A Phase II Study of PDR001 Combination Therapy for Radioiodine-Resistant Thyroid Cancer

Full Title

Phase II Study of PDR001 in Combination with MAPK Pathway Inhibitors in Patients with Radioiodine-Refractory Thyroid Cancer

Purpose

Radioiodine is a common treatment for thyroid cancer. But some patients’ cancers grow or come back despite this treatment. In this study, researchers are evaluating the safety and effectiveness of the investigational drug PDR001 when given with either trametinib or dabrafenib in patients with thyroid cancer that cannot be successfully treated with radioiodine.

PDR001 is a type of immunotherapy. It works by boosting the power of the immune system to find and kill cancer cells. It is given intravenously (by vein). Dabrafenib works by blocking the mutated BRAF protein, which lets cancer cells grow without stopping. Trametinib blocks another protein, called MEK, which also fuels cancer cell growth. These two drugs are already used together to treat melanoma and lung cancer that contains mutated BRAF. Their use in this study is considered investigational. Both medications are taken orally (by mouth).

Patients’ tumor tissue will be tested for genetic changes. Patients whose tumors have a BRAF gene mutation will receive PDR001 and dabrafenib, and those without this mutation will receive PDR001 and trametinib.

Eligibility

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

• Patients must have recurrent or metastatic follicular thyroid cancer that doctors believe cannot be treated successfully with radioiodine.
• No prior radioiodine therapy is allowed within 6 months of entering the study. At least 4 weeks must pass between the completion of previous radiation therapy, targeted therapy, or chemotherapy and entry into the study.
• Patients receiving dabrafenib must have experienced cancer growth despite prior treatment with a BRAF inhibitor (such as vemurafenib or dabrafenib).
• Patients may not have received prior immunotherapy.
• Patients must be physically well enough that they are fully ambulatory, capable of all self-care, and capable of all but physically strenuous activities. As an example, patients must be well enough that they would be able to carry out office work or light housework.
• 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 646-608-3774.