Clinical trial NCT05907122: A Study to Evaluate Similarity of ABP 206 Compared With OPDIVO® (Nivolumab) in Subjects With Resected Melanoma
Official title: A Randomized, Double-blind Study Evaluating Pharmacokinetic Similarity of ABP 206 Compared With OPDIVO® (Nivolumab) in Resected Stage III or Stage IV Melanoma Subjects in the Adjuvant Setting
Study type: INTERVENTIONAL
Overall status: ACTIVE_NOT_RECRUITING
Phase: PHASE3
Conditions: Melanoma
Keywords: Pharmacokinetic similarity study
Adjuvant melanoma treatment
Advanced Melanoma
Lead sponsor: Amgen
Sponsor class: INDUSTRY
First posted: 2023-06-18
Enrollment: 256
Sex: ALL
Minimum age (years): 18
Maximum age (years): 99
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief 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.

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

Primary outcomes:
measure: Area Under the Serum Concentration-time Curve from Time Zero to 28 Days (AUC0-28d)
timeFrame: Day 1 (Postdose) through Day 28
measure: Area Under the Serum Concentration-time Curve Over the Dosing Interval at Steady State (AUCtau_SS)
timeFrame: Week 17 through Week 21
Secondary outcomes:
measure: Maximum Observed Serum Concentration Following the First Dose (Cmax_dose 1)
timeFrame: Week 1 (Baseline) through Week 9, Week 17 to 29, Week 41, and Week 53 (End of Study)
measure: Maximum Observed Serum Concentration at Steady State (Cmax_ss)
timeFrame: Week 1 (Baseline) through Week 9, Week 17 to 29, Week 41, and Week 53 (End of Study)
measure: Serum Concentrations at Predose (Ctrough)
timeFrame: Week 1 (Baseline) through Week 9, Week 17 to 29, Week 41, and Week 53 (End of Study)
measure: Number of Subjects With Treatment-Emergent Serious Adverse Events
timeFrame: Week 1 (First dose of study drug) through Week 53 (End of Study)
measure: Number of Subjects With Treatment-Emergent Adverse Events
timeFrame: Week 1 (First dose of study drug) through Week 53 (End of Study)
measure: Number of Subjects With Treatment-emergent Adverse Events-of-interest
timeFrame: Week 1 (First dose of study drug) through Week 53 (End of Study)
measure: Number of Subjects With Anti-drug Antibodies (ADAs)
timeFrame: Predose on Week 1 (Baseline), Weeks 5, 9, 17, 21, 29, 41, and at Week 53 (End of Study)
measure: Recurrence-free Survival (RFS)
timeFrame: Randomization through 12 months (or until RFS criteria is met)
measure: Time to reach Cmax following the first dose (Tmax_dose 1)
timeFrame: Week 1 (Baseline) through Week 9, Week 17 to 29, Week 41, and Week 53 (End of Study)
measure: Time to reach Cmax at steady state (Tmax_ss)
timeFrame: Week 1 (Baseline) through Week 9, Week 17 to 29, Week 41, and Week 53 (End of Study)
measure: Serum Concentrations (Ctrough)
timeFrame: At Week 5 (Pre-dose), and at Weeks 17 and 21 (Pre-dose)
Other outcomes:
Locations:
city: Long Beach
country: United States
facility: Cancer and Blood Specialty Clinic
state: California
city: Torrance
country: United States
facility: The Lundquist Institute - Main
state: California
city: Orlando
country: United States
facility: AdventHealth
state: Florida
city: Baltimore
country: United States
facility: University of Maryland Medical Center-Greenebaum Cancer Ctr
state: Maryland
city: Billings
country: United States
facility: St. Vincent Frontier Cancer Crt
state: Montana
city: Viedma
