A Phase IB Study of Vemurafenib plus Copanlisib to Enhance Response to Radioiodine Therapy in People with Thyroid Cancer

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Full Title

A Phase Ib Trial of Vemurafenib Plus Copanlisib to Enhance Radioiodine Avidity in Radioiodine-Refractory Thyroid Cancers

Purpose

Radioactive iodine (RAI) is the standard treatment for thyroid cancer. Thyroid cancers that have mutations in a gene called BRAF are less likely to respond to RAI. The purpose of this study is to develop a new drug treatment to reverse this resistance in BRAF-mutant tumors to make RAI more effective.

In this study, researchers want to find the highest doses of the drugs vemurafenib and copanlisib that, when given in combination, do not cause serious side effects. They also want to determine if this drug combination can make RAI work better in patients with BRAF-mutant thyroid cancers.

Vemurafenib blocks an altered form of the BRAF protein. Copanlisib works by targeting an enzyme called PI3K, which drives cancer growth. Vemurafenib is used to treat cancers with BRAF mutations, such as melanoma, and copanlisib is used to treat follicular lymphoma. Their use together in this study is considered investigational. Vemurafenib is taken orally (by mouth) and copanlisib is given intravenously (by vein).

Eligibility

To be eligible for this study, patients must meet several criteria, including but not limited to the following:

  • Patients must have thyroid cancer that has been shown to be resistant to RAI, either through continued growth while on RAI treatment or on an imaging test.
  • At least 6 months must pass between the receipt of the study drugs and RAI treatment and 4 weeks since completing any prior chemotherapy, targeted therapy, or radiation therapy.
  • Patients must be able to walk and do routine activities for more than half of their normal waking hours.
  • This study is for patients age 18 and older.

For more information about this study and to inquire about eligibility, please contact Dr. Alan L. Ho at 646-888-4235.

Protocol

20-053

Phase

I

Disease Status

Newly Diagnosed & Relapsed/Refractory

Investigator