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Trial Title:
Neoadjuvant Nivolumab and Relatlimab in Merkel Cell Carcinoma
NCT ID:
NCT06151236
Condition:
Merkel Cell Carcinoma
Conditions: Official terms:
Carcinoma, Merkel Cell
Carcinoma
Nivolumab
Relatlimab
Study type:
Interventional
Study phase:
Phase 2
Overall status:
Recruiting
Study design:
Allocation:
N/A
Intervention model:
Single Group Assignment
Intervention model description:
Open label, single centre clinical trial
Primary purpose:
Treatment
Masking:
None (Open Label)
Intervention:
Intervention type:
Drug
Intervention name:
Nivolumab 240 mg / Relatlimab 80 mg in a fixed dose combination
Description:
Dual inhibition of the distinct LAG3 and PD-1 checkpoint pathways
Arm group label:
Neoadjuvant Treatment
Other name:
Opdualag
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
Detailed description:
This is a phase 2, open label, single cohort, single centre, clinical trial of
neoadjuvant immunotherapy with dual inhibition of PD-1 and LAG-3 immune checkpoint
pathways. The hypothesis is that neoadjuvant therapy produces a higher pathological
response rate (pCR) and a longer recurrence-free survival in a cohort of treatment-naïve
patients with resectable stage I (≥10 mm) to stage III Merkel cell carcinoma compared to
neoadjuvant nivolumab monotherapy in Checkmate 358 (n=123, NCT02488759, historical
control).
Criteria for eligibility:
Criteria:
Inclusion Criteria:
- 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.
Exclusion Criteria:
- Clinical or radiographic 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
- 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
Gender:
All
Minimum age:
18 Years
Maximum age:
N/A
Healthy volunteers:
No
Locations:
Facility:
Name:
Melanoma Institute Australia
Address:
City:
Wollstonecraft
Zip:
2065
Country:
Australia
Status:
Recruiting
Facility:
Name:
Melanoma Institute Australia
Address:
City:
Wollstonecraft
Zip:
2065
Country:
Australia
Status:
Recruiting
Contact:
Last name:
Monica Osorio
Phone:
+612 9911 7296
Email:
monica.osorio@melanoma.org.au
Investigator:
Last name:
Georgina Long
Email:
Principal Investigator
Start date:
March 11, 2024
Completion date:
April 2034
Lead sponsor:
Agency:
Melanoma Institute Australia
Agency class:
Other
Collaborator:
Agency:
Bristol-Myers Squibb
Agency class:
Industry
Source:
Melanoma Institute Australia
Record processing date:
ClinicalTrials.gov processed this data on November 12, 2024
Source: ClinicalTrials.gov page:
https://clinicaltrials.gov/ct2/show/NCT06151236
