MelanomaPhase 3NCT05907122
A Study to Evaluate Similarity of ABP 206 Compared With OPDIVO® (Nivolumab) in Subjects With Resected Melanoma
A Phase 3 study testing ABP 206, FDA-licensed Nivolumab and EU-authorized Nivolumab in people with Melanoma, run by Amgen at 76 sites in 22 countries.
Trial summary
The purpose of this study is to investigate the pharmacokinetic (PK) similarity and efficacy, safety, and immunogenicity of ABP 206 compared with OPDIVO® (nivolumab) in subjects with resected advanced melanoma. Read more about this study
- Who is it for?
- Ages 18 to 99 years
- Conditions the study is for
- Melanoma
- What is being tested?
- ABP 206, FDA-licensed Nivolumab and EU-authorized Nivolumab
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 256 participants
- Where
- 76 sitesin 22 countries
- Study dates
- 26 Jul 2023to 31 Oct 2025
- 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 to 99 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- At least 18 years of age
- Completely removed melanoma by surgery performed within 12 weeks of randomization
- Advanced Melanoma
- Tumor tissue from the resected site of the disease must be available for biomarker analyses in order to be randomized
- Subject has an Eastern Cooperative Oncology Group (ECOG) performance status score of 0 or 1
Who cannot join
- Previous anti-cancer treatment
- Known hypersensitivity to monoclonal antibodies or to any of the excipients of the study drug
- Ocular or uveal melanoma or history of carcinomatosis meningitis
- History of auto-immune disease
- Subject has medical conditions requiring systemic immunosuppression with either corticosteroids or other immunosuppressive medications within 14 days of the first dose of the investigational product
- Other protocol-defined inclusion/exclusion criteria apply
Trial locations and contacts
76 sites in 22 countries.
76 sites in 22 countries
Brazil9 sites
Fundacao Pio XII - Hospital de Cancer de Barretos - Hospital de Amor
Barretos, São Paulo, 14784 400
Cto Centro de Tratamento Oncologico Ltda
Belém, Pará, 66063-495
Hospital Sirio Libanes - Brasilia - Oncology
Brasília, Federal District, 70200 730
Instituto de Oncologia do Parana
Curitiba, Paraná, 80040170
CEPON - Centro de Pesquisas Oncológicas
Florianópolis, Santa Catarina, 888034-000
ATO Oncologia
Fortaleza, Ceará, 60140-025
PUCRS - Hospital Sao Lucas - Uniao Brasileira de Educacao e Assistence
Porto Alegre, Rio Grande do Sul, 90610-000
Hospital Sao Rafael
Salvador, Estado de Bahia, 41256900
Faculdade de Medicina de Sao Jose do Rio Preto-SP (FAMERP) - Hospital de Base (HB) - Oncology
São Paulo, 15090-000
Japan8 sites
National Hospital Organization Kagoshima Medical Center - Haematology
Kagoshima, Kagosima [Kagoshima], 892-0853
Shizuoka Cancer Center - Dermatology
Kōtoku, Tôkyô [Tokyo], 135-8550
Kumamoto University Hospital - Dermatology
Kumamoto, 860-8556
Nagoya City University Hospital - Dermatology
Nagoya, Aiti [Aichi], 467-8601
Niigata Cancer Center Hospital - Dermatology
Niigata, 951-8566
Osaka International Cancer Institute - Dermatological Oncology
Osaka, Ôsaka [Osaka], 541-8567
Sapporo Medical University Hospital
Sapporo, Hokkaidô [Hokkaido], 060-8543
Keio University Hospital - Dermatology
Shinjuku-ku, Tôkyô [Tokyo], 160-8582
Malaysia6 sites
Hospital Kuala Lumpur - Surgery
