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New treatment option for Squamous Cell Carcinoma of the Skin
Official title Nivolumab for Treatment of Squamous Cell Carcinoma of the Skin
ClinicalTrials.gov ID: NCT04204837
What this study is testing
What is Nivolumab?
Nivolumab is an investigational medicine, given as an infusion into a vein, being studied as a potential treatment for squamous cell carcinoma of the skin.
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
- To determine the Objective Response Rate (ORR) of immunotherapy with Nivolumab (Group 1) and Nivolumab plus Relatlimab (Group 2) in patients with locally advanced/metastatic squamous cell carcinoma of the skin using Response Criteria in Solid Tumors Version 1.1 (RECIST1.1) per site assessment (Time Frame Group 2: From first dose up to 5 years)
- Phase 2: a mid-size study of how well it works
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
- 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...
- Archival tumor tissue available for evaluation of PD-L1 and LAG-3 expression
- Measurable disease based on Response Criteria in Solid Tumors Version 1.1 (RECIST 1.1)
- Life expectancy of at least 12 weeks
You likely can't join if
- Patient is currently participating and receiving study therapy or has participated in a study of an investigational agent and received study therapy...
- Prior therapy with CTLA-4, PD-1 or LAG-3 antibodies
- History of myocarditis, regardless of etiology
- Troponin T (TnT) or I (TnI) \> 2× institutional upper limit of normal (ULN). Participants with TnT or TnI levels between \> 1× to 2× ULN will be...
- A condition requiring systemic treatment with either corticosteroids (\> 10 mg daily prednisone equivalents) or other immunosuppressive medications...
- Known active central nervous system (CNS) metastases and/or carcinomatous meningitis
See the full eligibility criteria
- 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 and LAG-3 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/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 =...
- AST/ALT ≤ 3 x ULN
- Total Bilirubin ≤ 1.5 x ULN (except people with Gilbert Syndrome, who can have total bilirubin \< 3.0 mg/dL)
- Negative pregnancy test and effective contraception (Pearl-Index \<1) for for women of childbearing potential (WOCBP) if the risk of conception exists
- Prior radiotherapy must have been completed at least 2 weeks prior to study drug administration
- Prior systemic antibiotic treatment must have been completed at least 30 days prior to stool sample collection
- 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...
- Prior therapy with CTLA-4, PD-1 or LAG-3 antibodies
- History of myocarditis, regardless of etiology
- Troponin T (TnT) or I (TnI) \> 2× institutional upper limit of normal (ULN). Participants with TnT or TnI levels between \> 1× to 2× ULN will be permitted if repeat levels within 24 hours are ≤ 1× ULN. If TnT or TnI...
- 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...
- 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. people are permitted to enroll if they have vitiligo, type I diabetes mellitus, residual hypothyroidism due to autoimmune condition only requiring hormone replacement...
- 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 ß-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...
- Known hypersensitivity reaction to any of the components of study treatment
The study team makes the final eligibility decision.
Where it's taking place
- Graz, Austria
- Innsbruck, Austria
- Klagenfurt, Austria
- Salzburg, Austria
- Sankt Pölten, Austria
- Vienna, Austria
- Wels, Austria
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 listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to 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 Graz, Austria; Innsbruck, Austria; Klagenfurt, Austria; Salzburg, Austria; Sankt Pölten, Austria; Vienna, Austria and 1 more location(s). Enter your location above to see the nearest site and check your eligibility.
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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.