A Phase 3 interventional study of JPB898 (Induction and Maintenance) and Opdivo-EU (Induction) in Melanoma, sponsored by Sandoz. Terminated at 22 sites in 11 countries. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-02-24.
Sponsored by Sandoz · Phase 3, Interventional, and Treatment
The purpose of the study is to demonstrate similar PK and efficacy and to show comparable safety and immunogenicity between JPB898, Opdivo-EU, and Opdivo-US, all administered in combination with Yervoy-EU (induction phase only), in participants with advanced (unresectable Stage III or metastatic Stage IV) melanoma.
3,006 studies on the registry are indexed under Melanoma; 520 are open to participants now.
This study's enrollment of 52 is above the median of 38 across 2,351 interventional studies indexed under Melanoma.
Browse Melanoma studies →Sandoz is the lead sponsor of 136 studies on the registry; none are open to participants now.
Of its 10 completed or terminated interventional studies of FDA-regulated products, 5 (50%) have results posted.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria
Participants will receive JPB898 combined with Yervoy-EU during the induction phase. Participants will receive JPB898 during maintenance phase.
Drug: JPB898 (Induction and Maintenance) · Drug: Yervoy-EU (Induction)
Participants will receive Opdivo-EU combined with Yervoy-EU during the induction phase. Participants will receive Opdivo-EU during the maintenance phase.
Drug: Opdivo-EU (Induction) · Drug: Yervoy-EU (Induction) · Drug: Opdivo-EU (Maintenance)
Participants will receive Opdivo-US combined with Yervoy-EU during the induction phase. Participants will receive Opdivo-EU during the maintenance phase.
Drug: Opdivo-US (Induction) · Drug: Yervoy-EU (Induction) · Drug: Opdivo-EU (Maintenance)
Induction and Maintenance: Intravenous (IV)
Induction: Intravenous (IV)
Induction: Intravenous (IV)
Induction: Intravenous (IV)
Maintenance: Intravenous (IV)
Demonstrate PK similarity between JPB898, Opdivo-US, and Opdivo-EU
Area under the serum concentration-time curve measured from the time of dosing of the first dose to the second dose (AUCtrunc) after the first dose
Time frame: Days 1 to 22
Demonstrate PK similarity between JPB898, Opdivo-US, and Opdivo-EU between JPB898 and Opdivo-US/-EU
Area under the serum concentration-time curve measured from the time of dosing to the last measurable serum concentration in the dosing interval, tau (AUCtau) after the fourth dose
Time frame: Days 64 to 85
Demonstrate efficacy similarity for Best overall response (BOR) between JPB898 and Opdivo-US/-EU defined as the best overall response based on blinded central tumor assessments using Response Evaluation Criteria in Solid Tumors (RECIST) 1.1 criteria
The assessment of response for the primary efficacy is based on tumor response data as per blinded independent central review and according to RECIST 1.1
Time frame: BOR (Complete response (CR) or partial response (PR)) from baseline up to 28 weeks
Plan to share: No
No publications or documents are linked to this record.
This study is terminated, as verified in Feb 2026. You cannot join it, but the record below documents what was studied.
Get an email when the registry record changes — status, dates, results — or when someone posts here.
Sign in to followQuestions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.
Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.
Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.
Sandoz