Locally Recurrent Skin Squamous Cell CarcinomaPhase 2NCT07042295
Treatment With Amivantamab and Hyaluronidase or Cetuximab for Advanced Skin Cancer in People With a Weakened Immune System
A Phase 2 study testing Amivantamab and Recombinant Human Hyaluronidase, Biospecimen Collection and Cetuximab in people with Locally Recurrent Skin Squamous Cell Carcinoma and Metastatic Skin Squamous Cell Carcinoma, run by National Cancer Institute (NCI) at 55 sites in United States.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Locally Recurrent Skin Squamous Cell Carcinoma, Metastatic Skin Squamous Cell Carcinoma
- What is being tested?
- Amivantamab and Recombinant Human Hyaluronidase, Biospecimen Collection and Cetuximab
- Type of treatment
- Injection or infusion, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 86 participants
- Where
- 55 sitesUnited States
- Study dates
- 23 Mar 2026to 28 Feb 2029
- Phase
- Phase 2
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Show all 54Show fewer
- 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
Who cannot join
None listed.
Trial locations and contacts
55 sites in 1 country. Contact the study team or a site near you to ask about taking part.
55 sites in 1 country
United States55 sites, 55 recruiting
- Recruiting
University of Michigan Rogel Cancer Center
Ann Arbor, Michigan, 48109
Site Public Contact, 800-865-1125, CancerAnswerLine@med.umich.edu
Paul L. Swiecicki
- Recruiting
Emory University Hospital Midtown
Atlanta, Georgia, 30308
Site Public Contact, 888-946-7447
Jose A. Monteiro de Oliveira Novaes
- Recruiting
Emory University Hospital/Winship Cancer Institute
Atlanta, Georgia, 30322
Site Public Contact, 404-778-1868
Jose A. Monteiro de Oliveira Novaes
- Recruiting
UCHealth University of Colorado Hospital
Aurora, Colorado, 80045
Site Public Contact, 720-848-0650
Sapna P. Patel
- Recruiting
UH Seidman Cancer Center at UH Avon Health Center
Avon, Ohio, 44011
Site Public Contact, 800-641-2422
Ankit Mangla
- Recruiting
Memorial Sloan Kettering Basking Ridge
Basking Ridge, New Jersey, 07920
Site Public Contact, 212-639-7592
Lara A. Dunn
- Recruiting
UHHS-Chagrin Highlands Medical Center
Beachwood, Ohio, 44122
Site Public Contact, 800-641-2422, CTUReferral@UHhospitals.org
Ankit Mangla
- Recruiting
University of Alabama at Birmingham Cancer Center
Birmingham, Alabama, 35233
Site Public Contact, gingerreeves@uabmc.edu
Mehran Yusuf
- Recruiting
University of Chicago Comprehensive Cancer Center
Chicago, Illinois, 60637
Site Public Contact, 773-702-8222, cancerclinicaltrials@bsd.uchicago.edu
Noura Choudhury
- Recruiting
University of Cincinnati Cancer Center-UC Medical Center
Cincinnati, Ohio, 45219
Site Public Contact, 513-584-7698, cancer@uchealth.com
Rekha T. Chaudhary
- Recruiting
Case Western Reserve University
Cleveland, Ohio, 44106
Site Public Contact, 800-641-2422, CTUReferral@UHhospitals.org
Ankit Mangla
- Recruiting
Memorial Sloan Kettering Commack
Commack, New York, 11725
Site Public Contact, 212-639-7592
Lara A. Dunn
- Recruiting
UM Sylvester Comprehensive Cancer Center at Coral Gables
Coral Gables, Florida, 33146
Site Public Contact, 305-243-2647
Leonel F. Hernandez-Aya
- Recruiting
UM Sylvester Comprehensive Cancer Center at Coral Springs
Coral Springs, Florida, 33065
Site Public Contact, 305-243-2647
Leonel F. Hernandez-Aya
- Recruiting
UChicago Medicine Northwest Indiana
Crown Point, Indiana, 46307
Site Public Contact, 855-702-8222, cancerclinicaltrials@bsd.uchicago.edu
Noura Choudhury
- Recruiting
Carle at The Riverfront
Danville, Illinois, 61832
Site Public Contact, 800-446-5532, Research@Carle.com
Suparna Mantha
- Recruiting
UM Sylvester Comprehensive Cancer Center at Deerfield Beach
Deerfield Beach, Florida, 33442
Site Public Contact, 305-243-2647
Leonel F. Hernandez-Aya
- Recruiting
Henry Ford Hospital
Detroit, Michigan, 48202
