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MelanomaPhase 3NCT06054555

A Study to Evaluate ABP 206 Compared With OPDIVO® (Nivolumab) in Subjects With Unresectable or Metastatic Melanoma

A Phase 3 study testing ABP 206 and Nivolumab in people with Melanoma, run by Amgen at 180 sites in 31 countries.

Active, not recruiting

Under way, not looking for participants. Everyone needed has enrolled. The study is still running.

Official record
Search all trials

Trial summary

The purpose of this study is to assess the efficacy, safety, and immunogenicity of ABP 206 compared with Nivolumab in Subjects with Treatment-Naïve Unresectable or Metastatic 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 and Nivolumab
Type of treatment
Injection or infusion
Could I receive a placebo?
No, everyone receives an active treatment
How many people
633 participants
Where
180 sitesin 31 countries
Study dates
2 Nov 2023to 25 Jan 2028
Phase
Phase 3
Are there results?
Not yet: the study is under way

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.
  • Histologically confirmed unresectable or metastatic melanoma.
  • Subject has no prior systemic treatment for advanced disease.
  • Subject must have measurable disease according to Response Evaluation Criteria in Solid Tumors (RECIST version 1.1).
  • Tumor tissue from site of unresectable or metastatic melanoma must be available for biomarker analyses in order to be randomized.
  • Eastern Cooperative Oncology Group (ECOG) performance status (PS) 0 or 1.

Who cannot join

  • Subject has had any prior systemic anti-cancer therapy for the treatment of advanced melanoma.
  • Known hypersensitivity to monoclonal antibodies or to any of the excipients of the study drug.
  • Subject has active central nervous system (CNS) metastases not previously treated.
  • Ocular melanoma.
  • Subject has active or known immune-mediated disorders.
  • Subject has had prior treatment with PD-1/PD-L1 and cytotoxic T lymphocyte- associated protein 4 inhibitors, or other antibodies targeting immune checkpoint pathways.
  • Subject has medical conditions requiring systemic immunosuppression with either corticosteroids or other immunosuppressive medications within 14 days of the first dose of investigational product.
  • Other protocol-defined inclusion/exclusion criteria apply.

Trial locations and contacts

180 sites in 31 countries.

180 sites in 31 countries

Italy22 sites

  • AO Ss Antonio, Biagio e Arrigo

    Alessandria, 15121

  • AUO Consorziale-Policlinico Bari

    Bari, 70124

  • Istituto dei Tumori Giovanni Paolo II - Oncologia Medica - Tumori Rari e Melanoma

    Bari, 70124

  • ASST Papa Giovanni XXIII - Oncologia

    Bergamo, 24127

  • Ospedale Maggiore Di Crema - Oncologia e Day Hospital oncologico

    Crema, Cremona, 26013

  • AOU Careggi

    Florence, 50134

  • IRST Dino Amadori (IRST IRCCS) - UNK

    Meldola, Forli, 47014

  • IRCCS Ca'Granda Maggiore Policlinic

    Milan, 20122

  • Ospedale San Raffaele, IRCCS - Oncologia Medica

    Milan, 20132

  • AOU Luigi Vanvitelli

    Naples, 80131

  • Azienda Ospedaliera Universitaria Federico II

    Naples, 80131

  • Azienda Sanitaria Locale Napoli 1 Centro (ASL Napoli 1) - Ospedale del Mare

    Naples, 80147

  • Fondazione IRCCS Policlinico San Matteo

    Pavia, 27100

  • Arcispedale Santa Maria Nuova

    Reggio Emilia, 42123

  • Fondazione Policlinico Universitario Campus Bio-medico - Oncologia Medica

    Roma, 00128

  • IRCCS IFO, Istituto Nazionale dei Tumori Regina Elena (IRE)

