NL-OMON54313
Recruiting
Phase 3
Multicenter phase 3 trial comparing NeoADjuvant Ipilimumab + Nivolumab versus standard Adjuvant nivolumab in macroscopic stage III melanoma - NADINA - NADINA
Antoni van Leeuwenhoek Ziekenhuis0 sites150 target enrollmentTBD
Overview
- Phase
- Phase 3
- Intervention
- Not specified
- Conditions
- melanoma
- Sponsor
- Antoni van Leeuwenhoek Ziekenhuis
- Enrollment
- 150
- Status
- Recruiting
- Last Updated
- 2 years ago
Overview
Brief Summary
No summary available.
Investigators
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:
- •o a palpable node, confirmed as melanoma by pathology,or;
- •o a non\-palpable but enlarged lymph node according to RECISTv1\.1 (at least 15
- •mm in short axis), confirmed as melanoma by pathology, or;
Exclusion Criteria
- •Distantly metastasized melanoma;
- •Uveal/ocular or mucosal melanoma;
- •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 vitiligo, 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);
Outcomes
Primary Outcomes
Not specified
Similar Trials
Active, not recruiting
Phase 3
NADINA2024-513519-28-00Het Nederlands Kanker Instituut-Antoni van Leeuwenhoek Ziekenhuis Stichting280
Active, not recruiting
Phase 1
Multicenter phase 3 trial comparing NeoADjuvant Ipilimumab + Nivolumab versus standard Adjuvant nivolumab - NADINAResectable stage III cutaneous or unknown primary melanoma patients with one or more clinical detectable lymph node metastasis that can be biopsied.MedDRA version: 20.0Level: LLTClassification code 10027155Term: Melanoma skinSystem Organ Class: 100000004864Therapeutic area: Diseases [C] - Cancer [C04]EUCTR2021-001492-16-ITTHE NETHERLANDS CANCER INSTITUTE420
Active, not recruiting
Phase 1
Study in melanoma patients with lymph node metastases into treatment with ipilimumab and nivolumab before surgery compared to standard nivolumab treatment after surgery.Patients with stage III melanomaTherapeutic area: Diseases [C] - Cancer [C04]EUCTR2021-001492-16-PLStichting Het Nederlands Kanker Instituut – Antoni van Leeuwenhoek Ziekenhuis420
Active, not recruiting
Phase 1
ADINACTIS2024-513519-28-00Het Nederlands Kanker Instituut-Antoni van Leeuwenhoek Ziekenhuis Stichting395
Active, not recruiting
Phase 1
A Study of Nivolumab Plus NKTR-214 vs Nivolumab Alone vsStandard of Care in Participants With Bladder Cancer That HasInvaded Into the Muscle Wall of the BladderEUCTR2018-002676-40-ESBristol-Myers Squibb International Corporation720