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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/study/NCT06054555




Registration number
NCT06054555
Ethics application status
Date submitted
20/09/2023
Date registered
26/09/2023

Titles & IDs
Public title
A Study to Evaluate ABP 206 Compared With OPDIVO® (Nivolumab) in Subjects With Unresectable or Metastatic Melanoma
Scientific 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
Secondary ID [1] 0 0
2023-503288-40
Secondary ID [2] 0 0
20210031
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Melanoma 0 0
Condition category
Condition code
Cancer 0 0 0 0
Malignant melanoma

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Treatment: Drugs - ABP 206
Treatment: Drugs - Nivolumab

Experimental: ABP 206 - Subjects will receive Dose A of ABP 206 via intravenous (IV) infusion.

Active comparator: Nivolumab - Subjects will receive Dose A of Nivolumab via IV infusion.


Treatment: Drugs: ABP 206
ABP 206 will be given intravenously over a period of 30 or 60 minutes, every 4 weeks (Q4W) for a total of 24 months.

Treatment: Drugs: Nivolumab
Nivolumab will be given intravenously over a period of 30 or 60 minutes, Q4W for a total of 24 months.
Intervention code [1] 0 0
Treatment: Drugs
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Objective response by Week 49
Timepoint [1] 0 0
Week 49
Primary outcome [2] 0 0
Objective response at Week 17
Timepoint [2] 0 0
Week 17
Primary outcome [3] 0 0
Progression-free survival (PFS)
Timepoint [3] 0 0
From Randomization until Follow-up or End of treatment (EOT) or Early termination (ET) (Approximately 105 Weeks)
Primary outcome [4] 0 0
Overall survival (OS)
Timepoint [4] 0 0
From Randomization until Follow-up or EOT or ET (Approximately 105 Weeks)
Primary outcome [5] 0 0
Duration of response (DOR)
Timepoint [5] 0 0
From Randomization until Follow-up or EOT or ET (Approximately 105 Weeks)
Secondary outcome [1] 0 0
Number of subjects with treatment-emergent adverse events
Timepoint [1] 0 0
Week 1 until Week 105
Secondary outcome [2] 0 0
Number of subjects with treatment-emergent serious adverse events
Timepoint [2] 0 0
Week 1 until Week 105
Secondary outcome [3] 0 0
Number of subjects with treatment-emergent adverse events of interest
Timepoint [3] 0 0
Week 1 until Week 105
Secondary outcome [4] 0 0
Number of subjects with anti-drug antibodies
Timepoint [4] 0 0
Predose on Week 1 (Baseline), Weeks 9, 17, 29, 41, 53, 65, 77, 89, 101 and Week 105
Secondary outcome [5] 0 0
Serum concentrations of ABP 206 and nivolumab (Ctrough)
Timepoint [5] 0 0
Predose on Week 1 (Baseline), Weeks 9, 17, 29, 41, 53, 65, 77, 89, 101 and Week 105

Eligibility
Key inclusion criteria
Key

* 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.

Key
Minimum age
18 Years
Maximum age
99 Years
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
* 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.

Study design
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?
The people receiving the treatment/s


