A Phase 2 Clinical Trial of Neoadjuvant Relatlimab and Nivolumab in High Risk, Clinical Stage II … (NCT05418972) | Clinical Trial Compass
Active — Not RecruitingPhase 2
A Phase 2 Clinical Trial of Neoadjuvant Relatlimab and Nivolumab in High Risk, Clinical Stage II Cutaneous Melanoma
Australia20 participantsStarted 2023-08-14
Plain-language summary
Neoadjuvant therapy is feasible in stage II melanoma, and the dual inhibition of the distinct LAG-3 and PD-1 checkpoint pathways with relatlimab and nivolumab has a synergistic effect in the tumour microenvironment leading to a pathological response after 2 doses of therapy.
Who can participate
Age range18 Years
SexALL
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Inclusion criteria
✓. The patient (or legally acceptable representative, if applicable) provides written informed consent for the trial.
✓. Male/female patients who are at least 18 years of age on the day of signing informed consent.
✓. Histologically confirmed primary cutaneous melanoma from a partial core biopsy, punch biopsy, or excisional biopsy with residual macroscopic disease.
✓. AJCC (8th edition) clinical stage IIB (T3b and T4a) or IIC (T4b) melanoma, or stage IIA (T2b and T3a) melanoma with a ≥ 20% risk of recurrence at 5 years according to the MIA stage II risk calculator (melanomarisk.org.au).
✓. Synchronous primaries are acceptable if there is certainty that a lesion does not represent in-transit disease and consideration should be given to the need for multiple lymph mapping requirements.
✓. Past history of a primary melanoma that has been completely excised. If a patient had an SNB, this must be negative.
✓. Locoregional, nodal or metastatic spread must be ruled out with clinical examination, dermoscopy, RCM and LC-OCT, CT, MRI (or CT) brain, PET, SPECT/CT and lymphoscintigraphy (including ultrasound of draining nodal basin(s)). Patients with demonstrated clinical stage III melanoma are not eligible.
✓. BRAF / NRAS mutant or wild type melanoma included.
Exclusion criteria
✕. Clinical or radiographic evidence of nodal, in-transit, satellite or microsatellite metastases or distant melanoma metastases.
. Any contraindication to the administration of relatlimab or nivolumab.
✕. A history of allergy or hypersensitivity to study treatment components.
✕. Prior immunotherapy for any malignancy (including, but not limited to: anti-PD-1, CTLA-4, PDL-1 or anti-LAG3 or any other antibody or drug specifically targeting T-cell co-stimulation or immune checkpoint pathways).
✕. Patients with a condition requiring chronic systemic steroid therapy (in dosing 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