RecruitingPhase 2NCT05668962

Restor. I-131 Upt. + Selpercatinib in RET F-P RAI-R TC

Restoration of Radioiodine Uptake with Selpercatinib in RET Fusion-Positive Radioiodine-Refractory Thyroid Cancer: a Phase 2 Study Performed in Collaboration with the International Thyroid Oncology Group (ITOG)

Sponsor

Massachusetts General Hospital

Enrollment

30 participants

Start Date

Mar 1, 2023

Study Type

INTERVENTIONAL

Conditions

Thyroid Cancer Thyroid Carcinoma Papillary Thyroid Cancer Metastatic Thyroid Cancer Follicular Thyroid Cancer Unresectable Thyroid Gland Carcinoma

Summary

This research is being done to determine the efficacy of selpercatinib to restore radioactive iodine (I-131 NaI) uptake and allow for I-131 treatment in people with RET fusion-positive radioiodine-refractory thyroid cancer. This research study involves the study drug selpercatinib in combination with standard of care treatments, I-131 and thyrotropin alfa (rhTSH).

Eligibility

Min Age: 12 Years

Plain Language Summary

Simplified for easier understanding

This study tests whether a targeted therapy called selpercatinib can help re-sensitize certain thyroid cancers to radioactive iodine (I-131) treatment. Thyroid cancers with a specific genetic change called a RET gene fusion often stop responding to standard iodine therapy. This trial explores a new approach to restore that response. **You may be eligible if...** - You are 18 or older - You have a type of thyroid cancer derived from follicular cells (not anaplastic) that has spread or cannot be removed surgically - Your tumor has a confirmed RET gene fusion found through genetic testing - Your cancer no longer responds to radioactive iodine treatment **You may NOT be eligible if...** - Your thyroid cancer does not have a RET gene fusion - You have received certain prior treatments recently - You have significant heart, liver, or other organ problems - You are pregnant or breastfeeding Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

DRUGSelpercatinib

Selpercatinib Oral, twice daily during initial treatment period (28 Days). A second course of selpercatinib if the participant is demonstrating clinical benefit to the initial course selpercatinib and deemed clinically appropriate by the treating investigator

DRUGSodium Iodine I-131

I-131 NaI, oral, is a standard treatment for all types of follicular-derived thyroid cancers, except anaplastic thyroid cancer

DRUGrhTSH

RhTSH injection, dosage per protocol, timing per protocol during the initial treatment period per standard of care. Participants may receive a second course of rhTSH if the participant is demonstrating clinical benefit to the initial course rhTSH and deemed clinically appropriate by the treating investigator.