Study on Vudalimab for Treating Advanced Anaplastic or Hurthle Cell Thyroid Cancer
Sponsor: Northwestern University
ClinicalTrials ID:NCT05453799
This clinical trial is testing whether the drug vudalimab can help shrink tumors in patients with advanced anaplastic thyroid cancer or Hurthle cell thyroid cancer. The study aims to see if vudalimab, an immunotherapy drug, can help the immune system attack cancer cells and stop them from growing and spreading.
Patient Parameters
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Program Overview
This phase II study is exploring the effectiveness of vudalimab, an immunotherapy drug, in shrinking tumors in patients with advanced anaplastic thyroid cancer or Hurthle cell thyroid cancer. These cancers have either spread to nearby tissues or lymph nodes (locally advanced) or to other parts of the body (metastatic). Vudalimab may help the immune system target and destroy cancer cells, potentially preventing them from growing and spreading further.
Description
The main goal of this study is to see how well vudalimab works in treating anaplastic thyroid cancer by measuring how much the tumors shrink. Researchers will also look at how long patients live without the cancer getting worse and overall survival rates. They will assess the safety of vudalimab and any side effects it may cause.
Patients will receive vudalimab through an IV infusion over one hour on the first and fifteenth day of each 28-day cycle. This treatment will continue for up to 24 months unless the cancer progresses or side effects become unacceptable.
After finishing the treatment, patients will have follow-up visits every three months for the first year and then every six months for the next four years to monitor their health and any long-term effects of the treatment.
Eligibility Criteria
Inclusion Criteria
- Must have a confirmed diagnosis of anaplastic thyroid cancer or Hurthle cell thyroid cancer.
- Cancer must be advanced, either having spread locally or to other parts of the body.
- For anaplastic thyroid cancer with a BRAF V600E mutation, patients must have tried and not responded to BRAF/MEK inhibitors.
- Must have tried all standard treatments without success or have no other treatment options available.
- Must be 18 years or older.
- Must have a performance status that allows for daily activities with some limitations.
- Must have adequate blood counts and organ function.
- Must agree to use effective birth control during the study and for a period after the study ends.
- Must not have active infections like hepatitis B, hepatitis C, or HIV unless well-controlled.
- Must be willing to provide a tumor sample for research purposes if available.
Exclusion Criteria
- Must not have allergies to vudalimab or similar drugs.
- Must not have received certain prior cancer treatments like CTLA4 or PD-1/PD-L1 therapies.
- Must not be on other cancer treatments or immunosuppressive medications recently.
- Must not have active brain metastases unless treated and stable.
- Must not have active autoimmune diseases requiring systemic treatment.
- Must not be pregnant or breastfeeding.
- Must not have serious infections within 30 days before starting the study.
Locations
| FACILITY | ZIP | CITY | STATE |
|---|---|---|---|
| Northwestern University | 60611 | Chicago | Illinois |
| M D Anderson Cancer Center | 77030 | Houston | Texas |
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