Neoadjuvant Nivolumab and Relatlimab in Merkel Cell Carcinoma
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Nivolumab 240 mg / Relatlimab 80 mg in a fixed dose combination.
- Who it may be relevant to
- Registry conditions: Merkel Cell Carcinoma. Basic parameters: from 18 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- Australia
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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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
Overview
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 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).
Interventions
- Drug Nivolumab 240 mg / Relatlimab 80 mg in a fixed dose combination
Dual inhibition of the distinct LAG3 and PD-1 checkpoint pathways
Primary outcome measures
- Pathological complete response rate [Time frame: Week 6]
Secondary outcome measures (11)
- Pathological non-complete response rate to neoadjuvant immunotherapy [Time frame: Week 6]
- Toxicity and tolerability of neoadjuvant immunotherapy [Time frame: Week 24]
- Objective response rate to neoadjuvant immunotherapy [Time frame: Week 6]
- Metabolic response rate to neoadjuvant immunotherapy [Time frame: Week 6]
- Recurrence-free survival [Time frame: 10 years]
- Disease progression rate [Time frame: Week 6]
- Event-free survival (EFS) rate [Time frame: 10 years]
- Overall survival rate [Time frame: 10 years]
- Patient reported quality of life [Time frame: 1 year]
- Study treatment completion rate [Time frame: Week 8]
- Surgical-related adverse events [Time frame: 12 weeks]
Eligibility criteria
Inclusion criteria
- 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.
Exclusion criteria
- 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
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- N/A
- Model
- Single group
- Masking
- Open label
- Primary purpose
- Treatment
Study locations
Australia · 1 center
- Melanoma Institute Australia — Wollstonecraft
Identifiers
NCT: NCT06151236 · MIA2023/489 · CA224-1064