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Testing Lenvatinib and Cetuximab in Patients With Advanced Head and Neck Squamous Cell Carcinoma and Cutaneous Squamous Cell Carcinoma | Clinical Trials | Clareo Health

COMPLETEDPHASE1

Testing Lenvatinib and Cetuximab in Patients With Advanced Head and Neck Squamous Cell Carcinoma and Cutaneous Squamous Cell Carcinoma

A Phase I/Ib Study of Lenvatinib and Cetuximab in Patients With Recurrent/Metastatic Head and Neck Squamous Cell Carcinoma and Cutaneous Squamous Cell Carcinoma

NCT03524326•Memorial Sloan Kettering Cancer Center

View on ClinicalTrials.gov

Summary

This is a phase I study, which tests the safety of different doses of lenvatinib in combination with cetuximab, to see which dose is the safest in people. This study will help find out if lenvatinib and cetuximab is a safe and useful combination for treating patients with HNSCC and cSCC.

Eligibility

Age

All ages

Sex

ALL

Healthy Volunteers

Inclusion Criteria

•Histological or cytologic diagnosis of squamous cell cancer
•Clinical diagnosis of squamous cell cancer of the head and neck (non-nasopharynx primary tumors: oral cavity, oropharynx, hypopharynx, larynx and sinonasal) or skin
•HNSCC and cSCC cannot be curable by surgery and/or radiation therapy
•Measureable disease as per RECIST v1.1, which includes locoregional lesions (not amenable to curative surgery and/or radiation) and distant metastatic lesions
•Blood pressure \< 150/90 at screening with or without antihypertensive medications and no change in antihypertensive medications within 1 week prior to initiation of treatment
•ECOG Performance Status of 0-1
•Adequate renal function as evidenced by calculated creatinine clearance \> 30 ml/min according to the Cockcroft and Gault Formula or by 24 hour urine creatinine clearance
•Adequate liver function as determined by (1) Bilirubin \< 1.5 x upper limit of normal (ULN) except for unconjugated hyperbilirubinemia or Gilbert"s syndrome; (2) ALT and AST \< 3 x ULN (\<5 x ULN if subject has liver mets)
•Adequate hematologic function as determined by (1) platelets \> 100,000; (2) Hemoglobin \> 9 gm/dl; (3) absolute neutrophil count \> 1200
•Adequate archival tissue to perform molecular analysis through MSK-IMPACT if MSK-IMPACT has not been performed previously on the patient"s tumor; if MSK-IMACT has not been previously performed and adequate archival tissue is not available, a patient should be agreeable to a pre-treatment biopsy

Exclusion Criteria

•Prior grade 3 hypersensitivity to cetuximab requiring discontinuation
•Prior lenvatinib
•Major surgery within 2 weeks of first dose of lenvatinib
•Metastatic brain or leptomeningeal tumors (treated metastatic brain or leptomeningeal tumors are allowed).
•Anticancer treatment (e.g., radiation therapy, chemotherapy) within 21 days of first dose
•°An exception is cetuximab treatment, which can be received within 21 days of the first treatment on study
•No prior palliative radiation to a target lesion is allowed, unless there is clear biopsy proven progression following radiation. Note, prior radiations to a non-target lesion is allowed. Please see section 9.3.Subjects having a spot Urine Protein:Creatinine ratio of \>1 will undergo 24-hour collection for quantitative assessment of proteinuria. If urine protein \> 1 gram/24 hours, the subject will be ineligible
•Significant cardiovascular impairment within 6 months as defined as (1) congestive heart failure greater than New York Heart Association Class II, (2) unstable angina, (3) myocardial infarction; (4) stroke, (5) symptomatic cardiac arrhythmia
•On electrocardiogram, QTc interval \> 500 msec
•Active infection requiring systemic therapy
+8 more criteria

Locations (7)

Memoral Sloan Kettering Basking Ridge

Basking Ridge, New Jersey, United States

Memoral Sloan Kettering Monmouth

Middletown, New Jersey, United States

Memorial Sloan Kettering Bergen

Montvale, New Jersey, United States

Memorial Sloan Kettering Cancer Center @ Commack

Commack, New York, United States

Memoral Sloan Kettering Westchester

Harrison, New York, United States

Memorial Sloan - Kettering Cancer Center

New York, New York, United States

Memorial Sloan Kettering Nassau

Uniondale, New York, United States

Key Dates

Start Date

April 30, 2018

Primary Completion Date

October 13, 2022

Completion Date

October 13, 2022

Last Updated

May 13, 2025

Enrollment

ACTUAL participants

Conditions

Head and Neck Squamous Cell CarcinomaCutaneous Squamous Cell CarcinomaHead and Neck CancerHead and Neck Carcinoma

Interventions

Lenvatinib Pill

DRUG

Lenvatinib Pill

DRUG

Lenvatinib Pill

DRUG

Cetuximab

DRUG

Lenvatinib Pill

DRUG

Lenvatinib Pill

DRUG

IACS-6274 With or Without Bevacizumab and Paclitaxel for the Treatment of Advanced Solid Tumors

NCT05039801

Advanced Endometrial CarcinomaAdvanced Head and Neck Squamous Cell Carcinoma+36 more

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RECRUITINGPHASE2

Testing Whether Cemiplimab (REGN2810) Plus CDX-1140 Given Prior to Surgery Are Better Than Cemiplimab (REGN2810) Alone in Patients With Stage III-IV Head and Neck Cancer

NCT06980038

Head and Neck Squamous Cell CarcinomaHypopharyngeal Squamous Cell Carcinoma+20 more

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Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: May 13, 2025Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

View ClinicalTrials.gov Terms and Conditions

Testing Lenvatinib and Cetuximab in Patients With Advanced Head and Neck Squamous Cell Carcinoma and Cutaneous Squamous Cell Carcinoma

Inclusion Criteria

Exclusion Criteria

IACS-6274 With or Without Bevacizumab and Paclitaxel for the Treatment of Advanced Solid Tumors

Testing Whether Cemiplimab (REGN2810) Plus CDX-1140 Given Prior to Surgery Are Better Than Cemiplimab (REGN2810) Alone in Patients With Stage III-IV Head and Neck Cancer

A Study to Test Whether Treatment With BI 770371 in Combination With Pembrolizumab With or Without Cetuximab Helps People With Head and Neck Cancer Compared With Pembrolizumab Alone

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