RecruitingPhase 2

Neoadjuvant Nivolumab and Relatlimab in Merkel Cell Carcinoma

Australia20 participantsStarted 2024-03-11

Plain-language 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

Age range18 Years

SexALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

✓. 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

✕. 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

Pathological complete response rate

Timeframe: Week 6

NCT IDNCT06151236

SponsorMelanoma Institute Australia

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2026-12

Monica Osorio

Who can participate

Age range18 Years

SexALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

✓. 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

✕. 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