Using linear transformation, raw scores are standardized, so that scores range from 0 to 100. Azacitidine will be administered i.v or s.c. This book provides the immune oncology (IO) community with a deeper understanding of the scope of the biomarker methods to potentially improve the outcome from immunotherapy. Information provided by (Responsible Party): This trial will seek to extend the preliminary findings of efficacy of MBG453 in combination with hypomethylating agents (HMA) by evaluating MBG453 in combination with the HMA azacitidine and the Bcl-2 inhibitor venetoclax. History of severe hypersensitivity reactions to any ingredient of the study treatment (azacitidine, decitabine or MGB453) or their excipients, or to monoclonal antibodies (mAbs). This is an adaptive two-stage phase II clinical trial to assess the activity of the anti-TIM-3, (T cell immunoglobulin domain and mucin domain) antibody, MBG453, in patients with lower-risk myelodysplastic syndromes (MDS), not eligible for or progressing on frontline therapy. Found inside – Page 357Investigational Drug Class gov Drugs Phase Myelofibrosis Setting Identifier AURKA inhibitor Alisertib I/II R/R to RUX ... and itacitinib (INCB039110) are JAK inhibitors actively being investigated in late-phase clinical trials in MF. The Huntsman Cancer Institute has researchers who treat, find and diagnose, prevent, and manage cancer and side effects from treatment. Novartis Clinical Trials. Amer M. Zeidan, Jordi Esteve, Aristoteles Giagounidis, Hee-Je Kim, Yasushi Miyazaki, Uwe Platzbecker, Andre C. Schuh, Mikkael A. Sekeres, Jörg Westermann, Zhijian Xiao, Kamel Malek, Jeffrey Scott, Julie Niolat, Severine Peyrard, Fei Ma, Flavia Kiertsman, Mario Stegert, Sabine Hertle, Pierre Fenaux, Valeria Santini; The STIMULUS Program: Clinical Trials Evaluating Sabatolimab (MBG453 … Member State Concerned. Prior therapy with immune check point inhibitors (e.g. A.2. Not eligible at the time of screening, for hematopoietic stem-cell transplantation (HSCT) according to the investigator, based on local standard medical practice and institutional guidelines for treatment decisions. Found inside – Page 139TABLE 2 | Current clinical trials of checkpoint blockade molecules. ... Locally advanced or metastatic solid tumors Advanced malignancies LY3321367 MBG453 Spartalizumab (anti-PD1 Ab) MBG453 MBG453 PDR001 (anti-PD1 Ab) INCAGN02390 ... Choosing to participate in a study is an important personal decision. EORTC-QLQ-C30 is a 30-item questionnaire developed to assess the quality of life of cancer patients. The purpose of this first-in-human study of MBG453 is to characterize the safety, tolerability, pharmacokinetics, pharmacodynamics and anti-tumor activity of MBG453 administered i.v. Cumulative times of intervals with no evidence of Red Blood Cell (RBC) transfusion for at least 8 weeks after randomization. To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor. The STIMULUS clinical trial program is evaluating the efficacy and safety of MBG453 combination therapy in pts with HR-MDS or AML. The immune system harbors great potential for controlling and eliminating tumors. Recent developments in the field of immuno-oncology has led to unprecedented clinical benefits for a broad spectrum of solid tumors. Topical, inhaled, nasal, ophthalmic steroids are allowed. The total score ranges from 0 to 52 with higher values representing better quality of life. The book examines recent results, publications and current areas of interest including 'immune editing' and the specific issues that are affecting the research and development of vaccines, providing insight into how these problems may be ... Eastern Cooperative Oncology Group (ECOG) performance status of 0, 1 or 2. Found insideSCID/athymic mice lacking adaptive immune system). This latter practice played a detrimental role in appreciating the role of anticancer immunity in cancer therapy. Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03946670. Found insideImmunological Concepts in Transfusion Medicine provides a thorough discussion of the immune aspects of blood component transfusion, with in-depth information on the intricacies of immune responses to blood components and the immune ... For all subjects, TP53wt status must be characterized by, at a minimum, no mutations noted in exons 5, 6, 7 and 8. EORTC-QLQ-C30 is a 30-item questionnaire developed to assess the quality of life of cancer patients. Nonetheless, numerous incremental technical advances remain to be achieved. Thus, this volume highlights the possible R&D paths, which will ultimately facilitate clinical delivery of cutting edge curative products. A dose of Placebo 800 mg will be administered intravenously every 4 weeks (Q4W). Patients will take MBG453 plus hypomethylating agents. A.3. Information provided by (Responsible Party): Participants will receive MBG453 plus Azacitidine. A high score indicates a high / healthy level of functioning. To characterize the safety and tolerability of 1) MBG453 as a single agent or in combination with PDR001 or 2) PDR001 and/or MBG453 in combination with decitabine or azacitidine in AML and intermediate or high- risk MDS patients, and to identify recommended doses for future studies. Percentage of subjects with at least 3 point confirmed improvement from baseline will be presented. Sabatolimab is being evaluated for treatment of patients (pts) with intermediate to very high risk MDS or AML … You have reached the maximum number of saved studies (100). Percentage of subjects with at least 10 point confirmed improvement from baseline in physical functioning will be presented. The register also displays information on 18700 older paediatric trials (in scope of Article 45 of the Paediatric Regulation (EC) No 1901/2006). This volume records some of the scientific highlights of the 16th such annual con ference, and is a witness to the continuing evolution and popularity of leukocyte culture and of immunology. A Phase 1/2 trial ( NCT02608268 ) is investigating the safety and effectiveness of MBG453, either alone or combined with another immunotherapy, in patients with solid tumors. Two study designs from the STIMULUS clinical trial program are described. Talk with your doctor and family members or friends about deciding to join a study. Found inside – Page 271These molecules, including blocking anti-LAG-3 antibodies (relatlimab) and soluble LAG-3–Ig fusion proteins, showed some activity in early-stage clinical trials, when administered as a monotherapy or in combination (NCT02720068; ... ICH GCP. Interventional study (clinical trial) — studies new tests, treatments, drugs, surgical procedures or devices. The EU Clinical Trials Register currently displays 40400 clinical trials with a EudraCT protocol, of which 6609 are clinical trials conducted with subjects less than 18 years old. The purpose of this first-in-human study of MBG453 is to characterize the safety, tolerability, pharmacokinetics, pharmacodynamics and anti-tumor activity of MBG453 administered i.v. Novartis today announced that the US Food and Drug Administration (FDA) has granted fast track designation for sabatolimab (MBG453) for the treatment of adult patients with myelodysplastic syndromes (MDS) defined with an IPSS-R risk category of high or very high risk in combination with hypomethylating agents. Found insideThis book systematically reviews the most important findings on cancer immune checkpoints, sharing essential insights into this rapidly evolving yet largely unexplored research topic. Found inside – Page 62Clinical Cancer Research. 2017. ... Available from: https://clinicaltrials.gov [Acce ssed: 2018-01-27] Clinical Trial.gov [Internet]. ... Study of PDR 001 and/or MBG453 in combination with Decitabine with AML or high risk MDS. ClinicalTrials.gov Identifier: NCT04150029, Interventional Found inside – Page 246Till now, an anti-LAG3 monoclonal antibody (BMS-986016) was put under scrutiny in two clinical trials in advanced lung cancer (Phase I NCT02966548 and phase I/IIa NCT01968109) alone or in combination with an anti-PD-1 antibody [11]. The primary purpose of Part 1 (Safety Run-in) is to rule out excessive toxicity of MBG453, when administered in combination with azacitidine and venetoclax. Signed informed consent must be obtained prior to participation in the study. The EQ-5D-5L comprises 5 dimensions: mobility, self-care, usual activities, pain/discomfort, anxiety/depression. (STIMULUS-MDS1) The safety and scientific validity of this study is the responsibility of … FACIT-Fatigue score is a 13-item questionnaire designed to assess fatigue in cancer patients. However, previous treatment with hydroxyurea or leukopheresis to reduce WBC count is allowed prior to randomization. Divided into sections to allow quick access to the necessary information, this title covers general principles of diagnosis and treatment, short and long term care, and oncological emergencies, before moving on to chapters on specific ... This is a Phase III multi-center, randomized, two-arm parallel-group, double-blind, placebo controlled study of MBG453 or placebo added to azacitidine in adult subjects with intermediate, high or very high risk myelodysplastic syndrome (MDS) as per IPSS-R, or Chronic Myelomonocytic Leukemia-2 (CMML-2). Found inside – Page 287An anti-TIM-3 mAb (MBG453, Novartis) has recently entered clinical testing in a Phase I trial for advanced malignancies, as a monotherapy or in combination with an anti-PD-1 mAb (NCT02608268). The EU Clinical Trials Register currently displays 40593 clinical trials with a EudraCT protocol, of which 6635 are clinical trials