Multicenter phase 3 trial comparing NeoADjuvant Ipilimumab + Nivolumab versus standard Adjuvant nivolumab in macroscopic stage III melanoma – NADINA - NADINA

Stichting Het Nederlands Kanker Instituut – Antoni van Leeuwenhoek Ziekenhuis0 sites420 target enrollmentNovember 3, 2021

ConditionsPatients with stage III melanoma Therapeutic area: Diseases [C] - Cancer [C04]

DrugsOPDIVO YERVOY

Overview

Phase: Phase 1
Intervention: Not specified
Conditions: Patients with stage III melanoma
Sponsor: Stichting Het Nederlands Kanker Instituut – Antoni van Leeuwenhoek Ziekenhuis
Enrollment: 420
Status: Active, not recruiting
Last Updated: 4 years ago

Overview Investigators Eligibility Criteria Outcomes Similar Trials

Overview

Brief Summary

No summary available.

Registry

who.int

Start Date

November 3, 2021

End Date

TBD

Last Updated

4 years ago

Study Type

Interventional clinical trial of medicinal product

Sex

All

Investigators

Sponsor

Stichting Het Nederlands Kanker Instituut – Antoni van Leeuwenhoek Ziekenhuis

Eligibility Criteria

Inclusion Criteria

•\- 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:
•o a palpable node, confirmed as melanoma by pathology;
•o a non\-palpable but enlarged lymph node according to RECISTv1\.1 (at least 15 mm in short axis), confirmed as melanoma by pathology;
•o 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;
•\- No prior targeted therapy targeting BRAF and/or MEK;
•\- No immunosuppressive medications within 6 months prior study inclusion (steroids equivalent to prednisolone \=10 mg are allowed);

Exclusion Criteria

•\- 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;
•\- 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);Subjects with history of allergy to study drug components or history of severe hypersensitivity reaction to monoclonal antibodies.
•\- Subjects with underlying medical conditions or active infection that, in the investigator's opinion, will make the administration of study drug hazardous or obscure the interpretation of toxicity or adverse events;
•\- Women who are pregnant or breastfeeding;
•\- Concurrent medical condition requiring the use of immunosuppressive medications, or immunosuppressive doses of systemic or absorbable topical corticosteroids \>10 mg prednisolone daily equivalent;