Nivolumab for Treatment of Squamous Cell Carcinoma of the Skin

  • STATUS
    Recruiting
  • End date
    Dec 23, 2023
  • participants needed
    31
  • sponsor
    Salzburger Landeskliniken
Updated on 23 January 2021
measurable disease
non-melanoma skin cancer
neutrophil count
pd-l1
solid tumors

Summary

To determine the Objective Response Rate (ORR) of immunotherapy with Nivolumab in patients with locally advanced/metastativ squamous cell carcinoma of the skin using Response Criteria in Solid Tumors Version 1.1 (RECIST 1.1) per site assessment up to 2 years

Details
Condition Squamous Cell Carcinoma of the Skin, Cutaneous Squamous Cell Carcinoma, Skin Squamous Cell Carcinoma, squamous cell skin cancer
Treatment Nivolumab
Clinical Study IdentifierNCT04204837
SponsorSalzburger Landeskliniken
Last Modified on23 January 2021

Eligibility

Yes No Not Sure

Inclusion Criteria

Is your age greater than or equal to 18 yrs?
Gender: Male or Female
Do you have Squamous Cell Carcinoma of the Skin?
Do you have any of these conditions: Squamous Cell Carcinoma of the Skin or Cutaneous Squamous Cell Carcinoma or Skin Squamous Cell Carcinoma or squamous cell skin cancer?
Men and women, 18 years of age and older on day of signing written informed consent
Histologically or cytologically documented locally-advanced and/or metastatic squamous cell carcinoma of the skin (stage III/IV AJCC 2010) that is incurable
Archival tumor tissue available for evaluation of PD-L1 expression
Measurable disease based on Response Criteria in Solid Tumors Version 1.1 (RECIST 1.1)
Life expectancy of at least 12 weeks
Eastern Cooperative Oncology Group (ECOG) Performance status of 0-2
Screening laboratory values must meet the following criteria and should be obtained within 14 days prior to registration
WBC 2000/l
Neutrophils 1500/L
Platelets 100 x103/L
Hemoglobin > 9.0 g/dL
Serum creatinine 1.5 x ULN or creatinine clearance (CrCl) 40 mL/min (if using the Cockcroft-Gault formula below)
Female CrCl = (140 - age in years) x weight in kg x 0.85/72 x serum creatinine
in mg/dL Male CrCl = (140- age in years) x weight in kg x 1.00/72 x serum
creatinine in mg/dL
AST/ALT 3 x ULN
Total Bilirubin 1.5 x ULN (except subjects with Gilbert Syndrome, who can have total bilirubin < 3.0 mg/dL)
Negative pregnancy test for female subjects and effective contraception (Pearl-Index <1) for both male and female subjects if the risk of conception exists
Prior radiotherapy must have been completed at least 2 weeks prior to study drug administration

Exclusion Criteria

Patient is currently participating and receiving study therapy or has participated in a study of an investigational agent and received study therapy or used an investigational device within 4 weeks of the first dose of treatment
Prior therapy with CTLA-4 or PD-1 antibodies
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 topical steroids and adrenal replacement doses > 10 mg daily prednisone equivalents are permitted in the absence of active autoimmune disease
Known active central nervous system (CNS) metastases and/or carcinomatous meningitis
Known additional malignancy that is progressing or requires active treatment. Patients with chronic lymphocytic leukemia that is stable under active therapy are eligible for inclusion
An active, known or suspected autoimmune disease. Subjects are permitted to enroll if they have vitiligo, type I diabetes mellitus, residual hypothyroidism due to autoimmune condition only requiring hormone replacement, psoriasis not requiring systemic treatment, or conditions not expected to recur in the absence of an external trigger
Patients with serious intercurrent illness, requiring hospitalization
Other serious illnesses, e.g. serious infections requiring antibiotics
Known psychiatric or substance abuse disorders that would interfere with cooperation with the requirements of the trial
Pregnancy (absence to be confirmed by -HCG urinary test, minimum sensitivity 25 IU/L or equivalent units of HCG)) or lactation period
Women of childbearing potential (WOCBP): Refusal or inability to use effective means of contraception (Pearl-Index <1)
History of testing positive for human immunodeficiency virus (HIV) or known acquired immunodeficiency syndrome (AIDS)
Positive test for hepatitis B virus surface antigen (HBV sAg) or hepatitis C virus ribonucleic acid (HCV antibody) indicating acute or chronic infection
History or current evidence of any condition, therapy, or laboratory abnormality that might confound the results of the study, interfere with the patient's participation for the full duration of the study, or is not in the best interest of the patient to participate, in the opinion of the treating Investigator
Known hypersensitivity reaction to any of the components of study treatment
Clear my responses

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If you are confirmed eligible after full screening, you will be required to understand and sign the informed consent if you decide to enroll in the study. Once enrolled you may be asked to make scheduled visits over a period of time.

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