Site Public Contact, 313-916-3721, CTOResearch@hfhs.org
Amy M. Weise
- Recruiting
UM Sylvester Comprehensive Cancer Center at Doral
Doral, Florida, 33166
Site Public Contact, kginnity@med.miami.edu
Leonel F. Hernandez-Aya
- Recruiting
Duke University Medical Center
Durham, North Carolina, 27710
Site Public Contact, 888-275-3853
Eric Powers
- Recruiting
Carle Physician Group-Effingham
Effingham, Illinois, 62401
Site Public Contact, 800-446-5532, Research@carle.com
Suparna Mantha
- Recruiting
Banner MD Anderson Cancer Center
Gilbert, Arizona, 85234
Site Public Contact, 602-747-9738
Saba H. Radhi
- Recruiting
Memorial Sloan Kettering Westchester
Harrison, New York, 10604
Site Public Contact, 212-639-7592
Lara A. Dunn
- Recruiting
Ingalls Memorial Hospital
Harvey, Illinois, 60426
Site Public Contact, 708-915-4673, clinicaltrials@ingalls.org
Kimberly R. Kruczek
- Recruiting
Penn State Milton S Hershey Medical Center
Hershey, Pennsylvania, 17033-0850
Site Public Contact, 717-531-3779, CTO@hmc.psu.edu
Joseph J. Drabick
- Recruiting
UT MD Anderson Cancer Center
Houston, Texas, 77030
Site Public Contact, 866-632-6789, askmdanderson@mdanderson.org
Michael Wotman
- Recruiting
UC San Diego Moores Cancer Center
La Jolla, California, 92093
Site Public Contact, 858-822-5354, cancercto@ucsd.edu
Soo Park
- Recruiting
The Angeles Clinic and Research Institute - West Los Angeles Office
Los Angeles, California, 90025
Site Public Contact, protocols@swog.org
Inderjit Mehmi
- Recruiting
USC / Norris Comprehensive Cancer Center
Los Angeles, California, 90033
Site Public Contact, 323-865-0451
Gino K. In
- Recruiting
Carle Physician Group-Mattoon/Charleston
Mattoon, Illinois, 61938
Site Public Contact, 800-446-5532, Research@carle.com
Suparna Mantha
- Recruiting
Froedtert Menomonee Falls Hospital
Menomonee Falls, Wisconsin, 53051
Site Public Contact, 262-257-5100
Stuart J. Wong
- Recruiting
University of Miami Miller School of Medicine-Sylvester Cancer Center
Miami, Florida, 33136
Site Public Contact, 305-243-2647
Leonel F. Hernandez-Aya
- Recruiting
UM Sylvester Comprehensive Cancer Center at Kendall
Miami, Florida, 33176
Site Public Contact, 305-243-2647
Leonel F. Hernandez-Aya
- Recruiting
Memorial Sloan Kettering Monmouth
Middletown, New Jersey, 07748
Site Public Contact, 212-639-7592
Lara A. Dunn
- Recruiting
Medical College of Wisconsin
Milwaukee, Wisconsin, 53226
Site Public Contact, 414-805-3666
Stuart J. Wong
- Recruiting
Memorial Sloan Kettering Bergen
Montvale, New Jersey, 07645
Site Public Contact, 212-639-7592
Lara A. Dunn
- Recruiting
Froedtert and MCW Moorland Reserve Health Center
New Berlin, Wisconsin, 53151
Site Public Contact, 414-805-0505
Stuart J. Wong
- Recruiting
Yale University
New Haven, Connecticut, 06520
Site Public Contact, 203-785-5702, canceranswers@yale.edu
Barbara A. Burtness
- Recruiting
UC Comprehensive Cancer Center at Silver Cross
New Lenox, Illinois, 60451
Site Public Contact, 773-702-8222, cancerclinicaltrials@bsd.uchicago.edu
Noura Choudhury
- Recruiting
Memorial Sloan Kettering Cancer Center
New York, New York, 10065
Site Public Contact, 212-639-7592
Lara A. Dunn
- Recruiting
Carle BroMenn Medical Center
Normal, Illinois, 61761
Site Public Contact, 800-446-5532, Research@Carle.com
Suparna Mantha
- Recruiting
Carle Cancer Institute Normal
Normal, Illinois, 61761
Site Public Contact, 800-446-5532, Research@Carle.com
Suparna Mantha
- Recruiting
University of Miami Sylvester Comprehensive Cancer Center at Sole Mia
North Miami, Florida, 33181
Site Public Contact, kginnity@med.miami.edu
Leonel F. Hernandez-Aya
- Recruiting
Drexel Town Square Health Center
Oak Creek, Wisconsin, 53154
Site Public Contact, 414-805-0505
Stuart J. Wong
- Recruiting
University of Oklahoma Health Sciences Center
Oklahoma City, Oklahoma, 73104
Site Public Contact, 405-271-8777, ou-clinical-trials@ouhsc.edu
