Enhancing Radioiodine Incorporation Into BRAF Mutant Thyroid Cancers With the Combination of Vemurafenib and KTN3379

Phase 1 Completed 7 enrolled Celldex Therapeutics Memorial Sloan Kettering Cancer Center · collab

NaSingle-groupOpen-labelTreatment

Summary

This is a patient pilot study testing the hypothesis that vemurafenib with the addition of KTN3379 can restore iodine incorporation in BRAF mutant (MUT), radioiodine-refractory (RAIR) thyroid cancer patients.

Timeline

Start: 2015-06
Primary completion: 2016-10-13
Completion: 2016-10-13

Outcome

Met primary endpoint

paper The endpoints for success were met, providing preliminary evidence of vemurafenib+CDX-3379 safety and efficacy for enhancing RAI uptake. PMID 35045748 ↗

paper No grade 3 or 4 toxicities related to CDX-3379 were observed. PMID 35045748 ↗

paper Five patients had increased RAI uptake after treatment; in 4 patients this increased uptake warranted therapeutic 131I. PMID 35045748 ↗

Publications

Tchekmedyian V, Dunn L, Sherman E, Baxi SS, Grewal RK, Larson SM, Pentlow KS, Haque S, Tuttle RM, Sabra MM, Fish S, Boucai L, Walters J, Ghossein RA, Seshan VE, Knauf JA, Pfister DG, Fagin JA, Ho AL. Enhancing Radioiodine Incorporation in BRAF-Mutant, Radioiodine-Refractory Thyroid Cancers with Vemurafenib and the Anti-ErbB3 Monoclonal Antibody CDX-3379: Results of a Pilot Clinical Trial. Thyroid. 2022 Mar;32(3):273-282. doi: 10.1089/thy.2021.0565.

Drugs

Evaluation	Drug	Modality	Dose	Route
Subject	CDX-3379	Unknown	1000 mg	Intravenous
Subject	Vemurafenib	Small molecule	960 mg	Oral