This study is being done to find out if all / any of the combinations of study treatment following thoracic radiation therapy will improve 6-month progression-free survival compared with a similar historical control group. This is an open-label, multi-center study to determine the efficacy and safety of tremelimumab in the treatment of different cohorts of patients with selected advanced solid tumors. novelty of this clinical trial was the study of tremelimumab as an antiviral: tremelimumab decreased the median values in viral load in all the patients; however, six patients with Extensive-stage small cell lung cancer is associated with aggressive biology and poor outcomes. ORR was assessed by the site Investigator using RECIST 1.1 and was defined as the percentage of patients with a confirmed overall response of CR or PR and was based on all treated patients who had measurable disease at baseline (Day 1) and who sequenced to durvalumab monotherapy (MEDI treatment phase) or durvalumab + tremelimumab combination therapy (COMBO treatment phase). This randomized clinical trial compares durvalumab, with or without tremelimumab, with chemotherapy as a first-line treatment for metastatic non–small cell lung. Tremelimumab is being tested in a clinical trial programme in combination with Imfinzi in NSCLC, … 95% confidence intervals (CIs) were calculated using the Clopper Pearson method. Subjects received durvalumab (3 mg/kg Q2W for 12 or 13 cycles) and tremelimumab (1 mg/kg Q4W for 6 cycles, then Q12W or Q4W for 4 cycles). Immunotherapy with monoclonal antibodies, such as tremelimumab, may help the body’s immune system attack the cancer, and may interfere with the ability of tumor cells to grow and spread. Chemotherapy drugs such as carboplatin and etoposide, work in work in different ways to stop the growth of tumor cells, either by killing the cells, by stopping them from dividing, or by stopping them from spreading. Location: 6 locations, The purpose of the study is to determine the recommended dose of durvalumab and tremelimumab (immunotherapy drugs) in pediatric patients with advanced solid and hematological cancers and expand in a second phase to test the efficacy of these drugs once this dose is determined. Results from the global Phase II Study 22 trial testing AstraZeneca’s tremelimumab, an anti-CTLA4 antibody, added to Imfinzi (durvalumab) demonstrated promising clinical activity and tolerability in patients with advanced hepatocellular carcinoma (HCC). To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor. PFS during the retreatment phase was assessed by the site Investigator using RECIST 1.1 and defined as the time from the date of enrollment until the date of objective disease progression or death (by any cause in the absence of progression), regardless of whether the patient withdrew from therapy or received another anticancer therapy prior to progression. Here, we review the use of this antibody in a number of clinical trials against solid tumors. Interventional (Clinical Trial) Actual Enrollment : 64 participants: Allocation: N/A: Intervention Model: Single Group Assignment: Masking: None (Open Label) Primary Purpose: Treatment: Official Title: A Phase II, Multi-Center, Open-Label Study of Tremelimumab Monotherapy in Patients With Advanced Solid Tumors Location: 5 locations, This phase II trial studies how well durvalumab, tremelimumab, and radiation therapy work in treating patients with hepatocellular carcinoma or biliary tract cancer that cannot be removed via surgery (unresectable) or that has spread to other parts of the body (metastatic). Active or prior documented autoimmune or inflammatory disorders; 4. DCR during the initial tremelimumab monotherapy phase was defined as the percentage of patients who had a best objective response (BoR) of CR or PR in the first 3 months (PDAC patients) or 4 months (UBC and TNBC patients) and 12 months (all patients), or who had demonstrated stable disease (SD) for a minimum interval of 3, 4 or 12 months following the start of study treatment. The time of the initial response was defined as the latest of the dates contributing toward the first visit response of CR or PR. Location: 2 locations, This clinical trial studies the effect of durvalumab and tremelimumab in treating patients with stage II-IIIB non-small cell lung cancer who have undergone surgical removal and completed after surgery treatment with or without radiation therapy and now have detectable tumor DNA in the blood. Tremelimumab stimulates (wakes up) the immune system to attack the tumor by inhibiting a protein molecule called cytotoxic T lymphocyte associated 4 (CTLA-4) on immune cells. Tremelimumab is a fully human monoclonal antibody against CTLA-4. Additionally, all users will need to accept the terms and conditions of the SAS MSE to gain access. Design, setting, and participants: Part A of this multicenter, 2-part, phase 2 randomized clinical trial was a lead-in safety, open-label study with planned expansion to part B pending an efficacy signal from part A. Signed Data Sharing Agreement (non-negotiable contract for data accessors) must be in place before accessing requested information. Brachytherapy, also known as internal radiation therapy, uses radioactive material placed directly into or near a tumor to kill tumor cells. Researchers are studying the combination of these two immunotherapy drugs and are comparing their findings to the usual approaches that are used for treating malignant pleural mesothelioma. Location: 20 locations, This is a Phase III, Randomized, Double-blind, Placebo-controlled, Multi-center, International Study of Durvalumab or Durvalumab and Tremelimumab as Consolidation Treatment for Patients with LS-SCLC Who Have Not Progressed Following Concurrent Chemoradiation Therapy Giving durvalumab with tremelimumab may work better in treating patients with somatically hypermutated solid tumors compared to standard treatment (chemotherapy, immunotherapy [using your immune system to treat your cancer] with other agents, or palliative care [no treatment]). Immunotherapy with monoclonal antibodies, such as durvalumab and tremelimumab, may help the body's immune system attack the cancer, and may interfere with the ability of tumor cells to grow and spread. For general information, Learn About Clinical Studies. D demonstrated a PFS and OS advantage over placebo in locally advanced NSCLC following cCRT. Optional extended treatment comprised durvalumab monotherapy administered at the recommended fixed dose of 1500 mg Q4W. Choosing to participate in a study is an important personal decision. 