Therapeutic Drug Monitoring of Pembrolizumab and Nivolumab to Determine Dosages for Cancer Treatment


  • Study type

  • Study IDs

  • Describes the nature of a clinical study. Types include:

    • Observational study — observes people and measures outcomes without affecting results.
    • Interventional study (clinical trial) — studies new tests, treatments, drugs, surgical procedures or devices.
    • Medical records research — uses historical information collected from medical records of large groups of people to study how diseases progress and which treatments and surgeries work best.
  • Site IRB
    • Rochester, Minnesota: 17-002103
    Sponsor Protocol Number: 17-002103

About this study

Drug monitoring of Pembrolizumaband Nivolumab for determining the pharmacokinetic (PK) profile of these medications and  to provide information for dose adjustments to guide physicians in the future.

Participation eligibility

Participant eligibility includes age, gender, type and stage of disease, and previous treatments or health concerns. Guidelines differ from study to study, and identify who can or cannot participate. If you need assistance understanding the eligibility criteria, please contact the study team.

See eligibility criteria

Inclusion Criteria:

  • Adults who are just initiating monoclonal antibody therapy with pembrolizumab or nivolumab for melanoma or non-small cell lung cancer.

Exclusion Criteria: 

  • Patients who already are prescribed and taking pembrolizumab or nivolumab.

Participating Mayo Clinic locations

Study statuses change often. Please contact us for help.

Mayo Clinic Location Status Contact

Rochester, Minn.

Mayo Clinic principal investigator

Paul Jannetto, Ph.D.

Open for enrollment

Contact information:

Renee Bradshaw


More information


Publications are currently not available

Study Results Summary

Not yet available

Supplemental Study Information

Not yet available


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