Trial Title:
A Study to Evaluate Similarity of ABP 206 Compared With OPDIVO® (Nivolumab) in Subjects With Resected Melanoma
NCT ID:
NCT05907122
Condition:
Melanoma
Conditions: Official terms:
Melanoma
Nivolumab
Conditions: Keywords:
Pharmacokinetic similarity study
Adjuvant melanoma treatment
Advanced Melanoma
Study type:
Interventional
Study phase:
Phase 3
Overall status:
Recruiting
Study design:
Allocation:
Randomized
Intervention model:
Parallel Assignment
Primary purpose:
Treatment
Masking:
Double (Participant, Investigator)
Masking description:
The study is double-blinded; therefore, the investigators, study personnel (with the
exception of the data monitoring committee, authorized unblinded sponsor and contract
research organization staff, and unblinded site pharmacy staff), and the study subjects
will remain blinded to treatment allocation. ABP 206 and nivolumab will be coded and
labeled to protect blinding.
Intervention:
Intervention type:
Drug
Intervention name:
ABP 206
Description:
ABP 206 will be given intravenously over a period of 30 minutes, every 4 weeks (Q4W) for
a total of 12 months.
Arm group label:
ABP 206
Intervention type:
Drug
Intervention name:
FDA-licensed Nivolumab
Description:
FDA-licensed Nivolumab will be given intravenously over a period of 30 minutes, Q4W for a
total of 12 months.
Arm group label:
FDA-licensed Nivolumab
Other name:
OPDIVO®
Intervention type:
Drug
Intervention name:
EU-authorized Nivolumab
Description:
FDA-licensed Nivolumab will be given intravenously over a period of 30 minutes, Q4W for a
total of 12 months.
Arm group label:
EU-authorized Nivolumab
Other name:
OPDIVO®
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.
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.
Criteria for eligibility:
Criteria:
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
Gender:
All
Minimum age:
18 Years
Maximum age:
99 Years
Healthy volunteers:
No
Locations:
Facility:
Name:
Cancer and Blood Specialty Clinic
Address:
City:
Long Beach
Zip:
90806
Country:
United States
Status:
Recruiting
Facility:
Name:
The Lundquist Institute - Main
Address:
City:
Torrance
Zip:
90502-2004
Country:
United States
Status:
Recruiting
Facility:
Name:
AdventHealth
Address:
City:
Orlando
Zip:
32804
Country:
United States
Status:
Recruiting
Facility:
Name:
University of Maryland Medical Center-Greenebaum Cancer Ctr
Address:
City:
Baltimore
Zip:
21201
Country:
United States
Status:
Recruiting
Facility:
Name:
St. Vincent Frontier Cancer Crt
Address:
City:
Billings
Zip:
59102-6746
Country:
United States
Status:
Recruiting
Facility:
Name:
Clínica Viedma
Address:
City:
Viedma
Zip:
R8500ACE
Country:
Argentina
Status:
Recruiting
Facility:
Name:
Fundación CENIT
Address:
City:
Caba
Zip:
1125
Country:
Argentina
Status:
Recruiting
Facility:
Name:
CIMMDP
Address:
City:
Mar del Plata
Zip:
7600
Country:
Argentina
Status:
Recruiting
Facility:
Name:
Instituto de Oncologia de Rosario
Address:
City:
Rosario
Zip:
2000
Country:
Argentina
Status:
Recruiting
Facility:
Name:
ISIS Clinica Especializada
Address:
City:
Santa Fe
Zip:
S3000FFU
Country:
Argentina
Status:
Recruiting
Facility:
Name:
University Clinical Centre of the Republic of Srpska - Gastroenterology
Address:
City:
Banjaluka
Zip:
78000
Country:
Bosnia and Herzegovina
Status:
Recruiting
Facility:
Name:
University Clinical Hospital Mostar
Address:
City:
Mostar
Zip:
88000
Country:
Bosnia and Herzegovina
Status:
Recruiting
Facility:
Name:
Clinical Center University of Sarajevo
Address:
City:
Sarajevo
Zip:
71000
Country:
Bosnia and Herzegovina
Status:
Recruiting
Facility:
Name:
University Clinical Center Tuzla
Address:
City:
Tuzla
Zip:
75000
Country:
Bosnia and Herzegovina
Status:
Recruiting
Facility:
Name:
Cantonal hospital Zenica
Address:
City:
Zenica
Zip:
72000
Country:
Bosnia and Herzegovina
Status:
Recruiting
Facility:
Name:
Hospital Sao Rafael
Address:
City:
Salvador
Country:
Brazil
Status:
Recruiting
Facility:
Name:
Centro de Oncologia Leonardo da Vinci -ATO Oncologia
Address:
City:
Fortaleza
Zip:
60140-025
Country:
Brazil
Status:
Recruiting
Facility:
Name:
Hospital Sirio Libanes - Brasilia
Address:
City:
Brasilia
Zip:
70200 730
Country:
Brazil
Status:
Recruiting
Facility:
Name:
Centro de Tratamento Oncologico
Address:
City:
Belém
Zip:
66063-495
Country:
Brazil
Status:
Recruiting
Facility:
Name:
Hospital Sao Lucas da PUCRS
Address:
City:
Porto Alegre
Zip:
90610-000
Country:
Brazil
Status:
Recruiting
Facility:
Name:
CEPON - Centro de Pesquisas Oncológicas
Address:
City:
Florianopolis
Zip:
888034-000
Country:
Brazil
Status:
Recruiting
Facility:
Name:
Hospital de Cancer de Barretos
Address:
City:
Barretos
Zip:
14784 400
Country:
Brazil
Status:
Recruiting
Facility:
Name:
Hospital e Maternidade Brasil
Address:
City:
Sao Paulo
Zip:
CEP 04501-000
Country:
Brazil
Status:
Recruiting
Facility:
Name:
Fac Med de Sao Jose do Rio Preto
Address:
City:
São José do Rio Preto
Zip:
15090-000
Country:
Brazil
Status:
Recruiting
Facility:
Name:
Instituto de Oncologia do Parana
Address:
City:
Curitiba
Country:
Brazil
Status:
Recruiting
Facility:
Name:
Instituto Nacional de Câncer - INCA
Address:
City:
Rio de Janeiro
Zip:
20231-050
Country:
Brazil
Status:
Recruiting
Facility:
Name:
Centro de Estudios Clínicos SAGA SpA
Address:
City:
Santiago
Zip:
7500653
Country:
Chile
Status:
Recruiting
Facility:
Name:
Oncocentro APYS
Address:
City:
Viña Del Mar
Zip:
2520612
Country:
Chile
Status:
Recruiting
Facility:
Name:
University Hospital Centre Zagreb
Address:
City:
Zagreb
Zip:
10 000
Country:
Croatia
Status:
Recruiting
Facility:
Name:
KBC "Sestre milosrdnice"
Address:
City:
Zagreb
Zip:
10000
Country:
Croatia
Status:
Recruiting
Facility:
Name:
Hôpital F Mitterrand - Dermatology
Address:
City:
Dijon
Zip:
21000
Country:
France
Status:
Completed
Facility:
Name:
CHU de Bordeaux - Hopital Saint André
Address:
City:
Bordeaux
Zip:
33000
Country:
France
Status:
Completed
Facility:
Name:
CHU de Poitiers
Address:
City:
Poitiers
Zip:
21079
Country:
France
Status:
Recruiting
Facility:
Name:
Hopital Ambroise Paré - Dermatologie
Address:
City:
Boulogne Billancourt cedex
Zip:
92104
Country:
France
Status:
Completed
Facility:
Name:
ISR-GEO Med Res Clin Healthycore
Address:
City:
Tbilisi
Zip:
0112
Country:
Georgia
Status:
Recruiting
Facility:
Name:
LLC "Todua Clinic"
Address:
City:
Tbilisi
Zip:
0112
Country:
Georgia
Status:
Recruiting
Facility:
Name:
JSC KE Nat Ctr of Exp and Clin Surg
Address:
City:
Tbilisi
Zip:
0159
Country:
Georgia
Status:
Recruiting
Facility:
Name:
