RecruitingPhase IEN originalMelanoma

Pharmacokinetics, Safety, and Immunogenicity Comparison of Bmab1700 and Opdivo® as Adjuvant Monotherapy in Participants With Melanoma

⚠️

This is not medical advice. AI-assisted translation — inaccuracies may occur. Always verify the original and consult your oncologist before taking any steps.

About the trial

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.

Original English text from ClinicalTrials.gov

Who can (and can't) join

✓ Qualifies

  • •Osoby w wieku 18 lat lub starsze, które rozumieją i chcą wziąć udział w badaniu.
  • •Osoby z czerniakiem w zaawansowanym stadium (IIB, IIC, III lub IV), który został całkowicie usunięty podczas operacji.
  • •Osoby, u których czerniak został całkowicie usunięty operacyjnie w ciągu ostatnich 12 tygodni.
  • •Osoby, u których po operacji nie stwierdzono obecności czerniaka, co potwierdzono badaniami.
  • •Osoby, których ogólny stan zdrowia pozwala na udział w badaniu (oceniany przez lekarza).

✗ Disqualifies

  • •Osoby z historią czerniaka oka lub błony naczyniowej oka.
  • •Osoby z aktywnymi lub podejrzewanymi chorobami autoimmunologicznymi (np. chorobami, w których układ odpornościowy atakuje własne tkanki).
  • •Osoby, które były leczone na choroby autoimmunologiczne w ciągu ostatnich 2 lat.
  • •Osoby z inną aktywną chorobą nowotworową (poza czerniakiem) w ciągu ostatnich 3 lat, chyba że była to choroba wczesnego stadium, która została wyleczona.

Simplified criteria — AI translation

Trial details

Minimum age
18 Years
Last updated (source)
September 25, 2026
Sex
No restrictions

Therapies / drugs in trial

Locations (46)

Biocon Investigational Site

Bento Gonçalves, Brazil

Biocon Investigational Site

Ijuí, Brazil

Biocon Investigational Site

Pará, Brazil

Biocon Investigational Site

Porto Alegre, Brazil

Biocon Investigational Site

Rio de Janeiro, Brazil

Biocon Investigational Site 1

Santa Catarina, Brazil

Biocon Investigational Site 2

Santa Catarina, Brazil

Biocon Investigational Site

Santa Catarina, Brazil

Biocon Investigational Site 1

São Paulo, Brazil

Biocon Investigational Site 2

São Paulo, Brazil

Biocon Investigational Site

São Paulo, Brazil

Biocon Investigational Site

Providencia, Chile

Biocon Investigational Site

Recoleta, Chile

Biocon Investigational Site 1

Santiago, Chile

Biocon Investigational Site

Santiago, Chile

Biocon Investigational Site

Batumi, Georgia

Biocon Investigational Site

Kutaisi, Georgia

Biocon Investigational Site 1

Tbilisi, Georgia

Biocon Investigational Site 3

Tbilisi, Georgia

Biocon Investigational Site 4

Tbilisi, Georgia

Biocon Investigational Site 5

Tbilisi, Georgia

Biocon Investigational Site

Tbilisi, Georgia

Biocon Investigational Site

Chisinau, Moldova

Biocon Investigational Site

Bucharest, Romania

Site 26

Cluj-Napoca, Romania

Biocon Investigational Site

Craiova, Romania

Biocon Investigational Site 1

Belgrade, Serbia

Biocon Investigational Site

Belgrade, Serbia

Biocon Investigational Site

Kamenitz, Serbia

Biocon Investigational Site

Kragujevac, Serbia

Biocon Investigational Site

Niš, Serbia

Biocon Investigational Site

George, South Africa

Biocon Investigational Site 1

Johannesburg, South Africa

Biocon Investigational Site

Johannesburg, South Africa

Biocon Investigational Site 1

Barcelona, Spain

Biocon Investigational Site

Barcelona, Spain

Biocon Investigational Site

Madrid, Spain

Biocon Investigational Site

Murcia, Spain

Biocon Investigational Site

Sabadell, Spain

Biocon Investigational Site 1

Seville, Spain

Biocon Investigational Site

Seville, Spain

Biocon Investigational Site

Ankara, Turkey (Türkiye)

Biocon Investigational Site

Bornova, Turkey (Türkiye)

Biocon Investigational Site

Konak, Turkey (Türkiye)

Biocon Investigational Site

Ivano-Frankivsk, Ukraine

Biocon Investigational Site

Kyiv, Ukraine

Trial contact

Dr. Gursharan Singh, MBBS; PhD Pharm Med; LLM-IP

Contact information from ClinicalTrials.gov. Contact in English.

Share this trial

Data from ClinicalTrials.gov. AI-assisted translation, last sync: 9/26/2026.

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