Study of Pembrolizumab (MK-3475) in Patients with Advanced Solid Tumors

Sponsor: Merck Sharp & Dohme LLC

Sponsor score: 40
Inactive

ClinicalTrials ID:NCT02628067

This clinical trial is testing the drug pembrolizumab (MK-3475) in patients with various types of advanced solid tumors that have not responded to standard treatments.

Patient Parameters

Program Overview

The purpose of this study is to evaluate the effectiveness of pembrolizumab (MK-3475) in treating patients with advanced solid tumors that cannot be surgically removed or have spread to other parts of the body. Participants must have tried standard treatments without success before joining this study.

Eligibility Criteria

Inclusion Criteria

  • Have an advanced solid tumor of specific types, such as anal, biliary, neuroendocrine, endometrial, cervical, vulvar, small cell lung, mesothelioma, thyroid, or salivary gland carcinoma.
  • Have a tumor that is Microsatellite Instability-High (MSI-H) or Mismatch Repair Deficient (dMMR), especially for colorectal cancer in Chinese participants.
  • Have a tumor that has not responded to at least one standard treatment and is Tumor Mutational Burden-High (TMB-H).
  • Have experienced tumor growth or intolerance to treatments that usually help.
  • Be able to provide a tumor sample for study analysis.
  • Have a measurable disease that can be tracked by scans.
  • Have a performance status score of 0 or 1, indicating full activity or some restriction in strenuous activities.
  • Have a life expectancy of at least 3 months.
  • Have adequate organ function as determined by specific tests.
  • Female participants of childbearing potential must agree to use effective contraception during the study and for 120 days after the last dose.

Exclusion Criteria

  • Currently participating in another study or have used an investigational drug or device within 4 weeks before starting this study.
  • Have an immune system deficiency or are taking immunosuppressive drugs within 7 days before starting the study.
  • Have an active autoimmune disease requiring treatment in the past 2 years.
  • Have received certain cancer treatments within 4 weeks before starting the study and have not recovered from side effects.
  • Have another active cancer within the past 2 years, except for certain skin cancers or in situ cancers.
  • Have active cancer spread to the brain or spinal cord.
  • Have a history of severe lung disease or current lung issues.
  • Have an active infection needing treatment.
  • Have psychiatric or substance abuse issues that would interfere with the study.
  • Are pregnant, breastfeeding, or planning to have children during the study and for 120 days after.
  • Have participated in previous pembrolizumab studies or received similar treatments.
  • Have a history of HIV, active Hepatitis B or C, or tuberculosis.
  • Have received a live vaccine within 30 days before starting the study.
  • Have a severe allergy to pembrolizumab or its ingredients.
  • Have had a tissue or organ transplant.

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