New hope for immunocompromised skin cancer patients: amivantamab combo tested

NCT ID NCT07042295

Disease control Sponsor: National Cancer Institute (NCI) Source: ClinicalTrials.gov ↗

First seen Jun 25, 2026 · Last updated Sep 01, 2026 · Updated 17 times

Summary

This phase II trial tests whether a combination of amivantamab and hyaluronidase works as well as cetuximab for treating skin squamous cell carcinoma that has come back or spread. The study enrolls 86 immunocompromised participants, including organ transplant recipients. The goal is to compare safety and effectiveness, with a focus on controlling the cancer rather than curing it.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance: amivantamab and hyaluronidase
What this could lead to: If it works, this could offer a new treatment option for immunocompromised patients with advanced skin cancer that has returned or spread.
What could go wrong: This is a small, early-phase trial that is currently suspended. The treatment may cause serious side effects like skin rash or organ rejection in transplant patients, and it may not work better than the existing drug cetuximab.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Phase 2

Tests whether the treatment actually works, and watches for side effects, in a larger group.

Participants

About 86 people

The number the study aims to enrol. It can still change while the study runs.

Started

Mar 2026

Expected to finish

Feb 2029

An estimate. End dates often move.

Lead sponsor

A government research agency

The lead sponsor is the US National Institutes of Health.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

18 years and older

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

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

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Conditions

The condition(s) this trial relates to.

metastatic squamous cell carcinoma skin squamous cell carcinoma

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Locally recurrent skin squamous cell carcinoma Metastatic skin squamous cell carcinoma

How to take part

Only the study team decides who joins. These are the ways to reach them.

The places running it

51 sites. The list below names each one and where it is.
The official record

The full official record for this study. This one lists no contact details, but it is the first place any would appear.

Open the record ↗
A doctor treating you

A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.

Contacts and locations

Locations

Banner MD Anderson Cancer Center

Gilbert, Arizona, 85234, United States
Carle BroMenn Medical Center

Normal, Illinois, 61761, United States
Carle Cancer Center

Urbana, Illinois, 61801, United States
Carle Cancer Institute Normal

Normal, Illinois, 61761, United States
Carle Physician Group-Effingham

Effingham, Illinois, 62401, United States
Carle Physician Group-Mattoon/Charleston

Mattoon, Illinois, 61938, United States
Carle at The Riverfront

Danville, Illinois, 61832, United States
Case Western Reserve University

Cleveland, Ohio, 44106, United States
Drexel Town Square Health Center

Oak Creek, Wisconsin, 53154, United States
Froedtert Menomonee Falls Hospital

Menomonee Falls, Wisconsin, 53051, United States
Froedtert West Bend Hospital/Kraemer Cancer Center

West Bend, Wisconsin, 53095, United States
Froedtert and MCW Moorland Reserve Health Center

New Berlin, Wisconsin, 53151, United States
Henry Ford Hospital

Detroit, Michigan, 48202, United States
Huntsman Cancer Institute/University of Utah

Salt Lake City, Utah, 84112, United States
Ingalls Memorial Hospital

Harvey, Illinois, 60426, United States
Medical College of Wisconsin

Milwaukee, Wisconsin, 53226, United States
Memorial Sloan Kettering Basking Ridge

Basking Ridge, New Jersey, 07920, United States
Memorial Sloan Kettering Bergen

Montvale, New Jersey, 07645, United States
Memorial Sloan Kettering Cancer Center

New York, New York, 10065, United States
Memorial Sloan Kettering Commack

Commack, New York, 11725, United States
Memorial Sloan Kettering Monmouth

Middletown, New Jersey, 07748, United States
Memorial Sloan Kettering Nassau

Uniondale, New York, 11553, United States
Memorial Sloan Kettering Westchester

Harrison, New York, 10604, United States
Penn State Milton S Hershey Medical Center

Hershey, Pennsylvania, 17033-0850, United States
Smilow Cancer Hospital Care Center - Waterford

Waterford, Connecticut, 06385, United States
Smilow Cancer Hospital Care Center-Trumbull

Trumbull, Connecticut, 06611, United States
UC Comprehensive Cancer Center at Silver Cross

New Lenox, Illinois, 60451, United States
UC San Diego Moores Cancer Center

La Jolla, California, 92093, United States
UCHealth University of Colorado Hospital

Aurora, Colorado, 80045, United States
UChicago Medicine Northwest Indiana

Crown Point, Indiana, 46307, United States
UH Seidman Cancer Center at UH Avon Health Center

Avon, Ohio, 44011, United States
UHHS-Chagrin Highlands Medical Center

Beachwood, Ohio, 44122, United States
UM Sylvester Comprehensive Cancer Center at Coral Gables

Coral Gables, Florida, 33146, United States
UM Sylvester Comprehensive Cancer Center at Coral Springs

Coral Springs, Florida, 33065, United States
UM Sylvester Comprehensive Cancer Center at Deerfield Beach

Deerfield Beach, Florida, 33442, United States
UM Sylvester Comprehensive Cancer Center at Doral

Doral, Florida, 33166, United States
UM Sylvester Comprehensive Cancer Center at Kendall

Miami, Florida, 33176, United States
UM Sylvester Comprehensive Cancer Center at Plantation

Plantation, Florida, 33324, United States
UPMC Hillman Cancer Center

Pittsburgh, Pennsylvania, 15232, United States
USC / Norris Comprehensive Cancer Center

Los Angeles, California, 90033, United States
UT MD Anderson Cancer Center

Houston, Texas, 77030, United States
University of Alabama at Birmingham Cancer Center

Birmingham, Alabama, 35233, United States
University of Chicago Comprehensive Cancer Center

Chicago, Illinois, 60637, United States
University of Chicago Medicine-Orland Park

Orland Park, Illinois, 60462, United States
University of Cincinnati Cancer Center-UC Medical Center

Cincinnati, Ohio, 45219, United States
University of Cincinnati Cancer Center-West Chester

West Chester, Ohio, 45069, United States
University of Miami Miller School of Medicine-Sylvester Cancer Center

Miami, Florida, 33136, United States
University of Miami Sylvester Comprehensive Cancer Center at Sole Mia

North Miami, Florida, 33181, United States
University of Michigan Rogel Cancer Center

Ann Arbor, Michigan, 48109, United States
University of Oklahoma Health Sciences Center

Oklahoma City, Oklahoma, 73104, United States
Yale University

New Haven, Connecticut, 06520, United States

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