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New treatment option for Metastatic Skin Squamous Cell Carcinoma
Official title Cemiplimab Before and After Surgery for the Treatment of High Risk Cutaneous Squamous Cell Cancer
ClinicalTrials.gov ID: NCT04428671
What this study is testing
What is Cemiplimab?
Cemiplimab is an investigational medicine, given as an infusion into a vein, being studied as a potential treatment for metastatic skin squamous cell carcinoma.
Also referred to as Cemiplimab RWLC, Cemiplimab-rwlc.
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 I trial studies how well cemiplimab before and after surgery works in treating patients with high risk cutaneous squamous cell cancer. Immunotherapy with monoclonal antibodies, such as cemiplimab, may help the body's immune system attack the cancer, and may interfere with the ability of tumor cells to grow and spread.
- Phase 1: an early, usually small safety study
- Time commitment: about 10 years
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
- Patient must have a known diagnosis of high risk cSCC defined by the following criteria:
- Nodal disease with extracapsular extension (ECE) and at least one node \>= 20 mm on the surgical pathology report
- In-transit metastases (ITM) defined as skin or subcutaneous metastases that are \> 2 cm from the primary lesion but are not beyond the regional nodal...
- T4 lesion for head and neck CSCC
- Perineural invasion (PNI), defined as clinical and/or radiologic involvement of named nerves
You likely can't join if
- Determined not to be a surgical candidate due to medical co-morbidities or extent of disease
- Treatment with chronic immunosuppressants (e.g., cyclosporine following transplantation)
- Prior organ allograft or allogeneic bone marrow transplantation
- people with active or history of immune mediated pneumonitis, colitis, hepatitis, nephritis, or skin reactions as these patients may be at increased...
- people with a condition requiring systemic treatment with either corticosteroids (\> 10 mg daily prednisone equivalents) or other immunosuppressive...
- Women who are pregnant or lactating
See the full eligibility criteria
Who can join
- Patient must have a known diagnosis of high risk cSCC defined by the following criteria:
- Nodal disease with extracapsular extension (ECE) and at least one node \>= 20 mm on the surgical pathology report
- In-transit metastases (ITM) defined as skin or subcutaneous metastases that are \> 2 cm from the primary lesion but are not beyond the regional nodal basin
- T4 lesion for head and neck CSCC
- Perineural invasion (PNI), defined as clinical and/or radiologic involvement of named nerves
- Recurrent CSCC, defined as CSCC that arises within the area of the previously resected tumor, or at least one of the following additional features:
- \>= N2b disease associated with the recurrent lesion
- Nominal \>= T3 (recurrent lesion \>= 4 cm in diameter or minor bone erosion or deep invasion \> 6 mm measured from the granular layer of normal adjacent epithelium)
- Poorly differentiated histology and \>= 20 mm diameter of recurrent lesion. The recurrent lesion must be documented to be within the area of the previously resected CSCC by radial measurement of the greatest radius of...
- Cancer confirmed to be surgically resectable, with surgery evaluation with planned prior to resection
- No prior systemic immunotherapy, no prior anti-PD1 therapy
- Eastern Cooperative Oncology Group (ECOG) performance status =\< 1
- Hemoglobin \>= 9.0 g/dl (within 28 days of cycle 1 day 1)
- Absolute neutrophil count (ANC) \>= 1,500/mcL (within 28 days of cycle 1 day 1)
- Platelets \>= 100,000/mcL (within 28 days of cycle 1 day 1)
- Total bilirubin =\<1.5 institutional upper limit of normal (ULN) (within 28 days of cycle 1 day 1)
- Aspartate aminotransferase (AST)/alanine aminotransferase (ALT) =\< 2.5 institutional upper limit of normal (ULN) (within 28 days of cycle 1 day 1)
- Albumin \>= 3.0 g/dL (within 28 days of cycle 1 day 1)
- Serum creatinine =\ = 50 mL/min using Cockcroft-Gault formula) (within 28 days of cycle 1 day 1)
- International normalized ratio (INR) =\< 1.5 (within 28 days of cycle 1 day 1)
- Anticoagulation is allowed only with low molecular weight heparin (LMWH). Patient receiving LMW heparin on stable therapeutic dose for more than 2 weeks or with factor Xa level \< 1.1U/mL are allowed on the trial
- Clinically significant toxic effect(s) of the most recent prior anti-cancer therapy must be grade 1 or resolved (except alopecia and sensory neuropathy); patients with grade 2 adrenal insufficiency related to prior...
- Patients with a prior or concurrent malignancy whose natural history or treatment does not have the potential to interfere with the safety or how well it works assessment of the investigational regimen are eligible for...
- The effects of cemiplimab on the developing human fetus are unknown. For this reason female of child-bearing potential (FCBP) must have a negative serum or urine pregnancy test prior to starting therapy
- FCBP and men must agree to use adequate contraception (at least one highly effective method and one additional method of birth control at the same time or complete abstinence) prior to study entry, for the duration of...
- Patients must agree not to donate blood, sperm/ova while taking protocol therapy and for at least 6 months after stopping treatment
- Willingness and ability of the subject to comply with scheduled visits, drug administration plan, protocol-specified laboratory tests, other study procedures, and study restrictions
- Evidence of a personally signed informed consent indicating that the subject is aware of the neoplastic nature of the disease and has been informed of the procedures to be followed, the experimental nature of the...
What rules you out
- Determined not to be a surgical candidate due to medical co-morbidities or extent of disease
- Treatment with chronic immunosuppressants (e.g., cyclosporine following transplantation)
- Prior organ allograft or allogeneic bone marrow transplantation
- people with active or history of immune mediated pneumonitis, colitis, hepatitis, nephritis, or skin reactions as these patients may be at increased risk for developing immune therapy-induced exacerbation or recurrence...
- people with a condition requiring systemic treatment with either corticosteroids (\> 10 mg daily prednisone equivalents) or other immunosuppressive medications within 14 days of study drug administration. Inhaled or...
- Women who are pregnant or lactating
- Uncontrolled intercurrent illness including, but not limited to, human immunodeficiency virus (HIV)-positive people receiving combination antiretroviral therapy, ongoing or active infection, symptomatic congestive heart...
- Other medications, or severe acute/chronic medical or psychiatric condition, or laboratory abnormality that may increase the risk associated with study participation or study drug administration, or may interfere with...
- Clinical evidence of bleeding diathesis or coagulopathy
- people with a history of severe allergic reactions
- Patients with prior malignancies, are eligible if they have been disease free for \> 3 years
- Patients with prior low-risk non-melanoma skin cancers and in situ carcinomas are eligible provided there was complete removal
- Use of other investigational drugs (drugs not marked for any indication) within 28 days or at least 5 half-lives (whichever is longer) before study drug administration
- History of severe hypersensitivity reactions to other monoclonal antibodies
- Non-oncology vaccines within 28 days prior to starting treatment
- Prisoners and people who are compulsory detained
The study team makes the final eligibility decision.
Where it's taking place
- Atlanta, Georgia, United States
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 study runs about 10 years per participant, based on its public description. The team confirms the exact schedule and number of visits before you 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 Atlanta, Georgia, United States. 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.