It is not yet known whether durvalumab and radiation therapy with or without tremelimumab will work better in treating patients with non-small cell lung cancer. Radiation therapy uses high energy x-rays to kill tumor cells and shrink tumors. Brain metastases or spinal cord compression unless asymptomatic or treated and stable off steroids and anti-convulsants for at least 14 days prior to study treatment start; 5. 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). Durvalumab and tremelimumab is a monoclonal antibody that may interfere with the ability of tumor cells to grow and spread. Both durvalumab and tremelimumab are antibodies (proteins used by the immune system to fight infections and cancers). 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. PARP inhibitors, such as olaparib, can keep PARP from working, so tumor cells can't repair themselves, and they may stop growing. The trial is registered as NCT01008358 on the National Clinical Trials database (www.clinicaltrials.gov). tremelimumab monotherapy, with the option for eligible patients to be sequenced to MEDI4736 monotherapy or MEDI4736 + tremelimumab combination therapy after progressive disease (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). 95% CIs were calculated using the Clopper Pearson method. 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 … DoR was not defined for those patients who did not have documented response. Each study drug, durvalumab and tremelimumab, targets a different signal that may be stopping the body's immune system from killing the cancer. 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. This randomized clinical trial compares durvalumab, with or without tremelimumab, with chemotherapy as a first-line treatment for metastatic non–small cell lung. Radiation therapy uses high energy x-rays to kill tumor cells and shrink tumors. 2020 May;143:1-11. doi: 10.1016/j.lungcan.2020.02.016. Location: 2 locations, This phase I trial studies the side effects of durvalumab, tremelimumab, and radiation therapy in treating patients with gynecologic cancer that has spread to other places in the body or cannot be removed by surgery. 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 … 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. Why Should I Register and Submit Results? 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]). 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. More >> Recently Activated Trials . Biological: MEDI4736 + tremelimumab combination therapy. Giving olaparib and tremelimumab together may work better than olaparib alone in treating patients with ovarian, fallopian tube, or peritoneal cancer. The first time you have the drugs there will be a 1 hour gap between MEDI4736 and tremelimumab. 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. If a patient did not progress following a response, then their DoR was censored at the PFS censoring time. OS was defined as the time from the date of first dose until death due to any cause. Additionally, all users will need to accept the terms and conditions of the SAS MSE to gain access. 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 … Monoclonal antibodies, such as durvalumab and tremelimumab, may interfere with the ability of tumor cells to grow and spread. 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 … All trials on the list are supported by NCI. Tremelimumab (CP-675206) is an immunoglobulin (Ig) G2 cytotoxic T lymphocyte–associated antigen-4 (CTLA4) –blocking monoclonal antibody that has been tested in clinical trials in patients with cancer. Tremelimumab is a fully human monoclonal antibody against CTLA-4. 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. 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). Study record managers: refer to the Data Element Definitions if submitting registration or results information. 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. 95% CIs were calculated using the Clopper Pearson method. 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. 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 works by interacting with an immune molecule called PD-L1, located on the tumor cells and white blood cells. 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. 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 … 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. DoR was not defined for those patients who did not have documented response. Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02527434. Tremelimumab is being investigated in an extensive clinical trial programme, as monotherapy or in combination with durvalumab, in NSCLC, bladder, head and … Patients without evidence of tumor progression or unacceptable toxicities were … Giving durvalumab, tremelimumab, and radiation therapy may work better in treating patients with gynecologic cancer. The clinical trials on this list are studying Tremelimumab. 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. 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 . In this trial, six doses of tremelimumab (0.1 mg/kg, 1 mg/kg, 3 mg/kg, 6 mg/kg, 10 mg/kg, and 15 mg/kg) were tested with the possibility to re-enroll the patients of the first three cohorts (0.1 mg/kg, 1 mg/kg, and 3 mg/kg of the antibody). 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. 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. The antibodies in this study are designed to boost the body’s immune system, by allowing immune cells to be more active and fight the cancer. 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. While smaller trials have shown success, more research on the drug is needed to treat future patients. In the race to find new ways to prevent and treat COVID-19, CCTG has launched an innovative clinical trial focussed on strengthening the immune system for one of the most vulnerable populations – cancer patients. NCT03703297. Trial design. Location: NYP / Columbia University Medical Center / Herbert Irving Comprehensive Cancer Center, New York, New York, This phase II trial studies the side effects and how well brachytherapy with durvalumab or tremelimumab work for the treatment of gynecological malignancies that is resistant to platinum therapy (platinum-resistant), does not respond to treatment (refractory), has come back (recurrent), or has spread to other places in body (metastatic). 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. This is a randomized, open-label, multi-center, 3-arm, global Phase III study to determine the efficacy and safety of MEDI4736 + tremelimumab combination or MEDI4736 monotherapy versus SoC (EXTREME regimen) in the treatment of patients with SCCHN who have not received prior systemic chemotherapy for recurrent or metastatic disease. It is not yet known whether giving nab-paclitaxel, durvalumab, and tremelimumab with or without neoantigen vaccine will work better in treating patients with triple 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). Any concurrent chemotherapy, biologic, or hormonal therapy for cancer Treatment; 2. QT interval corrected for heart rate using Fridericia's formula (QTcF) ≥470 ms; 6. 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. US Clinical Trials Registry; Clinical Trials Nct Page; Phase 1 Study of Tremelimumab, Durvalumab, High-dose Chemotherapy, + Autologous Stem Cell Transplant A Phase 1 Study to Assess Safety and Tolerability of Tremelimumab and Durvalumab, Administered With High Dose Chemotherapy and Autologous Stem Cell Transplant (HDT/ASCT) 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 Stereotactic body radiation therapy uses special equipment to position a patient and deliver radiation to tumors with high precision. 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. The first published tremelimumab clinical trial included 34 melanoma, one colon cancer, and four renal cell carcinoma (RCC) patients. 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. A phase IB study of durvalumab with or without tremelimumab and platinum-doublet chemotherapy in advanced solid tumours: Canadian Cancer Trials Group Study IND226. 1. 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). 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. 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 ]. The BoR was summarized by percentage of patients for each category (CR, PR, SD, PD, and NE). 35. Median DoR was calculated using the Kaplan-Meier technique. 1. histologically or cytologically documented solid tumor malignancies, including but not limited to 1 of the following: UBC, Metastatic PDAC, TNBC; Are intolerant, are ineligible for, or have refused treatment with standard first-line therapy; 2. It is not yet known whether giving radiation therapy and durvalumab with or without tremelimumab will work better in treating participants with bladder cancer. Olaparib is an inhibitor of PARP, an enzyme that helps repair deoxyribonucleic acid (DNA) when it becomes damaged. 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). Median PFS was calculated using the Kaplan-Meier technique. Giving durvalumab, tremelimumab, and radiation therapy may work better at treating high risk soft-tissue sarcoma.
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