Minh Phan
- Recruiting
University of Chicago Medicine-Orland Park
Orland Park, Illinois, 60462
Site Public Contact, 773-702-8222, cancerclinicaltrials@bsd.uchicago.edu
Noura Choudhury
- Recruiting
UPMC Hillman Cancer Center
Pittsburgh, Pennsylvania, 15232
Site Public Contact, 412-647-8073
Diwakar Davar
- Recruiting
UM Sylvester Comprehensive Cancer Center at Plantation
Plantation, Florida, 33324
Site Public Contact, 305-243-2647
Leonel F. Hernandez-Aya
- Recruiting
Huntsman Cancer Institute/University of Utah
Salt Lake City, Utah, 84112
Site Public Contact, 888-424-2100, cancerinfo@hci.utah.edu
Siwen Hu-Lieskovan
- Recruiting
Smilow Cancer Hospital Care Center-Trumbull
Trumbull, Connecticut, 06611
Site Public Contact, 203-785-5702, canceranswers@yale.edu
Barbara A. Burtness
- Recruiting
Memorial Sloan Kettering Nassau
Uniondale, New York, 11553
Site Public Contact, 212-639-7592
Lara A. Dunn
- Recruiting
Carle Cancer Center
Urbana, Illinois, 61801
Site Public Contact, 800-446-5532, Research@carle.com
Suparna Mantha
- Recruiting
Smilow Cancer Hospital Care Center - Waterford
Waterford, Connecticut, 06385
Site Public Contact, 203-785-5702, canceranswers@yale.edu
Barbara A. Burtness
- Recruiting
Froedtert West Bend Hospital/Kraemer Cancer Center
West Bend, Wisconsin, 53095
Site Public Contact, 414-805-0505
Stuart J. Wong
- Recruiting
University of Cincinnati Cancer Center-West Chester
West Chester, Ohio, 45069
Site Public Contact, 513-584-7698, cancer@uchealth.com
Rekha T. Chaudhary
About this study
Official title: 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
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.
Read the detailed description
PRIMARY OBJECTIVES:
- To evaluate the safety and preliminary efficacy of amivantamab monotherapy in patients with locoregionally incurable or metastatic cutaneous squamous cell carcinoma and an active immunosuppressed condition. (Cohort A) II. To compare progression-free survival (PFS) of amivantamab monotherapy versus cetuximab monotherapy in patients with locoregionally incurable or metastatic cutaneous squamous cell carcinoma and an active immunosuppressed condition. (Cohort B)
SECONDARY OBJECTIVES:
- To estimate the frequency and severity of toxicities in each cohort and treatment arm.
II. To estimate confirmed objective response rate (ORR) (ORR, confirmed complete and partial responses by Response Evaluation Criteria in Solid Tumors [RECIST] version [v] 1.1) in each cohort and treatment arm.
III. To estimate duration of objective response, time to progression, time to next treatment, and overall survival in each cohort and treatment arm.
IV. To estimate ORR and progression free survival (PFS) in each cohort and treatment arm in subgroups defined by reason for immunosuppression: transplant, autoimmune disease, hematologic malignancy, or other reason.
BANKING OBJECTIVE:
- To bank specimens for future correlative studies.
OUTLINE: Patients in cohort A are assigned to arm I, patients in cohort B are randomized to arm I or II.
ARM I: Patients receive amivantamab and hyaluronidase subcutaneously (SC) over at least 5 minutes on days 1, 8, 15 and 22 of cycle 1 and day 1 of subsequent cycles. Cycles repeat every 28 days for 24 cycles in the absence of disease progression or unacceptable toxicity. Patients undergo blood sample collection on study and computed tomography (CT) and/or magnetic resonance imaging (MRI) throughout the study.
ARM II: Patients receive cetuximab intravenously (IV) on days 1 and 15 of each cycle. Cycles repeat every 28 days for 24 cycles in the absence of disease progression or unacceptable toxicity. Patients undergo blood sample collection on study and CT and/or MRI throughout the study.
After completion of study treatment, patients are followed up, per the treating investigator, for up 3 years.
