Neoplasms

All Conditions

Gland and Hormone Related Diseases

Rare Diseases

Carcinoma

Thyroid Neoplasms

Thyroid Cancer, Papillary

Thyroid Diseases

Adenocarcinoma, Follicular

Adenocarcinoma

Adenoma

Adenoma, Oxyphilic

Endocrine System Diseases

Endocrine Gland Neoplasms

Head and Neck Neoplasms

Adenocarcinoma, Papillary

Neoplasms, Glandular and Epithelial

Neoplasms by Histologic Type

Papillary Thyroid Carcinoma

Thyroid Cancer, Follicular

Pharmaceutical Solutions

All Drugs and Chemicals

Antineoplastic Agents

Trametinib

Dabrafenib

Spartalizumab

Protein Kinase Inhibitors

Enzyme Inhibitors

Immune Checkpoint Inhibitors

Antineoplastic Agents, Immunological

Cohort A (BRAF WT tumors): trametinib (T) 2mg by mouth daily plus PDR001 400mg IV every 4 weeks

Cohort B (BRAF Mutant, resistant to previous BRAF inhibitors): dabrafenib (D) 150 mg twice daily (OR at dose the patient previously tolerated) plus PDR001 400mg IV every 4 weeks.

2mg by mouth daily

\*If patient loses the ability to swallow while on study, trametinib may be provided as a powder in bottle for reconsititution. Trametinib, as a powder in bottle, will be mixed with sterile/purified water into an oral solution and administered PO or through enteral feeding tube

150 mg twice daily (OR at dose the patient previously tolerated)

PDR001

Alan L Ho, MD, PhD

The purpose of this study is to find out whether a drug called PDR001, combined with either trametinib or dabrafenib, is a safe and effective treatment for thyroid cancer.

PDR001 Combination Therapy for Radioiodine-Refractory Thyroid Cancer

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

Memorial Sloan Kettering Cancer Center supports the international committee of medical journal editors (ICMJE) and the ethical obligation of responsible sharing of data from clinical trials. The protocol summary, a statistical summary, and informed consent form will be made available on clinicaltrials.gov when required as a condition of Federal awards, other agreements supporting the research and/or as otherwise required. Requests for deidentified individual participant data can be made beginning 12 months after publication and for up to 36 months post publication. Deidentified individual participant data reported in the manuscript will be shared under the terms of a Data Use Agreement and may only be used for approved proposals. Requests may be made to: crdatashare@mskcc.org.

The primary endpoint is to determine the overall response rate (ORR=CR+PR) as documented by RECIST v1.1 criteria within each cohort.

Memorial Sloan Kettering Cancer Center

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization	Link
PDR001 Combination Therapy for Radioiodine-Refractory Thyroid Cancer	NCT04544111	Thyroid Cancer Thyroid Cancer,... Papillary Thyro... Follicular Thyr... Hurthle Cell Tu... Poorly Differen... Hurthle Cell Th...	Trametinib Dabrafenib PDR001	18 Years -	Memorial Sloan Kettering Cancer Center
PDR001 Combination Therapy for Radioiodine-Refractory Thyroid Cancer	NCT04544111	Thyroid Cancer Thyroid Cancer,... Papillary Thyro... Follicular Thyr... Hurthle Cell Tu... Poorly Differen... Hurthle Cell Th...	Trametinib Dabrafenib PDR001	18 Years -	Memorial Sloan Kettering Cancer Center

Spots Global Cancer Trial Database for hurthle cell thyroid neoplasia