Vudalimab for Thyroid Cancer

Not currently recruiting at 1 trial location

Overseen By Study Coordinator

Age: 18+

Sex: Any

Trial Phase: Phase 2

Sponsor: Northwestern University

Must not be taking: Corticosteroids, Immunosuppressives, others

Disqualifiers: CNS metastases, Autoimmune disease, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Prior Safety Data This treatment has passed at least one previous human trial

Compensation: Varies

Number of Visits: 5

Duration: 24 months

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. ^{1 2 3 4 5}

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. ^{1 2 4 6 7}

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

My liver cancer cannot be cured and has spread to other parts.

You need to have a negative test for hepatitis B surface antigen (HBsAg) and total hepatitis B core antibody (HBcAb), or a positive total HBcAb followed by a negative HBV DNA test.

I have been diagnosed with anaplastic thyroid cancer.

Exclusion Criteria

Subjects with evidence of any other clinical condition that would make them unsuitable for the trial

I have previously received treatments targeting my immune system.

I have active brain metastases or carcinomatous meningitis.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

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.

24 months

2 visits per cycle (in-person)

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.

5 years

Every 3 months for 1 year, then every 6 months for 4 years (in-person)

What Are the Treatments Tested in This Trial?

Interventions

• Vudalimab

Trial Overview

The trial is testing Vudalimab's effectiveness in shrinking tumors for patients with ATC or HCC that has spread. It's a phase II study where Vudalimab—a type of immunotherapy—aims to boost the immune system's fight against cancer and prevent tumor growth.

How Is the Trial Designed?

Group I: Treatment (vudalimab) Experimental Treatment 1 Intervention

Patients receive vudalimab IV 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.

Who Is Running the Clinical Trial?

Northwestern University

Lead Sponsor

Trials

1,674

Recruited

989,000+

National Cancer Institute (NCI)

Collaborator

Trials

14,080

Recruited

41,180,000+

Published Research Related to This Trial

Some patients with aggressive thyroid cancer do not respond well to standard treatments like surgery or radioactive iodine, highlighting the need for alternative therapies.

New treatments in development, such as tyrosine kinase inhibitors and other targeted therapies, show promise for managing aggressive forms of thyroid cancer that are resistant to conventional approaches.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Treatment of Aggressive Thyroid Cancer. Huang, J., Harris, EJ., Lorch, JH.[2021]

In a study of 103 patients with advanced cancer treated with combination anti-PD1/anti-CTLA4 therapies, 16.5% developed thyroid immune-related adverse events (irAEs), indicating that these side effects are relatively common and should be monitored regularly.

The occurrence of thyroid irAEs was associated with better overall survival rates, suggesting that these adverse events may have a positive prognostic significance in patients undergoing this treatment.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Thyroid Immune-Related Adverse Events in Patients with Cancer Treated with anti-PD1/anti-CTLA4 Immune Checkpoint Inhibitor Combination: Clinical Course and Outcomes. Lui, DTW., Lee, CH., Tang, V., et al.[2022]

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Vudalimab for Thyroid Cancer · Info for Participants

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Research progress of immunotherapy against anaplastic ...

The results demonstrated that 66% of the patients had a full response, 16% had stable illness, and 16% had progressing disease. The median ...

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News - vudalimab (XmAb717)

Preliminary data indicate XmAb20717 was generally well-tolerated and associated with evidence of antitumor.

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Vudalimab for the Treatment of Locally Advanced or ...

This phase II trial tests whether vudalimab works to shrink tumors in patients with anaplastic thyroid cancer or hurthle cell thyroid cancer.

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Vudalimab - Drug Targets, Indications, Patents

Safety data from the three studies of vudalimab remain consistent with prior data disclosures. ... cancer (Study XmAb717-06). Xencor continues to ...