- Being tested
- Amivantamab and Recombinant Human Hyaluronidase, Biospecimen Collection, Cetuximab, Computed Tomography, Magnetic Resonance Imaging
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Amivantamab and Recombinant Human HyaluronidaseDrug
Also called Amivantamab + Recombinant Human Hyaluronidase, Amivantamab and Hyaluronidase, Amivantamab and Hyaluronidase-lpuj, Amivantamab Plus Recombinant Human Hyaluronidase
Given SC
Biospecimen CollectionProcedure or surgery
Also called Biological Sample Collection, Biospecimen Collected, Sample Collection, Specimen Collection
Undergo blood sample collection
CetuximabBiological
Also called C 225, C-225, C225, Cetuxa
Given IV
Computed TomographyProcedure or surgery
Also called CAT, CAT Scan, Computed Axial Tomography, Computerized Axial Tomography
Undergo CT scan
Magnetic Resonance ImagingProcedure or surgery
Also called Magnetic Resonance, Magnetic Resonance Imaging (MRI), Magnetic resonance imaging (procedure), Magnetic Resonance Imaging Scan
Undergo MRI
| Study group | Role | What they receive |
|---|---|---|
| Arm I (amivantamab and hyaluronidase) | Experimental | Patients receive amivantamab and hyaluronidase SC over at least 5 minutes on days 1, 8, 15 and 22 of cycle 1 and day 1 of subsequent cycles. Cycles repeat every 28 days for 24 cycles in the absence of disease progression or unacceptable toxicity. Patients undergo blood sample collection on study and CT scan and/or MRI throughout the study. Receives: Drug: Amivantamab and Recombinant Human Hyaluronidase; Procedure: Biospecimen Collection; Procedure: Computed Tomography; Procedure: Magnetic Resonance Imaging |
| Arm II (cetuximab) | Active comparator | Patients receive cetuximab IV on days 1 and 15 of each cycle. Cycles repeat every 28 days for 24 cycles in the absence of disease progression or unacceptable toxicity. Patients undergo blood sample collection on study and CT and/or MRI throughout the study. Receives: Procedure: Biospecimen Collection; Biological: Cetuximab; Procedure: Computed Tomography; Procedure: Magnetic Resonance Imaging |
What is being measured
The primary outcome is the main question the study is designed to answer.
Incidence of toxicity of interest (cohort A)
Defined as grade 3 or 4 skin rash that does not recover within 14 days, grade 3 or 4 non-hematologic toxicity that does not recover within 7 days, grade 4 hematologic toxicity including febrile neutropenia or organ transplant failure (for transplant patients only).
Measured: Up to completion of the first cycle (cycle length = 28 days)
Progression free survival (PFS) (cohort B)
Measured: From date of registration to date of first documentation of progression or symptomatic deterioration, or death due to any cause, up to 3 years
Secondary outcomes (6)
Organ rejection
Will be monitored for participants with prior organ transplants.
Measured: Up to 5 years
Overall survival (OS)
Will estimate OS by cohort and treatment arm and within subgroups using the method of Kaplan-Meier. OS will be compared between arms using an un-stratified log-rank test. The hazard ratio and 95% confidence interval from an un-stratified Cox regression model with treatment as the only covariate will be descriptively reported for OS.
Measured: From date of registration to date of death due to any cause, up to 5 years
PFS
Will estimate PFS by cohort and treatment arm and within subgroups using the method of Kaplan-Meier.
Measured: From date of registration to date of first documentation of progression or symptomatic deterioration, or death due to any cause, up to 5 years
Time to next treatment
will be estimated using cumulative incidence curves with death before event accounted for as a competing event.
Measured: Up to 3 years
Time to progression
will be estimated using cumulative incidence curves with death before event accounted for as a competing event.
Measured: Up to 3 years
Duration of objective response
Will be estimated using cumulative incidence curves with death before event accounted for as a competing event.
Measured: Up to 5 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Jun 2025
- Study start23 Mar 2026
- Primary completion28 Feb 2029 (estimated)
- Study completion28 Feb 2029 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Locally Recurrent Skin Squamous Cell CarcinomaStudies of the same condition, open and under way.
- More trials run by National Cancer Institute (NCI)The sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 86 participants (estimated)
Sponsor and investigators
- Lead sponsor
- National Cancer Institute (NCI)
- Sponsor type
- US National Institutes of Health
- Responsible party
- Sponsor
- Investigators
- Paul L Swiecicki, Principal investigator, SWOG Cancer Research Network
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07042295
- Sponsor's protocol ID
- NCI-2025-04318
- Other IDs
- NCI-2025-04318, SN2426, SN2426, U10CA180888
- Status last verified
- Sep 2026
- First submitted
- 27 Jun 2025
- Last updated
- 15 Oct 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- Yes: NCI is committed to sharing data in accordance with NIH policy. For more details on how clinical trial data is shared, access the link to the NIH data sharing policy page.