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New treatment option for Locally Recurrent Skin Squamous Cell Carcinoma
Official title Treatment With Amivantamab and Hyaluronidase or Cetuximab for Advanced Skin Cancer in People With a Weakened Immune System
ClinicalTrials.gov ID: NCT07042295
What this study is testing
What is Amivantamab and Recombinant Human Hyaluronidase?
Amivantamab and Recombinant Human Hyaluronidase is an investigational medicine, given as an injection under the skin, being studied as a potential treatment for locally recurrent skin squamous cell carcinoma.
Also referred to as Amivantamab + Recombinant Human Hyaluronidase, Amivantamab and Hyaluronidase.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- 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.
- Phase 2: a mid-size study of how well it works
- Which group you join is decided by chance.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 and older
You may be able to join if
- Participants must have pathologically proven diagnosis of cutaneous squamous cell carcinoma based on pathology from original diagnosis or from a...
- 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...
- 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...
- Participants must be immunocompromised, defined as below. For cases where there is a lack of clarity, it is highly recommended study teams reach out...
See the full eligibility criteria
Who can 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 of chest/abdomen/pelvis (with contrast unless contraindicated) within 28 days prior to registration...
- 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...
- 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...
- 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...
- 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...
- Aspartate aminotransferase (AST)/alanine aminotransferase (ALT) ≤ 3 × institutional ULN with the exception of people with documented liver metastases: AST and/or ALT ≤ 5.0 x institutional ULN (within 14 days prior to...
- 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...
- 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...
- 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...
- 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...
- 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 how well it works assessment of...
- 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...
- Participants must be offered the opportunity to participate in specimen banking
The study team makes the final eligibility decision.
Where it's taking place
- Birmingham, Alabama, United States
- Gilbert, Arizona, United States
- La Jolla, California, United States
- New Haven, Connecticut, United States
- Trumbull, Connecticut, United States
- Waterford, Connecticut, United States
- Chicago, Illinois, United States
- Danville, Illinois, United States
- Effingham, Illinois, United States
- Mattoon, Illinois, United States
- New Lenox, Illinois, United States
- Normal, Illinois, United States
- Orland Park, Illinois, United States
- Urbana, Illinois, United States
- Crown Point, Indiana, United States
- Ann Arbor, Michigan, United States
- Detroit, Michigan, United States
- Basking Ridge, New Jersey, United States
- Middletown, New Jersey, United States
- Montvale, New Jersey, United States
+ 17 more site(s).
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years and older. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Birmingham, Alabama, United States; Gilbert, Arizona, United States; La Jolla, California, United States; New Haven, Connecticut, United States; Trumbull, Connecticut, United States; Waterford, Connecticut, United States and 31 more location(s). Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.