Clinical trial · Interventional
Enhancing Radioiodine Incorporation Into BRAF Mutant Thyroid Cancers With the Combination of Vemurafenib and KTN3379
Enhancing Radioiodine (RAI) Incorporation Into BRAF Mutant, RAI Refractory Thyroid Cancers With the Combination of BRAF Inhibitor Vemurafenib and Anti-ErbB3 Antibody KTN3379: A Pilot Study With a Phase 1 Run-in
NCT02456701CI-TRIAL-00029416completedPhase 1ClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Thyroid Cancer | Malignant Thyroid Gland Neoplasm | CURATED_EXACT | 0.92 |
Interventions
Interventions (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| KTN3379 | Biological | — | UNRESOLVED |
| vemurafenib | Drug | Vemurafenib | ALIAS |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- Combination of Vemurafenib and KTN3379
- description
- Vemurafenib 960 mg po bid KTN3379 1000 mg IV q2weeks
- interventionNames
- Biological: KTN3379
- Drug: vemurafenib
Primary outcomes (1)
- measure
- The number of patients with BRAF MUT, radioiodine-refractory thyroid cancer in which the combination of vemurafenib and KTN3379 can increase tumoral iodine incorporation to warrant 131I treatment
- timeFrame
- 4 to 6 weeks
Secondary outcomes (1)
- measure
- Safety and tolerability of the combination of vemurafenib and KTN3379 by assessing adverse events
- timeFrame
- 6 to 8 weeks
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: * Patients must have histologically or cytologically confirmed thyroid carcinoma of follicular origin (including papillary, follicular, or poorly differentiated subtypes and their respective variants). * Confirmation in a CLIA certified laboratory or in an FDA-approved assay that one of the patient's thyroid tumors (primary tumor, recurrent tumor, or metastasis) possesses a BRAF mutation at V600. * Patients must have measurable disease defined by RECIST criteria 1.1. * Tumors in previously irradiated fields may be considered measureable if there is evidence of tumor progression after radiation treatment. * RAI-refractory disease on structural imaging * Age ≥ 18 years. * ECOG performance status ≤ 2 * Patients must have normal organ and marrow function as defined below: * Absolute neutrophil count (ANC) \> 1500/mcl * Hemoglobin ≥ 9 g/dL * Platelets ≥ 100,000/mcl * Albumin ≥ 2.5 g/dL * Total bilirubin ≤ 1.5x institutional ULN * Aspartate aminotransferase (AST) and alanine aminotransferase (ALT) ≤ 2x institutional ULN unless it is related to the primary disease * Creatinine ≤ 1.5 mg/dL OR calculated creatinine clearance (Cockcroft-Gault formula) ≥ 50 mL/min OR 24-hour urine creatinine clearance ≥ 50 mL/min Exclusion Criteria: * Concomitant malignancies or previous malignancies treated within the past 3 years. Exception: Patients who have been disease-free for 3 years, patients with a history of completely resected non-melanoma skin cancer, and/or patients with indolent secondary malignancies, are eligible. * Use of other investigational drugs within 28 days preceding the first dose of vemurafenib on this study. * Symptomatic or untreated leptomeningeal or brain metastases or spinal cord compression. * History or evidence of cardiovascular risk including any of the following: * Corrected QT (QTc) interval ≥ 450 msec at baseline or history of congenital long QT syndrome or uncorrectable electrolyte abnormalities. (Patients with well controlled atrial fibrillation are exempt from this criteria.) * History of cerebrovascular attack or transient ischemic attack within 6 months prior to the initiation of therapy on this protocol. * Uncontrolled intercurrent illness including, but not limited to, ongoing or active infection or psychiatric illness/social situations that would limit compliance with study requirements.
References
Publications (1)
- DERIVEDTchekmedyian 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. PMID 35045748