NCT04204837

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

• Status: Recruiting
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 61 (estimated)
• Sponsor: Salzburger Landeskliniken · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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)

Conditions

• Squamous Cell Carcinoma of the Skin

Interventions

Type	Name	Description
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

Timeline

• Start date: 2017-03-06
• Primary completion: 2026-12-01
• Completion: 2027-12-01
• First posted: 2019-12-19
• Last updated: 2024-04-18

Locations

7 sites across 1 country: Austria

Regulatory

• FDA-regulated drug study