RecruitingPhase 2NCT07042295

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

A Randomized Phase II Study of Amivantamab (JNJ-61186372) and Hyaluronidase (rHuPH20) Versus Cetuximab in Immunocompromised Participants With Recurrent Inoperable or Metastatic Cutaneous Squamous Cell Carcinoma


Sponsor

National Cancer Institute (NCI)

Enrollment

86 participants

Start Date

Mar 23, 2026

Study Type

INTERVENTIONAL

Conditions

Summary

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.


Eligibility

Min Age: 18 Years

Plain Language Summary

Simplified for easier understanding

This study is testing two targeted cancer treatments — amivantamab with hyaluronidase and cetuximab — in people with advanced skin cancer (cutaneous squamous cell carcinoma, or cSCC) who have a weakened immune system (due to organ transplant, HIV, or other causes). Standard immunotherapy drugs are not safe for people with compromised immunity, so this trial explores alternative options. **You may be eligible if...** - You have been diagnosed with cutaneous squamous cell carcinoma (a type of skin cancer) confirmed by biopsy - Your cancer has spread or come back and cannot be removed by surgery - You have a weakened immune system (for example, due to an organ transplant or HIV) - Your disease can be measured on imaging scans - Your organ function meets the required levels **You may NOT be eligible if...** - You have a different type of skin cancer - Your immune system is functioning normally - You have had certain prior treatments that would interfere with the study drugs - You have serious heart or other organ conditions - You are pregnant or breastfeeding Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

DRUGAmivantamab and Recombinant Human Hyaluronidase

Given SC

PROCEDUREBiospecimen Collection

Undergo blood sample collection

BIOLOGICALCetuximab

Given IV

PROCEDUREComputed Tomography

Undergo CT scan

PROCEDUREMagnetic Resonance Imaging

Undergo MRI


Locations(30)

Banner MD Anderson Cancer Center

Gilbert, Arizona, United States

UC San Diego Moores Cancer Center

La Jolla, California, 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

Carle at The Riverfront

Danville, Illinois, United States

Carle Physician Group-Effingham

Effingham, Illinois, United States

Carle Physician Group-Mattoon/Charleston

Mattoon, Illinois, United States

Carle BroMenn Medical Center

Normal, Illinois, United States

Carle Cancer Institute Normal

Normal, Illinois, United States

Carle Cancer Center

Urbana, Illinois, United States

University of Michigan Rogel Cancer Center

Ann Arbor, 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

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 Pittsburgh Cancer Institute (UPCI)

Pittsburgh, Pennsylvania, 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

View Full Details on ClinicalTrials.gov

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NCT07042295


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