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Nivolumab for Treatment of Squamous Cell Carcinoma of the Skin

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04204837
Recruitment Status : Active, not recruiting
First Posted : December 19, 2019
Last Update Posted : March 17, 2021
Sponsor:
Collaborator:
Bristol-Myers Squibb
Information provided by (Responsible Party):
Martin Laimer, MD, MSc, Salzburger Landeskliniken

Tracking Information
First Submitted Date  ICMJE December 17, 2019
First Posted Date  ICMJE December 19, 2019
Last Update Posted Date March 17, 2021
Actual Study Start Date  ICMJE March 6, 2017
Estimated Primary Completion Date March 31, 2021   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: December 17, 2019)
Objective Response Rate (ORR) [ Time Frame: up to 2 years ]
using Response Criteria in Solid Tumors Version 1.1 (RECIST1.1) per site assessment
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: December 17, 2019)
  • Disease Control Rate (DCR) [ Time Frame: up to 2 years ]
    Disease Control Rate (DCR) using Response Criteria in Solid Tumors version 1.1 (RECIST1.1) per site assessment
  • Duration of Response (DOR) in patients who achieve partial response (PR) or better [ Time Frame: up to 3 years ]
  • Progression Free Survival (PFS) [ Time Frame: up to 3 years ]
  • Overall Survival (OS) [ Time Frame: up to 2 years ]
  • ORR, DCR, DOR, PFS and OS for patients with PD-L1-positive tumor expression (>5% positive tumor cells) [ Time Frame: up to 3 years ]
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Nivolumab for Treatment of Squamous Cell Carcinoma of the Skin
Official Title  ICMJE Phase II Study of Nivolumab in Patients With Locally Advanced/ Metastatic Squamous Cell Carcinoma of the Skin
Brief 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
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 2
Study Design  ICMJE Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE Squamous Cell Carcinoma of the Skin
Intervention  ICMJE Drug: Nivolumab
Nivolumab 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.
Study Arms  ICMJE Experimental: Nivolumab
Nivolumab 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.
Intervention: Drug: Nivolumab
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Active, not recruiting
Actual Enrollment  ICMJE
 (submitted: December 17, 2019)
31
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE December 2023
Estimated Primary Completion Date March 31, 2021   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Austria
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT04204837
Other Study ID Numbers  ICMJE CA209-587
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Product Manufactured in and Exported from the U.S.: Yes
IPD Sharing Statement  ICMJE Not Provided
Current Responsible Party Martin Laimer, MD, MSc, Salzburger Landeskliniken
Original Responsible Party Same as current
Current Study Sponsor  ICMJE Salzburger Landeskliniken
Original Study Sponsor  ICMJE Same as current
Collaborators  ICMJE Bristol-Myers Squibb
Investigators  ICMJE
Principal Investigator: Martin Laimer, MD Salzburger Landeskliniken
PRS Account Salzburger Landeskliniken
Verification Date March 2021

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP