Study of Pembrolizumab (MK-3475) in Participants With Advanced Solid Tumors (MK-3475-158/KEYNOTE-158)

  • End date
    Jun 18, 2026
  • participants needed
  • sponsor
    Merck Sharp & Dohme LLC
Updated on 4 October 2022
systemic therapy
measurable disease
squamous cell carcinoma
solid tumors
solid tumour
solid tumor
solid neoplasm
line of therapy
small intestine
anal squamous cell carcinoma
neuroendocrine tumor
thyroid carcinoma
small cell carcinoma
squamous cell carcinoma of cervix
endometrial carcinoma
vulvar carcinoma


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).

Condition Advanced 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
Treatment Pembrolizumab
Clinical Study IdentifierNCT02628067
SponsorMerck Sharp & Dohme LLC
Last Modified on4 October 2022


Yes No Not Sure

Inclusion Criteria

Histologically or cytologically-documented, advanced solid tumor of one of the following
Anal Squamous Cell Carcinoma
Biliary Adenocarcinoma (gallbladder or biliary tree (intrahepatic or extrahepatic cholangiocarcinoma) except Ampulla of Vater cancers)
Neuroendocrine Tumors (well- and moderately-differentiated) of the lung, appendix, small intestine, colon, rectum, or pancreas
Endometrial Carcinoma (sarcomas and mesenchymal tumors are excluded)
Cervical Squamous Cell Carcinoma
Vulvar Squamous Cell Carcinoma
Small Cell Lung Carcinoma
Thyroid Carcinoma
Salivary Gland Carcinoma (sarcomas and mesenchymal tumors are excluded)
Any advanced solid tumor, with the exception of colorectal carcinoma (CRC), which is Microsatellite Instability (MSI)-High (MSI-H) OR
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
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
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. Participants must not have melanoma or
Progression of tumor or intolerance to therapies known to provide clinical benefit
There is no limit to the number of prior treatment regimens
Can supply tumor tissue for study analyses (dependent on tumor type)
Radiologically-measurable disease
Performance status of 0 or 1 on the Eastern Cooperative Oncology Group (ECOG)
Life expectancy of at least 3 months
Performance Scale within 3 days prior to first dose of pembrolizumab
Adequate organ function
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. 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. The length of time required to
continue contraception for each study intervention is as follows: MK-3475 (120 days)

Exclusion Criteria

Active autoimmune disease that has required systemic treatment in the past 2 years
Known active central nervous system (CNS) metastases and/or carcinomatous meningitis
Currently participating and receiving study therapy or has participated in a study of
Has known glioblastoma multiforme of the brain stem
an investigational agent and received study therapy or used an investigational device
within 4 weeks of the first dose of study treatment
Diagnosis of immunodeficiency or receiving systemic steroid therapy or any other form
Active infection requiring systemic therapy
of immunosuppressive therapy within 7 days prior to the first dose of study treatment
Prior anti-cancer monoclonal antibody (mAb) within 4 weeks prior to study Day 1 or not
Known history of Human Immunodeficiency Virus (HIV)
recovered from an adverse event caused by mAbs administered more than 4 weeks earlier
Known active Hepatitis B or C
Prior chemotherapy, targeted small molecule therapy, or radiation therapy within 2
Received live vaccine within 30 days of planned start of study treatment
weeks of study Day 1 or not recovered from adverse events caused by a previously
administered agent
Known additional malignancy within 2 years prior to enrollment with the exception of
Known history of active tuberculosis (TB, Bacillus tuberculosis)
Has had an allogenic tissue/solid organ transplant
curatively treated basal cell carcinoma of the skin, squamous cell carcinoma of the
skin and/or curatively resected in situ cancers
Has a history of (noninfectious) pneumonitis/interstitial lung disease that required
steroids or has current pneumonitis/interstitial lung disease
Known psychiatric or substance abuse disorders that would interfere with the
participant's ability to cooperate with the requirements of the study
Pregnant, breastfeeding, or expecting to conceive or father children within the
projected duration of the study, starting with the screening visit through 120 days
after the last dose of study treatment
Previously participated in any other pembrolizumab (MK-3475) study, or received prior
therapy with an anti-programmed cell death (PD)-1, anti-PD-Ligand 1 (anti-PD-L1)
anti-PD-Ligand 2 (anti-PD-L2), or any other immunomodulating mAb or drug specifically
targeting T-cell co-stimulation or checkpoint pathways
Has severe hypersensitivity (≥Grade 3) to pembrolizumab and/or any of its excipients
Clear my responses

How to participate?

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Additional screening procedures may be conducted by the study team before you can be confirmed eligible to participate.

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If you are confirmed eligible after full screening, you will be required to understand and sign the informed consent if you decide to enroll in the study. Once enrolled you may be asked to make scheduled visits over a period of time.

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Complete your scheduled study participation activities and then you are done. You may receive summary of study results if provided by the sponsor.

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