A Phase 3, Randomized, Double-Blind, Placebo-Controlled, Multicenter Study to Investigate the Efficacy and Safety of Mongersen (GED-0301) for the Treatment of Subjects with Active Crohn's Disease (WIRB Protocol # 20151742)
This is a clinical trial evaluating an investigational new treatment in people with moderate to severe Crohn's disease. The investigational treatment is taken by mouth. Subjects must be at least 18 years old, have been diagnosed with Crohn's Disease for at least 3 months, and have active Crohn's that did not improve or stay impoved after trying at least one Crohn's therapy, or had to stop therapy because of side effects. The study may last up to 15 months and will require visits to the study center every 4 weeks and up to three colonoscopy examinations. For more information, please contact Ann Foley at 774-442-4098 or email IBDClinicalTrials@umassmed.edu.
Cancer - Ovarian - A Randomized, Open-Label Study Comparing the Combination of YONDELIS and DOXIL/CAELYX with DOXIL/CAELYX Monotherapy for the Treatment of Advance-Relapsed Epithelial Ovarian, Primary Peritoneal, or Fallopian Tube Cancer (WIRB Protocol # 20131130)
For more information, please contact the Cancer Research Office at 508-856-3216 or email Cancer.Research@umassmed.edu.
Cancer - Lung - A Randomized, Double-Blind, Phase III Study of Carboplatin-Paclitaxel/Nab-Paclitaxel Chemotherapy with or without Pembrolizumab (MK-3475) in First Line Metastatic Squamous Non small Cell Lung Cancer Subjects (KEYNOTE-407) (WIRB Protocol # 20160968)
The purpose of this study is to: (1)Test the safety of the research study drug, Pembrolizumab (MK-3475). (2) To evaluate whether the addition of Pembrolizumab (MK-3475) to the standard chemotherapy regimen improves survival in first line metastatic non-small cell lung cancer (NSCLC) patients. (3) Test if there are any drug interactions when giving Pembrolizumab plus carboplatin and paclitaxel or nab-paclitaxel together. For more information, please contact the Cancer Research Office at 508-856-3216 or email Cancer.Research@umassmed.edu.
Cancer - Pancreatic - A Phase 3, Randomized, Double-Blind, Placebo-Controlled, Multicenter Study of PEGylated Recombinant Human Hyaluronidase (PEGPH20) in Combination With nab-Paclitaxel Plus Gemcitabine Compared With Placebo Plus nab-Paclitaxel and Gemcitabine in Subjects with Hyaluronan-High Stage IV Previously Untreated Pancreatic Ductal Adenocarcinoma (WIRB Protocol # 20152434)
The purpose of the study is to compare the efficacy (how well the drug works) and safety (how well the drug is tolerated) of the study drug, PEGPH20 compared with Placebo (normal saline, that is, a mixture of salt and water with an amount of salt similar to body fluids) in combination with two chemotherapy drugs nab-paclitaxel (NAB) and gemcitabine (GEM). The study will answer whether the experimental treatment (PEGPH20 with NAB and GEM) is as good as or better than Placebo with NAB and GEM. For more information, please contact the Cancer Research Office at 508-856-3216 or email Cancer.Research@umassmed.edu.
Cancer - Bladder - An Open-Label, Multicenter, Phase 3 Study to Evaluate the Efficacy and Tolerability of Intravesical Vicinium in Subjects with Non Muscle-Invasive Carcinoma in Situ (CIS) and/or High-Grade Papillary Disease of the Bladder Previously Treated with Bacillus Calmette-Guerin (BCG) (WIRB Protocol # 20151041)
The purpose of this research study is to obtain information on the safety and the effectiveness of Vicinium when it is given to patients with bladder cancer that has not spread to the muscle in the bladder. Vicinium is made of an antibody connected to a protein that can kill cells. This protein is a modified “pseudomonas exotoxin A.” Vicinium is designed to attach to cells that have a different protein called EpCAM on the outside of the cell. After attaching to a cell, the modified pseudomonas exotoxin A can be released inside the cell causing the cell to die. It is thought that almost all bladder cancer cells have EpCAM on the surface of their cells. For more information, please contact the Cancer Research Office at 508-856-3216 or email Cancer.Research@umassmed.edu.
