Neoadjuvant Nivolumab and Relatlimab in Cutaneous Squamous Cell Carcinoma
ConditionCutaneous Squamous Cell Carcinoma
Trial statusRecruiting
Trial phasePhase 2
Trial typeInterventional
Biological sexAll
Age18+
SponsorMelanoma Institute Australia
About this trial
The goal of this study is to test neoadjuvant therapy with the dual inhibition of Programmed cell death protein 1 (PD-1) and lymphocyte activation gene 3 (LAG-3) immune checkpoint pathways in a cohort of treatment-naïve, resectable stage II to IV cutaneous squamous cell carcinoma on the pathological response rate (pCR) and recurrence-free survival.
Eligibility criteria
Qualifiers
≥ 18 years of age
Written informed consent
stage II (T2, N0, M0)
stage III (T3, N0, M0; or T1-3, N1, M0)
Disqualifiers
Clinical or radiographic evidence of distant metastasis
SCC of the eyelid, vulva, penis and perianus
Any contraindication to the administration of nivolumab and / or relatlimab
Prior anti-PD-1, CTLA-4 (Cytotoxic T-lymphocyte associated protein 4), PDL-1 (Programmed death-ligand 1) or LAG 3 (Lymphocyte-Activation Gene 3) antibody exposure, or an agent directed to another stimulatory or co-inhibitory T-cell receptor for any disease or any chemotherapy or experimental local or systemic drug treatment
Trial design
Treatments tested in this trial
- Nivolumab 240 mg / Relatlimab 80 mg in a fixed dose combination
Treatment groups
20 Participants
are divided into 1 treatment groupSponsors and collaborators
Melanoma Institute Australia
Lead sponsor
Bristol-Myers Squibb
Collaborator
Source ClinicalTrials.gov