DoR was not defined for those patients who did not have documented response. DCR during the retreatment phase was defined as the percentage of patients who had a BoR of CR or PR in the first 3 months (PDAC patients) or 4 months (UBC and TNBC patients) or who had demonstrated SD for a minimum interval of 3 or 4 months following the start of study treatment. 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. Any patient not known to have died at the time of analysis was censored based on the last recorded date on which the patient was known to be alive. Tremelimumab is being tested in a clinical trial programme in combination with Imfinzi in NSCLC, … Between November 26, 2015, and March 23, 2017, 65 patients with mPDAC who had previously received only 1 first-line fluorouracil-based or gemcitabine-based treatment were enrolled at 21 sites in 6 … Listing a study does not mean it has been evaluated by the U.S. Federal Government. Somatic hypermutation is a cellular mechanism that happens when the immune system adapts to a new foreign element (e.g. Location: UCLA / Jonsson Comprehensive Cancer Center, Los Angeles, California, This phase I trial studies how well durvalumab and tremelimumab given in combination with platinum-based chemotherapy work in treating patients with untreated extensive-stage small cell lung cancer. 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 Giving olaparib and tremelimumab together may work better than olaparib alone in treating patients with ovarian, fallopian tube, or peritoneal cancer. 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]). The Company is pursuing a comprehensive clinical trial programme that includes Imfinzi as a monotherapy and in combination with tremelimumab in multiple tumour types, stages of disease, and lines of therapy, and where relevant using the PD-L1 biomarker as a decision-making tool to define the best potential treatment path for a patient. OS was defined as the time from the date of first dose until death due to any cause. It is hoped that by blocking these signals, the immune cells will once again be able to prevent or slow down cancer growth. The information learned from the combination of immune boosting drugs may be identified as not excessively toxic and may be studied further to determine the benefit of using these as a therapy for extensive-stage small cell lung cancer. Radiation therapy uses high energy x-rays to kill tumor cells and shrink tumors. Biological: MEDI4736 + tremelimumab combination therapy. Active or prior documented autoimmune or inflammatory disorders; 4. Tremelimumab (T) is a selective human IgG2 mAb against CTLA-4. tremelimumab monotherapy, with the option for eligible patients to be sequenced to MEDI4736 monotherapy or MEDI4736 + tremelimumab combination therapy after progressive disease (PD). To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor. Location: 2 locations, This phase II trial studies how well durvalumab and tremelimumab work in treating patients with ovarian, primary peritoneal, or fallopian tube cancer that has come back (recurrent) or does not respond to treatment (refractory). Location: 7 locations, This phase Ib / II trial studies the side effects of durvalumab when given together with chemotherapy and radiation therapy in treating patients with esophageal or gastroesophageal junction cancer. 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. This phase II trial studies how well olaparib with or without tremelimumab works in treating patients with ovarian, fallopian tube, or peritoneal cancer that has come back (recurrent). Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02527434. Location: University of Nebraska Medical Center, Omaha, Nebraska, This phase I / Ib trial studies the side effects and how well durvalumab with or without tremelimumab or olaparib works after thoracic radiation therapy in treating patients with extensive stage-small cell lung cancer. 24. DCR was determined programmatically based on RECIST 1.1 using site Investigator data and all data up until the first progression event. QT interval corrected for heart rate using Fridericia's formula (QTcF) ≥470 ms; 6. 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. Any patient not known to have died at the time of analysis was censored based on the last recorded date on which the patient was known to be alive. 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. ... Durvalumab, in combination with tremelimumab, has shown clinical activity in patients with advanced NSCLC in a phase 1 and 2 investigation. More >> Recently Activated Trials . 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. DoR was not defined for those patients who did not have documented response. Radiation therapy uses high energy x-rays to kill tumor cells and shrink tumors. Although still a work in progress, the use of tremelimumab as an immune checkpoint therapeutic agent is a promising approach alone or in combination with other anticancer drugs. Stereotactic body radiation therapy is a specialized radiation therapy that sends x-rays directly to the tumor using smaller doses over several days and may cause less damage to normal tissue. Here, we review the use of this antibody in a number of clinical trials against solid tumors. Location: 8 locations, This is a randomized, open-label, controlled, multi-center, global Phase III study to determine the efficacy and safety of combining durvalumab ± tremelimumab with standard of care (SoC) chemotherapy (cisplatin + gemcitabine or carboplatin + gemcitabine doublet) followed by durvalumab monotherapy versus SoC alone as first-line chemotherapy in patients with histologically or cytologically documented, unresectable, locally advanced or metastatic transitional cell carcinoma of the urothelium (including renal pelvis, ureters, urinary bladder, and urethra). PARP inhibitors are a type of targeted therapy. Brachytherapy, also known as internal radiation therapy, uses radioactive material placed directly into or near a tumor to kill tumor cells. Read our, ClinicalTrials.gov Identifier: NCT02527434, Interventional 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. For general