A Study to Evaluate Similarity of ABP 206 Compared With OPDIVO® (Nivolumab) in Subjects With Resected Melanoma

PHASE3Active, not recruitingINTERVENTIONAL
Enrollment

256

Participants

Timeline

Start Date

July 26, 2023

Primary Completion Date

October 4, 2025

Study Completion Date

November 30, 2025

Conditions
Melanoma
Interventions
DRUG

ABP 206

ABP 206 will be given intravenously over a period of 30 minutes, every 4 weeks (Q4W) for a total of 12 months.

DRUG

FDA-licensed Nivolumab

FDA-licensed Nivolumab will be given intravenously over a period of 30 minutes, Q4W for a total of 12 months.

DRUG

EU-authorized Nivolumab

FDA-licensed Nivolumab will be given intravenously over a period of 30 minutes, Q4W for a total of 12 months.

Trial Locations (111)

1125

Fundación CENIT, CABA

2000

Instituto de Oncologia de Rosario, Rosario

2193

Wits Clinical Research, Parktown, Johannesburg

2196

Medical Oncology Cent of Rosebank, Johannesburg

7570

Cape Town Oncology Trials, Kraaifontein

7600

CIMMDP, Mar del Plata

7700

Rondebosch Oncology Centre, Cape Town

10000

"KBC Sestre milosrdnice", Zagreb

Hanoi Oncology Hospital, Hanoi

10003

Hospital San Pedro de Alcántara, Cáceres

10117

Charité - Universitätsmedizin Berlin KöR, Berlin

10330

King Chulalongkorn Memorial Hospital [Medical Oncology], Bangkok

10700

Siriraj Hospital, Bangkok

11000

Military Medical Academy, Belgrade

11070

Specialized hospital Oncomed System, Belgrade

11696

Taipei Municipal Wanfang Hospital - Managed by Taipei Medical University, Taipei

14080

Oncare Viaducto Napoles, Mexico City

16150

Hospital Universiti Sains Malaysia, Kubang Kerian

18108

University Clinical Center Nis, Niš

20115

Centro de Inv Medica Aguascalientes, Aguascalientes

20132

Ospedale San Raffaele, IRCCS, Milan

20141

Istituto Europeo di Oncologia IRCCS, Milan

21079

CHU de Poitiers, Poitiers

21100

ASST Sette Laghi - Ospedale di Circolo Fondazione Macchi, Varese

21201

University of Maryland Medical Center-Greenebaum Cancer Ctr, Baltimore

21204

Vojvodina Institute for Oncology, Kamenitz

23561

Taipei Medical University - Shuang Ho Hospital Ministry of Health and Welfare, New Taipei City

24127

ASST Papa Giovanni XXIII, Bergamo

27100

Fondazione IRCCS Policlinico San Matteo, Pavia

28033

M.D. Anderson Center Madrid, Madrid

30120

H.U.V.Arrixaca, El Palmar

32804

AdventHealth, Orlando

34000

University Clinical Center Kragujevac, Kragujevac

40002

Khon Kaen University, Srinagarind Hospital, Khonkaen

40447

China Medical University Hospital - Internal Medicine, Taichung

41009

Hospital Universitario Virgen De La Macarena, Seville

44630

Centro Inmuno Oncolog de Occidente, Guadalajara

46014

Consorcio Hospital General Universitario de Valencia, Valencia

47014

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

48108

Inje University Haeundae Paik Hospital, Busan

50937

University Hospital Cologne AöR, Cologne

53100

Azienda ospedaliero Universitaria Senese - Policlinico Le Scotte, Siena

56000

Hospital Canselor Tuanku Muhriz UKM, Kuala Lumpur

62250

Institut Kanser Negara, Putrajaya

64710

I CAN ONCOLOGY CENTER SA de CV, Monterrey

66278

Althian Research Management Center, San Pedro Garza García

Centro Medico Zambrano Hellion, San Pedro Garza García

70000

HCM Oncology Hospital, Ho Chi Minh City

70124

"Istituto dei Tumori Giovanni Paolo II", Bari

71000

Clinical Center University of Sarajevo, Sarajevo

72000

Cantonal hospital Zenica, Zenica

72530

Clinica Integral Internac Oncologia, Puebla City

75000

University Clinical Center Tuzla, Tuzla

78000

University Clinical Centre of the Republic of Srpska - Gastroenterology, Banja Luka

