PDR001 Combination Therapy for Radioiodine-Refractory Thyroid Cancer (NCT04544111)

🧪 Interventions in This Study

• Trametinib (DRUG)
• Dabrafenib (DRUG)
• PDR001 (DRUG)

Check every box below. If you can check all of them, you may meet the study's basic screening requirements (final eligibility is confirmed by the site team).

1. Cohort A Only: Confirmation in a CLIA certified laboratory that one of the patient's thyroid tumors (primary tumor, recurrent tumor, or metastases) does not possess a BRAFV600- mutation (non-V600- BRAF mutations, including BRAF translocations, may be included in this cohort).
2. Cohort A Only: Evidence of progressive disease (e.g. presence of new or growing lesion(s) on radiologic imaging and/or new or worsening tumor-related symptoms) within 14 months of study enrollment
3. Cohort B Only: Confirmation in a CLIA certified laboratory that one of the patient's thyroid tumors (primary tumor, recurrent tumor, or metastases) possesses a BRAFV600- mutation (e.g. V600E, V600K, V600D).
4. Cohort B Only: Patients must have documented progression (evidence of tumor growth or appearance of new tumor) on prior BRAF directed therapy (e.g. (but not limited to) vemurafenib, dabrafenib) and must have tolerated this therapy without \> Grade 3 toxicity on their most recent evaluation (excluding Grade 4 asymptomatic laboratory abnormalities).
5. Patients must have pathologically or cytologically confirmed differentiated thyroid cancer of follicular origin (including papillary thyroid carcinoma, follicular thyroid carcinoma, hurthle cell carcinomas, poorly differentiated thyroid carcinoma and their respective variants).
6. Patients must have RECIST v1.1 measurable disease.
7. Patients must have recurrent or metastatic disease not amenable to curative surgery or radiation.
8. Age \> 18 years.
9. ECOG performance status of 0 or 1.
10. Patients must have no recent treatment for thyroid cancer as defined as:
11. No prior RAI therapy is allowed \<6 months prior to initiation of therapy on this protocol. A diagnostic study using \<10 mCi of RAI is not considered RAI therapy
12. No external beam radiation therapy \<4weeks prior to initiation of therapy on this protocol.

🔍 Extracted verbatim from the official NIH eligibility criteria. Always confirm with the study coordinator.

📍 All Participating Trial Locations (7 Sites)

• Memorial Sloan Kettering Basking Ridge (Limited Protocol Activities) — Basking Ridge, New Jersey
• Memorial Sloan Kettering Monmouth (Limited protocol activities) — Middletown, New Jersey
• Memorial Sloan Kettering Bergen (Limited Protocol Activities) — Montvale, New Jersey
• Memorial Sloan Kettering Cancer Center @ Suffolk - Commack (Limited Protocol Activities) — Commack, New York
• Memorial Sloan Kettering Westchester (Limited protocol activities) — Harrison, New York
• Memorial Sloan Kettering Cancer Center (All Protocol Activities) — New York, New York
• Memorial Sloan Kettering Nassau (Limited protocol activities) — Rockville Centre, New York

📞 Contact the Study Coordinator

Phone: (800) 525-2225

Coordinator details come directly from the registered NIH protocol. Confirm the study is still recruiting before traveling.

💰 Cost, Insurance & Patient Rights

• 100% Free Items: The investigational treatment and protocol-required procedures are supplied at zero cost by the sponsor.
• Routine Patient Care: Under federal law (ACA § 2709) and many state statutes, routine care costs are covered during participation.
• Voluntary Participation: You may withdraw at any time without affecting your standard medical care.

More studies in Thyroid Cancer

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• A Study to Collect Information About the Use of Redifferentiating Medications as a Standard Treatment for Thyroid Cancer — New York, New York
• Restor. I-131 Upt. + Selpercatinib in RET F-P RAI-R TC — Washington D.C., District of Columbia
• Phase II Trial of Pembrolizumab in Metastatic or Locally Advanced Anaplastic/Undifferentiated Thyroid Cancer — Palo Alto, California

Explore by condition: All Thyroid Cancer clinical trials

💡 How to Participate

1. Check the checklist above to see if you may qualify.
2. Contact the study coordinator using the phone/email above.
3. Ask about the visit schedule, what is covered at no cost, and any travel support.
4. Confirm with your own doctor before making a decision.