Neoadjuvant Nivolumab and Relatlimab in Merkel Cell Carcinoma
ConditionMerkel Cell Carcinoma
Trial statusRecruiting
Trial phasePhase 2
Trial typeInterventional
Biological sexAll
Age18+
SponsorMelanoma Institute Australia
About this trial
The goal of this clinical trial is to test neoadjuvant dual immunotherapy in Merkel cell carcinoma with the aim to improve recurrence-free survival
Eligibility criteria
Qualifiers
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
Disqualifiers
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
Trial design
Treatments tested in this trial
- Nivolumab 240 mg / Relatlimab 80 mg in a fixed dose combination
Treatment groups
20 Participants
are divided into 1 treatment groupSponsors and collaborators
Melanoma Institute Australia
Lead sponsor
Bristol-Myers Squibb
Collaborator
Source ClinicalTrials.gov