Study on Immune-Related Side Effects with Different Dosing of Standard Immunotherapies

Sponsor: University of Kansas Medical Center

Sponsor score: 0

ClinicalTrials ID:NCT07174453

This clinical trial is comparing the side effects of different dosing schedules of two immunotherapy drugs, Pembrolizumab and Nivolumab, in patients with confirmed cancer diagnoses.

Patient Parameters

Program Overview

This study is testing whether higher doses of the immunotherapy drugs Pembrolizumab and Nivolumab cause more immune-related side effects compared to lower doses. Participants will be randomly assigned to receive either the higher or lower dose of these medications, and researchers will monitor for any side effects related to the immune system.

Eligibility Criteria

Inclusion Criteria

  • Must understand the study and be willing to sign a consent form.
  • Men and women aged 18 years or older.
  • Must have a performance status score between 0 and 2, indicating good overall health.
  • Women who can have children must test negative for pregnancy before starting treatment.
  • Must have a confirmed diagnosis of a solid tumor cancer.
  • Eligible to receive treatment with Pembrolizumab or Nivolumab.
  • Can be in any stage of cancer treatment, including before surgery, after surgery, or for cancer that cannot be removed or has spread.
  • Must have adequate organ function, including specific levels of white blood cells, platelets, hemoglobin, kidney function, and liver enzymes.

Exclusion Criteria

  • Currently participating in another treatment study.
  • Planning to use other immunotherapies or radiation during the study.
  • Have not fully recovered from side effects of previous immunotherapy treatments, unless stable as determined by the study doctor.
  • Have a psychiatric condition or social situation that would make it difficult to follow the study requirements.
  • Currently pregnant or breastfeeding.
  • Have a known allergy to any ingredient in the study drugs.
  • Have a severe infection within two weeks before starting the study treatment.

Locations

FACILITYZIPCITYSTATE
The University of Kansas Cancer Center66205WestwoodKansas

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