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NCT06151236 | RECRUITING | Merkel Cell Carcinoma

Neoadjuvant Nivolumab and Relatlimab in Merkel Cell Carcinoma
Sponsor:

Melanoma Institute Australia

Brief 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

Condition or disease

Merkel Cell Carcinoma

Intervention/treatment

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

Phase

PHASE2

Detailed Description:

This is a phase 2, open label, single cohort, single centre, clinical trial of neoadjuvant immunotherapy with dual inhibition of PD-1 and LAG-3 immune checkpoint pathways. The hypothesis is that neoadjuvant therapy produces a higher pathological response rate (pCR) and a longer recurrence-free survival in a cohort of treatment-naïve patients with resectable stage I (≥10 mm) to stage III Merkel cell carcinoma compared to neoadjuvant nivolumab monotherapy in Checkmate 358 (n=123, NCT02488759, historical control).

Study Type : INTERVENTIONAL
Estimated Enrollment : 20 participants
Masking : NONE
Primary Purpose : TREATMENT
Official Title : A Phase 2, Open Label, Single Arm Clinical Trial of Neoadjuvant Nivolumab and Relatlimab in Stage I To III Resectable Merkel Cell Carcinoma
Actual Study Start Date : 2024-03-11
Estimated Primary Completion Date : 2026-04
Estimated Study Completion Date : 2034-04

Information not available for Arms and Intervention/treatment

Ages Eligible for Study: 18 Years
Sexes Eligible for Study: ALL
Accepts Healthy Volunteers:
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
Neoadjuvant Nivolumab and Relatlimab in Merkel Cell Carcinoma

Location Details

NCT06151236

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Locations

RECRUITING

Australia, New South Wales

Melanoma Institute Australia

Wollstonecraft, New South Wales, Australia, 2065

RECRUITING

Australia, New South Wales

Melanoma Institute Australia

Wollstonecraft, New South Wales, Australia, 2065