country: Argentina
facility: Clínica Viedma
state: Río Negro
city: Caba
country: Argentina
facility: Fundación CENIT
city: Mar del Plata
country: Argentina
facility: CIMMDP
city: Rosario
country: Argentina
facility: Instituto de Oncologia de Rosario
city: Santa Fe
country: Argentina
facility: ISIS Clinica Especializada
city: Banjaluka
country: Bosnia and Herzegovina
facility: University Clinical Centre of the Republic of Srpska - Gastroenterology
state: Republika Srpska
city: Mostar
country: Bosnia and Herzegovina
facility: University Clinical Hospital Mostar
city: Sarajevo
country: Bosnia and Herzegovina
facility: Clinical Center University of Sarajevo
city: Tuzla
country: Bosnia and Herzegovina
facility: University Clinical Center Tuzla
city: Zenica
country: Bosnia and Herzegovina
facility: Cantonal hospital Zenica
city: Salvador
country: Brazil
facility: Hospital Sao Rafael
state: Bahia
city: Fortaleza
country: Brazil
facility: Centro de Oncologia Leonardo da Vinci -ATO Oncologia
state: Ceará
city: Brasilia
country: Brazil
facility: Hospital Sirio Libanes - Brasilia
state: Distrito Federal
city: Belém
country: Brazil
facility: Centro de Tratamento Oncologico
state: Pará
city: Porto Alegre
country: Brazil
facility: Hospital Sao Lucas da PUCRS
state: Rio Grande Do Sul
city: Florianopolis
country: Brazil
facility: CEPON - Centro de Pesquisas Oncológicas
state: Santa Catarina
city: Barretos
country: Brazil
facility: Hospital de Cancer de Barretos
state: São Paulo
city: Sao Paulo
country: Brazil
facility: Hospital e Maternidade Brasil
state: São Paulo
city: São José do Rio Preto
country: Brazil
facility: Fac Med de Sao Jose do Rio Preto
state: São Paulo
city: Curitiba
country: Brazil
facility: Instituto de Oncologia do Parana
city: Rio de Janeiro
country: Brazil
facility: Instituto Nacional de Câncer - INCA
city: Santiago
country: Chile
facility: Centro de Estudios Clínicos SAGA SpA
city: Viña Del Mar
country: Chile
facility: Oncocentro APYS
city: Zagreb
country: Croatia
facility: University Hospital Centre Zagreb
state: Grad Zagreb
city: Zagreb
country: Croatia
facility: KBC "Sestre milosrdnice"
state: Grad Zagreb
city: Poitiers
country: France
facility: CHU de Poitiers
state: Haute-Vienne
city: Boulogne Billancourt cedex
country: France
facility: Hopital Ambroise Paré - Dermatologie
state: Hauts-de-Seine
city: Tbilisi
country: Georgia
facility: ISR-GEO Med Res Clin Healthycore
city: Tbilisi
country: Georgia
facility: LLC "Todua Clinic"
city: Tbilisi
country: Georgia
facility: JSC KE Nat Ctr of Exp and Clin Surg
city: Köln
country: Germany
facility: University Hospital Cologne AöR
state: Nordrhein-Westfalen
city: Gera
country: Germany
facility: SRH Wald-Klinikum Gera gGmbH
state: Thüringen
city: Berlin
country: Germany
facility: Charité - Universitätsmedizin Berlin KöR
city: Meldola
country: Italy
facility: Istituto Romagnolo Per Lo Studio Dei Tumori Dino Amadori IRST S.R.L
state: Forli
city: Bari
country: Italy
facility: Istituto dei Tumori "Giovanni Paolo II"
city: Bergamo
country: Italy
facility: ASST Papa Giovanni XXIII
city: Milano
country: Italy
facility: Ospedale San Raffaele, IRCCS
city: Milano
country: Italy
facility: Istituto Europeo di Oncologia IRCCS
city: Napoli
country: Italy
facility: Azienda Ospedaliera Universitaria Federico II
city: Pavia
country: Italy
