tremelimumab clinical trials

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 … Giving durvalumab, tremelimumab, and radiation therapy may work better than radiation therapy alone in treating patients with hepatocellular carcinoma or biliary tract cancer. 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: 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. 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. AstraZeneca will meet or exceed data availability as per the commitments made to the EFPIA Pharma Data Sharing Principles. Durvalumab targets a signal on tumor cells and tremelimumab targets a signal on immune cells. 95% CIs were calculated using the Clopper Pearson method. It has been undergoing human trials for the treatment of various cancers but has not attained approval for any. tremelimumab monotherapy, with the option for eligible patients to be sequenced to MEDI4736 monotherapy or MEDI4736 + tremelimumab combination therapy after progressive disease (PD). Antibodies are normally made by the body to destroy germs, like bacteria and viruses. 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. The goal of this clinical trial is to test the safety and the effectiveness of both durvalumab and tremelimumab. 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 ... Over 60,000 cancer patients enrolled on clinical trials in … 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. MEDI4736 and tremelimumab You have MEDI4736 and tremelimumab, as a drip into a vein every 4 weeks. The first time you have the drugs there will be a 1 hour gap between MEDI4736 and tremelimumab. 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. 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. The clinical trials on this list are studying Tremelimumab. Any concurrent chemotherapy, biologic, or hormonal therapy for cancer Treatment; 2. 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. Abstract. 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. 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. 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 … 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. 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: 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). The BoR was summarized by percentage of patients for each category (CR, PR, SD, PD, and NE). Location: University of Kentucky / Markey Cancer Center, Lexington, Kentucky, This phase II trial studies how well durvalumab and tremelimumab work in treating patients with liver cancer undergoing drug-eluting bead transarterial chemoembolization. DCR was determined programmatically based on RECIST 1.1 using site Investigator data and all data up until the first progression event. Tremelimumab is being tested in a clinical trial programme in combination with Imfinzi in NSCLC, … Radiation therapy uses high energy x-rays to kill tumor cells and shrink tumors. Talk to your doctor for help in deciding if one is right for you. At least 1 lesion, not previously irradiated, that can be accurately measured at baseline as ≥10 mm in the longest diameter (except lymph nodes, which must have short axis ≥15 mm) with computed tomography (CT) (preferred) or magnetic resonance imaging (MRI) scans and that is suitable for accurate repeated measurements. 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. About The Trial. Each study drug, durvalumab and tremelimumab, targets a different signal that may be stopping the body's immune system from killing the cancer. Median DoR was calculated using the Kaplan-Meier technique. 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. Brachytherapy, also known as internal radiation therapy, uses radioactive material placed directly into or near a tumor to kill tumor cells. Radiation therapy uses high energy x-rays to kill tumor cells and shrink tumors. 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 You have reached the maximum number of saved studies (100). D demonstrated a PFS and OS advantage over placebo in locally advanced NSCLC following cCRT. Location: UCLA / Jonsson Comprehensive Cancer Center, Los Angeles, California, Complementary & Alternative Medicine (CAM), Coping with Your Feelings During Advanced Cancer, Late Effects of Childhood Cancer Treatment, Frederick National Laboratory for Cancer Research, Milestones in Cancer Research and Discovery, Tech Transfer & Small Business Partnerships, Step 1: Application Development & Submission, How to Work With Your Health Insurance Plan, Questions to Ask about Treatment Clinical Trials, Drugs Approved for Different Types of Cancer, Drugs Approved for Conditions Related to Cancer, Testing the Addition of an Immunotherapy Drug, Tremelimumab, to the PARP Inhibition Drug, Olaparib, for Recurrent Ovarian, Fallopian Tube or Peritoneal Cancer, Study of Durvalumab + Tremelimumab, Durvalumab, and Placebo in Limited Stage Small-Cell Lung Cancer in Patients Who Have Not Progressed Following Concurrent Chemoradiation Therapy, Study of Durvalumab and Tremelimumab as First-line Treatment in Patients With Advanced Hepatocellular Carcinoma, Study of Durvalumab Given With Chemotherapy, Durvalumab in Combination With Tremelimumab Given With Chemotherapy, or Chemotherapy in Patients With Unresectable Urothelial Cancer, Testing the Addition of an Individualized Vaccine to Nab-Paclitaxel, Durvalumab