78200

Ctro At Inv Cardio Potosi, San Luis Potosí City

80131

Azienda Ospedaliera Universitaria Federico II, Napoli

88000

University Clinical Hospital Mostar, Mostar

90110

Prince of Songkla University - Faculty of Medicine, Songkhla

90806

Cancer and Blood Specialty Clinic, Long Beach

92104

Hopital Ambroise Paré - Dermatologie, Boulogne-Billancourt

93586

Hospital Umum Sarawak, Kuching

97134

Centro De Atenc E Inv Clín En Onco, Mérida

100000

Vietnam National Cancer Hopsital, Hanoi

400015

Arensia - Iocn, Cluj-Napoca

2520612

Oncocentro APYS, Viña del Mar

7500653

Centro de Estudios Clínicos SAGA SpA, Santiago

90502-2004

The Lundquist Institute - Main, Torrance

59102-6746

St. Vincent Frontier Cancer Crt, Billings

R8500ACE

Clínica Viedma, Viedma

S3000FFU

ISIS Clinica Especializada, Santa Fe

60140-025

Centro de Oncologia Leonardo da Vinci -ATO Oncologia, Fortaleza

Unknown

Hospital Sao Rafael, Salvador

Instituto de Oncologia do Parana, Curitiba

Hospital Pulau Pinang, Pulau Pinang

Hospital Umum Sarawak, Kuching

Hospital Kuala Lumpur, Kuala Lumpur

Clinical Research Institute S.C., Tlalnepantla

Institute for Oncology and Radiology of Serbia, Belgrade

70200 730

Hospital Sirio Libanes - Brasilia, Brasília

66063-495

Centro de Tratamento Oncologico, Belém

90610-000

Hospital Sao Lucas da PUCRS, Porto Alegre

888034-000

CEPON - Centro de Pesquisas Oncológicas, Florianópolis

14784 400

Hospital de Cancer de Barretos, Barretos

15090-000

Fac Med de Sao Jose do Rio Preto, São José do Rio Preto

CEP 04501-000

Hospital e Maternidade Brasil, São Paulo

20231-050

Instituto Nacional de Câncer - INCA, Rio de Janeiro

10 000

University Hospital Centre Zagreb, Zagreb

0112

ISR-GEO Med Res Clin Healthycore, Tbilisi

"LLC Todua Clinic", Tbilisi

0159

JSC KE Nat Ctr of Exp and Clin Surg, Tbilisi

07548

SRH Wald-Klinikum Gera gGmbH, Gera

00167

Istituto Dermopatico dell'Immacolata (IDI) - IRCCS, Roma

467-8601

Nagoya City University Hospital - Dermatology, Nagoya

060-8543

Sapporo Medical University Hospital, Sapporo

892-0853

NHO Kagoshima Medical Center, Kagoshima

135-8550

Shizuoka Cancer Center - Dermatology, Kōtoku

160-8582

Keio University Hospital - Dermatology, Shinjuku-ku

860-8556

Kumamoto University Hospital - Dermatology, Kumamoto

951-8566

Niigata Cancer Center Hospital, Niigata

541-8567

Osaka International Cancer Institute - Dermatological Oncology, Osaka

MD-2025

IMSP Institutul Oncologic, ARENSIA, Chisinau

4818 CK

Amphia Ziekenhuis (Amphia Hospital Breda) - Locatie Molengracht, Breda

022328

Arensia - Iob, Bucharest

0181

Mary Potter Oncology Centre, Pretoria

03722

Severance Hospital, Yonsei University Health System, Seoul

05505

Asan Medical Center, Seoul

06351

Samsung Medical Center, Seoul

08916

Institut Català d'Oncologia-Hospital Universitari Germans Trias i Pujol, Badalona

08025

Hospital de La Santa Creu i Sant Pau, Barcelona

08035

Hospital Universitari Vall D Hebron, Barcelona

08036

Hospital Clinic De Barcelona, Barcelona

Sponsors

Lead Sponsor

All Listed Sponsors
lead

Amgen

INDUSTRY