New immunotherapy combo aims to stop merkel cell cancer return
NCT ID NCT06151236
First seen Jun 27, 2026 · Last updated Jun 27, 2026
Summary
This study tests whether giving two immunotherapy drugs (nivolumab and relatlimab) before surgery can improve outcomes for people with Merkel cell carcinoma, a rare skin cancer. About 20 adults with stage I to III resectable cancer will receive the drugs for six weeks, then have surgery to remove the tumor. The main goal is to see how many patients have no cancer cells left in the removed tissue.
This is an AI summary of the original study and may miss details. Read our disclaimer.
Study facts
What this study's own registry entry says, in plain language.
- Phase
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Phase 2
Tests whether the treatment actually works, and watches for side effects, in a larger group.
- Participants
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About 20 people
The number the study aims to enrol. It can still change while the study runs.
- Started
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Mar 2024
- Expected to finish
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Apr 2034
An estimate. End dates often move.
- Lead sponsor
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Other sponsor
The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.
Who can take part
This study's own entry requirements. Only the study team can say for certain whether you qualify.
- Ages
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18 years and older
- Sex
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Anyone
- Healthy volunteers
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Not accepted
This study is not open to healthy volunteers. The entry requirements below say who it is open to.
Show the full entry requirements Hide the full entry requirements
Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.
Inclusion Criteria: 1. Aged ≥ 18 years 2. Written consent 3. Histologically confirmed, resectable Merkel cell carcinoma with AJCC (8th ed) clinical or pathological stage I (≥ 10 mm), IIA, or IIB or III disease 4. In-transit metastases are permitted if they are completely resectable 5. Measurable disease according to RECIST 1.1 criteria 6. Previous radiotherapy permitted if there is RECIST-measurable progression of disease since the completion of radiotherapy 7. 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. 8. ECOG 0-1 9. Adequate organ function on blood pathology 10. Life expectancy \>12 months 11. Female patients to use effective contraception during study treatment and for 5 months after last dose. Exclusion Criteria: 1. Clinical, radiographic or pathological evidence of distant metastases 2. Contraindication to nivolumab and / or relatlimab 3. 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 4. Active autoimmune disease or requirement for chronic steroid therapy other than hormone replacement therapy 5. A diagnosis of immunodeficiency or chronic steroid therapy \>10 mg OD prednisone or equivalent 6. Additional malignancy active within past 3 years; patients with chronic lymphocytic leukaemia can be included in this study. 7. Uncontrolled cardiovascular disease or history of myocarditis 8. Has had an allogenic tissue/solid organ transplant 9. Troponin T (TnT) or I (TnI) \>2 × institutional ULN 10. Has a history of (non-infectious) pneumonitis/interstitial lung disease that required steroids or has current pneumonitis or current interstitial lung disease 11. Has an active infection requiring systemic therapy 12. Active Hepatitis B (defined as Hepatitis B surface antigen \[HBsAg\] reactive) or Hepatitis C virus (defined as HCV RNA \[qualitative\] is detected) infection. 13. Known HIV 14. Pregnant or breast feeding females 15. Concurrent medical or social conditions that may prevent the patient attending assessments or procedures per schedule
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Conditions
The condition(s) this trial relates to.
As listed by the trial registrant
The condition terms exactly as the trial's registrant entered them.
How to take part
Only the study team decides who joins. These are the ways to reach them.
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The places running it
1 site. The list below names each one and where it is.
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The official record
ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.
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A doctor treating you
A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.
Contacts and locations
Locations
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Melanoma Institute Australia
RECRUITINGWollstonecraft, New South Wales, 2065, Australia
More trials for these conditions
Other studies related to the condition(s) this trial covers.
- Can a new antibody help the immune system fight Hard-to-Treat tumors?
- Could a lighter immunotherapy schedule keep advanced cancers in check?
- Blood markers could spot hidden skin cancer return
- Cancer-Killing virus shows promise in early trial for advanced tumors
- Immune cell therapy shows promise for tough cancers
- New database aims to crack the code on three rare skin cancers