Neoadjuvant Nivolumab and Relatlimab in Merkel Cell Carcinoma
Recruiting now · Phase 2
Conditions studied: Merkel Cell Carcinoma
In brief
The goal of this clinical trial is to test neoadjuvant dual immunotherapy in Merkel cell carcinoma with the aim to improve recurrence-free survival
Key facts
- Study ID
- NCT06151236
- Run by
- Melanoma Institute Australia
- People needed
- 20
- Starts
- 2024-03-11
- Expected to finish
- 2034-04-01
- Last updated by the study team
- 2026-02-17
Who can join
Age: 18 and older. Sex: any. Healthy volunteers: not accepted.
You may qualify if…
- 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.
You may not qualify if…
- 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
Where it is running
- Melanoma Institute Australia — Wollstonecraft, New South Wales, Australia (enrolling)
Full record on ClinicalTrials.gov
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