Neoadjuvant Nivolumab and Relatlimab in Cutaneous Squamous Cell Carcinoma

Recruiting now · Phase 2

Conditions studied: Cutaneous Squamous Cell Carcinoma

In brief

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.

Key facts

Study ID

NCT06288191

Run by

Melanoma Institute Australia

People needed

20

Starts

2024-06-21

Expected to finish

2036-07-01

Last updated by the study team

2026-07-08

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• ≥ 18 years of age
• Written informed consent
• Histologically confirmed, resectable stage II to IV cutaneous squamous cell carcinoma defined as:
• Non-head and neck cuSCC:
• stage II (T2, N0, M0)
• stage III (T3, N0, M0; or T1-3, N1, M0)
• stage IV (T1-3, N2 or N3, M0; or T4a or T4b, any N, M0)
• Cutaneous head and neck CC:
• stage II (T2, N0, M0)
• stage III (T3, N0, M0)
• stage IV (T4a or T4b, any N, M0)
• In-transit metastases (ITM) are permitted if they are completely resectable. ITM defined as skin or subcutaneous metastases that are > 20 mm from the primary lesion but not beyond the regional nodal basin.
• Measurable disease according to RECIST version 1.1 criteria (≥10 mm longest diameter for primary lesions and / or ≥10 mm in shortest diameter for lymph nodes as determined by CT imaging) within 2 weeks of the start of study treatment.
• Tumour amenable to a newly obtained core biopsy of a lesion which has not been previously irradiated. Archival tissue from a past primary or nodal cuSCC lesion (if applicable) or tissue taken for current diagnosis will also be collected.
• Previous radiotherapy permitted if performed at a prior site of disease not seen at baseline.
• Eastern Cooperative Oncology Group (ECOG) performance status of 0-1
• Documented adequate haematological, hepatic, renal, and thyroid function determined by blood pathology
• Anticipated life expectancy of > 12 months
• Women of childbearing potential must have a negative serum pregnancy test within 24 hours of the first dose of study treatment or within 72 hours if this is not feasible. Effective contraception should be used for the duration of study treatment and for 5 half-lives (or 5 months) after the last dose. Egg donation (ova, oocytes) should be avoided for the same period. There are no partner-pregnancy or sperm donation avoidance requirements for male patients.

You may not qualify if…

• 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
• Active autoimmune disease or a requirement for chronic steroid therapy other than hormone replacement therapy
• The following are permitted:
• Vitiligo
• Type I diabetes mellitus on stable insulin therapy
• Residual autoimmune hypothyroidism on stable hormone replacement
• Resolved childhood asthma or atopy
• Psoriasis not requiring systemic treatment
• Autoimmune conditions which are not expected to recur in the absence of an external trigger.
• Has a diagnosis of immunodeficiency or is receiving chronic systemic steroid therapy (in doses exceeding 10 mg daily of prednisone or equivalent) or any other form of immunosuppressive therapy within 14 days prior to the first dose of study treatment.
• The following are permitted:
• Replacement therapy (e.g. thyroxine, insulin, or physiologic corticosteroid replacement therapy for adrenal or pituitary insufficiency, etc.)
• Inhaled or intranasal corticosteroids (with minimal systemic absorption) may be continued if patient is on a stable dose
• Non-absorbed intra-articular steroid injections.
• Known additional malignancies (unless adequately treated) active within the previous 3 years, except for locally curable cancers that have been apparently cured.
• The following malignancies, if undergone successful definitive resection or curative treatment, are permitted:
• Basal cell carcinoma of the skin
• Squamous cell carcinoma of the skin
• Carcinoma in situ (e.g. breast carcinoma, cervical cancer in situ, but excluding carcinoma in situ of the bladder) that have undergone potentially curative therapy
• Prostatic intraepithelial neoplasia
• In situ melanoma
• Atypical melanocytic hyperplasia

Where it is running

• Melanoma Institute Australia — Wollstonecraft, New South Wales, Australia (enrolling)

Full record on ClinicalTrials.gov

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