Neoadjuvant Nivolumab and Relatlimab in Merkel Cell Carcinoma

• Status: Recruiting
• Trial end date: 2034-04-01
• Target enrollment: 0
• Participant gender: All

Summary

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

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Melanoma Institute Australia
• Collaborator: Bristol-Myers Squibb
• Treatments: Nivolumab; Relatlimab

Criteria

Inclusion Criteria:

• Aged ≥ 18 years

• Written consent Histologically confirmed, resectable Merkel cell carcinoma with AJCC (8th ed) clinical stage I (≥ 10 mm), II, or III

• In-transit metastases are permitted if they are completely resectable

• Measurable disease according to RECIST 1.1 criteria

• Tumour amenable to core biopsy

• Previous radiotherapy permitted if there is RECIST-measurable progression of disease since the completion of radiotherapy

• 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.

Exclusion Criteria:

• Clinical or radiographic 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

• 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