Pharmacokinetics, Safety, and Immunogenicity Comparison of Bmab1700 and Opdivo® as Adjuvant Monotherapy in Participants With Melanoma
Condition(s) studied
Investigational drug(s) / intervention(s)
Bmab1700: Intravenous infusion.
Opdivo: Intravenous infusion.
Study summary
The purpose of this study is to investigate the pharmacokinetics (PK) similarity of Bmab1700 (an intended nivolumab biosimilar), compared with United States (US)-licensed Opdivo, in participants after complete surgical removal of melanoma.
Eligibility
Primary outcome measure(s)
- Area Under the Concentration-Time Curve from Time 0 (Day 1) To Day 29 After the First Dose (AUC0-28days) of Bmab 1700 and Opdivo — Week 0 through Week 4
- Area Under the Concentration-Time Curve Over a Dosing Interval (AUC0-tau) of Bmab 1700 and Opdivo — Week 16 through Week 20
Trial sites (46)
| Facility | City | Region | Status |
|---|---|---|---|
| Biocon Investigational Site | Bento Gonçalves | Brazil | Not Yet Recruiting |
| Biocon Investigational Site | Ijuí | Brazil | Not Yet Recruiting |
| Biocon Investigational Site | Pará | Brazil | Not Yet Recruiting |
| Biocon Investigational Site | Porto Alegre | Brazil | Not Yet Recruiting |
| Biocon Investigational Site | Rio de Janeiro | Brazil | Not Yet Recruiting |
| Biocon Investigational Site 1 | Santa Catarina | Brazil | Not Yet Recruiting |
| Biocon Investigational Site 2 | Santa Catarina | Brazil | Not Yet Recruiting |
| Biocon Investigational Site | Santa Catarina | Brazil | Not Yet Recruiting |
| Biocon Investigational Site 1 | São Paulo | Brazil | Not Yet Recruiting |
| Biocon Investigational Site 2 | São Paulo | Brazil | Not Yet Recruiting |
| Biocon Investigational Site | São Paulo | Brazil | Not Yet Recruiting |
| Biocon Investigational Site | Providencia | Chile | Not Yet Recruiting |
| Biocon Investigational Site | Recoleta | Chile | Not Yet Recruiting |
| Biocon Investigational Site 1 | Santiago | Chile | Not Yet Recruiting |
| Biocon Investigational Site | Santiago | Chile | Not Yet Recruiting |
| Biocon Investigational Site | Batumi | Georgia | Not Yet Recruiting |
| Biocon Investigational Site | Kutaisi | Georgia | Not Yet Recruiting |
| Biocon Investigational Site 1 | Tbilisi | Georgia | Not Yet Recruiting |
| Biocon Investigational Site 3 | Tbilisi | Georgia | Not Yet Recruiting |
| Biocon Investigational Site 4 | Tbilisi | Georgia | Not Yet Recruiting |
| Biocon Investigational Site 5 | Tbilisi | Georgia | Not Yet Recruiting |
| Biocon Investigational Site | Tbilisi | Georgia | Not Yet Recruiting |
| Biocon Investigational Site | Chisinau | Moldova | Not Yet Recruiting |
| Biocon Investigational Site | Bucharest | Romania | Not Yet Recruiting |
| Site 26 | Cluj-Napoca | Romania | Not Yet Recruiting |
| Biocon Investigational Site | Craiova | Romania | Not Yet Recruiting |
| Biocon Investigational Site 1 | Belgrade | Serbia | Recruiting |
| Biocon Investigational Site | Belgrade | Serbia | Not Yet Recruiting |
| Biocon Investigational Site | Kamenitz | Serbia | Not Yet Recruiting |
| Biocon Investigational Site | Kragujevac | Serbia | Recruiting |
| Biocon Investigational Site | Niš | Serbia | Not Yet Recruiting |
| Biocon Investigational Site | George | South Africa | Not Yet Recruiting |
| Biocon Investigational Site 1 | Johannesburg | South Africa | Not Yet Recruiting |
| Biocon Investigational Site | Johannesburg | South Africa | Not Yet Recruiting |
| Biocon Investigational Site 1 | Barcelona | Spain | Not Yet Recruiting |
| Biocon Investigational Site | Barcelona | Spain | Not Yet Recruiting |
| Biocon Investigational Site | Madrid | Spain | Not Yet Recruiting |
| Biocon Investigational Site | Murcia | Spain | Not Yet Recruiting |
| Biocon Investigational Site | Sabadell | Spain | Not Yet Recruiting |
| Biocon Investigational Site 1 | Seville | Spain | Not Yet Recruiting |
+ 6 more sites — see the full list on the official registry below.
Other trials for the same condition
This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.
View NCT07476326 on ClinicalTrials.gov ↗ ← All trials in Turkey