Clinical trial · Interventional
A Study to Compare Nivolumab Drug Product Process D to Nivolumab Drug Product Process C in Participants With Stage IIIa/b/c/d or Stage IV Melanoma After Complete Resection
A Randomized, Double-Blind, Parallel, Phase 1 Study to Compare the Pharmacokinetics of BMSCHO1-Nivolumab Process D to Nivolumab Process C After Complete Resection of Stage IIIa/b/c/d or Stage IV Melanoma
NCT03980314CI-TRIAL-00072294completedPhase 1ClinicalTrials.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 compare the drug levels, immunogenicity and safety of Nivolumab Process D to Nivolumab Process C after complete resection of stage IIIa/b/c/d or stage IV 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 (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Nivolumab | Drug | Nivolumab | ALIAS |
Design
Arms and outcomes
Arms (2)
- type
- ACTIVE_COMPARATOR
- label
- Arm A (Process C)
- interventionNames
- Drug: Nivolumab
- type
- EXPERIMENTAL
- label
- Arm B (Process D)
- interventionNames
- Drug: Nivolumab
Primary outcomes (1)
- measure
- Area under the concentration-time curve in one dosing interval (AUC[TAU]) (336 h)
- timeFrame
- Over the dosing interval at Week 1 and Week 17
Secondary outcomes (9)
- measure
- Maximum Observed Plasma Concentration (Cmax)
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: * Histologically confirmed stage IIIa/b/c/d or stage IV melanoma * Complete resection of Stage III disease that is documented on the surgical and pathology reports or complete resection of Stage IV disease with margins negative for disease that is documented on the pathology report * Eastern Cooperative Oncology Group (ECOG) performance status score of 0 or 1 Exclusion Criteria: * Prior malignancy active within the previous 3 years, except for locally curable cancers that have been apparently cured * Any significant acute or chronic medical illness that is uncontrolled * History of ocular/uveal melanoma * Active, known or suspected autoimmune disease * Systemic treatment with either corticosteroids (\> 10 mg daily prednisone or equivalent) or other immunosuppressive medications within 14 days of study drug administration. Inhaled or topical steroids and adrenal replacement steroid doses \> 10 mg daily prednisone or equivalent, are permitted in the absence of active autoimmune disease. Other protocol-defined inclusion/exclusion criteria apply
References
Publications (0)
Data not yet available
No reference posted for this study.