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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03524326
Recruitment Status : Recruiting
First Posted : May 14, 2018
Last Update Posted : January 31, 2020
Sponsor:
Information provided by (Responsible Party):
Memorial Sloan Kettering Cancer Center

Brief 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.

Condition or disease Intervention/treatment Phase
Head and Neck Squamous Cell Carcinoma Cutaneous Squamous Cell Carcinoma Head and Neck Cancer Head and Neck Carcinoma Drug: Lenvatinib Pill Drug: Cetuximab Phase 1

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 28 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: 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
Actual Study Start Date : April 30, 2018
Estimated Primary Completion Date : April 2021
Estimated Study Completion Date : April 2021

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: Head and Neck Squamous or Cutaneous Squamous Cell Carcinoma
A 3+3 dose de-escalation design for three dose levels of lenvatinib combined with cetuximab will be used. A DLT will be defined as any toxicities of grade 3 or higher (per CTCAE v4 criteria) felt to be possibly, probably, or definitely related to lenvatinib, as well as grade 4 toxcities related to cetuximab, which occurs within 28 days following the first dose of lenvatinib in combination with cetuximab.
Drug: Lenvatinib Pill
24 mg oral daily
Other Name: Level 0 Lenvatinib

Drug: Lenvatinib Pill
20 mg oral daily
Other Name: Level -1 Lenvatinib

Drug: Lenvatinib Pill
14 mg oral daily
Other Name: Level -2 Lenvatinib

Drug: Cetuximab
400mg/m2 IV, then 500mg/m2 IV weekly

Drug: Lenvatinib Pill
10 mg oral daily
Other Name: Level -3 Lenvatinib

Drug: Lenvatinib Pill
4 mg oral daily
Other Name: Level -4 Lenvatinib




Primary Outcome Measures :
  1. Maximum tolerated dose of Lenvatinib when combined with Cetuximab [ Time Frame: 1 year ]


Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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Ages Eligible for Study:   Child, Adult, Older Adult
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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
  • Clinically significant hemoptysis or tumor bleeding within 2 weeks prior to first dose of lenvatinib
  • Other active malignancy except for basal cell or squamous cell carcinoma of the skin, or carcinoma in situ of the cervix or bladder
  • Women who are breast feeding or pregnant ° Men or women of reproductive potential who are not willing to employ effective birth control from screening to 30 days after the last dose of study drugs; the definition of adequate contraception will be based on the judgment of the principal investigator or a designated associate.

For a female patient to be considered as not of child bearing potential, she should fulfill one of the following:

° Post-menopausal women, defined as either women aged more than 50 years and amenorrhoeic for at least 12 months following cessation of all exogenous hormonal treatments, or, women under 50 years old who have been amenorrhoeic for at least 12 months following the cessation of exogenous hormonal treatments, and have serum follicle-stimulating hormone (FSH) and luteinizing hormone (LH) levels in the postmenopausal range for the institution.

Or

° Have documentation of irreversible surgical sterilisation by hysterectomy, bilateral oophorectomy or bilateral salpingectomy (but not tubal ligation)

  • Evidence of clinically significant disease (e.g., cardiovascular, respiratory, gastrointestinal, renal disease) that in the opinion of the investigator could affect the subject safety or interfere with the study assessments

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03524326


Contacts
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Contact: Lara Dunn, MD 646-888-4233 dunnl1@mskcc.org
Contact: Eric Sherman, MD 646-888-4234 shermane@mskcc.org

Locations
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United States, New Jersey
Memoral Sloan Kettering Basking Ridge Recruiting
Basking Ridge, New Jersey, United States, 07920
Contact: Lara Dunn, MD    646-888-4233    dunnl1@mskcc.org   
Memoral Sloan Kettering Monmouth Recruiting
Middletown, New Jersey, United States, 07748
Contact: Lara Dunn, MD    646-888-4233      
Memorial Sloan Kettering Bergen Recruiting
Montvale, New Jersey, United States, 07645
Contact: Lara Dunn, MD    646-888-4233      
United States, New York
Memorial Sloan Kettering Cancer Center @ Commack Recruiting
Commack, New York, United States, 11725
Contact: Lara Dunn, MD    646-888-4233      
Memoral Sloan Kettering Westchester Recruiting
Harrison, New York, United States, 10604
Contact: Lara Dunn, MD    646-888-4233      
Memorial Sloan - Kettering Cancer Center Recruiting
New York, New York, United States, 10021
Contact: Lara Dunn, MD    646-888-4233      
Memorial Sloan Kettering Nassau Not yet recruiting
Uniondale, New York, United States, 11553
Contact: Lara Dunn, MD    646-888-4233      
Sponsors and Collaborators
Memorial Sloan Kettering Cancer Center
Investigators
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Principal Investigator: Lara Dunn, MD Memorial Sloan Kettering Cancer Center
Additional Information:
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Responsible Party: Memorial Sloan Kettering Cancer Center
ClinicalTrials.gov Identifier: NCT03524326    
Other Study ID Numbers: 17-635
First Posted: May 14, 2018    Key Record Dates
Last Update Posted: January 31, 2020
Last Verified: January 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Memorial Sloan Kettering Cancer Center:
cetuximab
Lenvatinib
Memorial Sloan Kettering Cancer Center
17-635
Additional relevant MeSH terms:
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Carcinoma
Carcinoma, Squamous Cell
Squamous Cell Carcinoma of Head and Neck
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type
Neoplasms
Neoplasms, Squamous Cell
Head and Neck Neoplasms
Neoplasms by Site
Cetuximab
Lenvatinib
Antineoplastic Agents, Immunological
Antineoplastic Agents
Protein Kinase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action