Health TrialsbyHealthPanel

Nivolumab for Treatment of Squamous Cell Carcinoma of the Skin

ConditionSquamous Cell Carcinoma of the Skin
Trial statusRecruiting
Trial phasePhase 2
Trial typeInterventional
Biological sexAll
Age18+
SponsorSalzburger Landeskliniken

About this trial

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 criteria

This trial does not accept healthy volunteers

Qualifiers

Men and women, 18 years of age and older on day of signing written informed consent

Histologically or cytologically documented locally-advanced and/or metastatic squamous cell carcinoma of the skin (stage III/IV AJCC 2010) that is incurable

Archival tumor tissue available for evaluation of PD-L1 and LAG-3 expression

Measurable disease based on Response Criteria in Solid Tumors Version 1.1 (RECIST 1.1)

Disqualifiers

Patient is currently participating and receiving study therapy or has participated in a study of an investigational agent and received study therapy or used an investigational device within 4 weeks of the first dose of treatment

Prior therapy with CTLA-4, PD-1 or LAG-3 antibodies

History of myocarditis, regardless of etiology

Troponin T (TnT) or I (TnI) > 2× institutional upper limit of normal (ULN). Participants with TnT or TnI levels between > 1× to 2× ULN will be permitted if repeat levels within 24 hours are ≤ 1× ULN. If TnT or TnI levels are between > 1× to 2× ULN within 24 hours, the participant may undergo a cardiac evaluation and be considered for treatment, based on a favorable benefit/risk assessment by the Investigator. When repeat levels within 24 hours are not available, a repeat test should be conducted as soon as possible. If TnT or TnI repeat levels beyond 24 hours are < 2× ULN, the participant may undergo a cardiac evaluation and be considered for treatment, based on a favorable benefit/risk assessment by the Investigator

Trial design

Design model

Single group

Treatments tested in this trial

  • Nivolumab

    Drug

    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.

  • Nivolumab plus Relatlimab

    Drug

    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

Treatment groups

61 Participants
are divided into 2 treatment groups
Group A: NivolumabExperimental treatment 1 intervention
Group B: Nivolumab plus RelatlimabExperimental treatment 1 intervention

Trial outcomes

Primary outcomes

1

Objective Response Rate (ORR)

using Response Criteria in Solid Tumors Version 1.1 (RECIST1.1) per site assessment

Time frame
up to 5 years

Secondary outcomes

1

Disease Control Rate (DCR)

Disease Control Rate (DCR) using Response Criteria in Solid Tumors version 1.1 (RECIST1.1) per site assessment

Time frame
up to 5 years
2

Duration of Response (DOR) in patients who achieve partial response (PR) or better

Time frame
up to 5 years
3

Progression Free Survival (PFS)

Time frame
up to 5 years
4

Overall Survival (OS)

Time frame
up to 5 years

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Salzburger Landeskliniken

Lead sponsor

Bristol-Myers Squibb

Collaborator

Source ClinicalTrials.gov
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