information, Learn About Clinical Studies. While smaller trials have shown success, more research on the drug is needed to treat future patients. Clinical trials are research studies that involve people. Known allergy or hypersensitivity to IP or any IP excipient. Location: 3 locations, This phase I / II trial studies the side effects of durvalumab, tremelimumab, and radiation therapy and to see how well they work in treating participants with high risk soft-tissue sarcoma. Median DoR was calculated using the Kaplan-Meier technique. Location: Moffitt Cancer Center, Tampa, Florida, This phase II trial studies how well durvalumab works in combination with tremelimumab in treating patients with somatically hypermutated solid tumors that have come back or have not responded to treatment. microbes). Tremelimumab is being tested in a clinical trial programme in combination with Imfinzi in NSCLC, bladder cancer, head and neck cancer, liver cancer and blood cancers. 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 This is a randomized, open-label, multi-center, global, Phase II study to determine the efficacy and safety of MEDI4736 + tremelimumab combination therapy, MEDI4736 monotherapy and tremelimumab monotherapy in the treatment of patients with recurrent or metastatic PD-L1-negative squamous cell carcinoma of the head and neck (SCCHN) who have progressed during or after … About The Trial. Location: 2 locations, This phase II trials studies the side effects and best dose of durvalumab and radiation therapy with or without tremelimumab in treating patients with stage III non-small cell lung cancer that can be removed by surgery. 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. DoR during the initial tremelimumab monotherapy phase was assessed by the site Investigator using RECIST 1.1 and was defined as the time from the date of first documented response until the first date of documented progression or death in the absence of disease progression. DCR was determined programmatically based on RECIST 1.1 using site Investigator data and all data up until the first progression event. 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 . 95% CIs were calculated using the Clopper Pearson method. Tremelimumab is being investigated in an extensive clinical trial programme, as monotherapy or in combination with durvalumab, in NSCLC, bladder, head and … Both durvalumab and tremelimumab may help strengthen the immune system. Durvalumab targets a signal on tumor cells and tremelimumab targets a signal on immune cells. 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. D and D + T demonstrated a tolerable safety profile and antitumour activity in pretreated extensive stage SCLC. Giving durvalumab and tremelimumab may help prevent cancer from returning (called cancer recurrence) when tumor DNA is detected in the blood. Please remove one or more studies before adding more. Location: 3 locations, This phase I trial studies how well stereotactic body radiation therapy works in combination with tremelimumab and durvalumab in treating participants with cervical, vaginal, or vulvar cancers that have come back (recurrent) or spread to other areas of the body (metastatic). 35. The clinical trials on this list are studying Tremelimumab. Objective response rate (ORR) during the initial tremelimumab monotherapy phase was assessed by the site Investigator using Response Evaluation Criteria in Solid Tumors, Version 1.1 (RECIST 1.1) and was defined as the percentage of patients with a confirmed overall response of complete response (CR) or partial response (PR) and was based on all treated patients who had measurable disease at baseline (Day 1). 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. 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. Tremelimumab is a fully human monoclonal antibody against CTLA-4. Stereotactic body radiation therapy uses special equipment to position a patient and deliver radiation to tumors with high precision. In this investigator-initiated phase II, non-controlled, open-label, multicenter clinical trial, patients received intravenous tremelimumab at a dose of 15 mg/kg on day 1 of every 90-day cycle. Location: 7 locations, This phase II trial studies how well nab-paclitaxel, durvalumab, and tremelimumab with or without personalized synthetic long peptide vaccine (neoantigen vaccine) works in treating patients with triple negative breast cancer that has spread to other places in the body (metastatic). Median OS was calculated using the Kaplan-Meier technique. Clinical trials on tremelimumab have been conducted on cancer patients in an attempt to study the prevention, detection, or treatment of multiple diseases. It is not yet known whether giving radiation therapy and durvalumab with or without tremelimumab will work better in treating participants with bladder cancer. For details of our timelines, please rerefer to our disclosure commitment at: https://astrazenecagrouptrials.pharmacm.com/ST/Submission/Disclosure. Durvalumab works by interacting with an immune molecule called PD-L1, located on the tumor cells and white blood cells. The patients cannot be eligible for locoregional therapy. Tremelimumab blocks the activity of CTLA-4, contributing to T cell activation and boosting the immune response to cancer. If a patient did not progress following a response, then their DoR was censored at the progression-free survival (PFS) censoring time. Immunotherapy with monoclonal antibodies, such as tremelimumab and durvalumab, may help the body’s immune system attack the cancer, and may interfere with the ability of tumor cells to grow and spread. Location: 12 locations, This is a randomized, open-label, multi-center, global, Phase III study to assess the efficacy and safety of durvalumab plus tremelimumab combination therapy and durvalumab monotherapy versus sorafenib in the treatment of patients with no prior systemic therapy for unresectable HCC. Phase 1 Study of Mogamulizumab (KW-0761) in Combination With MEDI4736 (Durvalumab) and Mogamulizumab in Combination With Tremelimumab in Subjects With Advanced Solid Tumors: Actual Study Start Date : November 26, 2014: Actual