Phase II Study of Pembrolizumab for Advanced Anaplastic or Undifferentiated Thyroid Cancer

Sponsor: Stanford University

Sponsor score: 40

ClinicalTrials ID:NCT05119296

This clinical trial is testing the effectiveness of pembrolizumab, a medication given through an IV every three weeks, for patients with advanced anaplastic or undifferentiated thyroid cancer who have no other curative treatment options.

Patient Parameters

Program Overview

The study aims to evaluate how well pembrolizumab works in treating anaplastic or undifferentiated thyroid cancer that cannot be cured with other treatments. Patients will receive pembrolizumab (Keytruda) 200 mg through an IV every three weeks until the cancer progresses, they cannot tolerate the treatment, they choose to stop, or they pass away.

Eligibility Criteria

Inclusion Criteria

  • Diagnosed with anaplastic or undifferentiated thyroid cancer, confirmed by lab tests. A possible diagnosis is acceptable if symptoms match.
  • Cancer that cannot be surgically removed and is limited to the neck, or cancer that has spread (metastatic) and does not require neck surgery or radiation.
  • At least one tumor that can be measured by scans.
  • Aged 18 years or older.
  • Good overall health with a performance status score of 0 or 1.
  • Adequate blood cell counts and organ function as determined by specific blood tests.
  • Not pregnant or breastfeeding, and willing to use effective birth control if of childbearing potential.
  • Able to understand and willing to sign a consent form to participate in the study.

Exclusion Criteria

  • Previous treatment with pembrolizumab or similar drugs.
  • Recent cancer treatments, including certain medications or radiation, within a specified time before starting the study.
  • Participation in another clinical trial within four weeks before starting this study.
  • Active infections or immune system disorders requiring treatment.
  • Other active cancers needing treatment within the past year, except for certain skin cancers or localized cancers treated successfully.
  • Active brain cancer or cancer spread to the brain, unless stable and not requiring steroids.
  • History of lung disease requiring steroids or current lung disease.
  • Known HIV or active hepatitis B or C infections.
  • Severe allergies to pembrolizumab or its ingredients.
  • Other serious health conditions or psychiatric disorders that could interfere with the study.
  • Pregnant or breastfeeding, or planning to conceive or father a child during the study and for 120 days after the last treatment.
  • Previous organ transplant.

Locations

FACILITYZIPCITYSTATE
Stanford University94305Palo AltoCalifornia

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