35. Tremelimumab works by interacting with an immune molecule called CTLA-4, located on white blood cells. Please remove one or more studies before adding more. Radiation therapy uses high energy x-rays to kill tumor cells and shrink tumors. Location: UCLA / Jonsson Comprehensive Cancer Center, Los Angeles, California, This phase II trial studies the side effects and how well radiation therapy and durvalumab with or without tremelimumab work in treating participants with bladder cancer that cannot be removed by surgery, has spread to nearby tissue or lymph nodes, or that has spread to other parts of the body. The time of the initial response was defined as the latest of the dates contributing toward the first visit response of CR or PR. HCC is the most common type of liver cancer. NCI’s basic information about clinical trials explains the types and phases of trials and how they are carried out. Abstract. Radiation therapy uses high energy rays to kill tumor cells and shrink tumors. Location: 2 locations, The main purpose of this study is to determine the anti-tumor activity of durvalumab in combination with tremelimumab in patients with metastatic human epidermal growth factor receptor 2 (HER2)-negative breast cancer. This phase III study evaluated overall survival (OS) and other safety and efficacy end points in patients with advanced melanoma treated with tremelimumab or standard-of-care chemotherapy. Location: 7 locations, This phase II trial studies how well durvalumab and tremelimumab work in treating patients with germ cell tumors that have returned after a period of improvement (relapsed) or do not respond to treatment (refractory). Clinical Trials The Sidney Kimmel Comprehensive Cancer Center > Cancers We Treat > Liver Cancer If you would like more information on Liver, Bile Duct and Gallbladder Cancer Clinical Trials offered at the Sidney Kimmel Comprehensive Cancer Center at Johns … Brian A. Baldo, in Side Effects of Drugs Annual, 2014 Tremelimumab (CP-675,206; Ticilimumab) Tremelimumab is a fully humanised IgG2 mAb that binds to CTLA-4 expressed on the surface of activated T lymphocytes.. Observational studies: Some safety evaluations were reported in a phase III clinical trial comparing tremelimumab with standard-of-care chemotherapy in 655 randomly assigned … Trial design. For details of our timelines, please rerefer to our disclosure commitment at: https://astrazenecagrouptrials.pharmacm.com/ST/Submission/Disclosure. U.S. Department of Health and Human Services, The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. It is not yet known whether giving radiation therapy and durvalumab with or without tremelimumab will work better in treating participants with bladder cancer. All request will be evaluated as per the AZ disclosure commitment: https://astrazenecagrouptrials.pharmacm.com/ST/Submission/Disclosure, When a request has been approved AstraZeneca will provide access to the de-identified individual patient-level data in an approved sponsored tool . The clinical trials on this list are studying Tremelimumab. The BoR was summarized by percentage of patients for each category (CR, PR, SD, PD, and NE). To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. Background & aims: Tremelimumab is a monoclonal antibody that blocks cytotoxic T-lymphocyte-associated antigen 4 (CTLA-4), an inhibitory co-receptor that interferes with T cell activation and proliferation. ... Durvalumab, in combination with tremelimumab, has shown clinical activity in patients with advanced NSCLC in a phase 1 and 2 investigation. Monoclonal antibodies, such as durvalumab and tremelimumab, may interfere with the ability of tumor cells to grow and spread. Giving durvalumab and tremelimumab may help prevent cancer from returning (called cancer recurrence) when tumor DNA is detected in the blood. Study record managers: refer to the Data Element Definitions if submitting registration or results information. 24. Giving stereotactic body radiation therapy and durvalumab with or without tremelimumab before surgery may work better, and cause fewer short and long-term side-effects, in patients with oropharyngeal squamous cell cancer. Median DoR was calculated using the Kaplan-Meier technique. Studies a U.S. FDA-regulated Drug Product: Studies a U.S. FDA-regulated Device Product: Urothelial bladder cancer, Triple-negative breast cancer, Pancreatic ductal adenocarcinoma, Advanced Solid Tumors, Tremelimumab, MEDI4736, ORR, Percentage of Patients With Confirmed Overall Response During Tremelimumab Monotherapy Phase [ Time Frame: From baseline to 12 months in the tremelimumab monotherapy phase ], Median Duration of Response (DoR) During Tremelimumab Monotherapy Phase [ Time Frame: From baseline to 12 months in the tremelimumab monotherapy phase ], Disease Control Rate (DCR) During Tremelimumab Monotherapy Phase [ Time Frame: From baseline to 12 months in the tremelimumab monotherapy phase ], Median PFS During Tremelimumab Monotherapy Phase [ Time Frame: From baseline to 12 months in the tremelimumab monotherapy phase ], Best Objective Response (BoR) During Tremelimumab Monotherapy Phase [ Time Frame: From baseline to 12 months in the tremelimumab monotherapy phase ], Median Overall Survival (OS) During Tremelimumab Monotherapy Phase [ Time Frame: From baseline to final data cut-off date ], Percentage of Patients With Confirmed Overall Response During Retreatment Phase [ Time Frame: From baseline to 12 months in retreatment phase ], Median DoR During Retreatment Phase [ Time Frame: From baseline to 12 months in retreatment phase ], DCR During Retreatment Phase [ Time Frame: From baseline to 4 months in retreatment phase ], Median PFS During Retreatment Phase [ Time Frame: From baseline to 12 months in retreatment phase ], BoR During Retreatment Phase [ Time Frame: From baseline to 12 months in retreatment phase ], Median OS During Retreatment Phase [ Time Frame: From baseline in retreatment phase to final data cut-off date ].
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