Adjuvant nivolumab treatment in stage II high-risk melanoma – A randomized, controlled, phase III trial with biomarker-based risk stratification (NivoMela)

Status

Active, not recruiting

Phases

Phase 3

Study type

Interventional

Source

EU CTIS

Registry ID

CTIS2023-509394-23-00

Acronym

CA209-7DL

Enrollment

423

Registered

2024-08-12

Start date

2020-06-12

Completion date

Unknown

Last updated

2025-12-10

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Stage II melanoma arising from a primary cutaneous site after surgery therapy

Brief summary

Relapse / Recurrence-free survival (RFS) will be analyzed by stratified Cox regression. RFS is defined as the time from the date of registration until documented tumor recurrence date or date of death of any cause, whichever occurs first.

Detailed description

RFS rate, Distant metastasis-free survival (DMFS) rate, Melanoma-specific survival (MSS) rate, Overall survival (OS) rate, AEs and clinical laboratory values, Clinical utility of the MelaGenix GEP score

Interventions

DRUGOPDIVO 10 mg/mL concentrate for solution for infusion.

Eligibility

Sex/Gender

All

Age

18 Years to No maximum

Design outcomes

Primary

Measure	Time frame
Relapse / Recurrence-free survival (RFS) will be analyzed by stratified Cox regression. RFS is defined as the time from the date of registration until documented tumor recurrence date or date of death of any cause, whichever occurs first.	—

Secondary

Measure	Time frame
RFS rate, Distant metastasis-free survival (DMFS) rate, Melanoma-specific survival (MSS) rate, Overall survival (OS) rate, AEs and clinical laboratory values, Clinical utility of the MelaGenix GEP score	—

Countries

Germany

Outcome results

None listed

Source: EU CTIS · Data processed: Feb 4, 2026