RecruitingPhase 2NCT04204837

Nivolumab for Treatment of Squamous Cell Carcinoma of the Skin

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

Sponsor

Salzburger Landeskliniken

Enrollment

61 participants

Start Date

Mar 6, 2017

Study Type

INTERVENTIONAL

Conditions

Squamous Cell Carcinoma of the Skin

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

Min Age: 18 Years

Plain Language Summary

Simplified for easier understanding

This study is testing whether nivolumab (an immunotherapy drug) can effectively treat advanced squamous cell carcinoma of the skin that cannot be cured with surgery or radiation. **You may be eligible if...** - You are 18 or older - You have locally advanced or metastatic squamous cell skin cancer (stage III or IV) confirmed by biopsy - Your cancer cannot be cured with current treatments - You have measurable disease on imaging - You have a life expectancy of at least 12 weeks - Your overall health is good enough for treatment (ECOG 0–2) - Your blood counts, kidney, and liver function meet the required levels **You may NOT be eligible if...** - Your disease is early stage or curable - You do not have measurable tumors - Your organ function is too poor for treatment - You have conditions that would make immunotherapy unsafe Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

DRUGNivolumab

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.

DRUGNivolumab 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

View Full Details on ClinicalTrials.gov

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NCT04204837

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