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    The value of Revision has been updated from v2.9.3 to v2.9.5, indicating a recent change in the webpage content related to the study details of a Phase II trial investigating the effectiveness of Temozolomide followed by Nivolumab in MMR-proficient colorectal cancer patients.
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    The value 'Show more Revision: v2.9.0' has been updated to 'Drug Information available for: Nivolumab FDA Drug and Device Resources Show less Design Details Primary Purpose : Treatment Allocation : N/A Interventional Model : Single Group Assignment Interventional Model Description: Simon two-stage design, single arm study Masking : None (Open Label) Arms and Interventions Participant Group/Arm Intervention/Treatment Experimental : MMR-Proficient Colorectal Cancer The first 3 subjects will receive oral TMZ at 150mg/m2 day 1 to 5 during cycle 1, followed by nivolumab via IV infusion at 480 mg every four weeks (Q4W) starting 4 weeks after TMZ day 1 (i.e. Cycle 2 day 1). Nivolumab will continue for up for 2 years maximum. If confirmed that TMB increased in at least 2 of 3 subjects following 1 cycle of TMZ, then subsequent patients will continue to receive TMZ during cycle 1 only, and the original three participants will not be replaced. If it is determined that TMB did not increase following 1 cycle of TMZ, then subsequent patients will receive TMZ up to cycle 3, those first 3 patients will discontinue further Nivolumab and be replaced and an additional 6 patients will initially be enrolled. If confirmed that TMB increased in at least 1 of 6 subjects following 3 cycles of TMZ, then 12 more patients will be allowed to enroll for a total of 18 in stage I. Drug : TMZ Oral TMZ at 150mg/m2 Drug : Nivolumab Nivolumab via IV infusion at 480 mg every four weeks (Q4W) starting 4 weeks after TMZ day 1 Primary Outcome Measures Outcome Measure Measure Description Time Frame response rate of TMZ followed by nivolumab in participants with MMR-proficient Colorectal Cancer Response determined by RECIST 1.1 up to 2 years Keywords Provided by Memorial Sloan Kettering Cancer Center MMR-Proficient Colorectal Cancer Temozolomide Nivolumab Memorial Sloan Kettering Cancer Center 18-545 Additional Relevant MeSH Terms Intestinal Neoplasms Gastrointestinal Neoplasms Digestive System Neoplasms Neoplasms by Site Neoplasms Digestive System Diseases Gastrointestinal Diseases Colonic Diseases Intestinal Diseases Rectal Diseases Colorectal Neoplasms Antineoplastic Agents, Immunological Antineoplastic Agents Immune Checkpoint Inhibitors Molecular Mechanisms of Pharmacological Action Nivolumab Plan to Share Individual Participant Data (IPD)? Yes IPD Plan Description Here is the final approved MSK data sharing statement for posting on any trial opened 1/1/19 or later - • Memorial Sloan Kettering Cancer Center supports the international committee of medical journal editors (ICMJE) and the ethical obligation of responsible sharing of data from clinical trials. The protocol summary, a statistical summary, and informed consent form will be made available on clinicaltrials.gov when required as a condition of Federal awards, other agreements supporting the research and/or as otherwise required. Requests for deidentified individual participant data can be made beginning 12 months after publication and for up to 36 months post publication. Deidentified individual participant data reported in the manuscript will be shared under the terms of a Data Use Agreement and may only be used for approved proposals. Requests may be made to: crdatashare@mskcc.org. Studies a U.S. FDA-Regulated Drug Product Yes Studies a U.S. FDA-Regulated Device Product No Helpful Links Provided by Memorial Sloan Kettering Cancer Center Related Info Revision: v2.9.1'
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