Clinical Trials /

Nivolumab for Treatment of Squamous Cell Carcinoma of the Skin

NCT04204837

Description:

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

Related Conditions:
  • Skin Squamous Cell Carcinoma
Recruiting Status:

Recruiting

Phase:

Phase 2

Trial Eligibility

Document

Title

  • Brief Title: Nivolumab for Treatment of Squamous Cell Carcinoma of the Skin
  • Official Title: Phase II Study of Nivolumab in Patients With Locally Advanced/ Metastatic Squamous Cell Carcinoma of the Skin

Clinical Trial IDs

  • ORG STUDY ID: CA209-587
  • NCT ID: NCT04204837

Conditions

  • Squamous Cell Carcinoma of the Skin

Interventions

DrugSynonymsArms
NivolumabNivolumab

Purpose

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

Trial Arms

NameTypeDescriptionInterventions
NivolumabExperimentalNivolumab will be given on Day 1 of every 14-day cycle (Q2W) at a dose of 240 mg as an IV infusion until progression, unacceptable toxicity or discontinuation for other reasons for up to 2 years.
  • Nivolumab

Eligibility Criteria

        Inclusion Criteria:

          1. Men and women, 18 years of age and older on day of signing written informed consent

          2. Histologically or cytologically documented locally-advanced and/or metastatic squamous
             cell carcinoma of the skin (stage III/IV AJCC 2010) that is incurable

          3. Archival tumor tissue available for evaluation of PD-L1 expression

          4. Measurable disease based on Response Criteria in Solid Tumors Version 1.1 (RECIST 1.1)

          5. Life expectancy of at least 12 weeks

          6. Eastern Cooperative Oncology Group (ECOG) Performance status of 0-2

          7. Screening laboratory values must meet the following criteria and should be obtained
             within 14 days prior to registration:

               -  WBC ≥ 2000/μl

               -  Neutrophils ≥ 1500/μL

               -  Platelets ≥ 100 x103/μL

               -  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:

          1. 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

          2. Prior therapy with CTLA-4 or PD-1 antibodies

          3. 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

          4. Known active central nervous system (CNS) metastases and/or carcinomatous meningitis

          5. 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.

          6. 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

          7. Patients with serious intercurrent illness, requiring hospitalization

          8. Other serious illnesses, e.g. serious infections requiring antibiotics

          9. Known psychiatric or substance abuse disorders that would interfere with cooperation
             with the requirements of the trial

         10. Pregnancy (absence to be confirmed by ß-HCG urinary test, minimum sensitivity 25 IU/L
             or equivalent units of HCG)) or lactation period

         11. Women of childbearing potential (WOCBP): Refusal or inability to use effective means
             of contraception (Pearl-Index <1)

         12. History of testing positive for human immunodeficiency virus (HIV) or known acquired
             immunodeficiency syndrome (AIDS)

         13. Positive test for hepatitis B virus surface antigen (HBV sAg) or hepatitis C virus
             ribonucleic acid (HCV antibody) indicating acute or chronic infection

         14. 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

         15. Known hypersensitivity reaction to any of the components of study treatment
      
Maximum Eligible Age:N/A
Minimum Eligible Age:18 Years
Eligible Gender:All
Healthy Volunteers:No

Primary Outcome Measures

Measure:Objective Response Rate (ORR)
Time Frame:up to 2 years
Safety Issue:
Description:using Response Criteria in Solid Tumors Version 1.1 (RECIST1.1) per site assessment

Secondary Outcome Measures

Measure:Disease Control Rate (DCR)
Time Frame:up to 2 years
Safety Issue:
Description:Disease Control Rate (DCR) using Response Criteria in Solid Tumors version 1.1 (RECIST1.1) per site assessment
Measure:Duration of Response (DOR) in patients who achieve partial response (PR) or better
Time Frame:up to 3 years
Safety Issue:
Description:
Measure:Progression Free Survival (PFS)
Time Frame:up to 3 years
Safety Issue:
Description:
Measure:Overall Survival (OS)
Time Frame:up to 2 years
Safety Issue:
Description:
Measure:ORR, DCR, DOR, PFS and OS for patients with PD-L1-positive tumor expression (>5% positive tumor cells)
Time Frame:up to 3 years
Safety Issue:
Description:

Details

Phase:Phase 2
Primary Purpose:Interventional
Overall Status:Recruiting
Lead Sponsor:Salzburger Landeskliniken

Last Updated

December 17, 2019