PDR001 Combination Therapy for Radioiodine-Refractory Thyroid Cancer
NCT04544111 · Status: ACTIVE_NOT_RECRUITING · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 19
Last updated 2025-10-07
Summary
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.
Conditions
- Thyroid Cancer
- Thyroid Cancer, Follicular
- Papillary Thyroid Cancer
- Follicular Thyroid Cancer
- Hurthle Cell Tumor
- Poorly Differentiated Thyroid Gland Carcinoma
- Hurthle Cell Thyroid Neoplasia
Interventions
- DRUG
-
Trametinib
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
- DRUG
-
Dabrafenib
150 mg twice daily (OR at dose the patient previously tolerated)
- DRUG
-
PDR001
400mg IV every 4 weeks
Sponsors & Collaborators
-
Memorial Sloan Kettering Cancer Center
lead OTHER
Principal Investigators
-
Alan L Ho, MD, PhD · Memorial Sloan Kettering Cancer Center
Study Design
- Allocation
- RANDOMIZED
- Purpose
- TREATMENT
- Masking
- NONE
- Model
- PARALLEL
Eligibility
- Min Age
- 18 Years
- Sex
- ALL
- Healthy Volunteers
- No
Timeline & Regulatory
- Start
- 2020-09-02
- Primary Completion
- 2026-09-02
- Completion
- 2026-09-02
- FDA Drug
- Yes
Countries
- United States
Study Locations
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