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RECRUITING
NCT04204837
PHASE2

Nivolumab for Treatment of Squamous Cell Carcinoma of the Skin

Sponsor: Salzburger Landeskliniken

View on ClinicalTrials.gov

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)

Official title: 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

Key Details

Gender

All

Age Range

18 Years - Any

Study Type

INTERVENTIONAL

Enrollment

61

Start Date

2017-03-06

Completion Date

2027-12

Last Updated

2024-04-18

Healthy Volunteers

No

Interventions

DRUG

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.

DRUG

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

Locations (7)

Universitätsklinikum Graz - LKH, Klinische Abteilung für Onkologie

Graz, Austria

LKH Innsbruck Universitätsklinik für Dermatologie und Venerologie

Innsbruck, Austria

Klinikum Klagenfurt am Wörthersee

Klagenfurt, Austria

Universitätsklinik für Dermatologie und Allergologie der Paracelsus medizinischen Privatuniversität Salzburg

Salzburg, Austria

Abteilung für Haut- und Geschlechtskrankheiten, Universitätsklinikum St. Pölten Karl Landsteiner Privatuniversität für Gesundheitswissenschaften

Sankt Pölten, Austria

Med Uni Wien, Univ. Klinik für Dermatologie

Vienna, Austria

Klinikum Wels-Grieskirchen GmbH

Wels, Austria