A Phase 2, Open Label, Single Arm Clinical Trial of Neoadjuvant Nivolumab and Relatlimab in Stage I To III Resectable Merkel Cell Carcinoma
Status: Recruiting
Location: See all (2) locations...
Intervention Type: Drug
Study Type: Interventional
Study Phase: Phase 2
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
Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Healthy Volunteers: f
View:
• Aged ≥ 18 years
• Written consent Histologically confirmed, resectable Merkel cell carcinoma with AJCC (8th ed) clinical stage I (≥ 10 mm), II, or III
• In-transit metastases are permitted if they are completely resectable
• Measurable disease according to RECIST 1.1 criteria
• Tumour amenable to core biopsy
• Previous radiotherapy permitted if there is RECIST-measurable progression of disease since the completion of radiotherapy
• 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.
Locations
Other Locations
Australia
Melanoma Institute Australia
RECRUITING
Wollstonecraft
Melanoma Institute Australia
RECRUITING
Wollstonecraft
Contact Information
Primary
Monica Osorio
monica.osorio@melanoma.org.au
+ 61 2 9911 7296
Time Frame
Start Date:2024-03-11
Estimated Completion Date:2034-04
Participants
Target number of participants:20
Treatments
Experimental: Neoadjuvant Treatment
Nivolumab 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.