Share
Save
Neoadjuvant Nivolumab and Relatlimab in Merkel Cell Carcinoma
The goal of this clinical trial is to test neoadjuvant dual immunotherapy in Merkel cell carcinoma with the aim to improve recurrence-free survival.
Study details:
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).
Eligibility criteria
Researchers look for people who fit a certain description, called eligibility criteria. See if you qualify.
Inclusion criteria
Exclusion criteria
Eligibility
Age eligible for study : 18 and older
Healthy volunteers accepted : No
Gender eligible for study: All
Things to know
Study dates
Study start: 2024-03-11
Primary completion: 2026-04-01
Study completion finish: 2034-04-01
Study type
TREATMENT
Phase
PHASE2
Trial ID
NCT06151236
Intervention or treatment
DRUG: Nivolumab 240 mg / Relatlimab 80 mg in a fixed dose combination
Conditions
- • Merkel Cell Carcinoma
Find a site
Closest Location:
Melanoma Institute Australia
Research sites nearby
Select from list below to view details:
Melanoma Institute Australia
Wollstonecraft, New South Wales, Australia
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Participant Group/Arm | Intervention/Treatment |
---|---|
EXPERIMENTAL: Neoadjuvant Treatment
| DRUG: Nivolumab 240 mg / Relatlimab 80 mg in a fixed dose combination
|
What is the study measuring?
Primary outcome
Primary Outcome Measure | Primary Outcome Description | Primary Outcome Time Frame |
---|---|---|
Pathological complete response rate | Proportion of patients with a pathological complete response, as determined on the week 6 surgical specimen using the guidelines published by the International Neoadjuvant Melanoma Consortium: Complete pathological response (pCR) = 0% viable tumour cells in the surgical specimen | Week 6 |
Secondary outcome
Secondary Outcome Measure | Secondary Outcome Description | Secondary Outcome Time Frame |
---|---|---|
Pathological non-complete response rate to neoadjuvant immunotherapy | Proportion of patients with each non-pCR response category, as determined on the week 6 surgical specimen using the guidelines published by the International Neoadjuvant Melanoma Consortium: * Near complete pathological response - (near pCR) - \>0% - ≤10% viable tumour * Partial pathological response (pPR) - \>10 - ≤50% viable tumour * Non pathological response (pNR) - \>50% viable tumour | Week 6 |
Toxicity and tolerability of neoadjuvant immunotherapy and surgery | The proportion of patients with adverse events (AE) as described in CTCAE version 5.0, from the initiation of study treatment until at least 135 days after the end of treatment. Outcome measures include the proportion of patients with: * An AE by CTCAE term and grade and duration * AEs attributable to neoadjuvant study treatment * Grade 3/4/5 AEs by AE term * A requirement to interrupt study treatment and/or delay surgery within time limit due to an AE * A requirement to discontinue study treatment early due to an AE * A requirement for oral or parenteral steroid treatment for immune-related adverse events. * Post-operative complications (e.g. seroma formation, wound infection or lymphoedema) and duration of events. * and the Surgeon's assessment of 'operability' from baseline and at surgery. | Week 24 |
Objective response rate to neoadjuvant immunotherapy | The proportion of patients within each response category, as assessed using RECIST version 1.1, comparing week 6 to baseline CT and MRI. Objective response rate= CR and PR | Week 6 |
Metabolic response rate to neoadjuvant immunotherapy | The proportion of patients within each response category, as assessed using PERCIST (standardised uptake value \[SUV\]) comparing week 6 to baseline PET. Metabolic response rate = CMR and PMR. | Week 6 |
Recurrence-free survival | The proportion of patients alive and disease free from the time of surgery | 10 years |
Disease progression rate | 1. The proportion of patients alive and with RECIST-defined progression of disease from the date of consent to the first radiographical evidence of local, regional or distant progression. 2. Disease progression which leads to unresectable MCC. | Week 6 |
Event-free survival rate | The proportion of patients alive and disease free from the date of consent to the first radiographical evidence of local, regional or distant progression | 10 years |
Overall survival rate | The proportion of patients alive at years 1, 2, 5 and 10, and to actual date of death (in months), from the initiation of study treatment. | 10 years |
Patient reported quality of life | 1. Changes in patient rated quality of life scores using QLQ-C30 and EQ-5D-5L from date of consent to 6 -12 weekly intervals until the end of year 1. 2. The correlation of patient-rated quality of life scores with adverse events. | 1 year |
Study treatment completion rate | 1. Proportion of patients receiving full neoadjuvant drug treatment per schedule and number of treatments missed. 2. Proportion of patients undergoing planned surgery at week 6. 3. Reasons for incomplete study treatment e.g. adverse event, withdrawn consent, , disease progression, patient lost to follow-up. | Week 8 |
Frequently Asked Questions
Please note: some questions and answers are submitted by anonymous patients or using AI, and have not been verified by Clinrol
No questions submitted. Be the first to ask a question!