Nivolumab + Ipilimumab for Thyroid Cancer
What You Need to Know Before You Apply
What is the purpose of this trial?
This trial tests two investigational drugs, nivolumab (Opdivo) and ipilimumab (Yervoy), to determine their effectiveness in treating various thyroid cancers, including differentiated, medullary, and anaplastic types. The trial aims to understand how these drugs work alone or together against these cancers. Suitable participants have thyroid cancer that has spread or progressed despite previous treatments and experience symptoms affecting daily life. As a Phase 2 trial, the research focuses on measuring the treatment's effectiveness in an initial, smaller group of people.
Do I have to stop taking my current medications for the trial?
The trial protocol does not specify if you need to stop taking your current medications. However, you cannot participate if you are on systemic corticosteroids or other immunosuppressive medications within 14 days of starting the study drugs. It's best to discuss your specific medications with the trial team.
Is there any evidence suggesting that this trial's treatments are likely to be safe?
Research has shown that the combination of nivolumab and ipilimumab, experimental drugs, holds potential for treating certain cancers. Studies have found that many patients tolerate these drugs well. Specifically, using these drugs together has shown positive effects in treating aggressive thyroid cancers, such as anaplastic thyroid cancer.
However, this treatment can sometimes cause side effects. In past trials, some patients experienced immune-related side effects, which occur when the immune system becomes overly active. These side effects can range from mild to severe but are often manageable with proper medical care.
Both nivolumab and ipilimumab have received FDA approval for other uses, indicating a known safety profile. While this is reassuring, participating in a clinical trial means the treatment is still under study specifically for thyroid cancer. Always discuss potential risks with healthcare providers before joining a trial.12345Why are researchers excited about this trial's treatments?
Researchers are excited about the combination of Nivolumab and Ipilimumab for thyroid cancer because these drugs offer a unique approach compared to traditional treatments like surgery or radioactive iodine. Unlike standard treatments that often target the thyroid gland directly, Nivolumab and Ipilimumab are immunotherapies that work by boosting the body's immune system to better recognize and attack cancer cells. Nivolumab blocks a protein called PD-1, which helps keep immune cells active against cancer, while Ipilimumab targets CTLA-4, another protein that can dampen the immune response. This dual mechanism of action offers a promising new way to enhance the body's ability to fight thyroid cancer, potentially leading to more effective outcomes for patients.
What evidence suggests that this trial's treatments could be effective for thyroid cancer?
This trial will evaluate the use of nivolumab and ipilimumab, both separately and in combination, for various types of thyroid cancer. For differentiated thyroid cancer, some participants will receive nivolumab alone, while others will receive ipilimumab alone or both drugs combined. In more aggressive types, like anaplastic thyroid cancer, participants may receive either drug alone or in combination. Studies have shown that using nivolumab and ipilimumab together can treat different types of thyroid cancer by blocking proteins that prevent the immune system from attacking cancer cells, allowing the body to fight the cancer more effectively. Overall, these treatments offer hope for better outcomes for thyroid cancer patients.12467
Who Is on the Research Team?
Kartik Sehgal
Principal Investigator
Dana-Farber Cancer Institute
Are You a Good Fit for This Trial?
This trial is for adults with thyroid cancer, including those who've had prior treatments. It's open to patients with medullary thyroid cancer after TKI failure and anaplastic thyroid cancer, as well as metastatic RAI refractory differentiated thyroid cancer. Participants must be in good health otherwise, able to consent, and use effective contraception if of childbearing potential.Inclusion Criteria
Exclusion Criteria
Timeline for a Trial Participant
Screening
Participants are screened for eligibility to participate in the trial
Treatment
Participants receive Nivolumab and Ipilimumab sequentially or in combination, with treatment continuing until disease progression or withdrawal
Follow-up
Participants are monitored for safety and effectiveness after treatment
What Are the Treatments Tested in This Trial?
Interventions
- Ipilimumab
- Nivolumab
Ipilimumab is already approved in United States, European Union for the following indications:
- Advanced melanoma
- Stage III unresectable melanoma
- Stage IV metastatic melanoma
- Advanced melanoma
- Stage III unresectable melanoma
- Stage IV metastatic melanoma
Find a Clinic Near You
Who Is Running the Clinical Trial?
Dana-Farber Cancer Institute
Lead Sponsor
Bristol-Myers Squibb
Industry Sponsor
Christopher Boerner
Bristol-Myers Squibb
Chief Executive Officer since 2023
PhD in Business Administration from the Haas School of Business, University of California, Berkeley; BA in Economics and History from Washington University in St. Louis
Deepak L. Bhatt
Bristol-Myers Squibb
Chief Medical Officer since 2024
MD from Yale University; MSc in Clinical Epidemiology from the University of Pennsylvania