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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
Bristol-Myers Squibb
Information provided by (Responsible Party):
Martin Laimer, MD, MSc, Salzburger Landeskliniken

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

Condition or disease Intervention/treatment Phase
Squamous Cell Carcinoma of the Skin Drug: Nivolumab Phase 2

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 31 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Phase II Study of Nivolumab in Patients With Locally Advanced/ Metastatic Squamous Cell Carcinoma of the Skin
Actual Study Start Date : March 6, 2017
Estimated Primary Completion Date : March 31, 2021
Estimated Study Completion Date : December 2023

Resource links provided by the National Library of Medicine

Drug Information available for: Nivolumab

Arm Intervention/treatment
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.
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.

Primary Outcome Measures :
  1. Objective Response Rate (ORR) [ Time Frame: up to 2 years ]
    using Response Criteria in Solid Tumors Version 1.1 (RECIST1.1) per site assessment

Secondary Outcome Measures :
  1. 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

  2. Duration of Response (DOR) in patients who achieve partial response (PR) or better [ Time Frame: up to 3 years ]
  3. Progression Free Survival (PFS) [ Time Frame: up to 3 years ]
  4. Overall Survival (OS) [ Time Frame: up to 2 years ]
  5. ORR, DCR, DOR, PFS and OS for patients with PD-L1-positive tumor expression (>5% positive tumor cells) [ Time Frame: up to 3 years ]

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04204837

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Universitätsklinikum Graz - LKH, Klinik für Dermatologie und Venerologie
Graz, Austria, 8020
LKH Innsbruck Universitätsklinik für Dermatologie und Venerologie
Innsbruck, Austria, 6020
Klinikum Klagenfurt am Wörthersee
Klagenfurt, Austria, 9020
Universitätsklinik für Dermatologie und Allergologie der Paracelsus medizinischen Privatuniversität Salzburg
Salzburg, Austria, 5020
Abteilung für Haut- und Geschlechtskrankheiten, Universitätsklinikum St. Pölten Karl Landsteiner Privatuniversität für Gesundheitswissenschaften
St.Pölten, Austria, 3100
Med Uni Wien, Univ. Klinik für Dermatologie
Vienna, Austria, 1090
Klinikum Wels-Grieskirchen GmbH
Wels, Austria, 4600
Sponsors and Collaborators
Salzburger Landeskliniken
Bristol-Myers Squibb
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Principal Investigator: Martin Laimer, MD Salzburger Landeskliniken
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Responsible Party: Martin Laimer, MD, MSc, a.o. Univ.-Prof. Dr. med. univ., MSc, Salzburger Landeskliniken
ClinicalTrials.gov Identifier: NCT04204837    
Other Study ID Numbers: CA209-587
First Posted: December 19, 2019    Key Record Dates
Last Update Posted: March 17, 2021
Last Verified: March 2021

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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
Additional relevant MeSH terms:
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Carcinoma, Squamous Cell
Skin Neoplasms
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type
Neoplasms, Squamous Cell
Neoplasms by Site
Skin Diseases
Antineoplastic Agents, Immunological
Antineoplastic Agents
Immune Checkpoint Inhibitors
Molecular Mechanisms of Pharmacological Action