A Randomized Open-label Phase 3 Study of Amivantamab and mFOLFOX6 or FOLFIRI Versus Cetuximab and mFOLFOX6 or FOLFIRI as First-line Treatment in Participants With KRAS/NRAS and BRAF Wild-type Unresectable or Metastatic Left-sided Colorectal Cancer
This is a phase 3 study testing and comparing if study medicine amivantamab (monoclonal antibody) in combination with mFOLFOX6 or FOLFIRI (chemotherapy) is more beneficial than another medicine called cetuximab (Monoclonal antibody) in combination with mFOLFOX6 or FOLFIRI for patients whose colorectal cancer has spread from the primary location and that the tumor has KRAS/NRAS and BRAF wild-type genes. Patients will be divided into two groups. One group will receive amivantamab together with mFOLFOX6 or FOLFIRI, and the other group will receive cetuximab and mFOLFOX6 or FOLFIRI. All participants will have special scans taken to see if the study treatment is changing their tumor size and that the cancer is not progressing. The study team will collect blood samples from all patients to see how their bodies are responding to these medicines and whether antibodies to the study medicine are formed. Genetic testing will be done on blood and tumor samples in the hope of further helping patients. All patients will be monitored for side effects and safety throughout the study.
A Randomized Phase 2 Trial of Fruquintinib and TAS-102 as Compared to Fruquintinib in Patients with Refractory Advanced/Metastatic Microsatellite Stable Colorectal Cancer
This is a Phase 2 study testing whether a combination of TAS-102 and fruquintinib (a selective oral kinase inhibitor) is more effective and safer than fruquintinib alone in patients with advanced colorectal cancer that has spread from its primary location. TAS102 is a chemotherapy medication made of two different drugs that work by interfering with the cell cycle and DNA synthesis in cancer cells, killing the cancer cells. Patients will be randomly divided into two groups. One group will receive the combination of study medicines TAS-102 and fruquintinib, and the other group will receive Fruquintinib alone. Special scans will be done for all patients to check how their tumor size changes in response to the study medicines. Blood samples will be collected for all patients to monitor their overall well-being. The study team will examine and record the time interval for all patients from the start of treatment until their cancer comes back or worsens (progression-free survival). All patients will be closely monitored for potential side effects and safety concerns.
A RANDOMIZED PHASE 3 TRIAL OF CONTINUOUS VS. INTERMITTENT MAINTENANCE THERAPY WITH ZANUBRUTINIB AS UPFRONT TREATMENT IN OLDER PATIENTS WITH MANTLE CELL LYMPHOMA (INTERCON)
This is a Phase 3 study testing whether continuous or intermittent treatment with the study medicine Zanubrutinib (a kinase inhibitor) and rituximab (a monoclonal antibody) is a more effective treatment option for older patients with Mantle cell lymphoma. Once the patient is enrolled in the study, they will receive the study medicine Zanubrutinib and rituximab. Patients from this group whose cancer does not grow or spread will be randomly divided into two groups. Group A patients will continue the study medicine until their cancer comes back, or they have bad side effects from the study medicine. Group B patients will continue the study medicine until their cancer comes back (progression). Patients will restart the study medicine Zanubrutinib within less than 21 days after the confirmed progression of their cancer. Patients will continue to receive the study treatment until their cancer comes back for the second time (second progression) or unacceptable side effects. Special scans will be performed on all patients during the study to see whether the tumor size is changing. All patients will be closely monitored for side effects and safety concerns and will be followed up every 6 months for 10 years following registration.
A RANDOMIZED PHASE II TRIAL OF ADJUVANT NIVOLUMAB WITH OR WITHOUT CABOZANTINIB IN PATIENTS WITH RESECTED MUCOSAL MELANOMA
A RANDOMIZED PHASE II TRIAL OF ADJUVANT NIVOLUMAB WITH OR WITHOUT CABOZANTINIB IN PATIENTS WITH RESECTED MUCOSAL MELANOMA
A randomized phase II trial of adjuvant trastuzumab emtansine (T-DM1) followed by subcutaneous trastuzumab versus paclitaxel in combination with subcutaneous trastuzumab for Stage I HER2-positive breast cancer (ATEMPT 2.0)
This is a randomized phase II adjuvant study for women and men with Stage I HER2-positive invasive breast cancer. At least 500 eligible patients will be randomized 3:1 to trastuzumab emtansine (T-DM1), followed by subcutaneous (SC) trastuzumab (Herceptin Hylecta) (n = 375) or paclitaxel plus trastuzumab SC (TH) (n = 125). Patients may have any hormone receptor status, may be either pre- or post-menopausal, and must be systemic treatment-naïve for this cancer. HER-2 positivity will be confirmed by central testing in all patients. Patients will bestratified by Age (
A randomized phase III study of neoadjuvant chemotherapy followed by surgery versus surgery alone for patients with High Risk RetroPeritoneal Sarcoma (STRASS 2)
In this study, patients will fill out Health-Related Quality of Life (HRQoL) questionnaires when they visit the hospital for their scheduled appointments. These questionnaires will follow the EORTC guidelines. The main copies will be sent to the hospitals, and if more copies or translations are needed, they can be requested from the EORTC contact person. Clinical report forms will ask if the HRQoL questionnaires were completed, and if they weren't, the reasons will be noted. Patients will receive the questionnaires from the doctor or a study nurse before their check-ups, and they should complete them on their own in their own language during the visit. A designated person, like a research nurse, will help make sure that patients fill out the questionnaires correctly and completely. The study will check how well patients follow through with completing the questionnaires at each visit, and this will be reviewed every six months and included in reports.
A Randomized single-blind placebo-controlled study on the effect of perioperative administration of ketamine on pain after surgery for orthopedic trauma: A Pilot Trial
The purpose of this study is to examine whether ketamine given during and after surgery (in the recovery room) can improve postoperative pain, mood, and postoperative recovery in patients who undergo orthopedic trauma surgery.
A randomized single blind sham-controlled pilot trial of a novel therapeutic strategy for Autonomic Nervous System (ANS) dysfunction in Chronic Kidney Disease (CKD)
The purpose of this study is to test a possible treatment called transcutaneous auricular vagal nerve stimulation (TaVNS) in patients with chronic kidney disease (CKD) and autonomic dysfunction.
A RANDOMIZED TRIAL OF THE UTILITY OF RANDOM BIOPSIES IN PATIENTS WITH INFLAMMATORY BOWEL DISEASE (THE URBI STUDY)
The purpose of this research study is to compare two different commonly used clinical care biopsy strategies for patients with longstanding Inflammatory Bowel Disease (IBD).
A Real-world Patient Registry in Group 3 Pulmonary Hypertension Associated with Interstitial Lung Disease (PH-ILD)
The purpose of this patient registry is to observe, characterize, and capture real-world data from patients with Group 3 pulmonary hypertension associated with interstitial lung disease (PH-ILD). Group 3 pulmonary hypertension (PH), defined as PH associated with chronic lung disease or hypoxia, is associated with higher morbidity, mortality, and medical costs than similar patients without PH (Barberà 2015). Past registries focus solely on PH or chronic lung disease individually and lack clinically relevant data of the alternate group, making it necessary for acombined group registry.