    Roma, 00144

  • Istituto Dermopatico dell'Immacolata (IDI) - IRCCS - Oncologia

    Roma, 00167

  • Ospedale Isola Tiberina - Gemelli Isola - Oncologia Medica

    Roma, 00186

  • Istituto Clinico Humanitas

    Rozzano, Milano, 20089

  • AOU Senese, Policlinico Le Scotte

    Siena, 53100

  • PO Ospedale San Vincenzo - Oncologia Medica

    Taormina, Messina, 98039

  • Ospedale di Circolo, Presidio di Varese - Oncologia

    Varese, 21100

Other trials in Italy

Turkey (Türkiye)20 sites

  • Adana City Training and Research Hospital

    Adana, 01370

  • Gulhane Training and Research Hospital - Medical Oncology

    Ankara, 06010

  • Ankara University Medical Faculty - Medical Oncology

    Ankara, 06590

  • Ankara Liv Hospital

    Ankara, 06680

  • Memorial Ankara Hospital - Oncology

    Ankara, 6520

  • Dr Abdurrahman Yurtaslan Training and Research Hospital - Medical Oncology

    Ankara

  • Uludag University Medical Faculty

    Bursa, 16059

  • Medical Point Gaziantep Hospital - Medical Oncology

    Gaziantep, 27010

  • Gaziantep University Sahinbey Practise and Research Hospital - Internal Medicine- Endocrinology and

    Gaziantep, 27310

  • Bakirköy Dr. Sadi Konuk EÄŸitim ve AraÅŸtirma Hastanesi - Oncology

    Istanbul, 34098

  • Koc Universitesi Hastanesi; Tıbbi Onkoloji

    Istanbul, 34510

  • Memorial Bahçelievler Hospital

    Istanbul, 44280

  • Izmir Medical Point Hastanesi

    Izmir, 35560

  • Istanbul Goztepe Prof. Dr. Suleyman Yalcin City Hospital - Medical Oncology

    Kadıköy, Istanbul, 34722

  • Kocaeli University Research and Practice Hospital - Medical Oncology

    Kocaeli, 41380

  • Necmettin Erbakan University Meram Medical Faculty - Oncology

    Konya, 42080

  • Sakarya Training and Research Hospital

    Sakarya, 54290

  • VM Medical Park Samsun Hospital - Medical oncology

    Samsun, 00000

  • Namik Kemal Universitesi - Tip Fakultesi

    Tekirdağ, 59100

  • Gazi University Medical Faculty - Gynecology

    Yenimahalle/Ankara, Ankara, 6500

Other trials in Turkey (Türkiye)

Mexico15 sites

  • Centro de Investigación Médica Aguascalientes (CIMA) - Oncology

    Aguascalientes, 68000

  • Neurosciences Hospital Angeles Culiacán - Neurociencias Estudios Clínicos S.C.

    Culiacán, Sinaloa, 80020

  • Boca Clinical Trials México

    Guadalajara, 00000

  • Centro de Inm Onc de Occ Sa de Cv

    Guadalajra, Jalisco, 44630

  • Centro de Estudios y Prevención del Cancer AC

    Juchitán de Zaragoza, Oaxaca, 70000

  • Preparaciones Oncologica SC

    León, Guanajuato, 37000

  • Centro de Atención e Investigación Clínica en Oncología

    Mérida, Yucatán, 97130

  • Health Pharma Professional Research S.A de C.V.

    Mexico City, Mexico City, 3100

  • Oncare Cancer Center Viaducto CdMx

    Mexico City, 14080

  • iCan Oncology Center Centro Medico AVE

    Monterrey, Nuevo León, 64710

  • Centro Medico Zambrano Hellion TecSalud

    Monterrey, Nuevo León, 66278

  • 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

Other trials in Mexico

Romania12 sites

  • Memorial Healthcare International - Oncology

    Bucharest, 013823

  • Institutul Oncologic Prof Dr Alexandru Trestioreanu Bucuresti - Medical Oncology I

