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New treatment option for Cutaneous Squamous Cell Carcinoma
Official title Neoadjuvant Nivolumab and Relatlimab in Cutaneous Squamous Cell Carcinoma
ClinicalTrials.gov ID: NCT06288191
What this study is testing
What is Nivolumab 240 mg / Relatlimab 80 mg in a fixed dose combination?
Nivolumab 240 mg / Relatlimab 80 mg in a fixed dose combination is an investigational medicine, given as an infusion into a vein, being studied as a potential treatment for cutaneous squamous cell carcinoma.
Also referred to as Opdualag.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- 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.
- Phase 2: a mid-size study of how well it works
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 and older
You may be able to join 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)
You likely can't join 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)...
- Active autoimmune disease or a requirement for chronic steroid therapy other than hormone replacement therapy The following are permitted:
- Vitiligo
See the full eligibility criteria
Who can join
- ≥ 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...
- 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...
- 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...
What rules you out
- 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...
- 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...
- 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...
- 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
- Multiple primary melanomas
- Other malignancies for which the patient has been disease free for 3 years, not requiring active anti-cancer therapy.
- Uncontrolled or significant cardiovascular disease including, but not limited to any of the following:
- Myocardial infarction (MI) or stroke/transient ischemic attack within the 6 months prior to consent
- Uncontrolled angina within the 3 months prior to consent
- Any history of clinically significant arrhythmias (such as poorly controlled atrial fibrillation, ventricular tachycardia, ventricular fibrillation, or torsades de pointes)
- QTc (corrected QT interval) prolongation \> 480 ms
- History of other clinically significant cardiovascular disease (i.e. cardiomyopathy, congestive heart failure with New York Heart Association functional classification III-IV, pericarditis, significant pericardial...
- Cardiovascular disease-related requirement for daily supplemental oxygen
- History of 2 or more M.I.s OR 2 or more coronary revascularisation procedures (regardless of the number of stent placements during each procedure)
- Patients with history of myocarditis, regardless of aetiology.
- Troponin T (TnT) or I (TnI) \>2 × institutional ULN (upper limit of normal). 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...
- Has a history of (non-infectious) pneumonitis/interstitial lung disease that required steroids or has current pneumonitis or current interstitial lung disease.
- Has an active infection requiring systemic therapy.
- Has a known history of Human Immunodeficiency Virus (HIV). Note: no testing for HIV is required unless mandated by local health authority.
- Has a known history of Hepatitis B (defined as Hepatitis B surface antigen [HBsAg] reactive) or known active Hepatitis C virus (defined as HCV RNA [qualitative] is detected) infection. Note: no testing for Hepatitis B...
- Pregnant or breast-feeding females
- Concurrent medical or social conditions that may prevent the patient from attending assessments per schedule.
The study team makes the final eligibility decision.
Where it's taking place
- Wollstonecraft, New South Wales, Australia
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years and older. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Wollstonecraft, New South Wales, Australia. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.