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

Who is this study for? Adult patients with squamous cell skin carcinoma
What treatments are being studied? Nivolumab
Status: Recruiting
Location: See all (7) locations...
Intervention Type: Drug
Study Type: Interventional
Study Phase: Phase 2
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/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
Participation Requirements
Sex: All
Minimum Age: 18
Healthy Volunteers: f
View:

• 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 = (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 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

Locations
Other Locations
Austria
Universitätsklinikum Graz - LKH, Klinische Abteilung für Onkologie
RECRUITING
Graz
LKH Innsbruck Universitätsklinik für Dermatologie und Venerologie
RECRUITING
Innsbruck
Klinikum Klagenfurt am Wörthersee
COMPLETED
Klagenfurt
Universitätsklinik für Dermatologie und Allergologie der Paracelsus medizinischen Privatuniversität Salzburg
RECRUITING
Salzburg
Abteilung für Haut- und Geschlechtskrankheiten, Universitätsklinikum St. Pölten Karl Landsteiner Privatuniversität für Gesundheitswissenschaften
RECRUITING
Sankt Pölten
Med Uni Wien, Univ. Klinik für Dermatologie
RECRUITING
Vienna
Klinikum Wels-Grieskirchen GmbH
RECRUITING
Wels
Contact Information
Primary
Martin Laimer, MD
m.laimer@salk.at
+4357255
Backup
Roland Lang, PhD
r.lang@sak.at
+4357255
Time Frame
Start Date: 2017-03-06
Estimated Completion Date: 2027-12
Participants
Target number of participants: 61
Treatments
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.
Experimental: Nivolumab plus Relatlimab
Patients wil receive a fixed-dose combination of nivolumab 480 mg and relatlimab 160 mg by intravenous infusion every four weeks (Q4W) (Group 2) for up to two years after initial dosing or until PD - or absence of investigator-assessed clinical benefit
Related Therapeutic Areas
Sponsors
Collaborators: Bristol-Myers Squibb
Leads: Salzburger Landeskliniken

This content was sourced from clinicaltrials.gov