Kuala Lumpur, Wilayah Persekutuan Kuala Lump, 00000
Hospital Canselor Tuanku Muhriz UKM
Kuala Lumpur, Wilayah Persekutuan Kuala Lump, 56000
Hospital Universiti Sains Malaysia
Kubang Kerian, Terengganu, 16150
Hospital Umum Sarawak
Kuching, Sarawak, 93586
Hospital Pulau Pinang - Rheumatology
Pulau Pinang, Pahang, 00000
National Cancer Institute - Radiotherapy and Oncology
Putrajaya, Selangor, 62250
Bosnia and Herzegovina5 sites
University Clinical Centre of the Republic of Srpska - Gastroenterology
Banja Luka, Republika Srpska, 78000
University Clinical Hospital Mostar - Clinic for Lung Diseases
Mostar, 88000
Clinical Center University of Sarajevo - Clinic of Oncology
Sarajevo, Kanton Sarajevo, 71000
University Clinical Center Tuzla - Oncology, Hematology and Radio
Tuzla, Tuzlanski Kanton, 75000
Cantonal hospital Zenica - Oncology
Zenica, Zeničko-dobojski Kanton, 72000
Mexico5 sites
Centro de Inm Onc de Occ Sa de Cv
Guadalajra, Jalisco, 44630
ONCOCENTER PUEBLA - Dermatology
Puebla City, 72530
Hospital Angeles Centro Médico San Luis Potosí - Cardiologia
San Luis Potosí City, San Luis Potosí, 78200
Althian - Research Management Center
San Pedro Garza García, Nuevo León, 66278
Clinical Research Institute
Tlalnepantla, 54055
South Africa5 sites
Cape Gate Oncology Centre
Cape Town, Western Cape, 7570
Cancercare - Rondebosch Oncology
Cape Town, Western Cape, 7700
The Medical Oncology Centre of Rosebank
Johannesburg, Gauteng, 2196
Wits Clinical Research
Parktown, Johannesburg, Gauteng, 2193
Mary Potter Oncology Centre
Pretoria, Gauteng, 0181
South Korea5 sites
Inje University Haeundae Paik Hospital - Oncology
Busan, Busan Gwang'yeogsi [Pusan-Kwan, 48108
Severance Hospital, Yonsei University Health System - Division of Medical Oncology, Department of In
Seoul, Seoul Teugbyeolsi [Seoul-T'ukp, 03722
Asan Medical Center - Oncology
Seoul, Seoul Teugbyeolsi [Seoul-T'ukp, 05505
Samsung Medical Center - Family Medicine
Seoul, Seoul Teugbyeolsi [Seoul-T'ukp, 06351
The Catholic University of Korea, St. Vincent's Hospital
Suwon, Gyeonggido [Kyonggi-do], 16247
Spain5 sites
Hospital de la Santa Creu i Sant Pau - Oncología Médica
Barcelona, 08041
Hospital San Pedro de Alcántara - Oncología
Cáceres, Cáceres, 10003
H.U.V.Arrixaca - Oncología
El Palmar, Murcia, Región de, 30120
Hospital HLA Jerez Puerta Sur
Seville, 41009
Consorcio Hospital General Universitario de Valencia - Oncología
Valencia, 46014
Italy4 sites
Istituto Romagnolo Per Lo Studio Dei Tumori Dino Amadori IRST S.R.L
Meldola, Forli, 47014
Azienda Ospedaliera Universitaria Federico II
Naples, 80131
Istituto Dermopatico dell'Immacolata (IDI) - IRCCS - Oncologia
Roma, 00167
Policlinico Santa Maria alle Scotte, Azienda Ospedaliero Universitaria Senese - Immunoterapia Oncolo
Siena, 53100
Thailand4 sites
King Chulalongkorn Memorial Hospital [Medical Oncology]
Bangkok, Krung Thep Maha Nakhon [Bangko, 10330
Siriraj Hospital - Medical Oncology
Bangkok, Krung Thep Maha Nakhon [Bangko, 10700
Khon Kaen University, Srinagarind Hospital - Academic Clinical Research Office (ACRO)
Khonkaen, Changwat Khon Kaen, 40002
Prince of Songkla University
Songkhla, Changwat Songkhla, 90110
Serbia3 sites
Institute for Oncology and Radiology of Serbia, Department for Lung Cancer
Belgrade, 11000
University Clinical Center of Kragujevac, Center for Internal Oncology
