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New biosimilar aims to match opdivo for melanoma

NCT ID NCT05907122

Disease control Sponsor: Amgen Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed This study
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 26, 2026 · Last updated Jun 27, 2026 · Updated 1 time

Summary

This phase 3 trial tested whether ABP 206, a biosimilar to the cancer drug nivolumab (Opdivo), works similarly in people with advanced melanoma that has been surgically removed. 256 participants received either ABP 206 or Opdivo every 4 weeks for a year. The goal was to see if the drug levels in the blood were comparable, not to prove it cures the disease.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance
ABP 206 (a biosimilar to nivolumab)
What this could lead to
If successful, ABP 206 could offer a more affordable treatment option for advanced melanoma after surgery.
What could go wrong
This is a similarity study, not a test of new effectiveness. ABP 206 may not prove as effective or safe as Opdivo in the long run.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Phase 3

Large-scale testing in a bigger group. Usually the last step before a treatment can be approved.

Participants

256 people

The number who actually took part.

Started

Jul 2023

Finished

Oct 2025

Lead sponsor

A company

The lead sponsor is a pharmaceutical, biotech, or medical-device company.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

18 to 99 years

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

Inclusion Criteria: * 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 Exclusion Criteria: * 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

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Conditions

The condition(s) this trial relates to.

melanoma

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Melanoma

Contacts and locations

Locations

  • ATO Oncologia

    Fortaleza, Ceará, 60140-025, Brazil

  • Althian - Research Management Center

    San Pedro Garza García, Nuevo León, 66278, Mexico

  • Amphia Hospital - unspecified

    Breda, North Brabant, 4818 CK, Netherlands

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

    Chisinau, Moldova, Republic of, MD-2025, Moldova

  • Arensia Exploratory Medicine - Romania - Institutul Oncologic Prof Dr Alexandru Trestioreanu Bucures

    Bucharest, 022328, Romania

  • Arensia Exploratory Medicine - Romania - Institutul Oncologic Prof Dr Ion Chiricuta Cluj-Napoca - On

    Cluj-Napoca, Cluj, 400015, Romania

  • Asan Medical Center - Oncology

    Seoul, Seoul Teugbyeolsi [Seoul-T'ukp, 05505, South Korea

  • Azienda Ospedaliera Universitaria Federico II

    Naples, 80131, Italy

  • CEPON - Centro de Pesquisas Oncológicas

    Florianópolis, Santa Catarina, 888034-000, Brazil

  • Cancer and Blood Specialty clinic

    Long Beach, California, 90806, United States

  • Cancercare - Rondebosch Oncology

    Cape Town, Western Cape, 7700, South Africa

  • Cantonal hospital Zenica - Oncology

    Zenica, Zeničko-dobojski Kanton, 72000, Bosnia and Herzegovina

  • Cape Gate Oncology Centre

    Cape Town, Western Cape, 7570, South Africa

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

    Mar Del Plata, Río Negro Province, 7600, Argentina

  • Centro de Inm Onc de Occ Sa de Cv

    Guadalajra, Jalisco, 44630, Mexico

  • China Medical University Hospital - Internal Medicine

    Taichung, Taichung Municipality, 40447, Taiwan

  • Clinical Center University of Sarajevo - Clinic of Oncology

    Sarajevo, Kanton Sarajevo, 71000, Bosnia and Herzegovina

  • Clinical Research Institute

    Tlalnepantla, 54055, Mexico

  • Consorcio Hospital General Universitario de Valencia - Oncología

    Valencia, 46014, Spain

  • Cto Centro de Tratamento Oncologico Ltda

    Belém, Pará, 66063-495, Brazil

  • Faculdade de Medicina de Sao Jose do Rio Preto-SP (FAMERP) - Hospital de Base (HB) - Oncology

