Multicenter phase 3 trial comparing NeoADjuvant Ipilimumab + Nivolumab versus standard Adjuvant nivolumab - NADINA - NADINA

THE NETHERLANDS CANCER INSTITUTE0 sites420 target enrollmentFebruary 8, 2023

Overview

Phase: Phase 1
Intervention: Not specified
Conditions: Resectable stage III cutaneous or unknown primary melanoma patients with one or more clinical detectable lymph node metastasis that can be biopsied.
Sponsor: THE NETHERLANDS CANCER INSTITUTE
Enrollment: 420
Status: Active, Not Recruiting
Last Updated: 2 years ago

No summary available.

Registry

who.int

Start Date

February 8, 2023

End Date

TBD

Last Updated

2 years ago

Study Type

Interventional clinical trial of medicinal product

Sex

All

Sponsor

•Men and women, at least 16 years of age;
•World Health Organization (WHO) Performance Status 0 or 1;
•Cytologically or histologically confirmed resectable stage III melanoma of cutaneous or unknown primary origin with one or more macroscopic lymph node metastases (clinical detectable),
•that can be biopsied and a maximum of 3 additional resectable in\-transit metastases. A concurrent resectable primary melanoma is allowed. Clinical detectable lymph nodes are defined as
•either one:
•\-a palpable node, confirmed as melanoma by pathology;
•\-a non\-palpable but enlarged lymph node according to RECISTv1\.1 (at least 15 mm in short axis), confirmed as melanoma by pathology;
•\-a PET scan positive lymph node of any size confirmed as melanoma by pathology;
•No other malignancies, except adequately treated and with a cancer\-related life\-expectancy of more than 5 years;
•No prior immunotherapy targeting CTLA\-4, PD\-1 or PD\-L1;

•Distantly metastasized melanoma;
•Uveal/ocular or mucosal melanoma;
•in\-transit metastases only (without cytological or histological proven lymph node involvement)
•Subjects with any active autoimmune disease or a documented history of autoimmune disease, or history of syndrome that required systemic steroids or immunosuppressive medications.
•Subjects with resolved childhood asthma/atopy, type I diabetes mellitus, residual hypothyroidism due to autoimmune thyroiditis only requiring hormone replacement, skin disorders (such as
•vitiligo, psoriasis, or alopecia) not requiring systemic treatment, are permitted to enroll;
•Prior radiotherapy targeting the affected lymph node region(s);
•Subjects will be excluded if they test positive for hepatitis B virus surface antigen (HBsAg) or hepatitis C virus ribonucleic acid (HCV antibody), indicating acute or chronic infection. Subjects
•treated and being at least one year free from HCV are allowed to participate;
•Subjects will be excluded if they have known history of testing positive for human immunodeficiency virus (HIV) or known acquired immunodeficiency syndrome (AIDS);