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- Check4 days agoChange DetectedThe study has been updated to version v2.10.0, replacing the previous version v2.9.7.SummaryDifference0.3%
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- Check11 days agoChange DetectedThe website has been updated to Revision v2.9.7 from v2.9.6.SummaryDifference0.1%
- Check25 days agoChange DetectedThe value of Revision has been updated from v2.9.5 to v2.9.6, indicating a recent change in the webpage content.SummaryDifference0.1%
- Check30 days agoChange DetectedThe value of Revision has been updated from v2.9.3 to v2.9.5, indicating a recent revision in the content of the webpage.SummaryDifference0.1%
- Check31 days agoChange DetectedThe value of Revision has been updated from v2.9.1 to v2.9.3, indicating a recent revision in the content of the webpage.SummaryDifference0.1%
- Check32 days agoChange DetectedThe value 'Show more Show more Revision: v2.9.0' has been updated to 'Show less MedlinePlus Genetics related topics: Breast cancer MedlinePlus related topics: Breast Cancer Hormones FDA Drug and Device Resources Show less Design Details Primary Purpose : Treatment Allocation : N/A Interventional Model : Single Group Assignment Masking : None (Open Label) Arms and Interventions Participant Group/Arm Intervention/Treatment Experimental : Treatment (M7824, radiation therapy) Patients receive M7824 IV over 1 hour every 14 days. Cycles repeat every 28 days in the absence of disease progression or unacceptable toxicity. Beginning within 3 days after second dose of M7824, patients undergo radiation therapy QD for 5-10 days depending on the site of disease in the absence of disease progression or unacceptable toxicity. Drug : Bintrafusp Alfa Given IV Other Names: Anti-PDL1/TGFb Trap MSB0011359C M7824 MSB0011359C Radiation : Radiation Therapy Undergo radiation therapy Other Names: Cancer Radiotherapy Irradiate Irradiated irradiation Radiation Radiation Therapy, NOS Radiotherapeutics RADIOTHERAPY RT Therapy, Radiation Primary Outcome Measures Outcome Measure Measure Description Time Frame Recommended phase II dose (RP2D) of M7824 and radiation therapy in patients with metastatic HR+/HER2- breast cancer Will be determined by dose limiting toxicity. RP2D defined as the highest dose level with no more than 1 patient with DLT out of 6 patients that are treated. 6 weeks after first administration of M7824 Safety and tolerability in patients with metastatic HR+/HER2- breast cancer Will be graded according to the Common Terminology Criteria for Adverse Events (CTCAE) version (v) 4.03. Recommended phase 2 dose (RP2D) will be determined by '3+3' design, and the recommended phase II dose is defined when 6 patients have been treated on that dose with no more than 1 dose limiting toxicity (DLT). DLT will be evaluated within 6 weeks after first administration of anti-PD-L1/TGFbetaRII fusion protein M7824 (M7824). Detailed information collected for each adverse event (AE) will include a description of the event, duration, severity, relationship to study treatment, action taken, and clinical outcome. Severity of AEs will be graded according to the CTCAE v 4.0. Summary of AEs will include only AEs that started or worsened during the on-treatment period, the treatment-emergent AEs. However, all safety data (including those from the pre- and post-treatment periods) will be listed and those collected during the pre- and post-treatment are to be flagged. Start of study drug up to 30 days after study drug stopped Secondary Outcome Measures Outcome Measure Measure Description Time Frame Progression-free survival (PFS) PFS is defined as the time from treatment until objective tumor progression or death, whichever occurs first. Start of study drug up to 90 days after study drug stopped Overall survival (OS) OS is defined as the time from treatment until death from any cause. Start of study drug up to 90 days after study drug stopped Immunologic/molecular response Immunologic/molecular response is defined as % change in tumor infiltrating lymphocytes (TIL) pre and post therapy to M7824 and radiation therapy in patients with HR+/HER2- metastatic breast cancer. Up to 56 days Evaluation of the size of metastasis after treatment with M7824 with radiation (in-field) and non-irradiated (abscopal) sites Will be determined by Response Evaluation Criteria in Solid Tumors 1.1 criteria. Up to 56 days Additional Relevant MeSH Terms Neoplasms by Site Neoplasms Breast Diseases Skin Diseases Breast Neoplasms Immune Checkpoint Inhibitors Molecular Mechanisms of Pharmacological Action Antineoplastic Agents, Immunological Antineoplastic Agents Atezolizumab Studies a U.S. FDA-Regulated Drug Product Yes Studies a U.S. FDA-Regulated Device Product No Helpful Links Provided by M.D. Anderson Cancer Center MD Anderson Cancer Center Website Revision: v2.9.1'. This change represents an update in the content of the webpage related to a clinical trial involving the treatment of metastatic hormone receptor positive, HER2 negative breast cancer with M7824 and radiation therapy, detailing primary and secondary outcome measures, study design, and relevant study information.SummaryDifference27%
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