Kragujevac, Šumadijski Okrug, 34000
University Clinical Center of Nis, Clinic for Oncology
Niš, Nišavski Okrug, 18108
United States2 sites
St. Vincent Frontier Cancer Center - Oncology
Billings, Montana, 59102-6746
Cancer and Blood Specialty clinic
Long Beach, California, 90806
Croatia2 sites
Klinicki bolnicki centar "Sestre milosrdnice" - Pediatrics
Grad Zagreb, City of Zagreb, 10000
University Hospital Centre Zagreb - Oncology department
Zagreb, City of Zagreb, 10 000
Georgia2 sites
LTD "Israel-Georgian Medical Research Clinic Healthycore"
Tbilisi, 0112
JSC "K.Eristavi National Center of Experimental and Clinical Surgery"
Tbilisi, 0159
Romania2 sites
Arensia Exploratory Medicine - Romania - Institutul Oncologic Prof Dr Alexandru Trestioreanu Bucures
Bucharest, 022328
Arensia Exploratory Medicine - Romania - Institutul Oncologic Prof Dr Ion Chiricuta Cluj-Napoca - On
Cluj-Napoca, Cluj, 400015
Taiwan2 sites
Taipei Medical University - Shuang Ho Hospital Ministry of Health and Welfare
New Taipei City, Taipei, 23561
China Medical University Hospital - Internal Medicine
Taichung, Taichung Municipality, 40447
Vietnam2 sites
Vietnam National Cancer Hopsital
Hanoi, Ha Noi, Thu Do, 100000
HCM Oncology Hospital - Medical Oncology
Ho Chi Minh City, Ho Chi Minh, Thanh Pho [Sai Go, 70000
Argentina1 site
Centro De Investigaciones Medicas Mar Del Plata (CIMMDP) - Rheumatology
Mar Del Plata, Río Negro Province, 7600
Lithuania1 site
National Cancer Institute - Conservative Tumour Therapy
Vilnius, Vilnius County, LT-08660
Moldova1 site
Arensia Exploratory Medicine - Moldova - IMSP Institutul Oncologic - Oncology
Chisinau, Moldova, Republic of, MD-2025
Netherlands1 site
Amphia Hospital - unspecified
Breda, North Brabant, 4818 CK
About this study
Official title: A Randomized, Double-blind Study Evaluating Pharmacokinetic Similarity of ABP 206 Compared With OPDIVO® (Nivolumab) in Resected Stage III or Stage IV Melanoma Subjects in the Adjuvant Setting
The purpose of this study is to investigate the pharmacokinetic (PK) similarity and efficacy, safety, and immunogenicity of ABP 206 compared with OPDIVO® (nivolumab) in subjects with resected advanced melanoma.
Read the detailed description
Eligible subjects will be randomized in a 1:1:1 ratio to receive either ABP 206, Food and Drug Administration (FDA)-licensed nivolumab, or European Union (EU)-authorized nivolumab.
The treatment period is in alignment with the maximum treatment duration for OPDIVO® (nivolumab, reference product) in the adjuvant setting for melanoma.
All subjects will be treated until recurrence of disease, unacceptable toxicity, or subject withdrawal of consent with a maximum of 1 year of treatment.
The total duration of study participation for each subject will be approximately 13 months.
- Conditions
- Melanoma
- Being tested
- ABP 206, FDA-licensed Nivolumab, EU-authorized Nivolumab
- Keywords
- Pharmacokinetic similarity study, Adjuvant melanoma treatment, Advanced Melanoma
- Medical subject headings
- Melanoma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ABP 206Drug
ABP 206 will be given intravenously over a period of 30 minutes, every 4 weeks (Q4W) for a total of 12 months.
FDA-licensed NivolumabDrug
Also called OPDIVO®
FDA-licensed Nivolumab will be given intravenously over a period of 30 minutes, Q4W for a total of 12 months.
