MelanomaPhase 3NCT06587451
Integrated Pharmacokinetics (PK)/Efficacy, Safety, and Immunogenicity Study to Demonstrate Similarity of JPB898, a Proposed Biosimilar to Nivolumab, to Opdivo® in Combination With Yervoy®
A Phase 3 study testing JPB898 (Induction and Maintenance), Opdivo-EU (Induction) and Opdivo-US (Induction) in people with Melanoma, run by Sandoz at 22 sites in 11 countries.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Melanoma
- What is being tested?
- JPB898 (Induction and Maintenance), Opdivo-EU (Induction) and Opdivo-US (Induction)
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 52 participants
- Where
- 22 sitesin 11 countries
- Study dates
- 19 Dec 2024to 23 Jan 2026
- Phase
- Phase 3
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Male or female participants must be 18 years or older.
- Histologically confirmed melanoma.
- Unresectable or metastatic melanoma measurable by Computerized tomography (CT) or Magnetic resonance imaging (MRI).
- Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1.
- Known Programmed cell death ligand 1 (PD-L1) and BRAF mutational status or consent to testing.
- Sexually active participants must agree to use effective contraception.
Who cannot join
- Active brain or leptomeningeal metastases unless stable for 8 weeks.
- Ocular melanoma.
- Prior active malignancy within the last year untreated or still requiring treatment.
- Severe and uncontrolled conditions, active Hepatitis B/C, Human immunodeficiency virus (HIV), or autoimmune diseases requiring systemic treatment.
- Previous treatment with specific immune checkpoint inhibitors, systemic anticancer therapy, or radiotherapy for melanoma.
Trial locations and contacts
22 sites in 11 countries.
22 sites in 11 countries
Spain6 sites
Sandoz Investigational Site 2
Madrid
Sandoz Investigational Site
Málaga
Sandoz Investigational Site
Oviedo
Sandoz Investigational Site
Santander
Sandoz Investigational Site
Santiago de Compostela
Sandoz Investigational Site 2
Valencia
Malaysia3 sites
Sandoz Investigational Site
Kuala Lumpur
Sandoz Investigational Site
Pulau Pinang
Sandoz Investigational Site
Putrajaya
South Korea3 sites
Sandoz Investigational Site 1
Busan
Sandoz Investigational Site
Daejeon
Sandoz Investigational Site 2
Seoul
Chile2 sites
Sandoz Investigational Site 1
Santiago
Sandoz Investigational Site
Santiago
Greece2 sites
Sandoz Investigational Site
Athens
Sandoz Investigational Site
Thessaloniki
About this study
Official title: A Randomized, Double-blind, Parallel-group Study to Compare Pharmacokinetics, Efficacy, Safety, and Immunogenicity of JPB898 (Proposed Nivolumab Biosimilar) and US-licensed and EU-authorized Opdivo® in Combination With Yervoy® in Participants With Untreated Advanced (Unresectable/Metastatic) Melanoma
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.
- Conditions
- Melanoma
- Being tested
- JPB898 (Induction and Maintenance), Opdivo-EU (Induction), Opdivo-US (Induction), Yervoy-EU (Induction), Opdivo-EU (Maintenance)
- Medical subject headings
- Melanoma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
JPB898 (Induction and Maintenance)Drug
Induction and Maintenance: Intravenous (IV)
Opdivo-EU (Induction)Drug
Induction: Intravenous (IV)
Opdivo-US (Induction)Drug
Induction: Intravenous (IV)
Yervoy-EU (Induction)Drug
Induction: Intravenous (IV)
Opdivo-EU (Maintenance)Drug
Maintenance: Intravenous (IV)
| Study group | Role | What they receive |
|---|---|---|
| JPB898 | Experimental | Participants will receive JPB898 combined with Yervoy-EU during the induction phase. Participants will receive JPB898 during maintenance phase. Receives: Drug: JPB898 (Induction and Maintenance); Drug: Yervoy-EU (Induction) |
| Opdivo-EU | Active comparator | Participants will receive Opdivo-EU combined with Yervoy-EU during the induction phase. Participants will receive Opdivo-EU during the maintenance phase. Receives: Drug: Opdivo-EU (Induction); Drug: Yervoy-EU (Induction); Drug: Opdivo-EU (Maintenance) |
| Opdivo-US | Active comparator | Participants will receive Opdivo-US combined with Yervoy-EU during the induction phase. Participants will receive Opdivo-EU during the maintenance phase. Receives: Drug: Opdivo-US (Induction); Drug: Yervoy-EU (Induction); Drug: Opdivo-EU (Maintenance) |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 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
Measured: 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
Measured: BOR (Complete response (CR) or partial response (PR)) from baseline up to 28 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Sep 2024
- Study start19 Dec 2024
- Primary completion23 Jan 2026
- Study completion23 Jan 2026
Why it stopped: In light of the evolving regulatory landscape and growing indications that major Health Authorities will move towards a streamlined clinical development, Sandoz took a strategic decision and is winding down its CJPB898A12301 clinical study.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for MelanomaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 52 participants (actual)
Sponsor and investigators
- Lead sponsor
- Sandoz
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06587451
- Sponsor's protocol ID
- CJPB898A12301
- Status last verified
- Feb 2026
- First submitted
- 30 Aug 2024
- Last updated
- 24 Feb 2026
- Results posted
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 24 Feb 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized, Double-blind, Parallel-group Study to Compare Pharmacokinetics, Efficacy, Safety, and Immunogenicity of JPB898 (Proposed Nivolumab Biosimilar) and US-licensed and EU-authorized Opdivo® in Combination With Yervoy® in Participants With Untreated Advanced (Unresectable/Metastatic) Melanoma
- ClinicalTrials.gov ID
- NCT06587451
- Acronym / sponsor ID
- CJPB898A12301
- Conditions
- Melanoma
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: In light of the evolving regulatory landscape and growing indications that major Health Authorities will move towards a streamlined clinical development, Sandoz took a strategic decision and is winding down its CJPB898A12301 clinical study.
