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Checkpoint Inhibitor
A Phase 2 Clinical Trial of Neoadjuvant Relatlimab and Nivolumab in High Risk, Clinical Stage II Cutaneous Melanoma (Neo ReNi II Trial)
Phase 2
Recruiting
Led By Georgina Long
Research Sponsored by Melanoma Institute Australia
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 10 years
Awards & highlights
No Placebo-Only Group
Summary
Neoadjuvant therapy is feasible in stage II melanoma, and the dual inhibition of the distinct LAG-3 and PD-1 checkpoint pathways with relatlimab and nivolumab has a synergistic effect in the tumour microenvironment leading to a pathological response after 2 doses of therapy.
Eligible Conditions
- Melanoma
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ 10 years
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~10 years
Treatment Details
Study Objectives
Study objectives can provide a clearer picture of what you can expect from a treatment.Primary study objectives
Feasibility of recruitment
Pathological response rate
Secondary study objectives
Biomarker analyses
Microbiome analyses
Overall survival
+6 moreAwards & Highlights
No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.
Trial Design
1Treatment groups
Experimental Treatment
Group I: Neoadjuvant immunotherapy +/- Adjuvant immunotherapyExperimental Treatment1 Intervention
NEOADJUVANT: All participants will receive neoadjuvant therapy with the fixed dose combination of intravenous relatlimab 160 mg and nivolumab 480 mg x 2 doses on days 1 and 29.
SURGERY: All participants will have sentinel lymph node mapping and biopsy prior to a wide local excision of the primary melanoma between days 43 and 56.
ADJUVANT: Participants with no pathological response or partial pathological response will receive the fixed dose combination of intravenous relatlimab 160 mg and nivolumab 480 mg for a further 11 doses.
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Who is running the clinical trial?
Bristol-Myers SquibbIndustry Sponsor
2,696 Previous Clinical Trials
4,099,051 Total Patients Enrolled
179 Trials studying Melanoma
57,670 Patients Enrolled for Melanoma
Melanoma Institute AustraliaLead Sponsor
16 Previous Clinical Trials
3,267 Total Patients Enrolled
11 Trials studying Melanoma
3,054 Patients Enrolled for Melanoma
Georgina LongPrincipal InvestigatorMelanoma Institute Australia
2 Previous Clinical Trials
111 Total Patients Enrolled
2 Trials studying Melanoma
111 Patients Enrolled for Melanoma