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Histologically or cytologically-documented, advanced solid tumor of one of the following |
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types |
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Anal Squamous Cell Carcinoma |
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Biliary Adenocarcinoma (gallbladder or biliary tree (intrahepatic or extrahepatic cholangiocarcinoma) except Ampulla of Vater cancers) |
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Neuroendocrine Tumors (well- and moderately-differentiated) of the lung, appendix, small intestine, colon, rectum, or pancreas |
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Endometrial Carcinoma (sarcomas and mesenchymal tumors are excluded) |
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Cervical Squamous Cell Carcinoma |
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Vulvar Squamous Cell Carcinoma |
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Small Cell Lung Carcinoma |
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Mesothelioma |
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Thyroid Carcinoma |
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Salivary Gland Carcinoma (sarcomas and mesenchymal tumors are excluded) |
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Any advanced solid tumor, with the exception of colorectal carcinoma (CRC), which is Microsatellite Instability (MSI)-High (MSI-H) OR |
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Any advanced solid tumor (including Colorectal Carcinoma [CRC]) which is Mismatch Repair Deficient (dMMR)/MSI-H in participants from mainland China who are of Chinese descent. (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 |
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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 |
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Note: For participants to be eligible for enrollment they must have failed at least one |
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line of standard of care systemic therapy (ie, not treatment naïve), with the exception of |
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CRC participants who must have failed at least 2 lines of standard of care systemic |
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therapy, as per CRC specific eligibility criteria. Participants must not have melanoma or |
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NSCLC |
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Progression of tumor or intolerance to therapies known to provide clinical benefit |
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There is no limit to the number of prior treatment regimens |
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Can supply tumor tissue for study analyses (dependent on tumor type) |
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Radiologically-measurable disease |
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Performance status of 0 or 1 on the Eastern Cooperative Oncology Group (ECOG) |
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Life expectancy of at least 3 months |
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Performance Scale within 3 days prior to first dose of pembrolizumab |
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Adequate organ function |
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Female participants of childbearing potential must be willing to use adequate |
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contraception during the intervention period and for at least the time needed to |
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eliminate each study intervention after the last dose of study intervention. and |
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agrees not to donate eggs (ova, oocytes) to others or freeze/store for her own use for |
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the purpose of reproduction during this period. The length of time required to |
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continue contraception for each study intervention is as follows: MK-3475 (120 days) |
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Active autoimmune disease that has required systemic treatment in the past 2 years
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Known active central nervous system (CNS) metastases and/or carcinomatous meningitis
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Currently participating and receiving study therapy or has participated in a study of
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Has known glioblastoma multiforme of the brain stem
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an investigational agent and received study therapy or used an investigational device
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within 4 weeks of the first dose of study treatment
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Diagnosis of immunodeficiency or receiving systemic steroid therapy or any other form
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Active infection requiring systemic therapy
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of immunosuppressive therapy within 7 days prior to the first dose of study treatment
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Prior anti-cancer monoclonal antibody (mAb) within 4 weeks prior to study Day 1 or not
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Known history of Human Immunodeficiency Virus (HIV)
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recovered from an adverse event caused by mAbs administered more than 4 weeks earlier
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Known active Hepatitis B or C
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Prior chemotherapy, targeted small molecule therapy, or radiation therapy within 2
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Received live vaccine within 30 days of planned start of study treatment
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weeks of study Day 1 or not recovered from adverse events caused by a previously
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administered agent
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Known additional malignancy within 2 years prior to enrollment with the exception of
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Known history of active tuberculosis (TB, Bacillus tuberculosis)
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Has had an allogenic tissue/solid organ transplant
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curatively treated basal cell carcinoma of the skin, squamous cell carcinoma of the
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skin and/or curatively resected in situ cancers
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Has a history of (noninfectious) pneumonitis/interstitial lung disease that required
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steroids or has current pneumonitis/interstitial lung disease
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Known psychiatric or substance abuse disorders that would interfere with the
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participant's ability to cooperate with the requirements of the study
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Pregnant, breastfeeding, or expecting to conceive or father children within the
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projected duration of the study, starting with the screening visit through 120 days
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after the last dose of study treatment
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Previously participated in any other pembrolizumab (MK-3475) study, or received prior
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therapy with an anti-programmed cell death (PD)-1, anti-PD-Ligand 1 (anti-PD-L1)
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anti-PD-Ligand 2 (anti-PD-L2), or any other immunomodulating mAb or drug specifically
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targeting T-cell co-stimulation or checkpoint pathways
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Has severe hypersensitivity (≥Grade 3) to pembrolizumab and/or any of its excipients
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