What is the mechanism of action of this treatment?

Monoclonal antibodies, such as Vudalimab, work by helping the immune system recognize and attack cancer cells, and by interfering with the growth and spread of tumor cells. These treatments target specific proteins on the surface of cancer cells, enhancing the body's immune response against the tumor. This is particularly important for Thyroid Carcinoma patients as it offers a targeted approach that can potentially improve outcomes and reduce the side effects associated with traditional therapies. By focusing on the immune system and specific tumor markers, these treatments aim to provide more effective and personalized cancer care.

What side effects are associated with this type of intervention?

Common treatments for thyroid carcinoma, particularly those involving monoclonal antibodies like vudalimab, often lead to immune-related side effects. These can include rash, pruritus, diarrhea, and pneumonitis. More severe side effects may involve endocrine dysfunctions such as thyroiditis or hypophysitis, and other immune-mediated conditions. These side effects are typical of immune checkpoint inhibitors and similar immunotherapies.

What prior FDA approvals exist?

The FDA has approved several treatments for Thyroid Carcinoma that involve immunotherapy and monoclonal antibodies. Pembrolizumab, an anti-PD-1 monoclonal antibody, is one such drug that has been approved for various cancers, including certain types of thyroid cancer. It works by helping the immune system attack cancer cells and inhibiting tumor growth. Another example is Lenvatinib, a kinase inhibitor that targets multiple receptors involved in tumor growth and angiogenesis, although it is not a monoclonal antibody, it represents a targeted approach similar to immunotherapy.

What other types of research exist?

Promising novel alternatives to Vudalimab for Thyroid Carcinoma patients include Pembrolizumab and Nivolumab, both of which are immune checkpoint inhibitors targeting PD-1. These therapies have shown efficacy in various cancers by enhancing the immune system's ability to attack tumor cells and may offer similar benefits in Thyroid Carcinoma.

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Monoclonal Antibodies

Vudalimab for Thyroid Cancer

Phase 2

Waitlist Available

Led By Jochen H Lorch, M.D.

Research Sponsored by Northwestern University

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

EXPLORATORY COHORT (HCC): Subject's HCC must be incurable and metastatic

MAIN COHORT (ANAPLASTIC THYROID CANCER [ATC]): Subjects must have a histologically confirmed diagnosis of anaplastic thyroid cancer (ATC)

Must not have

Subjects who have previously received XmAb20717 or prior CTLA4 antibody or PD-1/PD-L1 therapy

Subjects with known active CNS metastases and/or carcinomatous meningitis

Timeline

Screening 3 weeks

Treatment Varies

Follow Up up to 5 years

Awards & highlights

No Placebo-Only Group

Summary

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.

Who is the study for?

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.

What is being tested?

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.

What are the potential side effects?

Potential side effects of Vudalimab may include reactions related to the immune system attacking normal cells leading to inflammation in various organs, infusion-related reactions due to the drug administration process, fatigue from treatment burden on the body, digestive issues as a common reaction to therapy affecting gut health.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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

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I have been diagnosed with anaplastic thyroid cancer.

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I have a BRAF V600E mutation and cannot tolerate or did not respond to BRAF/MEK inhibitors.

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I have been diagnosed with Hurthle cell thyroid cancer.

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I have liver cancer and previous treatments, especially those targeting blood vessel growth, didn’t work for me.

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I can understand and am willing to sign the consent form for the study.

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My cancer is either spreading or cannot be cured with surgery.

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I have available tissue samples from previous biopsies or surgeries for study.

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My cancer has worsened despite all standard treatments.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

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I have previously received treatments targeting my immune system.

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I have active brain metastases or carcinomatous meningitis.

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I am not pregnant, planning to become pregnant, or breastfeeding.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ up to 5 years

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~up to 5 years

This trial's timeline: 3 weeks for screening, Varies for treatment, and up to 5 years for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Objective response rate (ORR)

Secondary study objectives

Clinical benefit rate

Duration of clinical benefit(DoCB)

Duration of response

+4 more

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

Trial Design

1Treatment groups

Experimental Treatment

Group I: Treatment (vudalimab)Experimental Treatment1 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.

0 / 12Eligibility criteria met

Research Highlights

Information in this section is not a recommendation. We encourage patients to speak with their healthcare team when evaluating any treatment decision.

Mechanism Of Action

Side Effect Profile

Prior Approvals

Other Research

Monoclonal antibodies, such as Vudalimab, work by helping the immune system recognize and attack cancer cells, and by interfering with the growth and spread of tumor cells. These treatments target specific proteins on the surface of cancer cells, enhancing the body's immune response against the tumor. This is particularly important for Thyroid Carcinoma patients as it offers a targeted approach that can potentially improve outcomes and reduce the side effects associated with traditional therapies. By focusing on the immune system and specific tumor markers, these treatments aim to provide more effective and personalized cancer care.

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