    Bucharest, 022328

  • Institutul Oncologic Prof Dr Ion Chiricuta Cluj-Napoca - Medical Oncology

    Cluj-Napoca, Cluj, 400015

  • Medisprof - Medical Oncology

    Cluj-Napoca, Cluj, 400641

  • Oncolab - Medical Oncology

    Craiova, Dolj, 200385

  • Centrul de Oncologie Sf Nectarie - Medical Oncology

    Craiova, Dolj, 200746

  • Radiotherapy Center Cluj - Medical Oncology

    Floreşti, Cluj, 407280

  • Centrul de Oncologie Euroclinic - Oncology

    Iași, 700106

  • Medical Center Gral

    Ploieşti, Prahova, 100010

  • Spitalul Municipal Ploiesti - Oncologie

    Ploieşti, Prahova, 100337

  • Spitalul Clinic Judetean de Urgenta Sibiu - Oncologie

    Sibiu, 550245

  • Oncocenter- Oncologie Clinica - Medical Oncology

    Timișoara, Timiș County, 300166

Other trials in Romania

Spain10 sites

  • Institut Català d'Oncologia-Hospital Universitari Germans Trias i Pujol - Oncología Médica

    Badalona, Barcelona, 08916

  • Hospital Universitario Vall d'Hebron - Oncología Médica

    Barcelona, 08035

  • 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

  • M.D. Anderson Center Madrid

    Madrid, 28033

  • Hospital Regional Universitario de Malaga - Servicio de Oncología

    Málaga, 29011

  • Hospital Universitario Virgen de la Macarena - Oncología Médica

    Seville, Andalusia, 41009

  • Hospital HLA Jerez Puerta Sur

    Seville, 41009

  • Consorcio Hospital General Universitario de Valencia - Oncología

    Valencia, 46014

Other trials in Spain

Philippines9 sites

  • Riverside Medical Center

    Bacolod, Negros Occidental, 6100

  • Baguio General Hospital and Medical Center - Oncology

    Baguio City, Benguet, 2600

  • Cagayan de Oro Medical Center - Internal Medicine

    Cagayan de Oro, Misamis Oriental, 9000

  • Cebu Doctors' University Hospital - Oncology

    Cebu City, Cebu, 1000

  • The Medical City - Clinical Research Unit

    Iloilo City, Iloilo, 00000

  • Center for Skin Research, Testing and Product Development

    Makati City, National Capital Region, 1229

  • Philippine General Hospital

    Manila/Ermita, National Capital Region, 1000

  • The Medical City - Neurology

    Pasig, Metropolitan Manila, 1605

  • Cardinal Santos Madical Center

    San Juan City, National Capital Region, 1502

Other trials in Philippines

South Africa9 sites

  • Cape Gate Oncology Centre

    Cape Town, Western Cape, 7570

  • Cancercare - Rondebosch Oncology

    Cape Town, Western Cape, 7700

  • Rainbow Oncology Centre

    Durban, KwaZulu-Natal, 4058

  • Chris Hani Baragwanath Academic Hospital

    Johannesburg, Gauteng, 2193

  • The Medical Oncology Centre of Rosebank

    Johannesburg, Gauteng, 2196

  • Wits Clinical Research

    Parktown, Johannesburg, Gauteng, 2193

  • Steve Biko Academic Hospital

    Pretoria, Gauteng, 0002

  • Curo Oncology

    Pretoria, Gauteng, 0084

  • Little Company Of Mary Hospital - Oncology

    Pretoria, Gauteng, 0181

Other trials in South Africa

Malaysia7 sites

  • Hospital Kuala Lumpur - Surgery

    Kuala Lumpur, Wilayah Persekutuan Kuala Lump, 00000

  • Hospital Canselor Tuanku Muhriz UKM

    Kuala Lumpur, Wilayah Persekutuan Kuala Lump, 56000

