Zanzalintinib + Cemiplimab for Thyroid Cancer

SH
Overseen BySarah Hamidi, MD
No Placebo GroupAll trial participants will receive the active study treatment (no placebo)
Prior Safety DataThis treatment has passed at least one previous human trial

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests a combination of two treatments, zanzalintinib and cemiplimab (an immunotherapy drug), to determine if they can extend the life expectancy of people with an aggressive form of thyroid cancer. Participants will receive these treatments in cycles, aiming to improve survival by about four months. The trial seeks participants with advanced thyroid cancer that cannot be surgically removed or has spread to other parts of the body. Eligible individuals often have specific types of thyroid cancer that impact daily life, such as difficulty swallowing or breathing. As a Phase 2 trial, the research focuses on measuring the treatment's effectiveness in an initial, smaller group, offering a chance to contribute to significant advancements in thyroid cancer treatment.

Do I need to stop my current medications for the trial?

The trial protocol does not specify if you need to stop all current medications, but certain medications are prohibited. You must stop taking any small molecule kinase inhibitors, cytotoxic or biologic therapies, and certain anticoagulants before starting the trial. It's best to discuss your current medications with the trial team to see if any adjustments are needed.

Is there any evidence suggesting that the zanzalintinib + cemiplimab treatment combination is likely to be safe for humans?

Research has shown that the combination of zanzalintinib and cemiplimab can be safe and manageable for patients. Other studies have demonstrated promising results for this combination in treating certain types of thyroid cancer. For instance, similar drug combinations have proven safe, with manageable side effects for some patients. Additionally, when combined with another drug, zanzalintinib has shown a high success rate in controlling the disease, indicating it is generally well-tolerated.

While specific safety data for this exact combination in thyroid cancer remains limited, ongoing studies and past findings provide some reassurance about its safety in humans. As with any treatment, side effects may occur, but these studies suggest they are usually manageable.12345

Why are researchers excited about this study treatment for thyroid cancer?

Researchers are excited about Zanzalintinib + Cemiplimab for thyroid cancer because this combination targets the cancer in a novel way. Unlike traditional treatments such as surgery or radioactive iodine, Zanzalintinib is a small molecule inhibitor, which means it can block specific proteins that encourage cancer growth. Cemiplimab is an immune checkpoint inhibitor, which helps the body's immune system recognize and attack cancer cells more effectively. Together, these treatments could offer a more targeted approach, potentially leading to better outcomes for patients.

What evidence suggests that the zanzalintinib + cemiplimab treatment might be an effective treatment for thyroid cancer?

Research shows that combining zanzalintinib and cemiplimab may help treat thyroid cancer. Studies have found that patients with certain thyroid conditions live longer without their cancer worsening when treated with cemiplimab. Zanzalintinib has also been tested with similar drugs, showing improved survival rates in cancer patients. This trial examines the combination of zanzalintinib and cemiplimab in anaplastic thyroid cancer, as it might enhance the immune system's ability to fight the cancer. These findings suggest that this treatment could extend the lives of thyroid cancer patients.12346

Who Is on the Research Team?

SH

Sarah Hamidi, MD

Principal Investigator

M.D. Anderson Cancer Center

Are You a Good Fit for This Trial?

This trial is for adults (18+) with a specific aggressive thyroid cancer (anaplastic, BRAF wild-type or unable to get certain drugs), whose disease can't be removed by surgery or has spread. Participants must have good organ function and not be pregnant. People with serious infections, other cancers needing treatment, major heart/liver/kidney issues, or prior use of similar drugs cannot join.

Inclusion Criteria

I am able to care for myself and do daily activities.
I am able to understand and follow the study instructions.
Sexually active fertile subjects and their partners must agree to use highly effective method of contraception
See 9 more

Exclusion Criteria

My tumor has grown into a major blood vessel.
I have a serious wound, ulcer, or bone fracture that is not healing.
I have malabsorption syndrome.
See 35 more

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive zanzalintinib 60 mg daily and cemiplimab 350 mg IV every 21 days for up to 24 cycles

72 weeks
24 visits (in-person)

Follow-up

Participants are monitored for safety and effectiveness after treatment

36 months

What Are the Treatments Tested in This Trial?

Interventions

  • Cemiplimab
  • Zanzalintinib

Trial Overview

The study tests a combination of two medicines—zanzalintinib (a targeted therapy) and cemiplimab (an immunotherapy)—to see if they help people with advanced anaplastic thyroid cancer live longer. About 24 patients will receive both treatments together.

How Is the Trial Designed?

1

Treatment groups

Experimental Treatment

Group I: Treatment with Zanzalintinib + CemiplimabExperimental Treatment2 Interventions

Find a Clinic Near You

Who Is Running the Clinical Trial?

M.D. Anderson Cancer Center

Lead Sponsor

Trials
3,107
Recruited
1,813,000+

Citations

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Giving XL092 and cemiplimab before and after surgery may be safe, tolerable and/or effective in treating patients with BRAF V600E wild type anaplastic thyroid ...

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Patients who developed ir-thyroid disorders had significantly longer progression-free survival (hazard ratio [HR]=0.2; 95% confidence interval [CI]: 0.07–0.6, p ...

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To define and measure changes of patient-reported outcomes (PROs) and quality of life (QOL) as measured by MDASI-HN and EQ-5D in participants who receive ...

Trials - Thyroid Gland Carcinoma

A Multi-Center Single-Arm Phase 2 Trial Of Zanzalintinib In Combination With Cemiplimab In BRAF Wild-Type Anaplastic Thyroid Cancer: The ZEPHYR Trial ( ...

XL092 and Cemiplimab in BRAF WT Thyroid Cancer

This multicenter study examines the safety and feasibility of the combination of neoadjuvant XL092 and cemiplimab prior to surgical ...