Vudalimab for Thyroid Cancer
What You Need to Know Before You Apply
What is the purpose of this trial?
This trial examines how effectively vudalimab shrinks tumors in individuals with certain advanced thyroid cancers. Vudalimab, a type of immunotherapy, aids the immune system in fighting cancer cells. The trial includes patients with anaplastic thyroid cancer or Hurthle cell thyroid cancer that has spread or cannot be cured with standard treatments. Suitable candidates for this trial have one of these cancers that has either progressed after other treatments or lacks other treatment options. As a Phase 2 trial, the research focuses on assessing the treatment's effectiveness in an initial, smaller group of participants.
Do I need to stop my current medications for the trial?
The trial requires that you stop any anticancer therapies at least 1 week before starting the trial if you have anaplastic thyroid cancer, or 2 weeks before if you have Hurthle cell thyroid cancer. Additionally, you must stop taking corticosteroids or other immunosuppressive medications 14 days before the trial begins.
Is there any evidence suggesting that vudalimab is likely to be safe for humans?
Research shows that vudalimab is generally well-tolerated. Early data indicate that similar treatments have been safe, with manageable side effects. Although specific safety data for vudalimab is not yet available, studies of similar drugs suggest it is unlikely to cause serious issues. Participants in past studies reported some side effects, but these were usually mild and temporary. This trial is in an early phase, meaning initial safety has been checked, but researchers aim to confirm these results with more participants. If considering joining the trial, these findings suggest it is reasonably safe, but discussing any concerns with a doctor is important.12345
Why do researchers think this study treatment might be promising?
Vudalimab is unique because it targets thyroid cancer cells through a novel mechanism that differs from standard treatments like surgery, radioactive iodine, and traditional chemotherapy. Unlike these options, which primarily aim to remove or destroy cancer cells, Vudalimab works by enhancing the immune system's ability to recognize and attack cancer cells. This immunotherapy approach has the potential to offer a more precise and less toxic treatment option. Researchers are excited about Vudalimab because it could provide a new avenue for patients who do not respond well to existing therapies.
What evidence suggests that vudalimab might be an effective treatment for thyroid cancer?
Research has shown that vudalimab, a drug that aids the immune system, may effectively treat thyroid cancer. In studies, similar drugs have improved outcomes for individuals with thyroid issues. One study found that 66% of patients experienced a full response, with significant tumor shrinkage. Additionally, 16% of patients saw no change in their disease, while another 16% experienced disease progression. These findings suggest that vudalimab could help the immune system combat thyroid tumors effectively. Participants in this trial will receive vudalimab as part of the treatment regimen.12467
Who Is on the Research Team?
Jochen H Lorch, M.D.
Principal Investigator
Northwestern University
Are You a Good Fit for This Trial?
Adults with advanced or metastatic anaplastic thyroid cancer (ATC) or Hurthle cell thyroid cancer (HCC), who have tried all standard treatments without success. Participants must be in good enough health to perform daily activities, not pregnant, and willing to use contraception. They can't join if they've had certain previous therapies like CTLA4 or PD-1/PD-L1 inhibitors, are on immunosuppressants, have active brain metastases, serious infections recently, or known allergies to similar drugs.Inclusion Criteria
Exclusion Criteria
Timeline for a Trial Participant
Screening
Participants are screened for eligibility to participate in the trial
Treatment
Participants receive vudalimab intravenously over 1 hour on days 1 and 15 of each cycle. Cycles repeat every 28 days for up to 24 months in the absence of disease progression or unacceptable toxicity.
Follow-up
Participants are monitored for safety and effectiveness after treatment completion. Follow-up occurs every 3 months for 1 year and then every 6 months for 4 years.
What Are the Treatments Tested in This Trial?
Interventions
- Vudalimab
Find a Clinic Near You
Who Is Running the Clinical Trial?
Northwestern University
Lead Sponsor
National Cancer Institute (NCI)
Collaborator