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RECRUITING Phase 2 ClinicalTrials.gov

Treatment With Amivantamab and Hyaluronidase or Cetuximab for Advanced Skin Cancer in People With a Weakened Immune System

Sponsor: National Cancer Institute (NCI) • ClinicalTrials.gov ID: NCT07042295

Registry updated: 2026-10-15
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Description

This phase II trial compares the effect of amivantamab and hyaluronidase to cetuximab for the treatment of skin (cutaneous) squamous cell carcinoma that has come back after a period of improvement and has not spread to other parts of the body (locally recurrent) or that has spread from where it first started (primary site) to other places in the body (metastatic). Amivantamab is a monoclonal antibody that may interfere with the ability of tumor cells to grow and spread. A monoclonal antibody is a type of protein that can bind to certain targets in the body, such as molecules that cause the body to make an immune response (antigens). Hyaluronidase is an endoglycosidase. It helps to keep amivantamab in the body longer, so that the medications will have a greater effect. Cetuximab is in a class of medications called monoclonal antibodies. It binds to a protein called EGFR, which is found on some types of cancer cells. This may help keep cancer cells from growing. Giving amivantamab and hyaluronidase may be as effective as cetuximab for the treatment of locally recurrent or metastatic cutaneous squamous cell carcinoma.

Interventions

  • Amivantamab and Recombinant Human Hyaluronidase (Drug)
    Given SC
  • Biospecimen Collection (Procedure)
    Undergo blood sample collection
  • Cetuximab (Biological)
    Given IV
  • Computed Tomography (Procedure)
    Undergo CT scan
  • Magnetic Resonance Imaging (Procedure)
    Undergo MRI