Goethe University Hospital Frankfurt
Address:
City:
Frankfurt/Main
Zip:
60590
Country:
Germany
Status:
Recruiting
Facility:
Name:
University Hospital Cologne AöR
Address:
City:
Köln
Zip:
50937
Country:
Germany
Status:
Recruiting
Facility:
Name:
SRH Wald-Klinikum Gera gGmbH
Address:
City:
Gera
Zip:
07548
Country:
Germany
Status:
Recruiting
Facility:
Name:
Charité - Universitätsmedizin Berlin KöR
Address:
City:
Berlin
Zip:
10117
Country:
Germany
Status:
Recruiting
Facility:
Name:
Istituto Romagnolo Per Lo Studio Dei Tumori Dino Amadori IRST S.R.L
Address:
City:
Meldola
Zip:
47014
Country:
Italy
Status:
Recruiting
Facility:
Name:
Istituto dei Tumori "Giovanni Paolo II"
Address:
City:
Bari
Zip:
70124
Country:
Italy
Status:
Recruiting
Facility:
Name:
ASST Papa Giovanni XXIII
Address:
City:
Bergamo
Zip:
24127
Country:
Italy
Status:
Recruiting
Facility:
Name:
Ospedale San Raffaele, IRCCS
Address:
City:
Milano
Zip:
20132
Country:
Italy
Status:
Recruiting
Facility:
Name:
Istituto Europeo di Oncologia IRCCS
Address:
City:
Milano
Zip:
20141
Country:
Italy
Status:
Recruiting
Facility:
Name:
Azienda Ospedaliera Universitaria Federico II
Address:
City:
Napoli
Zip:
80131
Country:
Italy
Status:
Recruiting
Facility:
Name:
Fondazione IRCCS Policlinico San Matteo
Address:
City:
Pavia
Zip:
27100
Country:
Italy
Status:
Recruiting
Facility:
Name:
Istituto Dermopatico dell'Immacolata (IDI) - IRCCS
Address:
City:
Roma
Zip:
00167
Country:
Italy
Status:
Recruiting
Facility:
Name:
Azienda ospedaliero Universitaria Senese - Policlinico Le Scotte
Address:
City:
Siena
Zip:
53100
Country:
Italy
Status:
Recruiting
Facility:
Name:
ASST Sette Laghi - Ospedale di Circolo Fondazione Macchi
Address:
City:
Varese
Zip:
21100
Country:
Italy
Status:
Recruiting
Facility:
Name:
Nagoya City University Hospital - Dermatology
Address:
City:
Nagoya
Zip:
467-8601
Country:
Japan
Status:
Recruiting
Facility:
Name:
Sapporo Medical University Hospital
Address:
City:
Sapporo-Shi
Zip:
060-8543
Country:
Japan
Status:
Recruiting
Facility:
Name:
NHO Kagoshima Medical Center
Address:
City:
Kagoshima-Shi
Zip:
892-0853
Country:
Japan
Status:
Recruiting
Facility:
Name:
Shizuoka Cancer Center - Dermatology
Address:
City:
Koto-Ku
Zip:
135-8550
Country:
Japan
Status:
Recruiting
Facility:
Name:
Keio University Hospital - Dermatology
Address:
City:
Shinjuku-ku
Zip:
160-8582
Country:
Japan
Status:
Recruiting
Facility:
Name:
Kumamoto University Hospital - Dermatology
Address:
City:
Kumamoto
Zip:
860-8556
Country:
Japan
Status:
Recruiting
Facility:
Name:
Niigata Cancer Center Hospital
Address:
City:
Niigata
Zip:
951-8566
Country:
Japan
Status:
Recruiting
Facility:
Name:
Osaka International Cancer Institute - Dermatological Oncology
Address:
City:
Osaka-shi
Zip:
541-8567
Country:
Japan
Status:
Recruiting
Facility:
Name:
Inje University Haeundae Paik Hospital
Address:
City:
Busan
Zip:
48108
Country:
Korea, Republic of
Status:
Recruiting
Facility:
Name:
Severance Hospital, Yonsei University Health System
Address:
City:
Seoul
Zip:
03722
Country:
Korea, Republic of
Status:
Recruiting
Facility:
Name:
Asan Medical Center
Address:
City:
Seoul
Zip:
05505
Country:
Korea, Republic of
Status:
Recruiting
Facility:
Name:
Samsung Medical Center
Address:
City:
Seoul
Zip:
06351
Country:
Korea, Republic of
