Actively Recruiting
Treatment With Amivantamab and Hyaluronidase or Cetuximab for Advanced Skin Cancer in People With a Weakened Immune System
Led by National Cancer Institute (NCI) · Updated on 2026-05-13
86
Participants Needed
31
Research Sites
153 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
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.
CONDITIONS
Official Title
Treatment With Amivantamab and Hyaluronidase or Cetuximab for Advanced Skin Cancer in People With a Weakened Immune System
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Diagnosis of cutaneous squamous cell carcinoma confirmed by pathology
- Measurable or non-measurable disease assessed by CT scan within 28 to 42 days before registration
- Locally recurrent disease with contraindication to or refusal of surgery or radiation
- Immunocompromised due to active leukemia, lymphoma, multiple myeloma, organ transplant (except corneal or lung), or autoimmune disease under immunosuppressive treatment
- Stable allograft documented if transplant patient
- No active progression of treated brain metastases and no urgent need for CNS treatment
- No prior cetuximab or EGFR inhibitor treatment within 365 days
- Age 18 years or older
- Zubrod Performance Status 0 to 2
- Complete medical history and physical exam within 28 days prior to registration
- Adequate blood counts and liver and kidney function within 14 days prior to registration
- No history of interstitial lung disease, lung transplantation, or pulmonary graft versus host disease
- Adequate cardiac function (NYHA class 2B or better)
- Controlled HIV, hepatitis B or hepatitis C infection per specified criteria
- No uncontrolled illness or active infection requiring treatment
- No other malignancy affecting safety or efficacy assessments
- Not pregnant or nursing and agree to use effective contraception
- Agree to specimen banking
You will not qualify if you...
- Prior treatment with cetuximab or other EGFR inhibitors within the last 365 days
- Active or progressive brain metastases requiring immediate CNS treatment
- History of interstitial lung disease, pneumonitis, lung transplantation, or pulmonary graft versus host disease
- Uncontrolled illness including active infection or bleeding disorders
- Clinically unstable ophthalmologic conditions
- Pregnancy or breastfeeding
- Other malignancies that could interfere with study assessments
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 31 locations
1
Banner MD Anderson Cancer Center
Gilbert, Arizona, United States, 85234
Actively Recruiting
2
UC San Diego Moores Cancer Center
La Jolla, California, United States, 92093
Actively Recruiting
3
Yale University
New Haven, Connecticut, United States, 06520
Actively Recruiting
4
Smilow Cancer Hospital Care Center-Trumbull
Trumbull, Connecticut, United States, 06611
Actively Recruiting
5
Smilow Cancer Hospital Care Center - Waterford
Waterford, Connecticut, United States, 06385
Actively Recruiting
6
Carle at The Riverfront
Danville, Illinois, United States, 61832
Actively Recruiting
7
Carle Physician Group-Effingham
Effingham, Illinois, United States, 62401
Actively Recruiting
8
Carle Physician Group-Mattoon/Charleston
Mattoon, Illinois, United States, 61938
Actively Recruiting
9
Carle BroMenn Medical Center
Normal, Illinois, United States, 61761
Actively Recruiting
10
Carle Cancer Institute Normal
Normal, Illinois, United States, 61761
Actively Recruiting
11
Carle Cancer Center
Urbana, Illinois, United States, 61801
Actively Recruiting
12
University of Michigan Rogel Cancer Center
Ann Arbor, Michigan, United States, 48109
Actively Recruiting
13
Memorial Sloan Kettering Basking Ridge
Basking Ridge, New Jersey, United States, 07920
Actively Recruiting
14
Memorial Sloan Kettering Monmouth
Middletown, New Jersey, United States, 07748
Actively Recruiting
15
Memorial Sloan Kettering Bergen
Montvale, New Jersey, United States, 07645
Actively Recruiting
16
Memorial Sloan Kettering Commack
Commack, New York, United States, 11725
Actively Recruiting
17
Memorial Sloan Kettering Westchester
Harrison, New York, United States, 10604
Actively Recruiting
18
Memorial Sloan Kettering Cancer Center
New York, New York, United States, 10065
Actively Recruiting
19
Memorial Sloan Kettering Nassau
Uniondale, New York, United States, 11553
Actively Recruiting
20
UH Seidman Cancer Center at UH Avon Health Center
Avon, Ohio, United States, 44011
Actively Recruiting
21
UHHS-Chagrin Highlands Medical Center
Beachwood, Ohio, United States, 44122
Actively Recruiting
22
University of Cincinnati Cancer Center-UC Medical Center
Cincinnati, Ohio, United States, 45219
Actively Recruiting
23
Case Western Reserve University
Cleveland, Ohio, United States, 44106
Actively Recruiting
24
University of Cincinnati Cancer Center-West Chester
West Chester, Ohio, United States, 45069
Actively Recruiting
25
University of Pittsburgh Cancer Institute (UPCI)
Pittsburgh, Pennsylvania, United States, 15232
Actively Recruiting
26
M D Anderson Cancer Center
Houston, Texas, United States, 77030
Actively Recruiting
27
Froedtert Menomonee Falls Hospital
Menomonee Falls, Wisconsin, United States, 53051
Actively Recruiting
28
Medical College of Wisconsin
Milwaukee, Wisconsin, United States, 53226
Actively Recruiting
29
Froedtert and MCW Moorland Reserve Health Center
New Berlin, Wisconsin, United States, 53151
Actively Recruiting
30
Drexel Town Square Health Center
Oak Creek, Wisconsin, United States, 53154
Actively Recruiting
31
Froedtert West Bend Hospital/Kraemer Cancer Center
West Bend, Wisconsin, United States, 53095
Actively Recruiting
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
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