Is NCT07042295 recruiting in New Haven, CT?

Yes, NCT07042295 is currently recruiting participants at its New Haven, CT location. This locally recurrent skin squamous cell carcinoma clinical trial is actively enrolling qualified participants.

Is participation in this New Haven clinical trial free?

Yes, all study-related care is provided at no cost to qualified participants. Many studies also offer compensation for time and travel expenses.

Locally Recurrent Skin Squamous Cell Carcinoma Clinical Trial in New Haven, CT

Q: How do I join the locally recurrent skin squamous cell carcinoma clinical trial in New Haven?

To join this clinical trial in New Haven, complete the eligibility form on this page. A study coordinator will contact you to discuss next steps and determine if you qualify.

About This Locally Recurrent Skin Squamous Cell Carcinoma Study in New Haven

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.

Sponsor: National Cancer Institute (NCI)

Who Can Participate

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 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 active diagnosis of either chronic lymphocytic leukemia (CLL) or acute leukemia, 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

Participant must have Zubrod Performance Status of 0-2

Participant 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

Not sure if you qualify? Submit your interest and a study coordinator will help determine your eligibility.

Frequently Asked Questions

Q:Is this study available in New Haven?

Yes, this clinical trial (NCT07042295) has an active research site in New Haven, CT that is currently enrolling participants.

Q:Is it safe to participate?

Clinical trials follow strict safety guidelines and ethical standards. This study has been reviewed and approved, and participants are closely monitored by medical professionals. You can withdraw at any time.

Q:Will I be compensated?

Many clinical trials offer compensation for your time and travel expenses. Specific compensation details will be discussed during the screening process. All study-related medical care is provided at no cost.

Q:Can I leave the trial if I change my mind?

Absolutely. Participation is completely voluntary. You have the right to withdraw from the study at any time, for any reason, without penalty.

Still have questions? Our study coordinators are here to help.

Locally Recurrent Skin Squamous Cell Carcinoma Treatment Options in New Haven, CT

If you're searching for locally recurrent skin squamous cell carcinoma treatment options in New Haven, CT, this clinical trial (NCT07042295) may be an excellent opportunity. Clinical trials provide access to cutting-edge treatments that aren't yet available to the general public, often at no cost to participants.

Our New Haven research site is actively enrolling participants for this phase 2 clinical trial. You'll receive care from experienced locally recurrent skin squamous cell carcinoma specialists who are at the forefront of medical research. All study-related care, including examinations, treatments, and monitoring, is provided at no cost to qualified participants.

Looking for more options? Browse all locally recurrent skin squamous cell carcinoma clinical trials near you to find additional studies recruiting in your area.

Locally Recurrent Skin Squamous Cell Carcinoma Clinical Trial in New Haven, CT

Expert Care in New Haven

IRB Approved

No-Cost Care

Apply for This New Haven Location

Why Participate?

Simple Process