Status:
Recruiting
Facility:
Name:
Hospital Universiti Sains Malaysia
Address:
City:
Kubang Kerian
Zip:
16150
Country:
Malaysia
Status:
Recruiting
Facility:
Name:
Hospital Pulau Pinang
Address:
City:
Pulau Pinang
Country:
Malaysia
Status:
Recruiting
Facility:
Name:
Hospital Umum Sarawak
Address:
City:
Kuching
Country:
Malaysia
Status:
Recruiting
Facility:
Name:
Institut Kanser Negara
Address:
City:
Putrajaya
Zip:
62250
Country:
Malaysia
Status:
Recruiting
Facility:
Name:
Hospital Canselor Tuanku Muhriz UKM
Address:
City:
Kuala Lumpur
Zip:
56000
Country:
Malaysia
Status:
Recruiting
Facility:
Name:
Hospital Kuala Lumpur
Address:
City:
Kuala Lumpur
Country:
Malaysia
Status:
Recruiting
Facility:
Name:
Centro Inmuno Oncolog de Occidente
Address:
City:
Guadalajara
Zip:
44630
Country:
Mexico
Status:
Recruiting
Facility:
Name:
I CAN ONCOLOGY CENTER SA de CV
Address:
City:
Monterrey
Zip:
64710
Country:
Mexico
Status:
Recruiting
Facility:
Name:
Ctro At Inv Cardio Potosi
Address:
City:
San Luis Potosi
Zip:
78200
Country:
Mexico
Status:
Recruiting
Facility:
Name:
Centro De Atenc E Inv Clín En Onco
Address:
City:
Merida
Zip:
97134
Country:
Mexico
Status:
Recruiting
Facility:
Name:
Centro de Inv Medica Aguascalientes
Address:
City:
Aguascalientes
Zip:
20115
Country:
Mexico
Status:
Recruiting
Facility:
Name:
Oncare Viaducto Napoles
Address:
City:
Mexico City
Zip:
14080
Country:
Mexico
Status:
Recruiting
Facility:
Name:
Clinica Integral Internac Oncologia
Address:
City:
Puebla
Zip:
72530
Country:
Mexico
Status:
Recruiting
Facility:
Name:
Althian Research Management Center
Address:
City:
San Pedro Garza Garcia
Zip:
66278
Country:
Mexico
Status:
Recruiting
Facility:
Name:
Centro Medico Zambrano Hellion
Address:
City:
San Pedro Garza García
Zip:
66278
Country:
Mexico
Status:
Recruiting
Facility:
Name:
Clinical Research Institute S.C.
Address:
City:
Tlalnepantla de Baz
Country:
Mexico
Status:
Recruiting
Facility:
Name:
IMSP Institutul Oncologic, ARENSIA
Address:
City:
Chisinau
Zip:
MD-2025
Country:
Moldova, Republic of
Status:
Recruiting
Facility:
Name:
Amphia Ziekenhuis (Amphia Hospital Breda) - Locatie Molengracht
Address:
City:
Breda
Zip:
4818 CK
Country:
Netherlands
Status:
Recruiting
Facility:
Name:
Arensia - Iocn
Address:
City:
Cluj-Napoca
Zip:
400015
Country:
Romania
Status:
Recruiting
Facility:
Name:
Arensia - Iob
Address:
City:
Bucuresti
Zip:
022328
Country:
Romania
Status:
Recruiting
Facility:
Name:
Vojvodina Institute for Oncology
Address:
City:
Sremska Kamenica
Zip:
21204
Country:
Serbia
Status:
Recruiting
Facility:
Name:
Military Medical Academy
Address:
City:
Belgrade
Zip:
11000
Country:
Serbia
Status:
Recruiting
Facility:
Name:
Specialized hospital Oncomed System
Address:
City:
Belgrade
Zip:
11070
Country:
Serbia
Status:
Recruiting
Facility:
Name:
Institute for Oncology and Radiology of Serbia
Address:
City:
Beograd
Country:
Serbia
Status:
Recruiting
Facility:
Name:
University Clinical Center Kragujevac
Address:
City:
Kragujevac
Zip:
34000
Country:
Serbia
Status:
Recruiting
Facility:
Name:
University Clinical Center Nis
Address:
City:
Nis
Zip:
18108
Country:
Serbia
Status:
Recruiting
Facility:
Name:
Medical Oncology Cent of Rosebank
Address:
City:
Johannesburg
Zip:
2196
Country:
South Africa
