Clinical trial · Interventional
A Study to Evaluate Similarity of ABP 206 Compared With OPDIVO® (Nivolumab) in Subjects With Resected Melanoma
A Randomized, Double-blind Study Evaluating Pharmacokinetic Similarity of ABP 206 Compared With OPDIVO® (Nivolumab) in Resected Stage III or Stage IV Melanoma Subjects in the Adjuvant Setting
NCT05907122CI-TRIAL-00106646completedPhase 3ClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
The purpose of this study is to investigate the pharmacokinetic (PK) similarity and efficacy, safety, and immunogenicity of ABP 206 compared with OPDIVO® (nivolumab) in subjects with resected advanced melanoma.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Melanoma | Melanoma | ONTOLOGY_EXACT | 0.98 |
Interventions
Interventions (3)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| ABP 206 | Drug | Nivolumab | ALIAS |
| EU-authorized Nivolumab | Drug | — | UNRESOLVED |
| FDA-licensed Nivolumab | Drug | — | UNRESOLVED |
Design
Arms and outcomes
Arms (3)
- type
- EXPERIMENTAL
- label
- ABP 206
- description
- Subjects will receive Dose A of ABP 206 via intravenous (IV) infusion.
- interventionNames
- Drug: ABP 206
- type
- ACTIVE_COMPARATOR
- label
- FDA-licensed Nivolumab
- description
- Subjects will receive Dose A of FDA-licensed Nivolumab via IV infusion.
- interventionNames
- Drug: FDA-licensed Nivolumab
- type
- ACTIVE_COMPARATOR
- label
- EU-authorized Nivolumab
- description
- Subjects will receive Dose A of EU-authorized Nivolumab via IV infusion.
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
- Maximum age
- 99 Years
Show eligibility criteria text
Inclusion Criteria: * At least 18 years of age * Completely removed melanoma by surgery performed within 12 weeks of randomization * Advanced Melanoma * Tumor tissue from the resected site of the disease must be available for biomarker analyses in order to be randomized * Subject has an Eastern Cooperative Oncology Group (ECOG) performance status score of 0 or 1 Exclusion Criteria: * Previous anti-cancer treatment * Known hypersensitivity to monoclonal antibodies or to any of the excipients of the study drug * Ocular or uveal melanoma or history of carcinomatosis meningitis * History of auto-immune disease * Subject has medical conditions requiring systemic immunosuppression with either corticosteroids or other immunosuppressive medications within 14 days of the first dose of the investigational product Other protocol-defined inclusion/exclusion criteria apply
References
Publications (0)
Data not yet available
No reference posted for this study.