Status:
RECRUITING
Neoadjuvant Nivolumab and Relatlimab in Merkel Cell Carcinoma
Lead Sponsor:
Melanoma Institute Australia
Collaborating Sponsors:
Bristol-Myers Squibb
Conditions:
Merkel Cell Carcinoma
Eligibility:
All Genders
18+ years
Phase:
PHASE2
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
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 neoad...
Eligibility Criteria
Inclusion
- Aged ≥ 18 years
- Written consent
- Histologically confirmed, resectable Merkel cell carcinoma with AJCC (8th ed) clinical 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
- 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
- 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
- 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
Key Trial Info
Start Date :
March 11 2024
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
April 1 2034
Estimated Enrollment :
20 Patients enrolled
Trial Details
Trial ID
NCT06151236
Start Date
March 11 2024
End Date
April 1 2034
Last Update
December 16 2025
Active Locations (1)
Enter a location and click search to find clinical trials sorted by distance.
1
Melanoma Institute Australia
Wollstonecraft, New South Wales, Australia, 2065