Nivolumab for Treatment of Squamous Cell Carcinoma of the Skin

Trial statusRecruiting
Trial phasePhase 2
Trial typeInterventional
Biological sexAll
Age18+
SponsorSalzburger Landeskliniken

About this trial

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)

Eligibility criteria

Qualifiers

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)

Disqualifiers

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, 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 levels are between > 1× to 2× ULN within 24 hours, the participant may undergo a cardiac evaluation and be considered for treatment, based on a favorable benefit/risk assessment by the Investigator. When repeat levels within 24 hours are not available, a repeat test should be conducted as soon as possible. If TnT or TnI repeat levels beyond 24 hours are < 2× ULN, the participant may undergo a cardiac evaluation and be considered for treatment, based on a favorable benefit/risk assessment by the Investigator

Trial design

Treatments tested in this trial

  • Nivolumab
  • Nivolumab plus Relatlimab

Treatment groups

61 Participants
are divided into 2 treatment groups

Locations

7
Universitätsklinikum Graz - LKH, Klinische Abteilung für Onkologie8020, Graz Austria
LKH Innsbruck Universitätsklinik für Dermatologie und Venerologie6020, Innsbruck Austria
Klinikum Klagenfurt am Wörthersee9020, Klagenfurt Austria
Universitätsklinik für Dermatologie und Allergologie der Paracelsus medizinischen Privatuniversität Salzburg5020, Salzburg Austria

Sponsors and collaborators

Salzburger Landeskliniken

Lead sponsor

Bristol-Myers Squibb

Collaborator