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PDR001 Combination Therapy for Radioiodine-Refractory Thyroid Cancer | Clinical Trials | Clareo Health

ACTIVE_NOT_RECRUITINGPHASE2

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

NCT04544111•Memorial Sloan Kettering Cancer Center

View on ClinicalTrials.gov

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.

Eligibility

Age

18 - No limit years

Sex

ALL

Healthy Volunteers

Inclusion Criteria

•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).
•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
•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).
•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).
•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).
•Patients must have RECIST v1.1 measurable disease.
•Patients must have recurrent or metastatic disease not amenable to curative surgery or radiation.
•Age \> 18 years.
•ECOG performance status of 0 or 1.
•Patients must have no recent treatment for thyroid cancer as defined as:
+22 more criteria

Exclusion Criteria

•Cohort A Only:
•* Patients with the following ophthalmological finding/conditions:
•Intraocular pressure \>21 mmHg, or uncontrolled glaucoma (irrespective of intraocular pressure).
•Current or past history of central serous retinopathy or retinal vein occlusion.
•Cohort A Only: Prior therapy with a MEK 1/2 targeted drug (with the exception of patients who received this therapy for a defined period of time to enhance radioiodine activity).
•Symptomatic metastatic brain or leptomeningeal tumors (asymptomatic or treated metastatic brain or leptomeningeal tumors are allowed).
•Prior therapy directed at the PD1/PD-L1 axis.
•Any of the following cardiovascular risks:
•* A QT interval corrected for heart rate using the Bazett's formula QTcB ≥ 480 msec.
•* Clinically significant uncontrolled arrhythmias (Exception: patients with controlled atrial fibrillation for \>30 days prior to enrollment are eligible).
+20 more criteria

Locations (7)

Memorial Sloan Kettering Basking Ridge (Limited Protocol Activities)

Basking Ridge, New Jersey, United States

Memorial Sloan Kettering Monmouth (Limited protocol activities)

Middletown, New Jersey, United States

Memorial Sloan Kettering Bergen (Limited Protocol Activities)

Montvale, New Jersey, United States

Memorial Sloan Kettering Cancer Center @ Suffolk - Commack (Limited Protocol Activities)

Commack, New York, United States

Memorial Sloan Kettering Westchester (Limited protocol activities)

Harrison, New York, United States

Memorial Sloan Kettering Cancer Center (All Protocol Activities)

New York, New York, United States

Memorial Sloan Kettering Nassau (Limited protocol activities)

Rockville Centre, New York, United States

Key Dates

Start Date

September 2, 2020

Primary Completion Date

September 2, 2026

Completion Date

September 2, 2026

Last Updated

October 7, 2025

Enrollment

ACTUAL participants

Conditions

Thyroid CancerThyroid Cancer, FollicularPapillary Thyroid CancerFollicular Thyroid CancerHurthle Cell TumorPoorly Differentiated Thyroid Gland CarcinomaHurthle Cell Thyroid Neoplasia

Interventions

Trametinib

DRUG

Dabrafenib

DRUG

PDR001

DRUG

The Clinical Outcomes and Prediction of Thermal Ablation for Low-risk Papillary Thyroid Carcinoma

NCT06316895

Papillary Thyroid Cancer

View study

RECRUITINGPHASE2

Lenvatinib 24 mg/Day Versus 10 mg/Day to Treat Symptomatic or Progressive Radioactive Iodine Resistant (RAIR) Differentiated Thyroid Cancer (DTC)

NCT07092514

Thyroid CancerCancer of the Thyroid

View study

Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: October 7, 2025Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

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PDR001 Combination Therapy for Radioiodine-Refractory Thyroid Cancer

Inclusion Criteria

Exclusion Criteria

The Clinical Outcomes and Prediction of Thermal Ablation for Low-risk Papillary Thyroid Carcinoma

Lenvatinib 24 mg/Day Versus 10 mg/Day to Treat Symptomatic or Progressive Radioactive Iodine Resistant (RAIR) Differentiated Thyroid Cancer (DTC)

Adjuvant Radiotherapy in High Risk Locally Advanced DTC

F-18 Tetrafluoroborate PET/CT in Differentiated Thyroid Cancer

RW Study of Adjuvant Radiotherapy in Locally Advanced Thyroid Cancer

Natural History Study of Children and Adults With Medullary Thyroid Cancer