    São Paulo, 15090-000, Brazil

  • Fundacao Pio XII - Hospital de Cancer de Barretos - Hospital de Amor

    Barretos, São Paulo, 14784 400, Brazil

  • H.U.V.Arrixaca - Oncología

    El Palmar, Murcia, Región de, 30120, Spain

  • HCM Oncology Hospital - Medical Oncology

    Ho Chi Minh City, Ho Chi Minh, Thanh Pho [Sai Go, 70000, Vietnam

  • Hospital Angeles Centro Médico San Luis Potosí - Cardiologia

    San Luis Potosí City, San Luis Potosí, 78200, Mexico

  • Hospital Canselor Tuanku Muhriz UKM

    Kuala Lumpur, Wilayah Persekutuan Kuala Lump, 56000, Malaysia

  • Hospital HLA Jerez Puerta Sur

    Seville, 41009, Spain

  • Hospital Kuala Lumpur - Surgery

    Kuala Lumpur, Wilayah Persekutuan Kuala Lump, 00000, Malaysia

  • Hospital Pulau Pinang - Rheumatology

    Pulau Pinang, Pahang, 00000, Malaysia

  • Hospital San Pedro de Alcántara - Oncología

    Cáceres, Cáceres, 10003, Spain

  • Hospital Sao Rafael

    Salvador, Estado de Bahia, 41256900, Brazil

  • Hospital Sirio Libanes - Brasilia - Oncology

    Brasília, Federal District, 70200 730, Brazil

  • Hospital Umum Sarawak

    Kuching, Sarawak, 93586, Malaysia

  • Hospital Universiti Sains Malaysia

    Kubang Kerian, Terengganu, 16150, Malaysia

  • Hospital de la Santa Creu i Sant Pau - Oncología Médica

    Barcelona, 08041, Spain

  • Inje University Haeundae Paik Hospital - Oncology

    Busan, Busan Gwang'yeogsi [Pusan-Kwan, 48108, South Korea

  • Institute for Oncology and Radiology of Serbia, Department for Lung Cancer

    Belgrade, 11000, Serbia

  • Instituto de Oncologia do Parana

    Curitiba, Paraná, 80040170, Brazil

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

    Roma, 00167, Italy

  • Istituto Romagnolo Per Lo Studio Dei Tumori Dino Amadori IRST S.R.L

    Meldola, Forli, 47014, Italy

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

    Tbilisi, 0159, Georgia

  • Keio University Hospital - Dermatology

    Shinjuku-ku, Tôkyô [Tokyo], 160-8582, Japan

  • Khon Kaen University, Srinagarind Hospital - Academic Clinical Research Office (ACRO)

    Khonkaen, Changwat Khon Kaen, 40002, Thailand

  • King Chulalongkorn Memorial Hospital [Medical Oncology]

    Bangkok, Krung Thep Maha Nakhon [Bangko, 10330, Thailand

  • Klinicki bolnicki centar "Sestre milosrdnice" - Pediatrics

    Grad Zagreb, City of Zagreb, 10000, Croatia

  • Kumamoto University Hospital - Dermatology

    Kumamoto, 860-8556, Japan

  • LTD "Israel-Georgian Medical Research Clinic Healthycore"

    Tbilisi, 0112, Georgia

  • Mary Potter Oncology Centre

    Pretoria, Gauteng, 0181, South Africa

  • Nagoya City University Hospital - Dermatology

    Nagoya, Aiti [Aichi], 467-8601, Japan

  • National Cancer Institute - Conservative Tumour Therapy

    Vilnius, Vilnius County, LT-08660, Lithuania

  • National Cancer Institute - Radiotherapy and Oncology

    Putrajaya, Selangor, 62250, Malaysia

  • National Hospital Organization Kagoshima Medical Center - Haematology

    Kagoshima, Kagosima [Kagoshima], 892-0853, Japan

  • Niigata Cancer Center Hospital - Dermatology

    Niigata, 951-8566, Japan

  • ONCOCENTER PUEBLA - Dermatology

    Puebla City, 72530, Mexico

  • Oncocentro Apys

    Valparaíso, Valparaiso, 2363058, Chile

  • Osaka International Cancer Institute - Dermatological Oncology

    Osaka, Ôsaka [Osaka], 541-8567, Japan

  • PUCRS - Hospital Sao Lucas - Uniao Brasileira de Educacao e Assistence

    Porto Alegre, Rio Grande do Sul, 90610-000, Brazil

  • Policlinico Santa Maria alle Scotte, Azienda Ospedaliero Universitaria Senese - Immunoterapia Oncolo

    Siena, 53100, Italy

  • Prince of Songkla University

    Songkhla, Changwat Songkhla, 90110, Thailand

  • Samsung Medical Center - Family Medicine

    Seoul, Seoul Teugbyeolsi [Seoul-T'ukp, 06351, South Korea

  • Sapporo Medical University Hospital

    Sapporo, Hokkaidô [Hokkaido], 060-8543, Japan

  • Severance Hospital, Yonsei University Health System - Division of Medical Oncology, Department of In

    Seoul, Seoul Teugbyeolsi [Seoul-T'ukp, 03722, South Korea

  • Shizuoka Cancer Center - Dermatology

    Kōtoku, Tôkyô [Tokyo], 135-8550, Japan

  • Siriraj Hospital - Medical Oncology

    Bangkok, Krung Thep Maha Nakhon [Bangko, 10700, Thailand

  • St. Vincent Frontier Cancer Center - Oncology

    Billings, Montana, 59102-6746, United States

  • Taipei Medical University - Shuang Ho Hospital Ministry of Health and Welfare

    New Taipei City, Taipei, 23561, Taiwan

  • The Catholic University of Korea, St. Vincent's Hospital

    Suwon, Gyeonggido [Kyonggi-do], 16247, South Korea

  • The Medical Oncology Centre of Rosebank

    Johannesburg, Gauteng, 2196, South Africa

  • University Clinical Center Tuzla - Oncology, Hematology and Radio

    Tuzla, Tuzlanski Kanton, 75000, Bosnia and Herzegovina

  • University Clinical Center of Kragujevac, Center for Internal Oncology

    Kragujevac, Šumadijski Okrug, 34000, Serbia

  • University Clinical Center of Nis, Clinic for Oncology

    Niš, Nišavski Okrug, 18108, Serbia

  • University Clinical Centre of the Republic of Srpska - Gastroenterology

    Banja Luka, Republika Srpska, 78000, Bosnia and Herzegovina

  • University Clinical Hospital Mostar - Clinic for Lung Diseases

    Mostar, 88000, Bosnia and Herzegovina

  • University Hospital Centre Zagreb - Oncology department

    Zagreb, City of Zagreb, 10 000, Croatia

  • Vietnam National Cancer Hopsital

    Hanoi, Ha Noi, Thu Do, 100000, Vietnam

  • Wits Clinical Research

    Parktown, Johannesburg, Gauteng, 2193, South Africa

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Other studies related to the condition(s) this trial covers.