Expired Study
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New York, New York 10065


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.

Study 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. Eligible patients with BRAF MUT, RAIR thyroid cancer will undergo human recombinant TSH (rhTSH or Thyrogen)-stimulated 124I PET/CT lesional dosimetry to quantify the baseline RAI avidity of index metastatic lesion(s). Patients will then receive vemurafenib followed by the addition of KTN3379 after which a second Thyrogen-stimulated 124I PET/CT lesional dosimetry will be performed. For patients whose tumor(s) demonstrate sufficient iodine incorporation warranting 131I therapy, Thyrogen-stimulated standard dosimetry will be performed and therapeutic 131I will be administered concurrently with vemurafenib and KTN3379. Subsequent to discontinuation of vemurafenib, tumor assessments will be conducted with serial radiologic scan(s) and thyroglobulins (scans will be performed at baseline, before 131I, 3 months (+/- 1 month) following 131I, and 6 months after 131I).


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.

Study is Available At:

Original ID:




Secondary ID:

Study Acronym:

Brief Title:

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

Official Title:

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

Overall Status:


Study Phase:

Phase 1



Minimum Age:

18 Years

Maximum Age:


Quick Facts

Healthy Volunteers
Oversight Has DMC
Study Is FDA Regulated
Study Is Section 801
Has Expanded Access

Study Source:

Celldex Therapeutics

Oversight Authority:

United States: Food and Drug Administration

Reasons Why Stopped:

Study Type:


Study Design:

Number of Arms:


Number of Groups:


Total Enrollment:


Enrollment Type:


Study Dates

Start Date:June 2015
Completion Date:October 13, 2016
Completion Type:Actual
Primary Completion Date:October 13, 2016
Primary Completion Type:Actual
Verification Date:August 2017
Last Changed Date:August 31, 2017
First Received Date:May 20, 2015

Study Outcomes

Outcome Type:Secondary Outcome
Measure:Safety and tolerability of the combination of vemurafenib and KTN3379 by assessing adverse events
Time Frame:6 to 8 weeks
Safety Issues:False
Outcome Type:Primary Outcome
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
Time Frame:4 to 6 weeks
Safety Issues:False

Study Interventions

Intervention Type:Biological
Description:IV every 2 weeks
Arm Name:Combination of Vemurafenib and KTN3379
Intervention Type:Drug
Description:960 mg po bid
Arm Name:Combination of Vemurafenib and KTN3379
Other Name:Zelboraf

Study Arms

Study Arm Type:Experimental
Arm Name:Combination of Vemurafenib and KTN3379
Description:Vemurafenib 960 mg po bid KTN3379 1000 mg IV q2weeks

Study Agencies

Agency Class:Industry
Agency Type:Lead Sponsor
Agency Name:Celldex Therapeutics
Agency Class:Other
Agency Type:Collaborator
Agency Name:Memorial Sloan Kettering Cancer Center

Sample and Retention Information

There are no available Sample and Retention Information

Study References

There are no available Study References

Data Source: ClinicalTrials.gov

Date Processed: January 21, 2020

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