  • Pantai Hospital Kuala Lumpur - Oncology

    Kuala Lumpur, Wilayah Persekutuan Kuala Lump, 59100

  • HOSPITAL UNIVERSITI SAINS MALAYSIA - Pediatrics

    Kubang Kerian, Terengganu, 16150

  • Sarawak General Hospital

    Kuching, Sarawak, 93586

  • Hospital Pulau Pinang

    Pulau Pinang, Pahang, 00000

  • National Cancer Institute - Radiotherapy and Oncology

    Putrajaya, Selangor, 62250

Other trials in Malaysia

Lebanon6 sites

  • Ain Wazein Hospital - internal medicine

    Beirut, +961

  • American University of Beirut Medical Center - Haematology

    Beirut, 00000

  • Hotel Dieu de France Hospital - Oncology

    Beirut, 111

  • Saint George Hospital University Medical Center

    El Achrafiyé, Beirut, 00000

  • Hammoud Hospital University Medical Center (HHUMC) - Hemato-Oncology

    Saida, Loubnâne Ej Jnoûbi, 652

  • Nini Hospital

    Tripoli, Loubnâne Ech Chemâli, 00000

Other trials in Lebanon

Portugal6 sites

  • Champalimaud Cancer Center

    Lisbon, 1400-038

  • Unidade Local De Saude De Lisboa Ocidental E.P.E.

    Lisbon, 1449-005

  • Centro Hospitalar de Lisboa Norte E.P.E. - H. Santa Maria Serviço de Oncologia Médica

    Lisbon, 1649-035

  • Instituto Portugues de Oncologia de Lisboa Francisco Gentil - Oncologia Medica

    Lisbon

  • Instituto Português Oncologia Francisco Gentil do Porto - Oncologia Medica

    Porto, 4200-072

  • Centro Hospitalar de Setúbal - Oncologia

    Setúbal, Setúbal District, 2910446

Other trials in Portugal

Thailand6 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

  • Maharaj Nakorn Chiangmai Hospital - Medical Oncology

    Muang, Chiang Mai, 50200

  • Ramathibodi Hospital - Immunology and Rheumatology

    Rajthevi, Krung Thep Maha Nakhon [Bangko, 10400

  • Prince of Songkla University

    Songkhla, Changwat Songkhla, 90110

Other trials in Thailand

United States5 sites

  • Our Lady of the Lake Physicians Group-Medical Oncology-Woman's Pavilion

    Baton Rouge, Louisiana, 70809

  • Hematology-Oncology Associates of Central New York, P.C. (HOA) - East Syracuse - CCOP

    East Syracuse, New York, 13057

  • Fort Wayne Medical Oncology and Hematology - Office of Clinical Research

    Fort Wayne, Indiana, 46825

  • Cancer and Blood Specialty clinic

    Long Beach, California, 90806

  • Oncology Hematology Associates

    Springfield, Missouri, 65807-5287

Other trials in United States

Argentina5 sites

  • Centro de Investigaciones Médicas y Desarrollo LC

    Buenos Aires, Ciudad Autónoma de Buenos Aire, 1125

  • Centro De Investigaciones Medicas Mar Del Plata (CIMMDP) - Rheumatology

    Mar Del Plata, Río Negro Province, 7600

  • Instituto De Oncologia De Rosario

    Rosario, Santa Fe Province, S2000KZE

  • ISIS Clinica Especializada

    Santa Fe, S3000FFU

  • Clínica Viedma - Oncology

    Viedma, Río Negro Province, R8500JYJ

Other trials in Argentina

Georgia5 sites

  • LTD "High technology hospital MEDCENTER"

    Batumi, Adjara, 6010

  • LLC "Todua Clinic"

    Tbilisi, 0112

  • LTD "Israel-Georgian Medical Research Clinic Healthycore"

    Tbilisi, 0112

  • JSC "K.Eristavi National Center of Experimental and Clinical Surgery"