The people analysing the results/data
Intervention assignment
Parallel
Other design features
Phase
Phase 3
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Recruiting
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
2/11/2023
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
25/01/2027
Actual
Sample size
Target
620
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
Recruitment outside Australia
Country [1] 0 0
United States of America
State/province [1] 0 0
California
Country [2] 0 0
United States of America
State/province [2] 0 0
Indiana
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United States of America
State/province [3] 0 0
Louisiana
Country [4] 0 0
United States of America
State/province [4] 0 0
Maryland
Country [5] 0 0
United States of America
State/province [5] 0 0
Missouri
Country [6] 0 0
United States of America
State/province [6] 0 0
New York
Country [7] 0 0
Argentina
State/province [7] 0 0
Río Negro
Country [8] 0 0
Argentina
State/province [8] 0 0
Caba
Country [9] 0 0
Argentina
State/province [9] 0 0
Rosario
Country [10] 0 0
Argentina
State/province [10] 0 0
Santa Fe
Country [11] 0 0
Bosnia and Herzegovina
State/province [11] 0 0
Republika Srpska
Country [12] 0 0
Bosnia and Herzegovina
State/province [12] 0 0
Mostar
Country [13] 0 0
Bosnia and Herzegovina
State/province [13] 0 0
Sarajevo
Country [14] 0 0
Bosnia and Herzegovina
State/province [14] 0 0
Tuzla
Country [15] 0 0
Bosnia and Herzegovina
State/province [15] 0 0
Zenica
Country [16] 0 0
Canada
State/province [16] 0 0
New Brunswick
Country [17] 0 0
Chile
State/province [17] 0 0
Viña Del Mar
Country [18] 0 0
Croatia
State/province [18] 0 0
Grad Zagreb
Country [19] 0 0
Croatia
State/province [19] 0 0
Osjecko-baranjska Županija
Country [20] 0 0
Czechia
State/province [20] 0 0
Hradec Kralove
Country [21] 0 0
Czechia
State/province [21] 0 0
Praha 2
Country [22] 0 0
Estonia
State/province [22] 0 0
Tallinn
Country [23] 0 0
Estonia
State/province [23] 0 0
Tartu
Country [24] 0 0
France
State/province [24] 0 0
Haute-Vienne
Country [25] 0 0
France
State/province [25] 0 0
Nord
Country [26] 0 0
Georgia
State/province [26] 0 0
Ajaria
Country [27] 0 0
Georgia
State/province [27] 0 0
Tbilisi
Country [28] 0 0
Germany
State/province [28] 0 0
Hessen
Country [29] 0 0
Germany
State/province [29] 0 0
Nordrhein-Westfalen
Country [30] 0 0
Italy
State/province [30] 0 0
Forli
Country [31] 0 0
Italy
State/province [31] 0 0
Messina
Country [32] 0 0
Italy
State/province [32] 0 0
Milano
Country [33] 0 0
Italy
State/province [33] 0 0
Bari
Country [34] 0 0
Italy
State/province [34] 0 0
Bergamo
Country [35] 0 0
Italy
State/province [35] 0 0
Firenze
Country [36] 0 0
Italy
State/province [36] 0 0
Napoli
Country [37] 0 0
Italy
State/province [37] 0 0
Roma
Country [38] 0 0
Italy
State/province [38] 0 0
Siena
Country [39] 0 0
Italy
State/province [39] 0 0
Varese
Country [40] 0 0
Lithuania
State/province [40] 0 0
Vilnius
Country [41] 0 0
Malaysia
State/province [41] 0 0
Kelantan
Country [42] 0 0
Malaysia
State/province [42] 0 0
Pahang
Country [43] 0 0
Malaysia
State/province [43] 0 0
Sarawak
Country [44] 0 0
Malaysia
State/province [44] 0 0
Selangor
Country [45] 0 0
Malaysia
State/province [45] 0 0
Wilayah Persekutuan Kuala Lump
Country [46] 0 0
Mexico
State/province [46] 0 0
Guanajuato
Country [47] 0 0
Mexico
State/province [47] 0 0
Jalisco
Country [48] 0 0
Mexico
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Nuevo León
Country [49] 0 0
Mexico
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Oaxaca
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Mexico
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San Luis Potosí
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Mexico
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Sinaloa
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Mexico
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Yucatán
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Mexico
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Aguascalientes
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Mexico
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Guadalajara
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Mexico
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Mexico City
Country [56] 0 0
Mexico
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Puebla
Country [57] 0 0
Mexico
State/province [57] 0 0
San Pedro Garza Garcia
Country [58] 0 0
Mexico
State/province [58] 0 0
San Pedro Garza García
Country [59] 0 0
Mexico
State/province [59] 0 0
Tlalnepantla de Baz
Country [60] 0 0
Moldova, Republic of
State/province [60] 0 0
Chisinau
Country [61] 0 0
Philippines
State/province [61] 0 0
Benguet
Country [62] 0 0
Philippines
State/province [62] 0 0
Metropolitan Manila
Country [63] 0 0
Philippines
State/province [63] 0 0
National Capital Region
Country [64] 0 0
Philippines
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Negros Occidental
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Philippines
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Cebu City
Country [66] 0 0
Portugal
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Setúbal
Country [67] 0 0
Portugal
State/province [67] 0 0
Lisboa
Country [68] 0 0
Romania
State/province [68] 0 0
Cluj
Country [69] 0 0
Romania
State/province [69] 0 0
Dolj
Country [70] 0 0
Romania
State/province [70] 0 0
Timis
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Romania
State/province [71] 0 0
Cluj-Napoca
Country [72] 0 0
Romania
State/province [72] 0 0
Iasi
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Romania
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Sibiu
Country [74] 0 0
Serbia
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Vojvodina
Country [75] 0 0
Serbia
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Kragujevac
Country [76] 0 0
South Africa
State/province [76] 0 0
Gauteng
Country [77] 0 0
South Africa
State/province [77] 0 0
Western Cape
Country [78] 0 0
Spain
State/province [78] 0 0
Andalucía
Country [79] 0 0
Spain
State/province [79] 0 0
Barcelona
Country [80] 0 0
Spain
State/province [80] 0 0
Cáceres
Country [81] 0 0
Spain
State/province [81] 0 0
Madrid
Country [82] 0 0
Spain
State/province [82] 0 0
Murcia, Región De
Country [83] 0 0
Spain
State/province [83] 0 0
Málaga
Country [84] 0 0
Spain
State/province [84] 0 0
Sevilla
Country [85] 0 0
Spain
State/province [85] 0 0
Valencia
Country [86] 0 0
Taiwan
State/province [86] 0 0
Taichung Municipality
Country [87] 0 0
Taiwan
State/province [87] 0 0
Taipei
Country [88] 0 0
Taiwan
State/province [88] 0 0
Changhua
Country [89] 0 0
Thailand
State/province [89] 0 0
Khon Kaen
Country [90] 0 0
Thailand
State/province [90] 0 0
Krung Thep Maha Nakhon [Bangko
Country [91] 0 0
Thailand
State/province [91] 0 0
Songkhla
Country [92] 0 0
Turkey
State/province [92] 0 0
Ankara
Country [93] 0 0
Turkey
State/province [93] 0 0
Gaziantep
Country [94] 0 0
Turkey
State/province [94] 0 0
Istanbul
Country [95] 0 0
Turkey
State/province [95] 0 0
Izmir
Country [96] 0 0
Turkey
State/province [96] 0 0
Kocaeli

