared with Dapagliflozin Alone on Chronic Kidney Disease (CKD) Progression in Participants with CKD and High Blood Pressure
The purpose of this study to learn more about the benefits and safety of treatment with a drug called baxdrostat in combination with dapagliflozin in patients with Chronic Kidney Disease (CKD) and high blood pressure and also to better understand the studied disease and associated health problems.