Phase II Study of Nivolumab (Group 1) and Nivolumab plus Relatlimab (Group 2) in Patients with Locally Advanced/ Metastatic Squamous Cell Carcinoma of the Skin

Gemeinnutzige Salzburger Landes kliniken Betriebsgesellschaft mbH6 sites in 1 country61 target enrollmentAugust 12, 2024

DrugsBMS936558 Nivolumab/Relatlimab BMS986016 OPDIVO 10 mg/mL concentrate for solution for infusion.ABP 206 BMS-986016 OPDIVO 10 mg/mL concentrate for solution for infusion., Nivolumab/Relatlimab

Overview

Phase: Phase 2
Intervention: Not specified
Conditions: Not specified
Sponsor: Gemeinnutzige Salzburger Landes kliniken Betriebsgesellschaft mbH
Enrollment: 61
Locations: 6
Primary Endpoint: To determine the Objective Response Rate (ORR) of immunotherapy with Nivolumab (Group 1) and Nivolumab plus Relatlimab (Group 2) 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 (Time Frame Group 2: From first dose up to 5 years)
Status: Recruiting
Last Updated: last year

Overview Investigators Eligibility Criteria Outcomes Sites Similar Trials

Overview

Brief Summary

To determine the Objective Response Rate (ORR) of immunotherapy with Nivolumab (Group 1) and Nivolumab plus Relatlimab (Group 2) 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 (Time Frame Group 2: From first dose up to 5 years)

Registry

euclinicaltrials.eu

Start Date

August 12, 2024

End Date

TBD

Last Updated

last year

Study Type

Interventional clinical trial of medicinal product

Investigators

Sponsor

Gemeinnutzige Salzburger Landes kliniken Betriebsgesellschaft mbH

Responsible Party

Principal Investigator

ao. Univ.-Prof. Dr. Martin Laimer, MSc

Scientific

Gemeinnutzige Salzburger Landes kliniken Betriebsgesellschaft mbH

Eligibility Criteria

Inclusion 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: o WBC ≥ 2000/μl o Neutrophils ≥ 1500/μL o Platelets ≥ 100 x103/μL o Hemoglobin > 9.0 g/dL o 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 o AST/ALT ≤ 3 x ULN o Total Bilirubin ≤ 1.5 x ULN (except subjects with Gilbert Syndrome, who can have total bilirubin < 3.0 mg/dL) o Negative pregnancy test and effective contraception (Pearl-Index <1) 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

Exclusion Criteria

•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
•Other serious illnesses, e.g. serious infections requiring antibiotics or hospitalization
•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 the best interest of the patient to participate, in the opinion of the treating Investigator
•Known hypersensitivity reaction to any of the components of study treatment
•Prior therapy with CTLA-4, PD-1 or LAG-3 antibodies

Outcomes

Primary Outcomes

Secondary Outcomes

Disease Control Rate (DCR) using Response Criteria in Solid Tumors version 1.1 (RECIST 1.1) per site assessment (Time Frame (Group 2): from first dose to date of first documented tumor progression or death, whichever comes first (up to 5 years))
Duration of Response (DOR) in patients who achieve partial response (PR) or better (Time Frame (Group 2): from date of documented PR or better to date of first documented tumor progression or death, whichever comes first (up to 5 years))
Progression Free Survival (PFS) (Time Frame (Group 2): From first dose to date of first documented tumor progression or death, whichever comes first (up to 5 years))
Overall Survival (OS) (Time Frame: From first dose to the date of death due to any cause (up to 5 years))
ORR, DCR, DOR, PFS and OS for patients with PD-L1-positive tumor expression (>1% positive tumor cells) and/or positive LAG-3 expression (i.e. >1% positive tumor-infiltrationg cells)
Safety and toxicity of Nivolumab plus Relatlimab (Group 2)