Funding & Sponsors
Primary sponsor type
Commercial sector/industry
Name
Amgen
Address
Country

Ethics approval
Ethics application status

Summary
Brief summary
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
MD
Address 0 0
Amgen
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Amgen Call Center
Address 0 0
Country 0 0
Phone 0 0
1-800-772-6436
Fax 0 0
Email 0 0
medinfo@amgen.com
Contact person for scientific queries

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
Yes
What data in particular will be shared?
De-identified individual patient data for variables necessary to address the specific research question in an approved data sharing request.

Supporting document/s available: Study protocol, Statistical analysis plan (SAP), Informed consent form (ICF)
When will data be available (start and end dates)?
Data sharing requests relating to this study will be considered beginning 18 months after the study has ended and either 1) the product and indication have been granted marketing authorization in both the US and Europe or 2) clinical development for the product and/or indication discontinues, and the data will not be submitted to regulatory authorities. There is no end date for eligibility to submit a data-sharing request for this study.
Available to whom?
Qualified researchers may submit a request containing the research objectives, the Amgen product(s) and Amgen study/studies in scope, endpoints/outcomes of interest, statistical analysis plan, data requirements, publication plan, and qualifications of the researcher(s). In general, Amgen does not grant external requests for individual patient data for the purpose of re-evaluating safety and efficacy issues already addressed in the product labelling. Requests are reviewed by a committee of internal advisors. If not approved, a Data Sharing Independent Review Panel will arbitrate and make the final decision. Upon approval, information necessary to address the research question will be provided under the terms of a data-sharing agreement. This may include anonymized individual patient data and/or available supporting documents, containing fragments of analysis code where provided in analysis specifications. Further details are available at the URL below.
Available for what types of analyses?
How or where can data be obtained?
IPD available at link: http://www.amgen.com/datasharing


What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents

No documents have been uploaded by study researchers.


Results not provided in https://clinicaltrials.gov/study/NCT06054555