Neoadjuvant Nivolumab and Relatlimab in Merkel Cell Carcinoma

Launched by MELANOMA INSTITUTE AUSTRALIA · Nov 21, 2023

Keywords

ClinConnect Summary

This clinical trial is studying a new treatment approach for Merkel cell carcinoma, a rare type of skin cancer. Researchers are testing a combination of two immunotherapy drugs, nivolumab and relatlimab, given before surgery to see if this treatment can help patients live longer without their cancer coming back. The trial is currently looking for participants aged 18 and older who have confirmed, operable Merkel cell carcinoma at certain stages, and who can provide written consent. People with specific health conditions, like active infections or certain autoimmune diseases, may not be eligible to participate.

If you or someone you know qualifies for this trial, participants can expect to receive the study drugs for a set period before their surgery. They will be closely monitored by the medical team throughout the treatment process to ensure their safety and to track how well the treatment is working. This study aims not only to improve treatment outcomes but also to gather more information about the safety of using these immunotherapy drugs together in this setting.

Gender

ALL

Eligibility 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