Primary Completion Date : December 8, 2017: Actual Study Completion Date : March 5, 2018 BoR during the initial tremelimumab monotherapy phase was calculated based on the overall visit responses from each RECIST 1.1 assessment and was defined as the best response a patient had during their time in the study (from CR, PR, SD, PD or not evaluable [NE]) obtained among all tumor assessment visits from baseline until end of treatment or determination of PD. All trials on the list are supported by NCI. Progression events that did not occur within 3 months (PDAC patients) or 4 months (UBC/TNBC patients) of the last evaluable assessment (or first dose) were censored. Giving durvalumab together with chemotherapy and radiation therapy before surgery may work better at treating patients with esophageal or gastroesophageal junction cancer. Radiation therapy uses high energy rays to kill tumor cells and shrink tumors. BoR during the retreatment phase was calculated based on the overall visit responses from each RECIST 1.1 assessment and was defined as the best response a patient had during their time in the study (from CR, PR, SD, PD or NE) obtained among all tumor assessment visits from baseline until end of treatment or determination of PD. 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). Vaccines made from peptides may help the body build an effective immune response to kill tumor cells. You may want to think about taking part in a clinical trial. Tremelimumab works by interacting with an immune molecule called CTLA-4, located on white blood cells. Olaparib is an inhibitor of PARP, an enzyme that helps repair deoxyribonucleic acid (DNA) when it becomes damaged. 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. 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. The first published tremelimumab clinical trial included 34 melanoma, one colon cancer, and four renal cell carcinoma (RCC) patients. 95% CIs were calculated using the Clopper Pearson method. Durvalumab attaches to a protein in tumors called PD-L1. Additionally, all users will need to accept the terms and conditions of the SAS MSE to gain access. Giving stereotactic body radiation therapy, tremelimumab, and durvalumab may work better in treating participants with cervical, vaginal, or vulvar cancers. Durvalumab, with or without tremelimumab, plus platinum-etoposide versus platinum-etoposide alone in first-line treatment of extensive-stage small-cell lung cancer (CASPIAN): updated results from a randomised, controlled, open-label, phase 3 trial. 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. ... Clinical trial identification. It is not yet known whether give durvalumab and tremelimumab in combination or sequential administration works better in treating patients with ovarian, primary peritoneal, or fallopian tube cancer. Brian A. Baldo, in Side Effects of Drugs Annual, 2014. You have reached the maximum number of saved studies (100). 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. 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. 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. 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 … Drugs used in chemotherapy, such as fluorouracil, leucovorin calcium, oxaliplatin, carboplatin and paclitaxel, 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. Information provided by (Responsible Party): A Phase II, Multi-Center, Open-Label Study of Tremelimumab Monotherapy in Patients with Advanced Solid Tumors. OS during the retreatment phase was defined as the time from the date of first dose until death due to any cause. OS is presented from start of tremelimumab monotherapy phase and includes the retreatment phase if the patient entered the corresponding treatment phase. Extensive-stage small cell lung cancer is associated with aggressive biology and poor outcomes. Location: Johns Hopkins University / Sidney Kimmel Cancer Center, Baltimore, Maryland, This phase Ib / II trial studies the side effects and how well stereotactic body radiation therapy and durvalumab with or without tremelimumab before surgery work in treating patients with human papillomavirus positive oropharyngeal squamous cell cancer. Purpose: In phase I/II trials, the cytotoxic T lymphocyte-associated antigen-4-blocking monoclonal antibody tremelimumab induced durable responses in a subset of patients with advanced melanoma. This randomized clinical trial compares durvalumab, with or without tremelimumab, with chemotherapy as a first-line treatment for metastatic non–small cell lung. The trial is registered as NCT01008358 on the National Clinical Trials database (www.clinicaltrials.gov). Immunotherapy with monoclonal antibodies, such as durvalumab and tremelimumab, may help the body’s immune system attack the tumor, and may interfere with the ability of tumor cells to grow and spread. PFS during the initial tremelimumab monotherapy phase was assessed by the site Investigator using RECIST 1.1 and was 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. Drugs used in chemotherapy, such as nab-paclitaxel, 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. Progression events that did not occur within 3 months (PDAC patients) or 4 months (UBC/TNBC patients) of the last evaluable assessment (or first dose) were censored. DOI: 10.1200/JCO.2020.38.15_suppl.9502 Journal of Clinical Oncology - published online before print May 25, 2020 CCTG BR.34: A randomized trial of durvalumab and tremelimumab +/- platinum-based chemotherapy in patients with metastatic (Stage IV) squamous or … 1. Immunotherapy with monoclonal antibodies, such as durvalumab and tremelimumab, may induce changes in the body's immune system and may interfere with the ability of tumor cells to grow and spread. Location: 7 locations, This is an open-label, multicenter Phase 1 / 2 study of the CTLA-4 antibody, tremelimumab, and the PD-L1 antibody, durvalumab (MEDI4736), in combination with the tumor microenvironment (TME) modulator polyICLC, a TLR3 agonist, in subjects with advanced, measurable, biopsy-accessible cancers. Lung Cancer. 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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