Keynote 158 clinical trials.gov skin#
Keynote 158 clinical trials.gov trial#

FluMist®) are live attenuated vaccines and are not allowed.Gastric adenocarcinoma, even when diagnosed at an early (localized) disease stage, poses a major health-care burden with cure rates that remain unsatisfactorily low, particularly in Western countries. Seasonal influenza vaccines for injection are generally killed virus vaccines and are allowed however, intranasal influenza vaccines (e.g. Examples of live vaccines include, but are not limited to, the following: measles, mumps, rubella, varicella/zoster (chicken pox), yellow fever, rabies, Bacillus Calmette-Guérin (BCG), and typhoid vaccine.

Has received a live vaccine within 30 days of planned start of study medication.

Known active Hepatitis B or Hepatitis C.

Known history of human immunodeficiency virus (HIV).

Has previously participated in any other pembrolizumab (MK-3475) trial, or received prior therapy with an anti-PD-1, anti-PD-L1, and anti-PD-L2 (including ipilimumab or any other antibody or drug specifically targeting T-cell co-stimulation or checkpoint pathways).

Keynote 158 clinical trials.gov trial#

Pregnant, breastfeeding, or expecting to conceive or father children within the projected duration of the trial, starting with the pre-screening or screening visit through 120 days after the last dose of trial treatment.Known psychiatric or substance abuse disorders that would interfere with cooperation with the requirements of the trial.Active infection requiring systemic therapy.Has evidence of interstitial lung disease or a history of (non-infectious) pneumonitis that required steroids or has current pneumonitis.Replacement therapy (e.g., thyroxine, insulin, or physiologic corticosteroid replacement therapy for adrenal or pituitary insufficiency, etc.) is not considered a form of systemic treatment with use of disease modifying agents, corticosteroids or immunosuppressive drugs).

Has an active autoimmune disease that has required systemic treatment in past 2 years (i.e.Known active CNS metastases and/or carcinomatous meningitis.

Keynote 158 clinical trials.gov skin#

Known additional malignancy that is progressing or requires active treatment excepting basal cell carcinoma of the skin, squamous cell carcinoma of the skin that has undergone potentially curative therapy, or in situ cervical cancer.Prior chemotherapy, targeted small molecule therapy, or radiation therapy within 2 weeks (12 weeks for measurable sites of central nervous system disease) prior to study Day 1 or not recovered from adverse events due to a previously administered agent.Prior anti-cancer therapy with a monoclonal antibody (mAb) within 4 weeks prior to study Day 1 or not recovered from adverse events due to mAbs administered more than 4 weeks earlier.Diagnosis of immunodeficiency or receiving systemic steroid therapy or any other form of immunosuppressive therapy within 7 days prior to the first dose of trial treatment.Is currently participating and receiving study therapy or has participated in a study of an investigational agent and received study therapy or used an investigational device within 4 weeks of the first dose of treatment.Male participants of childbearing potential must agree to use an adequate method of contraception starting with the first dose of study medication through 120 days after the last dose of study medication.Female participants of childbearing potential must be willing to use an adequate method of contraception for the course of the study through 120 days after the last dose of study medication.Eastern Cooperative Oncology Group (ECOG) Performance status of 0 or 1.Have measurable disease based on Response Criteria in Solid Tumors Version 1.1 (RECIST 1.1).Histologically or cytologically documented locally-advanced and/or metastatic solid malignancy that is incurable, and has failed prior standard therapy or for which standard therapy is not appropriate.

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