and agrees not to donate eggs (ova, oocytes) to others or freeze/store for her own use for the purpose of reproduction during this period. Female participants of childbearing potential must be willing to use adequate contraception during the intervention period and for at least the time needed to eliminate each study intervention after the last dose of study intervention.Performance status of 0 or 1 on the Eastern Cooperative Oncology Group (ECOG) Performance Scale within 3 days prior to first dose of pembrolizumab.Can supply tumor tissue for study analyses (dependent on tumor type).There is no limit to the number of prior treatment regimens Progression of tumor or intolerance to therapies known to provide clinical benefit.Participants must not have melanoma or NSCLC. Note: For participants to be eligible for enrollment they must have failed at least one line of standard of care systemic therapy (ie, not treatment naïve), with the exception of CRC participants who must have failed at least 2 lines of standard of care systemic therapy, as per CRC specific eligibility criteria. Any advanced solid tumor that has failed at least one line of therapy and is TMB-H (≥10 mut/Mb, F1CDx assay), excluding dMMR/MSI-H tumors.(CRC participants will have a histologically proven locally advanced unresectable or metastatic CRC which is dMMR/MSI-H that has received 2 prior lines of therapy) OR Any advanced solid tumor (including Colorectal Carcinoma ) which is Mismatch Repair Deficient (dMMR)/MSI-H in participants from mainland China who are of Chinese descent.Any advanced solid tumor, with the exception of colorectal carcinoma (CRC), which is Microsatellite Instability (MSI)-High (MSI-H) OR.Salivary Gland Carcinoma (sarcomas and mesenchymal tumors are excluded).Endometrial Carcinoma (sarcomas and mesenchymal tumors are excluded).Neuroendocrine Tumors (well- and moderately-differentiated) of the lung, appendix, small intestine, colon, rectum, or pancreas.Biliary Adenocarcinoma (gallbladder or biliary tree (intrahepatic or extrahepatic cholangiocarcinoma) except Ampulla of Vater cancers).Histologically or cytologically-documented, advanced solid tumor of one of the following types:. Official TitleĪ Clinical Trial of Pembrolizumab (MK-3475) Evaluating Predictive Biomarkers in Subjects With Advanced Solid Tumors (KEYNOTE 158) KeywordsĪdvanced Cancer, Anal Carcinoma, Anal Cancer, Biliary Cancer, Cholangiocarcinoma, Bile Duct Cancer, Neuroendocrine Tumor, Carcinoid Tumor, Endometrial Carcinoma, Endometrial Cancer, Cervical Carcinoma, Cervical Cancer, Vulvar Carcinoma, Vulvar Cancer, Small Cell Lung Carcinoma, Small Cell Lung Cancer (SCLC), Mesothelioma, Thyroid Carcinoma, Thyroid Cancer, Salivary Gland Carcinoma, Salivary Gland Cancer, Salivary Cancer, Parotid Gland Cancer, Advanced Solid Tumors, Colorectal Carcinoma, Programmed Cell Death-1 (PD1, PD-1), Programmed Death-Ligand 1 (PDL1, PD-L1), microsatellite instability (MSI), mismatch repair (MMR), Carcinoma, Neoplasms, Endometrial Neoplasms, Thyroid Neoplasms, Neuroendocrine Tumors, Colorectal Neoplasms, Salivary Gland Neoplasms, Anus Neoplasms, Bile Duct Neoplasms, Vulvar Neoplasms, Thyroid Diseases, Pembrolizumab, Pembrolizumab 200 mg, Pembrolizumab 400 mg In this study, participants with multiple types of advanced (unresectable and/or metastatic) solid tumors who have progressed on standard of care therapy will be treated with pembrolizumab (MK-3475).
0 Comments
Leave a Reply. |
AuthorWrite something about yourself. No need to be fancy, just an overview. ArchivesCategories |