Cancer - Leukemia - A Phase 3 Open-label, Multicenter, Randomized Study of ASP2215 versus Salvage Chemotherapy in Patients with Relapsed or Refractory Acute Myeloid Leukemia (AML) with FLT3 Mutation (WIRB Protocol # 20151102)
The purpose of the study is to see if a medicine called ASP2215 is both effective and safe as a treatment for AML patients with mutations in the FLT3 gene compared to salvage chemotherapy. This gene is identified by an investigational FLT3 Mutation Assay companion diagnostic, a specific lab test of blood or bone marrow, which is used to see if patients have a mutation of the FLT3 gene. Some AML patients have a mutation in the gene called FLT3. When patients have a FLT3 mutation, more of the FLT3 protein is on the leukemic cells, or the protein is more active. This may make the leukemic cells grow faster or live longer. For more information, please contact the Cancer Research Office at 508-856-3216 or email Cancer.Research@umassmed.edu.
A Phase 3b, 12-month, Open-label, Multicenter Study to Evaluate the Efficacy and Safety of BIIB019, Daclizumab, in Subjects with Relapsing-Remitting Multiple Sclerosis (RRMS) Switching from Natalizumab (SUSTAIN) (Protocol # 205MS305)
The purpose of this study is to see how those persons with Multiple Sclerosis who have been on Tysabri and now need to come off Tysabri and switch to another MS drug treatment. For more information, please contact Carolyn Griffin at 508-856-5006 or email Carolyn.Griffin@umassmemorial.org.
The Early Treatment Study (Docket # H-00010209)
The toal of this study is to help understand if the experimental drug paliperidone palmitate or oral antipsychotic medication is better at preventing a worsening of symptoms of schzophrenia or schizophreniform disorder. We seek men and women ages 18-35 that have a clinical diagnosis of psychosis within the last 2 years. Those who qualify will receive study-related medical exams, and lab tests at no charge. Compensation for your time and travel is available. For more information about the study, please call us at 508-856-MIND(6463) or email MIND@umassmed.edu.
The Memory Study (Docket # H-00004119)
This study seeks to see if Exenatide, an investigational drug when used in people with schizophrenia, can improve memory and thinking in people with schizophrenia. Participation in the study will last 24 weeks. We seek men and women ages 18-65 with a diagnosis of schizophrenia or schizoaffective disorder. Participants will be compensated for their time and travel, and all information will be kept private. For more information about the study, please call us at 508-856-MIND(6463) or email MIND@umassmed.edu.
Alcohol Behavioral Couple Therapy for Service Members and Veterans (Docket # H-00003823)
Researchers at UMass Medical School are developing an innovative program for Service Members and Veterans with alcohol-related concerns. The Alcohol Behavioral Couple Therapy Military treatment research program is designed to help service members or veterans and their partners learn skills that will help to reduce drinking and improve relationship functioning. The program will include a thorough assessment, 15 weekly outpatient couple therapy sessions (free of charge), and a follow-up session. Compensation will be provided for the intake and follow-up sessions. For more information, please contact Rachel Rosen at (855) 901-2228 or email@example.com.
The Depression Relapse Trial (Docket # H-00007086)
Individuals that are currently suffering from depression are invited to participate in a research study to determine the effectiveness and safety of vortioxetine in preventing relapse in depression for those subjects who respond to treatment with vortioxetine. Study participation will last up to 55 weeks and subjects will receive the study drug vortioxetine. Participants must be: 18 to 75 years of age, suffering from recurrent Major Depressive Disorder, experiencing current symptoms of depression, not be pregnant or have plans to become pregnant. Subjects will receive study drug and study-related care at no cost. Compensation provided. Contact Jessica Penny @ 774 455 4045.
Genetic Studies of Developmental, Metabolic and Nervous System Disorders (Docket # H-10275)
Do you have a diagnosis of bipolar disorder and are you between the ages of 18 and 65? If you answered yes, we invite you to participate in a research study looking at the genetic studies of Bipolar Disorder. Study participation will entail a commitment of one study visit, and one blood draw. Please call for more information:Jessica Penny 774.455.4045.
Observational Study of Improved Major Depressive Disorder (Docket # H-00006379)
This observational study will be gathering information about subjects’ daily activities, sleep quality, their speech and voice characteristics to see if predications can be made to see if one can predict worsening of MDD symptoms in the near future. Participants must have recently tried, and are currently on an antidepressant and their symptoms of depression are improving. Subjects will receive a Wrist Band and Smart Phone (LogPad®) to record their activities and sleep patterns, as well as speech and voice characteristics. Contact Jessica Penny @ 774-455-4045.