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

Conditions

Locally Advanced/Metastatic Squamous Cell Carcinoma of the Skin

Brief 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/metastativ squamous cell carcinoma of the skin using Response Criteria in Solid Tumors Version 1.1 (RECIST 1.1) per site assessment (Time Frame Group 2: From first dose up to 5 years)

Detailed description

Disease Control Rate (DCR) using Response Criteria in Solid Tumors version 1.1 (RECIST 1.1) per site assessment (Time Frame (Group 2): from first dose to date of first documented tumor progression or death, whichever comes first (up to 5 years)), Duration of Response (DOR) in patients who achieve partial response (PR) or better (Time Frame (Group 2): from date of documented PR or better to date of first documented tumor progression or death, whichever comes first (up to 5 years)), Progression Free Survival (PFS) (Time Frame (Group 2): From first dose to date of first documented tumor progression or death, whichever comes first (up to 5 years)), Overall Survival (OS) (Time Frame: From first dose to the date of death due to any cause (up to 5 years)), ORR, DCR, DOR, PFS and OS for patients with PD-L1-positive tumor expression (>1% positive tumor cells) and/or positive LAG-3 expression (i.e. >1% positive tumor-infiltrationg cells), Safety and toxicity of Nivolumab plus Relatlimab (Group 2)

Related papers

No related papers found yet.

Interventions

DRUGOPDIVO 10 mg/mL concentrate for solution for infusion.

DRUGNivolumab/Relatlimab

Eligibility

Sex/Gender

All

Age

18 Years to No maximum

Design outcomes

Primary

Measure	Time frame
To determine the Objective Response Rate (ORR) of immunotherapy with Nivolumab (Group 1) and Nivolumab plus Relatlimab (Group 2) in patients with locally advanced/metastativ squamous cell carcinoma of the skin using Response Criteria in Solid Tumors Version 1.1 (RECIST 1.1) per site assessment (Time Frame Group 2: From first dose up to 5 years)	—

Secondary

Measure	Time frame
Disease Control Rate (DCR) using Response Criteria in Solid Tumors version 1.1 (RECIST 1.1) per site assessment (Time Frame (Group 2): from first dose to date of first documented tumor progression or death, whichever comes first (up to 5 years)), Duration of Response (DOR) in patients who achieve partial response (PR) or better (Time Frame (Group 2): from date of documented PR or better to date of first documented tumor progression or death, whichever comes first (up to 5 years)), Progression Free Survival (PFS) (Time Frame (Group 2): From first dose to date of first documented tumor progression or death, whichever comes first (up to 5 years)), Overall Survival (OS) (Time Frame: From first dose to the date of death due to any cause (up to 5 years)), ORR, DCR, DOR, PFS and OS for patients with PD-L1-positive tumor expression (>1% positive tumor cells) and/or positive LAG-3 expression (i.e. >1% positive tumor-infiltrationg cells), Safety and toxicity of Nivolumab plus Relatlimab (Group 2	—

Measure

Time frame

Disease Control Rate (DCR) using Response Criteria in Solid Tumors version 1.1 (RECIST 1.1) per site assessment (Time Frame (Group 2): from first dose to date of first documented tumor progression or death, whichever comes first (up to 5 years)), Duration of Response (DOR) in patients who achieve partial response (PR) or better (Time Frame (Group 2): from date of documented PR or better to date of first documented tumor progression or death, whichever comes first (up to 5 years)), Progression Free Survival (PFS) (Time Frame (Group 2): From first dose to date of first documented tumor progression or death, whichever comes first (up to 5 years)), Overall Survival (OS) (Time Frame: From first dose to the date of death due to any cause (up to 5 years)), ORR, DCR, DOR, PFS and OS for patients with PD-L1-positive tumor expression (>1% positive tumor cells) and/or positive LAG-3 expression (i.e. >1% positive tumor-infiltrationg cells), Safety and toxicity of Nivolumab plus Relatlimab (Group 2

—

Countries

Austria

Outcome results

None listed