    Tbilisi, 0159

  • LTD "Multprofile Clinic Consilium Medulla" - Oncology

    Tbilisi, 0186

Other trials in Georgia

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

Other trials in South Korea

Bosnia and Herzegovina4 sites

  • University Clinical Center of Republic of Srpska

    Banja Luka, Republika Srpska, 78000

  • 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

Other trials in Bosnia and Herzegovina

Chile4 sites

  • Icegclinic Research & Care

    Estacion Central, Santiago Metropolitan, 8241479

  • IC La Serena Research

    La Serena, Coquimbo Region, 1720430

  • Centro de Investigacion y Desarrollo Oncologico

    Temuco, Araucania, 4810218

  • Oncocentro Apys

    Valparaíso, Valparaiso, 2363058

Other trials in Chile

Jordan4 sites

  • Al Khalidi Hospital and Medical Center - Research

    Amman, 'Ammān

  • The Speciality Hospital (TSH) / Advanced Clinical Center

    Amman, 'Ammān

  • King Hussein Cancer Center

    Amman, 11941.0

  • Pharmaceutical Research Center (KAUH)

    Irbid

Other trials in Jordan

Taiwan4 sites

  • Changhua Christian Medical Foundation - Changhua Christian Hospital - Internal Medicine

    Changhua, 50006

  • 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

  • Taipei Municipal Wanfang Hospital - Managed by Taipei Medical University - Hematology and Oncology

    Taipei, 11696

Other trials in Taiwan

Croatia3 sites

  • Klinicki bolnicki centar Osijek

    Osijek, Osjecko-baranjska Županija, 31000

  • University Hospital Centre Zagreb - Oncology department

    Zagreb, City of Zagreb, 10 000

  • Poliklinika Anova

    Zagreb, City of Zagreb, 10000

Other trials in Croatia

France3 sites

  • C.H.R.U Hopital Claude Huriez - Dermatologie

    Lille, Nord, 59037

  • CHU de Poitiers

    Poitier, Haute-Vienne, 21079

  • Centre Hospitalier De Saint Malo - Oncologie

    Rennes, Ille-et-Vilaine, 35042

Other trials in France

Germany3 sites

  • University Hospital of Cologne

    Cologne, North Rhine-Westphalia, 50937

  • Goethe University Frankfurt

    Frankfurt am Main, Hesse, 60590

  • Philipps-University Marburg

    Marburg, Hesse, 35043

Other trials in Germany

Vietnam3 sites

  • Hanoi Oncology Hospital

    Hanoi, Ha Noi, Thu Do, 100000

  • Vietnam National Cancer Hopsital

    Hanoi, Ha Noi, Thu Do, 10000

  • HCM Oncology Hospital - Medical Oncology

    Ho Chi Minh City, Ho Chi Minh, Thanh Pho [Sai Go

Other trials in Vietnam

Czechia2 sites

  • FN Hradec Kralove - Klinika onkologie a radioterap

    Hradec Kralove, Moravian-Silesian Region, 500 05

  • Vseobecna fakultni nemocnice v Praze - Dermatovenerologicka

    Prague, 128 08

Other trials in Czechia

Serbia2 sites

  • Institute for Oncology of Vojvodina, Clinic for Internal Oncology-Department of Soft Tissue, Skin, B

    Kamenitz, Vojvodina, 21204

  • University Clinical Center of Kragujevac, Center for Internal Oncology

    Kragujevac, Šumadijski Okrug, 34000

Other trials in Serbia

Canada1 site

  • Dr. Everett Chalmers Hospital - Oncology

    Fredericton, New Brunswick, E3B 5N5

Other trials in Canada

Estonia1 site

  • Tartu University Hospital - Oncology

    Tartu, Tartu, 51014

Other trials in Estonia

Lithuania1 site

  • National Cancer Institute - Conservative Tumour Therapy

    Vilnius, Vilnius County, LT-08660

Other trials in Lithuania

Moldova1 site

  • Arensia Exploratory Medicine - Moldova - IMSP Institutul Oncologic - Oncology

    Chisinau, Moldova, Republic of, MD-2025

Other trials in Moldova

Netherlands1 site

  • Amphia Ziekenhuis - Molengracht

    Breda, North Brabant, 4818 CK

Other trials in Netherlands

Ukraine1 site

  • TOV "ARENSIIa EKSPLORATORI MEDISIN"

