Actively Recruiting
Nivolumab for Treatment of Squamous Cell Carcinoma of the Skin
Led by Salzburger Landeskliniken · Updated on 2024-04-18
61
Participants Needed
7
Research Sites
560 weeks
Total Duration
On this page
Sponsors
S
Salzburger Landeskliniken
Lead Sponsor
B
Bristol-Myers Squibb
Collaborating Sponsor
AI-Summary
What this Trial Is About
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)
CONDITIONS
Official Title
Nivolumab for Treatment of Squamous Cell Carcinoma of the Skin
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Adults 18 years or older who have signed informed consent
- Histologically or cytologically confirmed locally advanced or metastatic squamous cell carcinoma of the skin (stage III/IV) that cannot be cured
- Archival tumor tissue available to evaluate PD-L1 and LAG-3 expression
- Measurable disease based on RECIST 1.1 criteria
- Life expectancy of at least 12 weeks
- Eastern Cooperative Oncology Group (ECOG) performance status of 0 to 2
- Laboratory tests within 14 days before registration meeting specific blood counts, kidney and liver function limits
- Negative pregnancy test and use of effective contraception for women who can become pregnant
- Prior radiotherapy completed at least 2 weeks before study drug administration
- Prior systemic antibiotic treatment completed at least 30 days before stool sample collection
You will not qualify if you...
- Participation in another clinical trial with investigational agents within 4 weeks before starting treatment
- Previous therapy with CTLA-4, PD-1, or LAG-3 antibodies
- History of myocarditis
- Elevated troponin T or I levels above set institutional limits without acceptable repeat test results
- Need for systemic corticosteroids over 10 mg prednisone or other immunosuppressive drugs within 14 days before treatment
- Active central nervous system metastases or carcinomatous meningitis
- Other active cancers requiring treatment, except stable chronic lymphocytic leukemia
- Active or suspected autoimmune disease except certain controlled conditions
- Serious illnesses requiring hospitalization or serious infections needing antibiotics
- Psychiatric or substance abuse disorders interfering with study participation
- Pregnancy or lactation
- Women who cannot use effective contraception
- History of HIV/AIDS
- Positive tests for hepatitis B or C infections
- Any condition or laboratory abnormality that might interfere with study participation
- Known allergy to any study treatment components
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 7 locations
1
Universitätsklinikum Graz - LKH, Klinische Abteilung für Onkologie
Graz, Austria, 8020
Actively Recruiting
2
LKH Innsbruck Universitätsklinik für Dermatologie und Venerologie
Innsbruck, Austria, 6020
Actively Recruiting
3
Klinikum Klagenfurt am Wörthersee
Klagenfurt, Austria, 9020
Completed
4
Universitätsklinik für Dermatologie und Allergologie der Paracelsus medizinischen Privatuniversität Salzburg
Salzburg, Austria, 5020
Actively Recruiting
5
Abteilung für Haut- und Geschlechtskrankheiten, Universitätsklinikum St. Pölten Karl Landsteiner Privatuniversität für Gesundheitswissenschaften
Sankt Pölten, Austria, 3100
Actively Recruiting
6
Med Uni Wien, Univ. Klinik für Dermatologie
Vienna, Austria, 1090
Actively Recruiting
7
Klinikum Wels-Grieskirchen GmbH
Wels, Austria, 4600
Actively Recruiting
Research Team
M
Martin Laimer, MD
CONTACT
R
Roland Lang, PhD
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NON_RANDOMIZED
Model
SINGLE_GROUP
Primary Purpose
TREATMENT
Number of Arms
2
Not the Right Trial for You?
Explore thousands of other clinical trials that might be a better match.
Sign up to get personalized trial recommendations delivered to your inbox.
Already have an account? Log in here