Merck Sharp & Dohme Corp., MK-3475-158, KEYNOTE, Ph 2, Multiple Tumor Types, Pembrolizumab

Summary

This study focuses on patients diagnosed with an advanced solid tumor that meets specific criteria. The purpose of the study is to evaluate the investigational use of a drug called pembrolizumab (MK-3475), which may help the immune system to fight cancer. Researchers will assess the safety, tolerability and anti-tumor activity of the drug. In addition, researchers aim to determine whether a biomarker test may help discover ways that pembrolizumab does or does not work to shrink tumors. A biomarker is a biological molecule found in blood, other body fluids, or tissues that may be a sign of a condition or disease.

Pembrolizumab has been approved by the U.S. Food and Drug Administration for certain types of melanoma, lung cancer, and head and neck cancer, but its use in this study is investigational. While pembrolizumab may help fight cancer, it can also result in side effects that may become serious.


Inclusion Criteria

  • - Histologically or cytologically-documented, advanced solid tumor of one of the following types:
  • Anal Squamous Cell Carcinoma
  • Biliary Adenocarcinoma (gallbladder or biliary tree (intrahepatic or extrahepatic cholangiocarcinoma) except Ampulla of Vater cancers)
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Study Location(s)

  • Cedars-Sinai Cancer at Beverly Hills (THO)
  • Cedars-Sinai Cancer at SOCC


More about this Clinical Trial

Full Title

MK-3475-158-00: A Clinical Trial of Pembrolizumab Evaluating Predictive Biomarkers in Subjects with Advanced Solid Tumors

Details
Disease Type/Condition

Anus, Cervix, Colon, Corpus Uteri, Lip, Oral Cavity and Pharynx, Liver, Lung, Pancreas, Small Intestine, Soft Tissue, Stomach, Thyroid

Principal Investigator

Hendifar, Andrew

Co-Investigators

Alain Mita, Arsen Osipov, Bobbie Jo Rimel, Christine Walsh, David Hoffman, Edwin Posadas, Jun Gong, Kamalesh Sankhala, Kevin Scher, Leland Green, Monica Mita, Ronald Natale, Sepehr Rokhsar, Solomon Hamburg, Steven Miles, Wendy Sacks

Age Group

Adult

Phase

II

IRB Number

Pro00043687

ClinicalTrials.gov ID

NCT02628067

Key Eligibility
ClinicalTrials.gov

Contact
Email
cancer.trial.info@cshs.org
Want to join the study or
learn more?

Details
Disease Type/Condition

Anus, Cervix, Colon, Corpus Uteri, Lip, Oral Cavity and Pharynx, Liver, Lung, Pancreas, Small Intestine, Soft Tissue, Stomach, Thyroid

Principal Investigator

Hendifar, Andrew

Age Group

Adult

Phase

II

IRB Number

MK-3475-158

ClinicalTrials.gov ID

NCT02628067

Key Eligibility
ClinicalTrials.gov

Contact
Email
cancer.trial.info@cshs.org
Want to join the study or
learn more?