Status:
Recruiting
Facility:
Name:
Wits Clinical Research
Address:
City:
Parktown, Johannesburg
Zip:
2193
Country:
South Africa
Status:
Recruiting
Facility:
Name:
Mary Potter Oncology Centre
Address:
City:
Pretoria
Zip:
0181
Country:
South Africa
Status:
Recruiting
Facility:
Name:
Rondebosch Oncology Centre
Address:
City:
Cape Town
Zip:
7700
Country:
South Africa
Status:
Recruiting
Facility:
Name:
Cape Town Oncology Trials
Address:
City:
Kraaifontein
Zip:
7570
Country:
South Africa
Status:
Recruiting
Facility:
Name:
Hospital Universitario Virgen De La Macarena
Address:
City:
Sevilla
Zip:
41009
Country:
Spain
Status:
Recruiting
Facility:
Name:
Institut Català d'Oncologia-Hospital Universitari Germans Trias i Pujol
Address:
City:
Badalona
Zip:
08916
Country:
Spain
Status:
Recruiting
Facility:
Name:
Hospital San Pedro de Alcántara
Address:
City:
Caceres
Zip:
10003
Country:
Spain
Status:
Recruiting
Facility:
Name:
M.D. Anderson Center Madrid
Address:
City:
Madrid,
Zip:
28033
Country:
Spain
Status:
Recruiting
Facility:
Name:
H.U.V.Arrixaca
Address:
City:
El Palmar
Zip:
30120
Country:
Spain
Status:
Recruiting
Facility:
Name:
Hospital de La Santa Creu i Sant Pau
Address:
City:
Barcelona
Zip:
08025
Country:
Spain
Status:
Recruiting
Facility:
Name:
Hospital Universitari Vall D Hebron
Address:
City:
Barcelona
Zip:
08035
Country:
Spain
Status:
Recruiting
Facility:
Name:
Hospital Clinic De Barcelona
Address:
City:
Barcelona
Zip:
08036
Country:
Spain
Status:
Recruiting
Facility:
Name:
Consorcio Hospital General Universitario de Valencia
Address:
City:
Valencia
Zip:
46014
Country:
Spain
Status:
Recruiting
Facility:
Name:
China Medical University Hospital - Internal Medicine
Address:
City:
Taichung
Zip:
40447
Country:
Taiwan
Status:
Recruiting
Facility:
Name:
Taipei Medical University - Shuang Ho Hospital Ministry of Health and Welfare
Address:
City:
New Taipei City
Zip:
23561
Country:
Taiwan
Status:
Recruiting
Facility:
Name:
Taipei Municipal Wanfang Hospital - Managed by Taipei Medical University
Address:
City:
Taipei
Zip:
11696
Country:
Taiwan
Status:
Recruiting
Facility:
Name:
Khon Kaen University, Srinagarind Hospital
Address:
City:
Khonkaen
Zip:
40002
Country:
Thailand
Status:
Recruiting
Facility:
Name:
King Chulalongkorn Memorial Hospital [Medical Oncology]
Address:
City:
Bangkok
Zip:
10330
Country:
Thailand
Status:
Recruiting
Facility:
Name:
Siriraj Hospital
Address:
City:
Bangkok
Zip:
10700
Country:
Thailand
Status:
Recruiting
Facility:
Name:
Prince of Songkla University - Faculty of Medicine
Address:
City:
Songkhla
Zip:
90110
Country:
Thailand
Status:
Recruiting
Facility:
Name:
Vietnam National Cancer Hopsital
Address:
City:
Hanoi
Zip:
100000
Country:
Vietnam
Status:
Recruiting
Facility:
Name:
Hanoi Oncology Hospital
Address:
City:
Hanoi
Zip:
10000
Country:
Vietnam
Status:
Recruiting
Facility:
Name:
HCM Oncology Hospital
Address:
City:
Ho Chi Minh
Zip:
70000
Country:
Vietnam
Status:
Recruiting
Start date:
July 26, 2023
Completion date:
November 30, 2025
Lead sponsor:
Agency:
Amgen
Agency class:
Industry
Source:
Amgen
Record processing date:
ClinicalTrials.gov processed this data on November 12, 2024
Source: ClinicalTrials.gov page:
https://clinicaltrials.gov/ct2/show/NCT05907122
http://www.amgentrials.com
