Nivolumab for Treatment of Squamous Cell Carcinoma of the Skin
ConditionSquamous 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 groupsSponsors and collaborators
Salzburger Landeskliniken
Lead sponsor
Bristol-Myers Squibb
Collaborator
Source ClinicalTrials.gov