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 range

18 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

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…

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

What they're measuring

Objective response rate (ORR)

Timeframe: Up to 5 years

Trial details

NCT IDNCT05453799

SponsorNorthwestern University

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2026-07-15

View on ClinicalTrials.gov More Locally Advanced Thyroid Gland Anaplastic Carcinoma trials