Vudalimab for the Treatment of Locally Advanced or Metastatic Anaplastic Thyroid Cancer or Hurthl… (NCT05453799) | Clinical Trial Compass
Active — Not RecruitingPhase 2
Vudalimab for the Treatment of Locally Advanced or Metastatic Anaplastic Thyroid Cancer or Hurthle Cell Thyroid Cancer
United States54 participantsStarted 2022-07-21
Plain-language summary
This phase II trial tests whether vudalimab works to shrink tumors in patients with anaplastic thyroid cancer or hurthle cell thyroid cancer that has spread to nearby tissue or lymph nodes (locally advanced) or has spread to other places in the body (metastatic). Immunotherapy with monoclonal antibodies, such as vudalimab, may help the body's immune system attack the cancer, and may interfere with the ability of tumor cells to grow and spread.
Who can participate
Age range18 Years
SexALL
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Inclusion Criteria:
* MAIN COHORT (ANAPLASTIC THYROID CANCER \[ATC\]): Subjects enrolling in the Main Cohort must have a histologically confirmed diagnosis of anaplastic thyroid cancer (ATC). This includes cases with pathologic findings supporting the clinical impression of anaplastic thyroid carcinoma. Diagnosis may include terminology consistent with or suggestive of: anaplastic thyroid carcinoma, undifferentiated carcinoma, squamous carcinoma; carcinoma with spindled, giant cell, or epithelial features; or poorly differentiated carcinoma with pleomorphism, extensive necrosis with tumor cells present. (This study will not conduct central pathology review. Documentation on a standard pathology report is sufficient for determination of eligibility.)
* MAIN COHORT (ATC): Subject's anaplastic thyroid cancer (ATC) must be either 1) metastatic ATC, or 2) incurable, locally-advanced ATC
* MAIN COHORT (ATC): Subjects whose ATC carries a known BRAF V600E mutation must previously have received and failed, or be intolerant to, a BRAF/MEK inhibitor (e.g., dabrafenib or trametinib). Note: BRAF V600E mutation is not required to enroll in the trial, but if known to be present, this criterion must be met
* MAIN COHORT (ATC): Subjects also must meet all general inclusion criteria
* EXPLORATORY COHORT HURTHLE CELL THYROID CANCER \[HCC\]): Subjects enrolling in the Exploratory Cohort must have a histologically confirmed diagnosis of Hurthle cell thyroid cancer (HCC). (This study will not con…