Eligibility criteria

Inclusion Criteria: * Participants must have pathologically proven diagnosis of cutaneous squamous cell carcinoma based on pathology from original diagnosis or from a metastatic/recurrent lesion * Participants must have measurable or non-measurable disease per RECIST 1.1 and must have their disease assessed by CT or MRI of chest/abdomen/pelvis (with contrast unless contraindicated) within 28 days prior to registration for measurable disease or within 42 days prior to registration for non-measurable disease. All known sites of disease must be assessed and documented on the Baseline Tumor Assessment Form (RECIST 1.1). Any lesions assessed using a non-diagnostic positron emission tomography (PET)/CT of chest/abdomen/pelvis will be considered non-measurable lesions. Pleural effusions, ascites and laboratory parameters are not acceptable as the only evidence of disease. Participants whose only measurable disease is within a previous radiation therapy port must demonstrate clearly progressive disease (in the opinion of the treating investigator) prior to registration to be considered measurable * NOTE: All diseases must be assessed and documented on the baseline tumor assessment form * Participants with exclusively locally recurrent disease must have either a contraindication to surgical treatment of lesions (i.e., complete resection is not possible or not expected to be clinically beneficial or resection conferring significant cosmetic or functional concerns) or have refused surgical or radiation treatment * Participants must be immunocompromised, defined as below. For cases where there is a lack of clarity, it is highly recommended study teams reach out to Drs. Swiecicki and Geiger for discussion: * An diagnosis of either chronic lymphocytic leukemia (CLL), acute leukemia, myelodysplastic syndrome, polycythemia vera, or myelofibrosis regardless of whether actively receiving therapy OR * A diagnosis of lymphoma or multiple myeloma either on antineoplastic therapy, or within 6 months after therapy completion OR * Recipient of an organ transplant (excluding corneal transplants or lung transplants) * If a transplant patient, documentation from the patient's transplant physician confirming that the patient's allograft is stable. Documentation must be dated within 180 days of registration OR * Autoimmune disease under active treatment with an immunosuppressive medication (as defined below) * Autoimmune diseases include but are not limited to: systemic lupus erythematosus, rheumatoid arthritis, inflammatory bowel disease, vasculitis, myasthenia gravis, Guillain-Barre syndrome, autoimmune hepatitis, scleroderma, primary biliary cirrhosis, pemphigus, and bullous pemphigoid * Vitiligo, psoriasis, type 1 diabetes mellitus, hypothyroidism, or resolved childhood asthma/atopy are not eligible diagnoses * Immunosuppressant medications include the following: * Tumor necrosis factor (TNF) inhibitors (adalimumab, certolizumab, etanercept, golimumab, and infliximab) * Interleukin inhibitors (anakinra, ustekinumab, secukinumab, sarilumab, siltuximab, sulfasalazine, tildrakizumab, tocilizumab, chloroquine, and hydroxychloroquine) * Janus kinase (JAK) inhibitors (baricitinib, filgotinib, and tofacitinib) * Calcineurin inhibitors (cyclosporine and tacrolimus) * Metabolic inhibitors (azathioprine, leflunomide, mercaptopurine, methotrexate) * mTOR (mammalian target of rapamycin) inhibitors (sirolimus \[rapamycin\], everolimus, and zotarolimus) * Inosine monophosphate dehydrogenase inhibitors (mycophenolate) * Phosphodiesterase inhibitors (apremilast) * B cell inhibitors (rituximab) * T cell inhibitors (abatacept) * Glucocorticoids * Active treatment is defined as current use of any one or more of the following: * Oral glucocorticoid therapy (Prednisone equivalent \> 10 mg/day) for 30 days prior to registration * Oral or subcutaneous immunosuppressive therapy for 90 days or more prior to registration * Two or more doses of intravenous non corticosteroid immunosuppressant within 90 days prior to registration * Participants with treated brain metastases must show no evidence of progression on follow-up brain imaging after central nervous system (CNS)-directed therapy * Participants with new or progressive brain metastases (active brain metastases) or leptomeningeal disease must not require immediate CNS specific treatment at the time of study registration or anticipated during the first cycle of therapy * Participants must not have had prior treatment with cetuximab or another EGFR inhibitor within the last 365 days * Participant must be ≥ 18 years old at the time of registration * Participants must have Zubrod Performance Status of 0-2 * Participants must have a complete medical history and physical exam within 28 days prior to registration * Leukocytes ≥ 3 x 10\^3/uL (within 14 days prior to registration) * Absolute neutrophil count ≥ 1.5 x 10\^3/uL (within 14 days prior to registration) * Platelets ≥ 100 x 10\^3/uL (within 14 days prior to registration) * Total bilirubin ≤ 1.5 x institutional upper limit of normal (ULN) unless history of Gilbert's disease. Participants with history of Gilbert's disease must have total bilirubin ≤ 5 x institutional ULN (within 14 days prior to registration) * Aspartate aminotransferase (AST)/alanine aminotransferase (ALT) ≤ 3 × institutional ULN with the exception of subjects with documented liver metastases: AST and/or ALT ≤ 5.0 x institutional ULN (within 14 days prior to registration) * Participants must have a measured OR calculated creatinine clearance ≥ 30 mL/min using the following Cockcroft-Gault Formula. This specimen must have been drawn and processed within 14 days prior to registration * Participants must not have an active or past medical history of interstitial lung disease (ILD)/pneumonitis, including drug-induced or radiation ILD/pneumonitis * Participants must not have a history of lung transplantation * Participants must not have a history of pulmonary graft versus host disease (GVHD) * Participants must have adequate cardiac function. Participants with known history or current symptoms of cardiac disease, must have a clinical risk assessment of cardiac function using the New York Heart Association Functional Classification. To be eligible for this trial, participants must be class 2B or better * Participants with a history human immunodeficiency virus (HIV)-infection must be on effective anti-retroviral therapy at registration and have undetectable viral load test on the most recent test results obtained within 6 months prior to registration * Participants with a history of chronic hepatitis B virus (HBV) infection must have undetectable HBV viral load while on suppressive therapy on the most recent test results obtained within 6 months prior to registration, if indicated * Participants with a history of hepatitis C virus (HCV) infection must have been treated and cured. Participants currently being treated for HCV infection must have undetectable HCV viral load test on the most recent test results obtained within 6 months prior to registration, if indicated * Participants must not have an uncontrolled illness, including but not limited to: * Ongoing or active infection (includes infection requiring treatment with antimicrobial therapy \[participants will be required to complete antibiotics 1 week prior to starting study treatment\]) * Active bleeding diathesis * Any ophthalmologic condition that is clinically unstable * Participants must not have a prior or concurrent malignancy whose natural history or treatment (in the opinion of the treating physician) has the potential to interfere with the safety or efficacy assessment of the investigational regimen * Participants must not be pregnant or nursing (nursing includes breast milk fed to an infant by any means, including from the breast, milk expressed by hand, or pumped) due to known toxicities of amivantamab. Individuals who are of reproductive potential must have agreed to use an effective contraceptive method with details provided as a part of the consent process. A person who has had menses at any time in the preceding 12 consecutive months or who has semen likely to contain sperm is considered to be of "reproductive potential." In addition to routine contraceptive methods, "effective contraception" also includes refraining from sexual activity that might result in pregnancy and surgery intended to prevent pregnancy (or with a side-effect of pregnancy prevention) including hysterectomy, bilateral oophorectomy, bilateral tubal ligation/occlusion, and vasectomy with testing showing no sperm in the semen. Participants must agree not to donate ova or sperm for the purpose of reproduction during the study and for a minimum of 6 months after receiving the last dose of study treatment. For female participants of childbearing potential, a negative pregnancy test is required within 72 hours prior to registration * Participants must be offered the opportunity to participate in specimen banking