EU-authorized NivolumabDrug
Also called OPDIVO®
FDA-licensed Nivolumab will be given intravenously over a period of 30 minutes, Q4W for a total of 12 months.
| Study group | Role | What they receive |
|---|---|---|
| ABP 206 | Experimental | Subjects will receive Dose A of ABP 206 via intravenous (IV) infusion. Receives: Drug: ABP 206 |
| FDA-licensed Nivolumab | Active comparator | Subjects will receive Dose A of FDA-licensed Nivolumab via IV infusion. Receives: Drug: FDA-licensed Nivolumab |
| EU-authorized Nivolumab | Active comparator | Subjects will receive Dose A of EU-authorized Nivolumab via IV infusion. Receives: Drug: EU-authorized Nivolumab |
What is being measured
The primary outcome is the main question the study is designed to answer.
Area Under the Serum Concentration-time Curve from Time Zero to 28 Days (AUC0-28d)
The PK similarity (AUC0-28d) of ABP 206 compared with nivolumab will be demonstrated in subjects with advanced melanoma in the adjuvant setting.
Measured: Day 1 (Postdose) through Day 28
Area Under the Serum Concentration-time Curve Over the Dosing Interval at Steady State (AUCtau_SS)
The PK similarity (AUCtau_ss) of ABP 206 compared with nivolumab will be demonstrated in subjects with advanced melanoma in the adjuvant setting.
Measured: Week 17 through Week 21
Secondary outcomes (11)
Maximum Observed Serum Concentration Following the First Dose (Cmax_dose 1)
The comparison of PK (Cmax_dose 1) of ABP 206 with nivolumab will be determined in subjects with advanced melanoma in the adjuvant setting.
Measured: Week 1 (Baseline) through Week 9, Week 17 to 29, Week 41, and Week 53 (End of Study)
Maximum Observed Serum Concentration at Steady State (Cmax_ss)
The comparison of PK (Cmax_ss) of ABP 206 with nivolumab will be determined in subjects with advanced melanoma in the adjuvant setting.
Measured: Week 1 (Baseline) through Week 9, Week 17 to 29, Week 41, and Week 53 (End of Study)
Serum Concentrations at Predose (Ctrough)
The PK similarity (Ctrough) of ABP 206 compared with nivolumab determined in subjects with advanced melanoma in the adjuvant setting.
Measured: Week 1 (Baseline) through Week 9, Week 17 to 29, Week 41, and Week 53 (End of Study)
Number of Subjects With Treatment-Emergent Serious Adverse Events
The safety (treatment-emergent serious adverse events) of ABP 206 compared with nivolumab will be assessed in subjects with advanced melanoma in the adjuvant setting.
Measured: Week 1 (First dose of study drug) through Week 53 (End of Study)
Number of Subjects With Treatment-Emergent Adverse Events
The safety (treatment-emergent adverse events) of ABP 206 compared with nivolumab will be assessed in subjects with advanced melanoma in the adjuvant setting.
Measured: Week 1 (First dose of study drug) through Week 53 (End of Study)
Number of Subjects With Treatment-emergent Adverse Events-of-interest
The safety (treatment-emergent adverse events-of-interest) of ABP 206 compared with nivolumab will be assessed in subjects with advanced melanoma in adjuvant setting.
Measured: Week 1 (First dose of study drug) through Week 53 (End of Study)
Number of Subjects With Anti-drug Antibodies (ADAs)
The immunogenicity of ABP 206 compared with nivolumab will be assessed in subjects with advanced melanoma in the adjuvant setting.
Measured: Predose on Week 1 (Baseline), Weeks 5, 9, 17, 21, 29, 41, and at Week 53 (End of Study)
Recurrence-free Survival (RFS)
The RFS is assessed to compare the efficacy of ABP 206 with nivolumab in subjects with advanced melanoma in the adjuvant setting. The RFS is defined as the time between the date of randomization and the date of first recurrence (local, regional, distant metastasis) or death (whatever the cause), or date of last visit/contact with disease assessments (for subjects who remain alive and whose disease has not recurred).
Measured: Randomization through 12 months (or until RFS criteria is met)
Time to reach Cmax following the first dose (Tmax_dose 1)
The comparison of PK (Tmax_dose 1) of ABP 206 with nivolumab will be determined in subjects with advanced melanoma in the adjuvant setting.
