NCT03246958

Nivolumab Plus Ipilimumab in Thyroid Cancer

A Phase 2 Study of Nivolumab Plus Ipilimumab in RAI Refractory, Aggressive Thyroid Cancer With Exploratory Cohorts in Medullary and Anaplastic Thyroid Cancer

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 53 (actual)
• Sponsor: Dana-Farber Cancer Institute · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

This research study is studying nivolumab, an investigational drug, in combination with ipilimumab, also an investigational drug, as a possible treatment for thyroid cancer. The drugs involved in this study are: * Nivolumab (Opdivo™) * Ipilimumab (Yervoy™)

Detailed description

This research study is a Phase 2 clinical trial. Phase 2 clinical trials test the safety and effectiveness of an investigational intervention to learn whether the intervention works in treating a specific disease. "Investigational" means that the intervention is being studied. The purpose of this study is to evaluate effectiveness (how well the drug/s work) of nivolumab combined with ipilimumab. Nivolumab and ipilimumab are types of immunotherapy. Immunotherapy works by encouraging the body's own immune system to attack cancer cells. Nivolumab has been approved by the US Food and Drug Administration (FDA) for the treatment of metastatic melanoma (a type of skin cancer), and specific types of previously treated advanced lung and kidney cancers. Ipilimumab is approved by the FDA for the treatment of metastatic melanoma. The combination of nivolumab and ipilimumab is now FDA approved as treatment for patients with metastatic melanoma. However, the use of nivolumab as well as ipilimumab alone or in combination for the treatment of patients with thyroid cancer is not approved

Conditions

• Thyroid Cancer

Interventions

Type	Name	Description
DRUG	Nivolumab	Ipilimumab are types of immunotherapy Immunotherapy works by encouraging the body's own immune system to attack cancer cells.
DRUG	Ipilimumab	Nivolumab are types of immunotherapy. Immunotherapy works by encouraging the body's own immune system to attack cancer cells.

Timeline

• Start date: 2017-10-03
• Primary completion: 2021-01-21
• Completion: 2021-07-31
• First posted: 2017-08-11
• Last updated: 2025-06-19
• Results posted: 2024-05-21

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated drug study