    Kyiv, Kyïv, 1135

Other trials in Ukraine

About this study

Official title: A Randomized, Double-Blind Study Evaluating the Efficacy, Safety, and Immunogenicity of ABP 206 Compared With OPDIVO® (Nivolumab) in Subjects With Treatment-Naïve Unresectable or Metastatic Melanoma

The purpose of this study is to assess the efficacy, safety, and immunogenicity of ABP 206 compared with Nivolumab in Subjects with Treatment-Naïve Unresectable or Metastatic Melanoma.

Read the detailed description

Eligible subjects will be randomized (1:1) to receive investigational product (ABP 206 or nivolumab).

All subjects will be treated until disease progression, unacceptable toxicity, or subject withdrawal of consent for a maximum of 24 months of treatment.

The total duration of study participation for each subject will be approximately 26 months.

Conditions
Melanoma
Being tested
ABP 206, Nivolumab
Keywords
Treatment-naive, Unresectable melanoma, Metastatic 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 or 60 minutes, every 4 weeks (Q4W) for a total of 24 months.

  • NivolumabDrug

    Also called OPDIVO®

    Nivolumab will be given intravenously over a period of 30 or 60 minutes, Q4W for a total of 24 months.

Study groups in NCT06054555
Study groupRoleWhat they receive
ABP 206ExperimentalSubjects will receive Dose A of ABP 206 via intravenous (IV) infusion.
Receives: Drug: ABP 206
NivolumabActive comparatorSubjects will receive Dose A of Nivolumab via IV infusion.
Receives: Drug: Nivolumab

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Objective response by Week 49

    Measured: Week 49

  2. Objective response at Week 17

    Measured: Week 17

  3. Progression-free survival (PFS)

    Measured: From Randomization until Follow-up or End of treatment (EOT) or Early termination (ET) (Approximately 105 Weeks)

  4. Overall survival (OS)

    Measured: From Randomization until Follow-up or EOT or ET (Approximately 105 Weeks)

  5. Duration of response (DOR)

    Measured: From Randomization until Follow-up or EOT or ET (Approximately 105 Weeks)

Secondary outcomes (5)

  1. Number of subjects with treatment-emergent adverse events

    Measured: Week 1 until Week 105

  2. Number of subjects with treatment-emergent serious adverse events

    Measured: Week 1 until Week 105

  3. Number of subjects with treatment-emergent adverse events of interest

    Measured: Week 1 until Week 105

  4. Number of subjects with anti-drug antibodies

    Measured: Predose on Week 1 (Baseline), Weeks 9, 17, 29, 41, 53, 65, 77, 89, 101 and Week 105

  5. Serum concentrations of ABP 206 and nivolumab (Ctrough)

    Measured: Predose on Week 1 (Baseline), Weeks 9, 17, 29, 41, 53, 65, 77, 89, 101 and Week 105

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted26 Sep 2023
  2. Study start2 Nov 2023
  3. Primary completion25 Jan 2028 (estimated)
  4. Study completion25 Jan 2028 (estimated)

Resources

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
633 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT06054555
Sponsor's protocol ID
20210031
Other IDs
2023-503288-40, 2023
Status last verified
Jan 2026
First submitted
20 Sep 2023
Last updated
12 Jan 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.

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing ABP 206 and Nivolumab in people with Melanoma, run by Amgen at 180 sites in 31 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 8 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: under way, not looking for participants, as of the sponsor's last update on 12 Jan 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 180 sites in Italy, Turkey (Türkiye), Mexico, Romania, Spain and 26 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?

This study is still under way. Results are not available in the source record yet.

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?

Objective response by Week 49 (time frame: Week 49). The study lists 5 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT06054555.

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 12 Jan 2026.

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