About AstraZeneca in lung cancer Each study drug, durvalumab and tremelimumab, targets a different signal that may be stopping the body's immune system from killing the cancer. 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). Tremelimumab (T) is a selective human IgG2 mAb against CTLA-4. The first published tremelimumab clinical trial included 34 melanoma, one colon cancer, and four renal cell carcinoma (RCC) patients. 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. 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). DCR was determined programmatically based on RECIST 1.1 using site Investigator data and all data up until the first progression event. Clinical trials are research studies that involve people. 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. 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. 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. 95% CIs were calculated using the Clopper Pearson method. 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 purpose of this pilot clinical trial was to test the antitumor and antiviral effect of tremelimumab in patients with hepatocellular carcinoma (HCC) and chronic hepatitis C virus (HCV) … 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 . 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). The time of the initial response was defined as the latest of the dates contributing toward the first visit response of CR or PR. Individual Participant Data (IPD) Sharing Statement: Qualified researchers can request access to anonymized individual patient-level data from AstraZeneca group of companies sponsored clinical trials via the request portal. OS was defined as the time from the date of first dose until death due to any cause. You have reached the maximum number of saved studies (100). Giving durvalumab together with chemotherapy and radiation therapy before surgery may work better at treating patients with esophageal or gastroesophageal junction cancer. 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. ... Clinical trial identification. Experimental: Escalation: 3 mg/kg Durva + 1 mg/kg Treme. For details of our timelines, please rerefer to our disclosure commitment at: https://astrazenecagrouptrials.pharmacm.com/ST/Submission/Disclosure. microbes). 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. Each drug takes about 1 hour. Stereotactic body radiation therapy uses special equipment to position a patient and deliver radiation to tumors with high precision. All trials on the list are supported by NCI. Radiation therapy uses high energy x-rays to kill tumor cells and shrink tumors. Durvalumab and tremelimumab is a monoclonal antibody that may interfere with the ability of tumor cells to grow and spread. About The Trial. Choosing to participate in a study is an important personal decision. PARP inhibitors, such as olaparib, can keep PARP from working, so tumor cells can't repair themselves, and they may stop growing. Signed Data Sharing Agreement (non-negotiable contract for data accessors) must be in place before accessing requested information. The BoR was summarized by percentage of patients for each category (CR, PR, SD, PD, and NE). The first time you have the drugs there will be a 1 hour gap between MEDI4736 and tremelimumab. Study record managers: refer to the Data Element Definitions if submitting registration or results information. Combining the actions of these drugs may result in better treatment options for patients with breast cancer. 95% CIs were calculated using the Clopper Pearson method. 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 … ... Durvalumab, in combination with tremelimumab, has shown clinical activity in patients with advanced NSCLC in a phase 1 and 2 investigation. Median DoR was calculated using the Kaplan-Meier technique. 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. D and D + T demonstrated a tolerable safety profile and antitumour activity in pretreated extensive stage SCLC. Optional extended treatment comprised durvalumab monotherapy administered at the recommended fixed dose of 1500 mg Q4W. 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. Tremelimumab works by interacting with an immune molecule called CTLA-4, located on white blood cells. Somatic hypermutation is a cellular mechanism that happens when the immune system adapts to a new foreign element (e.g. OS is presented from start of tremelimumab monotherapy phase and includes the retreatment phase if the patient entered the corresponding treatment phase. Listing a study does not mean it has been evaluated by the U.S. Federal Government. History of leptomeningeal carcinomatosis; 3. 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. 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. Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02527434. Monoclonal antibodies, such as durvalumab and tremelimumab, 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. 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. 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. It is an immune checkpoint blocker. Active or prior documented autoimmune or inflammatory disorders; 4. 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. MEDI4736 and tremelimumab You have MEDI4736 and tremelimumab, as a drip into a vein every 4 weeks. 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. 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. 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. The clinical trials on this list are studying Tremelimumab. Abstract. OS during the retreatment phase was defined as the time from the date of first dose until death due to any cause. 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). 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. 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: 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. Giving durvalumab, tremelimumab, and radiation therapy may work better than radiation therapy alone in treating patients with hepatocellular carcinoma or biliary tract cancer. Tremelimumab blocks the activity of CTLA-4, contributing to T cell activation, priming the immune response to cancer and fostering cancer cell death. 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. Both durvalumab and tremelimumab are antibodies (proteins used by the immune system to fight infections and cancers).