Measured: Week 1 (Baseline) through Week 9, Week 17 to 29, Week 41, and Week 53 (End of Study)
Time to reach Cmax at steady state (Tmax_ss)
The comparison of PK (Tmax_SS) of ABP 206 with nivolumab will be determined in subjects with advanced melanoma in the adjuvant setting.
Measured: Week 1 (Baseline) through Week 9, Week 17 to 29, Week 41, and Week 53 (End of Study)
Serum Concentrations (Ctrough)
The comparison of PK (Ctrough) of ABP 206 with nivolumab will be determined in subjects with advanced melanoma in the adjuvant setting.
Measured: At Week 5 (Pre-dose), and at Weeks 17 and 21 (Pre-dose)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Jun 2023
- Study start26 Jul 2023
- Primary completion26 Mar 2025
- Study completion31 Oct 2025
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.
- More trials run by AmgenThe sponsor's other registered studies.
- 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
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 256 participants (actual)
Sponsor and investigators
- Lead sponsor
- Amgen
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- MD, Study director, Amgen
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05907122
- Sponsor's protocol ID
- 20220083
- Status last verified
- Mar 2026
- First submitted
- 8 Jun 2023
- Last updated
- 27 Mar 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- Yes: De-identified individual patient data for variables necessary to address the specific research question in an approved data sharing request.
Study at a glance
From the registry record, last updated by the sponsor on 27 Mar 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized, Double-blind Study Evaluating Pharmacokinetic Similarity of ABP 206 Compared With OPDIVO® (Nivolumab) in Resected Stage III or Stage IV Melanoma Subjects in the Adjuvant Setting
- ClinicalTrials.gov ID
- NCT05907122
- Acronym / sponsor ID
- 20220083
- Conditions
- Melanoma
- Keywords
- Pharmacokinetic similarity study, Adjuvant melanoma treatment, Advanced Melanoma
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 256 participants (actual)
- Lead sponsor
- AmgenIndustry (pharma, biotech, devices)
- Study start
- 26 Jul 2023 (actual)
- Primary completion
- 26 Mar 2025 (actual)
- Study completion
- 31 Oct 2025 (actual)
- First posted
- 18 Jun 2023 (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 this study is to investigate the pharmacokinetic (PK) similarity and efficacy, safety, and immunogenicity of ABP 206 compared with OPDIVO® (nivolumab) in subjects with resected advanced melanoma.
Detailed description
Eligible subjects will be randomized in a 1:1:1 ratio to receive either ABP 206, Food and Drug Administration (FDA)-licensed nivolumab, or European Union (EU)-authorized nivolumab.
The treatment period is in alignment with the maximum treatment duration for OPDIVO® (nivolumab, reference product) in the adjuvant setting for melanoma.
All subjects will be treated until recurrence of disease, unacceptable toxicity, or subject withdrawal of consent with a maximum of 1 year of treatment.
The total duration of study participation for each subject will be approximately 13 months.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| ABP 206 | Experimental | Drug: ABP 206Subjects will receive Dose A of ABP 206 via intravenous (IV) infusion. |
| FDA-licensed Nivolumab | Active comparator | Drug: FDA-licensed NivolumabSubjects will receive Dose A of FDA-licensed Nivolumab via IV infusion. |
| EU-authorized Nivolumab | Active comparator | Drug: EU-authorized NivolumabSubjects will receive Dose A of EU-authorized Nivolumab via IV infusion. |
Who may qualify
- Ages
- 18 to 99 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- At least 18 years of age
- Completely removed melanoma by surgery performed within 12 weeks of randomization
- Advanced Melanoma
- Tumor tissue from the resected site of the disease must be available for biomarker analyses in order to be randomized
- Subject has an Eastern Cooperative Oncology Group (ECOG) performance status score of 0 or 1
Key exclusion criteria (6 listed)
- Previous anti-cancer treatment
- Known hypersensitivity to monoclonal antibodies or to any of the excipients of the study drug
- Ocular or uveal melanoma or history of carcinomatosis meningitis
- History of auto-immune disease
- Subject has medical conditions requiring systemic immunosuppression with either corticosteroids or other immunosuppressive medications within 14 days of the first dose of the investigational product
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 |
|---|---|---|
| ABP 206ABP 206 will be given intravenously over a period of 30 minutes, every 4 weeks (Q4W) for a total of 12 months. | Drug | ABP 206 |
| FDA-licensed NivolumabAlso: OPDIVO®FDA-licensed Nivolumab will be given intravenously over a period of 30 minutes, Q4W for a total of 12 months. | Drug | FDA-licensed Nivolumab |
| EU-authorized NivolumabAlso: OPDIVO®FDA-licensed Nivolumab will be given intravenously over a period of 30 minutes, Q4W for a total of 12 months. | Drug | EU-authorized Nivolumab |
Primary outcome
Area Under the Serum Concentration-time Curve from Time Zero to 28 Days (AUC0-28d)
Time frame: Day 1 (Postdose) through Day 28
The PK similarity (AUC0-28d) of ABP 206 compared with nivolumab will be demonstrated in subjects with advanced melanoma in the adjuvant setting.
