Study on PDR001 Combination Therapy for Thyroid Cancer Resistant to Radioiodine Treatment

Inclusion Criteria

• For Cohort A: Thyroid tumors must not have a BRAFV600 mutation.
• For Cohort A: Evidence of disease progression within 14 months before joining the study.
• For Cohort B: Thyroid tumors must have a BRAFV600 mutation.
• For Cohort B: Must have shown tumor growth on previous BRAF-targeted therapy and tolerated it well.
• Must have confirmed differentiated thyroid cancer of follicular origin.
• Must have measurable disease according to specific criteria.
• Must have recurrent or metastatic disease that cannot be cured with surgery or radiation.
• Must be over 18 years old.
• Must have a performance status score of 0 or 1, indicating full activity or some restriction in strenuous activities.
• No recent treatment for thyroid cancer, including:
  • No radioiodine therapy within 6 months before starting the study.
  • No external beam radiation therapy within 4 weeks before starting the study.
  • No chemotherapy or targeted therapy within 4 weeks before starting the study, except for dabrafenib in Cohort B.
• Must have radioiodine-refractory disease, defined by specific criteria.
• Must be able to swallow pills and have no significant gastrointestinal issues.
• Must have tumor tissue available for research studies.
• Must agree to undergo two research biopsies, unless exempted for specific reasons.
• Must meet specific laboratory criteria for blood counts and organ function.
• Must have normal heart function as measured by an echocardiogram.

Exclusion Criteria

• For Cohort A: Certain eye conditions, such as high eye pressure or history of specific retinal issues.
• For Cohort A: Previous treatment with MEK inhibitors, except for enhancing radioiodine activity.
• Symptomatic brain or spinal tumors, unless treated and stable.
• Previous treatment targeting the PD1/PD-L1 pathway.
• Certain heart conditions, such as uncontrolled arrhythmias or recent heart attacks.
• Recent treatment for other cancers, unless completed over 2 years ago.
• Recent use of live vaccines.
• Use of chronic steroid therapy or other immunosuppressive drugs.
• Active autoimmune diseases, except for specific controlled conditions.
• History of organ transplants.
• Severe allergic reactions to study drugs.
• Current lung disease or non-infectious pneumonitis.
• Active hepatitis B or C infections.
• HIV positive status.
• Pregnant or breastfeeding women.
• Women of childbearing potential not using effective contraception.
• Men not using condoms during treatment and for 150 days after stopping treatment.