RecruitingPhase 2NCT06151236

Neoadjuvant Nivolumab and Relatlimab in Merkel Cell Carcinoma

A Phase 2, Open Label, Single Arm Clinical Trial of Neoadjuvant Nivolumab and Relatlimab in Stage I To III Resectable Merkel Cell Carcinoma

Sponsor

Melanoma Institute Australia

Enrollment

20 participants

Start Date

Mar 11, 2024

Study Type

INTERVENTIONAL

Conditions

The goal of this clinical trial is to test neoadjuvant dual immunotherapy in Merkel cell carcinoma with the aim to improve recurrence-free survival

Min Age: 18 Years

Aged ≥ 18 years
Written consent
Histologically confirmed, resectable Merkel cell carcinoma with AJCC (8th ed) clinical or pathological stage I (≥ 10 mm), IIA, or IIB or III disease
In-transit metastases are permitted if they are completely resectable
Measurable disease according to RECIST 1.1 criteria
Previous radiotherapy permitted if there is RECIST-measurable progression of disease since the completion of radiotherapy
At least one of either, archival tissue from a primary or nodal MCC lesion (if applicable) for the current diagnosis and/or a newly obtained core biopsy of a lesion which has not been previously irradiated.
ECOG 0-1
Adequate organ function on blood pathology
Life expectancy \>12 months
Female patients to use effective contraception during study treatment and for 5 months after last dose.

Clinical, radiographic or pathological evidence of distant metastases
Contraindication to nivolumab and / or relatlimab
Prior anti-PD-1, CTLA-4, PDL-1 or LAG 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 requirement for chronic steroid therapy other than hormone replacement therapy
A diagnosis of immunodeficiency or chronic steroid therapy \>10 mg OD prednisone or equivalent
Additional malignancy active within past 3 years; patients with chronic lymphocytic leukaemia can be included in this study.
Uncontrolled cardiovascular disease or history of myocarditis
Has had an allogenic tissue/solid organ transplant
Troponin T (TnT) or I (TnI) \>2 × institutional ULN
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
Active Hepatitis B (defined as Hepatitis B surface antigen \[HBsAg\] reactive) or Hepatitis C virus (defined as HCV RNA \[qualitative\] is detected) infection.
Known HIV
Pregnant or breast feeding females
Concurrent medical or social conditions that may prevent the patient attending assessments or procedures per schedule

DRUGNivolumab 240 mg / Relatlimab 80 mg in a fixed dose combination

Dual inhibition of the distinct LAG3 and PD-1 checkpoint pathways

Melanoma Institute Australia

Wollstonecraft, New South Wales, Australia

View Full Details on ClinicalTrials.gov

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NCT06151236