Early access
Sign in
Taking people in RomaniaPhase 1

Comparing a proposed nivolumab copy with Opdivo after melanoma surgery

Compares how the body handles JPB898 and Opdivo in adults after melanoma surgery.

Key facts

Who runs it
H e x a l AG
Where
Bucharest, Cluj-Napoca, Craiova, Timisoara, and Timișoara, RomaniaSee the 5 sitesAlso in 4 other countries, 31 sites
Registry title
A PK study to compare JPB898 (proposed nivolumab biosimilar) and US-licensed Opdivo® in participants with resected stage IIB, IIC, or III melanoma in the adjuvant setting
Status
Recruiting
Phase
Phase 1
People taking part
89 people, planned
Started
10 Feb 2026
Expected to end
30 Sept 2028
Type of study
Interventional
Record updated
11 November 2026

Who can take part

AI summary

From the trial's eligibility criteria. Machine-read from the registry text on this page, so it can be wrong. The registry text below and the trial team decide who can take part.

The trial is looking for adults whose stage IIB, IIC or III melanoma has been surgically removed and who need adjuvant treatment (treatment after surgery). It compares JPB898 with Opdivo.

Age
18 years or older
Sex
All sexes can join
Disease stage
Melanoma stage IIB, IIC or III, removed by surgery, needing adjuvant treatment

Where in Romania

Also in 4 other countries, 31 sites

  • Institutul Oncologic Prof. Dr. Alexandru Trestioreanu BucurestiBucharest, RomaniaTaking people
  • Institute Of Oncology Prof. Dr. Ion Chiricuta Cluj-NapocaCluj-Napoca, RomaniaTaking people
  • Centrul De Oncologie SF Nectarie S.R.L.Craiova, RomaniaTaking people
  • Nova-Clin Medical Research Center S.R.L.Timisoara, RomaniaTaking people
  • Asociatia OncohelpTimișoara, RomaniaTaking people

Questions to ask the study team

  1. How often do I need to come in, and for how long each time?
  2. Are travel costs paid?
  3. Can I keep my own doctor?
  4. What happens if I want to stop?

Contact the study team: see the registry record

Print a page for my doctor

Data and sources

Registry record
Listed on the EU's official list of trials (CTIS).
Plain-language title
Comparing a proposed nivolumab copy with Opdivo after melanoma surgeryGenerated from the registry record. The registry title is the official one.
AI summary
From the trial's eligibility criteria. Read by machine on 12 November 2026.
Record updated
11 November 2026