Conditions

Locally Recurrent Skin Squamous Cell Carcinoma Metastatic Skin Squamous Cell Carcinoma

Locations

  • University of Alabama at Birmingham Cancer Center — Birmingham, Alabama, United States
  • Banner MD Anderson Cancer Center — Gilbert, Arizona, United States
  • UC San Diego Moores Cancer Center — La Jolla, California, United States
  • The Angeles Clinic and Research Institute - West Los Angeles Office — Los Angeles, California, United States
  • USC / Norris Comprehensive Cancer Center — Los Angeles, California, United States
  • UCHealth University of Colorado Hospital — Aurora, Colorado, United States
  • Yale University — New Haven, Connecticut, United States
  • Smilow Cancer Hospital Care Center-Trumbull — Trumbull, Connecticut, United States
  • Smilow Cancer Hospital Care Center - Waterford — Waterford, Connecticut, United States
  • UM Sylvester Comprehensive Cancer Center at Coral Gables — Coral Gables, Florida, United States
  • UM Sylvester Comprehensive Cancer Center at Coral Springs — Coral Springs, Florida, United States
  • UM Sylvester Comprehensive Cancer Center at Deerfield Beach — Deerfield Beach, Florida, United States
  • UM Sylvester Comprehensive Cancer Center at Doral — Doral, Florida, United States
  • University of Miami Miller School of Medicine-Sylvester Cancer Center — Miami, Florida, United States
  • UM Sylvester Comprehensive Cancer Center at Kendall — Miami, Florida, United States
  • University of Miami Sylvester Comprehensive Cancer Center at Sole Mia — North Miami, Florida, United States
  • UM Sylvester Comprehensive Cancer Center at Plantation — Plantation, Florida, United States
  • Emory University Hospital Midtown — Atlanta, Georgia, United States
  • Emory University Hospital/Winship Cancer Institute — Atlanta, Georgia, United States
  • University of Chicago Comprehensive Cancer Center — Chicago, Illinois, United States
  • Carle at The Riverfront — Danville, Illinois, United States
  • Carle Physician Group-Effingham — Effingham, Illinois, United States
  • Ingalls Memorial Hospital — Harvey, Illinois, United States
  • Carle Physician Group-Mattoon/Charleston — Mattoon, Illinois, United States
  • UC Comprehensive Cancer Center at Silver Cross — New Lenox, Illinois, United States
  • Carle BroMenn Medical Center — Normal, Illinois, United States
  • Carle Cancer Institute Normal — Normal, Illinois, United States
  • University of Chicago Medicine-Orland Park — Orland Park, Illinois, United States
  • Carle Cancer Center — Urbana, Illinois, United States
  • UChicago Medicine Northwest Indiana — Crown Point, Indiana, United States
  • University of Michigan Rogel Cancer Center — Ann Arbor, Michigan, United States
  • Henry Ford Hospital — Detroit, Michigan, United States
  • Memorial Sloan Kettering Basking Ridge — Basking Ridge, New Jersey, United States
  • Memorial Sloan Kettering Monmouth — Middletown, New Jersey, United States
  • Memorial Sloan Kettering Bergen — Montvale, New Jersey, United States
  • Memorial Sloan Kettering Commack — Commack, New York, United States
  • Memorial 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
  • Duke University Medical Center — Durham, North Carolina, United States
  • UH Seidman Cancer Center at UH Avon Health Center — Avon, Ohio, United States
  • UHHS-Chagrin Highlands Medical Center — Beachwood, Ohio, United States
  • University of Cincinnati Cancer Center-UC Medical Center — Cincinnati, Ohio, United States
  • Case Western Reserve University — Cleveland, Ohio, United States
  • University of Cincinnati Cancer Center-West Chester — West Chester, Ohio, United States
  • University of Oklahoma Health Sciences Center — Oklahoma City, Oklahoma, United States
  • Penn State Milton S Hershey Medical Center — Hershey, Pennsylvania, United States
  • UPMC Hillman Cancer Center — Pittsburgh, Pennsylvania, United States
  • UT MD Anderson Cancer Center — Houston, Texas, United States
  • Huntsman Cancer Institute/University of Utah — Salt Lake City, Utah, United States
  • Froedtert Menomonee Falls Hospital — Menomonee Falls, Wisconsin, United States
  • Medical College of Wisconsin — Milwaukee, Wisconsin, United States
  • Froedtert and MCW Moorland Reserve Health Center — New Berlin, Wisconsin, United States
  • Drexel Town Square Health Center — Oak Creek, Wisconsin, United States
  • Froedtert West Bend Hospital/Kraemer Cancer Center — West Bend, Wisconsin, United States
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Official Source

Data sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

View Official Record