Area Under the Serum Concentration-time Curve Over the Dosing Interval at Steady State (AUCtau_SS)
Time frame: Week 17 through Week 21
The PK similarity (AUCtau_ss) of ABP 206 compared with nivolumab will be demonstrated in subjects with advanced melanoma in the adjuvant setting.
11 secondary outcomes
Maximum Observed Serum Concentration Following the First Dose (Cmax_dose 1)
Time frame: Week 1 (Baseline) through Week 9, Week 17 to 29, Week 41, and Week 53 (End of Study)
Maximum Observed Serum Concentration at Steady State (Cmax_ss)
Time frame: Week 1 (Baseline) through Week 9, Week 17 to 29, Week 41, and Week 53 (End of Study)
Serum Concentrations at Predose (Ctrough)
Time frame: Week 1 (Baseline) through Week 9, Week 17 to 29, Week 41, and Week 53 (End of Study)
Number of Subjects With Treatment-Emergent Serious Adverse Events
Time frame: Week 1 (First dose of study drug) through Week 53 (End of Study)
Number of Subjects With Treatment-Emergent Adverse Events
Time frame: Week 1 (First dose of study drug) through Week 53 (End of Study)
Number of Subjects With Treatment-emergent Adverse Events-of-interest
Time frame: Week 1 (First dose of study drug) through Week 53 (End of Study)
Number of Subjects With Anti-drug Antibodies (ADAs)
Time frame: Predose on Week 1 (Baseline), Weeks 5, 9, 17, 21, 29, 41, and at Week 53 (End of Study)
Recurrence-free Survival (RFS)
Time frame: Randomization through 12 months (or until RFS criteria is met)
Time to reach Cmax following the first dose (Tmax_dose 1)
Time frame: Week 1 (Baseline) through Week 9, Week 17 to 29, Week 41, and Week 53 (End of Study)
Time to reach Cmax at steady state (Tmax_ss)
Time frame: Week 1 (Baseline) through Week 9, Week 17 to 29, Week 41, and Week 53 (End of Study)
Serum Concentrations (Ctrough)
Time frame: At Week 5 (Pre-dose), and at Weeks 17 and 21 (Pre-dose)
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Mar 2026.
- AmgenTrials clinical trials websiteLink provided by the sponsor.
- Individual participant dataSharing planned: Yes. De-identified individual patient data for variables necessary to address the specific research question in an approved data sharing request.
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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.
MD study director
Amgen
76 sites in 22 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing ABP 206, FDA-licensed Nivolumab and EU-authorized Nivolumab in people with Melanoma, run by Amgen at 76 sites in 22 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 5 inclusion and 6 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: finished, as of the sponsor's last update on 27 Mar 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 76 sites in Brazil, Japan, Malaysia, Bosnia and Herzegovina, Mexico and 17 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 is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Area Under the Serum Concentration-time Curve from Time Zero to 28 Days (AUC0-28d) (time frame: Day 1 (Postdose) through Day 28). The study lists 2 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 27 Mar 2026.