and Tremelimumab and Chemotherapy in Patients with Metastatic Triple Negative Breast Cancer, Tremelimumab in Treating Patients with Previously Treated Metastatic Urothelial Cancer, Durvalumab and Tremelimumab in Treating Patients with Relapsed or Refractory Germ Cell Tumors, Durvalumab, an Anti-PDLI Antibody, Tremelimumab, an Anti-CTLA4 Antibody, and Chemoradiation before Surgery for Esophageal Cancer, A Phase 1 / 2 Study of In Situ Vaccination With Tremelimumab and IV Durvalumab Plus PolyICLC in Subjects With Advanced, Measurable, Biopsy-accessible Cancers, Durvalumab and Tremelimumab for Pediatric Malignancies, Durvalumab, Tremelimumab, and Radiation Therapy in Treating Patients with Unresectable, Locally Advanced, or Metastatic Hepatocellular Carcinoma or Biliary Tract Cancer, Durvalumab, Tremelimumab, and Radiation Therapy in Treating Participants with High Risk Soft-Tissue Sarcoma, Stereotactic Body Radiation Therapy, Tremelimumab and Durvalumab in Treating Participants with Recurrent or Metastatic Cervical, Vaginal, or Vulvar Cancers, Durvalumab, Tremelimumab, and Radiation Therapy in Treating Patients with Gynecologic Cancer That Is Metastatic or Cannot Be Removed by Surgery, 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, Durvalumab and Tremelimumab in Treating Patients with Recurrent or Refractory Ovarian, Primary Peritoneal, or Fallopian Tube Cancer, Durvalumab and Tremelimumab in Treating Patients with Metastatic HER2 Negative Breast Cancer, Durvalumab and Tremelimumab for the Treatment of Stage II-IIIB Non-small Cell Lung Cancer, Brachytherapy with Durvalumab or Tremelimumab for the Treatment of Patients with Platinum-Resistant, Refractory, Recurrent, or Metastatic Gynecological Malignancies, Durvalumab and Tremelimumab in Combination with Platinum-based Chemotherapy for the Treatment of Patients with Untreated Extensive-Stage Small Cell Lung Cancer, Durvalumab with or without Tremelimumab or Olaparib after Thoracic Radiation Therapy in Treating Patients with Extensive Stage-Small Cell Lung Cancer, Durvalumab and Tremelimumab in Treating Patients with Somatically Hypermutated Recurrent or Refractory Solid Tumors, Durvalumab and Tremelimumab in Treating Patients with Liver Cancer Undergoing Drug-Eluting Bead Transarterial Chemoembolization, Stereotactic Body Radiation Therapy and Durvalumab with or without Tremelimumab before Surgery in Treating Patients with Human Papillomavirus Positive Oropharyngeal Squamous Cell Caner, Radiation Therapy and Durvalumab with or without Tremelimumab in Treating Participants with Unresectable, Locally Advanced, or Metastatic Bladder Cancer, U.S. Department of Health and Human Services. It may prevent cancer growth by helping certain blood cells of the immune system get rid of the tumor. NCI’s basic information about clinical trials explains the types and phases of trials and how they are carried out. 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. HCC is the most common type of liver cancer. Median OS was calculated using the Kaplan-Meier technique. 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. 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 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. 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 All trials on the list are supported by NCI. Extensive-stage small cell lung cancer is associated with aggressive biology and poor outcomes. Median PFS was calculated using the Kaplan-Meier technique. Please remove one or more studies before adding more. 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]). Tremelimumab blocks the activity of CTLA-4, contributing to T cell activation, priming the immune response to cancer and fostering cancer cell death. 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. 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. DCR was determined programmatically based on RECIST 1.1 using site Investigator data and all data up until the first progression event. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. Radiation therapy uses high energy rays to kill tumor cells and shrink tumors. Signed Data Sharing Agreement (non-negotiable contract for data accessors) must be in place before accessing requested information. Combining the actions of these drugs may result in better treatment options for patients with breast cancer. Optional extended treatment comprised durvalumab monotherapy administered at the recommended fixed dose of 1500 mg Q4W. The 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 lower viral load showed mutations in the hypervariable region 1 of hepatitis C virus. 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. 2020 May;143:1-11. doi: 10.1016/j.lungcan.2020.02.016. 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). 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). Both durvalumab and tremelimumab are antibodies (proteins used by the immune system to fight infections and cancers). 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. Radiation therapy uses high energy x-rays to kill tumor cells and shrink tumors. Lung Cancer. Radiation therapy uses high-energy x-rays to kill tumor cells and shrink tumors. Durvalumab attaches to a protein in tumors called PD-L1. Trial design. 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).

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