conducted with subjects less than 18 years old. The register also displays information on 18700 older paediatric trials (in scope of Article 45 of the Paediatric Regulation (EC) No 1901/2006). Two treatment arms will enroll subjects in parallel to characterize the safety, tolerability, PK, PD and preliminary … For all subjects, TP53wt status must be characterized by, at a minimum, no mutations noted in exons 5, 6, 7 and 8. A Study of MBG453 in Combination With Azacitidine and Venetoclax in AML Patients Unfit for Chemotherapy (STIMULUS-AML1) The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Individual Participant Data (IPD) Sharing Statement: Studies a U.S. FDA-regulated Drug Product: Studies a U.S. FDA-regulated Device Product: Complete remission (CR) rate [ Time Frame: 7 months after last patient first visit (LPFV) ], Progression Free Survival (PFS) [ Time Frame: Up to 4 yrs after Last Patient First Visit (LPFV) ], Overall Survival [ Time Frame: Up to 4 years after LPFV ], Event Free Survival [ Time Frame: Up to 4 years after LPFV ], Leukemia-free survival [ Time Frame: Up to 4 yrs after Last Patient First Visit (LPFV) ], Response Rate (CR/mCR/PR/HI) [ Time Frame: 7 months after Last Patient First Visit (LPFV) ], Duration of complete remission [ Time Frame: Up to 4 yrs after Last Patient First Visit (LPFV) ], Time to complete remission [ Time Frame: 7 months after Last Patient First Visit (LPFV) ], Percent of subjects who are red blood cells (RBC)/platelets transfusion independent after randomization as per IWG-MDS [ Time Frame: Up to 4 years after last randomized patient ], Red blood cells (RBC)/platelets transfusion independence duration after randomization [ Time Frame: Up to 4 years after last randomized patient ], Serum concentrations for MBG453 [ Time Frame: At Day 8 of each cycle (1 cycle = 28 days) until cycle 6 and at day 8 of cycles 9, 12, 18 and 24, and up to 150 day of the safety follow up period ], Immunogenicity of MBG453 when given in combination of hypomethylating agents [ Time Frame: Up to 4 years after Last Patient First Visit (LPFV) ]. Efficacy and safety have not been established. Found inside – Page 124Table 2 Immune checkpoint inhibitors in clinical trial. ... 2 2 AB154 Arcus Bio 1, 2 1 BGB-A1217 BeiGene 1 1 M6223 Merck 1 1 COM902 Compugen 1 Tim-3 2 INCAGN02390 Agenus 1, 2 9 MBG453 Novartis 1, 2, 3 4 TSR-022 Tesaro 1, ... Replacement therapy, steroids given in the context of a transfusion are allowed and not considered a form of systemic treatment. Keywords provided by Novartis ( Novartis Pharmaceuticals ): Why Should I Register and Submit Results? Found insideTrial NEOANTIGEN VACCINE Ability of a Dendritic Cell Vaccine to Immunize Melanoma or Epithelial Cancer Patients Against ... LY3300054 in Participants with Advanced Relapsed/Refractory Solid Tumors Safety and Efficacy of MBG453 as Single ... Patients and Methods: Primary objectives … Information provided by (Responsible Party): This Phase II is a multicenter, randomized, two-arm parallel-group, double-blind, placebo-controlled study of MBG453 or placebo added to hypomethylating agents (azacitidine or decitabine) in adult subjects with IPSS-R intermediate, high or very high risk myelodysplastic syndrome (MDS) not eligible for Hematopoietic Stem Cell Transplant (HSCT) or intensive chemotherapy. Found inside – Page 426TABLE 2 Overview of therapeutic antibodies targeting NK cell checkpoints (excluded from the list are anti-CTLA-4 and anti-PD-1 antibody trials)—cont'd Receptor Antibody Active clinical trials Phase MBG453 Advanced solid tumors ... Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04266301. Prior exposure to TIM-3 directed therapy at any time. MBG453 is an anti-TIM-3 monoclonal antibody in a pivotal Phase 2 trial for myelodysplastic syndrome. Current use or use within 14 days prior to randomization of systemic, steroid therapy (> 10 mg/day prednisone or equivalent) or any immunosuppressive therapy. The purpose of this first-in-human study of MBG453 is to characterize the safety, tolerability, pharmacokinetics, pharmacodynamics and anti-tumor activity of MBG453 administered i.v. Investigational treatment for MDS received within 4 weeks prior to randomization. Scope and fascinating appeal of immunology standard clinical practice the integral focus of the highlights! And clinical research on cancer immunotherapy potential for controlling and eliminating tumors or 2 spartalizumab! This volume highlights the possible R & D paths, which will ultimately facilitate clinical delivery of cutting curative... Are scored on a 5-point scale ranging from 0 to 4 ( at! And Rare Diseases information Center, Myelodysplastic/myeloproliferative disease, U.S. Department of health and Human Services no evidence of Blood! 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