Clinical Trials

The James Cancer Center Columbus, OH

open for enrollment

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

Protocol: OSU-15244

Full Title

A Clinical Trial of Pembrolizumab (MK-3475) Evaluating Predictive Biomarkers in Subjects with Advanced Solid Tumors (KEYNOTE 158)


In this study, participants with multiple types of advanced (unresectable and/or metastatic)

solid tumors that have progressed on standard of care therapy will be treated with


Are you eligible?

Inclusion Criteria:

Histologically or cytologically-documented, advanced solid tumor of one of the

following types:

Anal 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 Carcinoma

Vulvar 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)

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)

Performance Scale

Life expectancy of at least 3 months

Adequate organ function

Female participants of childbearing potential must be willing to use adequate

contraception for the course of the study through 120 days after the last dose of

study medication

Male participants with partners of must childbearing potential must be willing to use

adequate contraception for the course of the study through 120 days after the last

dose of study medication

Exclusion Criteria:

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 study medication

Diagnosis of immunodeficiency or receiving systemic steroid therapy or any other form

of immunosuppressive therapy within 7 days prior to the first dose of study


Active autoimmune disease that has required systemic treatment in the past 2 years

Prior anti-cancer monoclonal antibody (mAb) within 4 weeks prior to study Day 1 or

not recovered from an adverse event caused by mAbs administered more than 4 weeks


Prior chemotherapy, targeted small molecule therapy, or radiation therapy within 2

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

curatively treated basal cell carcinoma of the skin, squamous cell carcinoma of the

skin and/or curatively resected in situ cancers

Known active central nervous system (CNS) metastases and/or carcinomatous meningitis

Has known glioblastoma multiforme of the brainstem

History of non-infectious pneumonitis that required steroids or current pneumonitis

Active infection requiring systemic therapy

Known psychiatric or substance abuse disorders that would interfere with cooperation

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 medication

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-L2, or any other immunomodulating mAb or drug specifically targeting T-cell

co-stimulation or checkpoint pathways

Known history of Human Immunodeficiency Virus (HIV)

Known active Hepatitis B or C

Received live vaccine within 30 days of planned start of study medication

Brain Cancer Genitourinary Cancers Endocrine Cancers Gastrointestinal Cancers Gynecologic Cancers Bone Cancer Head & Neck Cancers Skin Cancers Sarcoma Lung Cancers Vulvar Cancer Anal Cancer Pituitary Tumor Liver Cancer Cervical Cancer Squamous Cell Carcinoma Neuroendocrine Cancer Stomach (Gastric) Cancer Endometrial Cancer Testicular Cancer Esophageal Cancer Bone & Spine Sarcoma Soft Tissue Sarcoma Laryngeal Cancer Skull Base Colon Cancer Oropharyngeal Cancer Bladder Cancer Small Intestine Cancer Parathyroid Cancer Pancreatic Cancer Kidney Cancer Ovarian Cancer Vaginal Cancer Lip & Oral Cavity Cancer Breast Cancer Rectal Cancer Basal Cell Carcinoma Melanoma Gliomas Thyroid Cancer Other Brain Cancers Prostate Cancer Gallbladder Cancer Kaposi Sarcoma Spine Tumors Gastrointestinal Carcinoid Tumors