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Merkel Cell CarcinomaPhase 2NCT06151236

Neoadjuvant Nivolumab and Relatlimab in Merkel Cell Carcinoma

A Phase 2 study testing Nivolumab 240 mg / Relatlimab 80 mg in a fixed dose combination in people with Merkel Cell Carcinoma, run by Melanoma Institute Australia at 1 site in Australia.

Recruiting

Looking for participants now. Contact the study team or a site below to ask about taking part.

Sites and contacts
Official record
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Trial 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 Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Merkel Cell Carcinoma
What is being tested?
Nivolumab 240 mg / Relatlimab 80 mg in a fixed dose combination
Type of treatment
Injection or infusion
Could I receive a placebo?
No, everyone receives an active treatment
How many people
20 participants
Where
1 siteAustralia
Study dates
11 Mar 2024to Apr 2034
Phase
Phase 2
Are there results?
Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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
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  • 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.

Who cannot join

  • 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.
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  • 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

Trial locations and contacts

1 site in 1 country. Contact the study team or a site near you to ask about taking part.

Monica Osorio contact

+ 61 2 9911 7296

monica.osorio@melanoma.org.au

Australia1 site, 1 recruiting

  • Melanoma Institute Australia

    Wollstonecraft, New South Wales, 2065

    Monica Osorio, +612 9911 7296, monica.osorio@melanoma.org.au

    Georgina V. Long

    Recruiting

Other trials in Australia

About this study

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

The goal of this clinical trial is to test neoadjuvant dual immunotherapy in Merkel cell carcinoma with the aim to improve recurrence-free survival

Read the 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).

Being tested
Nivolumab 240 mg / Relatlimab 80 mg in a fixed dose combination
Medical subject headings
Carcinoma, Merkel Cell

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Nivolumab 240 mg / Relatlimab 80 mg in a fixed dose combinationDrug

    Also called Opdualag

    Dual inhibition of the distinct LAG3 and PD-1 checkpoint pathways

Study groups in NCT06151236
Study groupRoleWhat they receive
Neoadjuvant TreatmentExperimentalNivolumab and relatlimab will be administered in a fixed dose combination (FDC). The FDC product contains nivolumab and relatlimab in a protein-mass ratio of 3:1 (nivolumab 240 mg and relatlimab 80 mg): in a 20 mL concentrate solution per single vial. The dose and dosing regimen for this study is nivolumab 480 mg and relatlimab 160 mg - 2 vials per infusion. This was primarily based on the observed benefit/risk profile observed in metastatic melanoma patients from Study CA224-020 pharmacokinetics (PK), pharmacodynamics, and extensive nivolumab monotherapy clinical experience. In addition, the Phase 2/3 Study CA224-047 established this dose as active in unresectable and metastatic melanoma. This study is open label and single arm, with all patients scheduled to receive two doses of nivolumab and relatlimab FDC prior to surgery on days 1 and 29.
Receives: Drug: Nivolumab 240 mg / Relatlimab 80 mg in a fixed dose combination

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. 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

    Measured: Week 6

Secondary outcomes (11)

  1. 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

    Measured: Week 6

  2. Toxicity and tolerability of neoadjuvant immunotherapy

    The treatment related adverse events (AE) as described in CTCAE version 5.0, from the initiation of study treatment up to 135 days after the last dose of study treatment

    Measured: Week 24

  3. 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

    Measured: Week 6

  4. 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.

    Measured: Week 6

  5. Recurrence-free survival

    The proportion of patients alive and disease free from the time of surgery

    Measured: 10 years

  6. 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.

    Measured: Week 6

  7. Event-free survival (EFS) rate

    The proportion of patients with EFS defined as from the time of first dose of study treatment to the earliest of:

    1. Disease progression to unresectable stage III or stage IV disease)
    2. Recurrence of MCC
    3. Treatment-related death
    4. Disease related death

    Measured: 10 years

  8. 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.

    Measured: 10 years

  9. 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.

    Measured: 1 year

  10. 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.

    Measured: Week 8

  11. Surgical-related adverse events

    Measured: 12 weeks

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted30 Nov 2023
  2. Study start11 Mar 2024
  3. Primary completionDec 2026 (estimated)
  4. Study completionApr 2034 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 2
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Model description
Open label, single centre clinical trial
Masking
None (open label)
Enrolment
20 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT06151236
Sponsor's protocol ID
MIA2023/489
Other IDs
CA224-1064
Status last verified
Jan 2026
First submitted
21 Nov 2023
Last updated
17 Feb 2026
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing Nivolumab 240 mg / Relatlimab 80 mg in a fixed dose combination in people with Merkel Cell Carcinoma, run by Melanoma Institute Australia at 1 site in Australia.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 11 inclusion and 15 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: looking for participants now, as of the sponsor's last update on 17 Feb 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Australia. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

Contact Monica Osorio (+ 61 2 9911 7296, monica.osorio@melanoma.org.au), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Pathological complete response rate (time frame: Week 6). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT06151236.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 17 Feb 2026; AzTrials last refreshed its copy on 7 Nov 2026.

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