- Enrolment
- 52 participants (actual)
- Lead sponsor
- SandozIndustry (pharma, biotech, devices)
- Study start
- 19 Dec 2024 (actual)
- Primary completion
- 23 Jan 2026 (actual)
- Study completion
- 23 Jan 2026 (actual)
- First posted
- 19 Sep 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| JPB898 | Experimental | Drug: JPB898 (Induction and Maintenance), Drug: Yervoy-EU (Induction)Participants will receive JPB898 combined with Yervoy-EU during the induction phase. Participants will receive JPB898 during maintenance phase. |
| Opdivo-EU | Active comparator | Drug: Opdivo-EU (Induction), Drug: Yervoy-EU (Induction), Drug: Opdivo-EU (Maintenance)Participants will receive Opdivo-EU combined with Yervoy-EU during the induction phase. Participants will receive Opdivo-EU during the maintenance phase. |
| Opdivo-US | Active comparator | Drug: Opdivo-US (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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Male or female participants must be 18 years or older.
- Histologically confirmed melanoma.
- Unresectable or metastatic melanoma measurable by Computerized tomography (CT) or Magnetic resonance imaging (MRI).
- Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1.
- Known Programmed cell death ligand 1 (PD-L1) and BRAF mutational status or consent to testing.
Key exclusion criteria (5 listed)
- Active brain or leptomeningeal metastases unless stable for 8 weeks.
- Ocular melanoma.
- Prior active malignancy within the last year untreated or still requiring treatment.
- Severe and uncontrolled conditions, active Hepatitis B/C, Human immunodeficiency virus (HIV), or autoimmune diseases requiring systemic treatment.
- Previous treatment with specific immune checkpoint inhibitors, systemic anticancer therapy, or radiotherapy for melanoma.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| JPB898 (Induction and Maintenance)Induction and Maintenance: Intravenous (IV) | Drug | JPB898 |
| Opdivo-EU (Induction)Induction: Intravenous (IV) | Drug | Opdivo-EU |
| Opdivo-US (Induction)Induction: Intravenous (IV) | Drug | Opdivo-US |
| Yervoy-EU (Induction)Induction: Intravenous (IV) | Drug | JPB898, Opdivo-EU, Opdivo-US |
| Opdivo-EU (Maintenance)Maintenance: Intravenous (IV) | Drug | Opdivo-EU, Opdivo-US |
Primary outcome
Demonstrate PK similarity between JPB898, Opdivo-US, and Opdivo-EU
Time frame: Days 1 to 22
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
Demonstrate PK similarity between JPB898, Opdivo-US, and Opdivo-EU between JPB898 and Opdivo-US/-EU
Time frame: Days 64 to 85
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
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
Time frame: BOR (Complete response (CR) or partial response (PR)) from baseline up to 28 weeks
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
Results and safety
The study was stopped early (reason given: In light of the evolving regulatory landscape and growing indications that major Health Authorities will move towards a streamlined clinical development, Sandoz took a strategic decision and is winding down its CJPB898A12301 clinical study.). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Feb 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
22 sites in 11 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing JPB898 (Induction and Maintenance), Opdivo-EU (Induction) and Opdivo-US (Induction) in people with Melanoma, run by Sandoz at 22 sites in 11 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 24 Feb 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 22 sites in Spain, Malaysia, South Korea, Chile, Greece and 6 more countries. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study was stopped early (reason given: In light of the evolving regulatory landscape and growing indications that major Health Authorities will move towards a streamlined clinical development, Sandoz took a strategic decision and is winding down its CJPB898A12301 clinical study.). Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Demonstrate PK similarity between JPB898, Opdivo-US, and Opdivo-EU (time frame: Days 1 to 22). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 24 Feb 2026.