Lenvatinib in Locally Advanced Invasive Thyroid Cancer

NCT04321954 | Active Not Recruiting Phase 2 DMC FDA Drug

• 1 other identifier: 19-524
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 3

Brief Summary

This research is being done to evaluate the safety and efficacy of neoadjuvant lenvatinib on surgical outcomes of patients with invasive extrathyroidal differentiated thyroid cancer (DTC). This research study involves a study drug called lenvatinib

Conditions

Advanced Cancer; Differentiated Thyroid Cancer

Keywords

Differentiated Thyroid Cancer; Advanced Cancer

Outcome Measures

Primary Outcomes (1)

• Overall R0/R1 resection rate

  Evaluate the overall R0/R1 resection rate, as defined by proportion of patients who undergo successful thyroidectomy with clear (R0) or microscopically positive surgical margins (R1).

  112 Days

Secondary Outcomes (6)

• Resection rate of R0

  112 Days

• Resection rate of R1

  112 Days

• Change in Surgical complexity and morbidity score (SCMS)

  112 Days

• Primary surgery response rate

  112 Days

• Number of Participants with Treatment Related Adverse Events as Assessed by CTCAE v 5.0

  Up to 18 months

Study Arms (1)

LENVATINIB

EXPERIMENTAL

Study procedures include screening for eligibility and study treatment, evaluations, and follow up visits * Lenvatinib will be administered orally daily at a predetermined dose for 2, 4, or 6 cycles, dependent on response. 1 cycle is 28 days. * Surgery per standard of care will follow lenvatinib treatment.

Drug: LENVATINIB

Interventions

LENVATINIB DRUG

Orally

Also known as: Lenvima

LENVATINIB

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• years of age at the time of informed consent and willing and able to provide written informed consent for the trial.
• Adult participants who are either initially diagnosed with locally advanced thyroid neoplasm or have experienced persistent or recurrent thyroid and/or cervical nodal recurrent DTC (participants with M1 disease are allowed, AJCC 8th edition stage I-IVb)), including:
• a. Papillary thyroid carcinoma (PTC) - classical and variants
• Follicular variant
• Variants including but not limited to tall cell, columnar cell, cribriform-morular, solid, oxyphil, Warthin's-like, trabecular, tumor with nodular fasciitis-like stroma, Hürthle cell variant of papillary carcinoma
• b. Follicular thyroid carcinoma (FTC)
• c. Hürthle cell carcinoma
• d. Poorly differentiated thyroid carcinoma
• e. Cytologically confirmed thyroid neoplasm, Bethesda 3, 4 and 5
• Evidence of extrathyroidal extension and/or locally invasive disease and deemed at risk for R2 resection by treating team on clinical and/or fiberoptic examination and/or radiographic evaluation in the primary or recurrent setting. Evidence of "at risk for R2 resection" includes:
• a. Vocal cord paralysis by fiberoptic examination
• b. Extrathyroid and/or extranodal extension on CT or MRI, including tracheal and/or laryngeal cartilage invasion, esophageal involvement, and/or involvement of perithyroid muscles (e.g. strap, sternocleidomastoid, inferior constrictor muscles) or bone involvement
• c. Extension into the mediastinum with visceral and/or vascular involvement
• d. Involvement of the carotid artery or other major vessel by 180 degrees or more (exclusive of complete encasement)
• e. Other factors that make the participant to be "at risk for R2 resection" may be allowed, after discussion with the study's principal investigator.

You may not qualify if:

• Diagnosis of medullary thyroid carcinoma or anaplastic (undifferentiated) thyroid carcinoma.
• Radiographically identified following findings:
• intraluminal airway tumor
• complete carotid encasement/infiltration
• Active hemoptysis (bright red blood ≥ 1/2 teaspoon) or other uncontrolled bleeding within 21 days prior to the study registration.
• Arterial/venous thromboembolic events in the last 12 months Treatment within 30 days prior to study registration with anticoagulant or antiplatelet therapy, apart from aspirin 81 mg daily.
• Prior radiotherapy to the neck.
• Prior treatment with lenvatinib or other VEGFR-directed therapy, including sorafenib.
• Known metastasis to central nervous system.
• Females who are pregnant or breastfeeding.
• If \> 1 + proteinuria on urine dipstick testing will undergo 24-hour urine collection for quantitative assessment of proteinuria. Participants with urine protein ≥1g/24 h will be ineligible.
• Gastrointestinal malabsorption or any other condition that in the opinion of the investigator might affect the absorption of study drug.
• Active infection requiring treatment.
• Significant cardiovascular impairment: history of congestive heart failure greater than New York Heart Association (NYHA) Class II, unstable angina, myocardial infarction, or stroke within 6 months of the first dose of study drug, or cardiac arrhythmia requiring medical treatment.
• Prolongation of corrected QT interval (QTc) to \> 480 ms as demonstrated by a repeated ECG or any clinically significant ECG abnormality

Sponsors & Collaborators

• Eisai Inc.: collaborator
• Massachusetts Eye and Ear Infirmary: lead

Study Sites (3)

Massachusetts General Hospital Cancer Center

Boston, Massachusetts, 02114, United States

Location

Memorial Sloan Kettering Cancer Center

New York, New York, 10065, United States

Location

MD Anderson Cancer Center

Houston, Texas, 77030, United States

Location

Related Publications (1)

• Farlow JL, McCrary HC, Sipos JA, Phay JE, Konda B, Agrawal A. Neoadjuvant dabrafenib and trametinib for functional organ preservation in recurrent BRAF V600E-mutated papillary thyroid cancer. Oral Oncol. 2023 Dec;147:106625. doi: 10.1016/j.oraloncology.2023.106625. Epub 2023 Nov 8.

  PMID: 37948895 DERIVED

MeSH Terms

Interventions

lenvatinib

Study Officials

• Gregory Randolph, MD

  Massachusetts Eye and Ear Infirmary (MEEI)

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor of Otolaryngology Head and Neck Surgery

Study Record Dates

• First Submitted: March 24, 2020
• First Posted: March 25, 2020
• Study Start: March 9, 2021
• Primary Completion: May 27, 2025
• Study Completion (Estimated): May 27, 2026
• Last Updated: February 27, 2026

Record last verified: 2026-02

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF
• Time Frame: Data can be shared no earlier than 1 year following the date of publication
• Access Criteria: Contact the Partners Innovations team at http://www.partners.org/innovation

Locations

US (3)