Vudalimab for Thyroid Cancer

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

54 Participants Needed

Trial Summary

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.

What data supports the effectiveness of the drug Vudalimab (XmAb717) for thyroid cancer?

Immune-checkpoint inhibitors, similar to Vudalimab, have shown improved outcomes in patients with thyroid dysfunction, suggesting that these types of drugs can enhance antitumor responses in various cancers, including thyroid cancer. ^{1 2 3 4 5}

Is Vudalimab (XmAb717) generally safe for humans?

While specific safety data for Vudalimab (XmAb717) is not provided, similar treatments like PD-1 and PD-L1 inhibitors have been associated with thyroid-related side effects, such as hypothyroidism (underactive thyroid) and thyrotoxicosis (overactive thyroid). These side effects are usually manageable and do not typically require stopping the treatment. ^{6 7 8 9 10}

What is the purpose of this trial?

This trial tests vudalimab, an immunotherapy drug, in patients with advanced or metastatic anaplastic thyroid cancer or Hurthle cell thyroid cancer. Vudalimab helps the immune system fight the cancer and aims to prevent it from growing and spreading.

Research Team

Jochen H Lorch, M.D.

Principal Investigator

Northwestern University

Eligibility Criteria

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

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)

Treatment Details

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.

Participant Groups

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+

Findings from Research

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]

References

1. Egypt pubmed.ncbi.nlm.nih.gov

CD8+ TIL recruitment may revert the association of MAGE A3 with aggressive features in thyroid tumors. [2018]

2. Greece pubmed.ncbi.nlm.nih.gov

Prognostic Value of Lymphocyte-to-Monocyte Ratio for Japanese Patients With Differentiated Thyroid Cancer Treated With Sorafenib Therapy. [2022]

3. Germany pubmed.ncbi.nlm.nih.gov

Improved survival in patients with thyroid function test abnormalities secondary to immune-checkpoint inhibitors. [2021]

4. United States pubmed.ncbi.nlm.nih.gov

Treatment of Aggressive Thyroid Cancer. [2021]

5. France pubmed.ncbi.nlm.nih.gov

[Advances in the treatment of thyroid cancer in the era of molecularly targeted therapies]. [2010]

6. England pubmed.ncbi.nlm.nih.gov

Severe Inflammatory Ophthalmopathy in a Euthyroid Patient during Nivolumab Treatment. [2022]

7. England pubmed.ncbi.nlm.nih.gov

Thyroid disorders in programmed death 1 inhibitor-treated patients: Is previous therapy with tyrosine kinase inhibitors a predisposing factor? [2021]

8. United States 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. [2022]

9. United States pubmed.ncbi.nlm.nih.gov

PD-L1 Inhibitor-Induced Thyroiditis Is Associated with Better Overall Survival in Cancer Patients. [2021]

10. Germany pubmed.ncbi.nlm.nih.gov

Nivolumab-induced Thyroid Dysfunctions in Patients with Previously Treated Non-small Cell Lung Cancer. [2019]