facility: Fondazione IRCCS Policlinico San Matteo
city: Roma
country: Italy
facility: Istituto Dermopatico dell'Immacolata (IDI) - IRCCS
city: Siena
country: Italy
facility: Azienda ospedaliero Universitaria Senese - Policlinico Le Scotte
city: Varese
country: Italy
facility: ASST Sette Laghi - Ospedale di Circolo Fondazione Macchi
city: Nagoya
country: Japan
facility: Nagoya City University Hospital - Dermatology
state: Aiti [Aichi]
city: Sapporo-Shi
country: Japan
facility: Sapporo Medical University Hospital
state: Hokkaidô [Hokkaido]
city: Kagoshima-Shi
country: Japan
facility: NHO Kagoshima Medical Center
state: Kagosima [Kagoshima]
city: Koto-Ku
country: Japan
facility: Shizuoka Cancer Center - Dermatology
state: Tôkyô [Tokyo]
city: Shinjuku-ku
country: Japan
facility: Keio University Hospital - Dermatology
state: Tôkyô [Tokyo]
city: Kumamoto
country: Japan
facility: Kumamoto University Hospital - Dermatology
city: Niigata
country: Japan
facility: Niigata Cancer Center Hospital
city: Osaka-shi
country: Japan
facility: Osaka International Cancer Institute - Dermatological Oncology
state: Ôsaka [Osaka]
city: Busan
country: Korea, Republic of
facility: Inje University Haeundae Paik Hospital
state: Busan Gwang'yeogsi [Pusan-Kwan
city: Seoul
country: Korea, Republic of
facility: Severance Hospital, Yonsei University Health System
state: Seoul Teugbyeolsi [Seoul-T'ukp
city: Seoul
country: Korea, Republic of
facility: Asan Medical Center
state: Seoul Teugbyeolsi [Seoul-T'ukp
city: Seoul
country: Korea, Republic of
facility: Samsung Medical Center
state: Seoul Teugbyeolsi [Seoul-T'ukp
city: Kubang Kerian
country: Malaysia
facility: Hospital Universiti Sains Malaysia
state: Kelantan
city: Pulau Pinang
country: Malaysia
facility: Hospital Pulau Pinang
state: Pahang
city: Kuching
country: Malaysia
facility: Hospital Umum Sarawak
state: Sarawak
city: Kuching
country: Malaysia
facility: Hospital Umum Sarawak
state: Sarawak
city: Putrajaya
country: Malaysia
facility: Institut Kanser Negara
state: Selangor
city: Kuala Lumpur
country: Malaysia
facility: Hospital Canselor Tuanku Muhriz UKM
state: Wilayah Persekutuan Kuala Lump
city: Kuala Lumpur
country: Malaysia
facility: Hospital Kuala Lumpur
state: Wilayah Persekutuan Kuala Lump
city: Guadalajara
country: Mexico
facility: Centro Inmuno Oncolog de Occidente
state: Jalisco
city: Monterrey
country: Mexico
facility: I CAN ONCOLOGY CENTER SA de CV
state: Nuevo León
city: San Luis Potosi
country: Mexico
facility: Ctro At Inv Cardio Potosi
state: San Luis Potosí
city: Merida
country: Mexico
facility: Centro De Atenc E Inv Clín En Onco
state: Yucatán
city: Aguascalientes
country: Mexico
facility: Centro de Inv Medica Aguascalientes
city: Mexico City
country: Mexico
facility: Oncare Viaducto Napoles
city: Puebla
country: Mexico
facility: Clinica Integral Internac Oncologia
city: San Pedro Garza Garcia
country: Mexico
facility: Althian Research Management Center
city: San Pedro Garza García
country: Mexico
facility: Centro Medico Zambrano Hellion
city: Tlalnepantla de Baz
country: Mexico
facility: Clinical Research Institute S.C.
city: Chisinau
country: Moldova, Republic of
facility: IMSP Institutul Oncologic, ARENSIA
city: Breda
country: Netherlands
facility: Amphia Ziekenhuis (Amphia Hospital Breda) - Locatie Molengracht
state: Noord-Brabant
city: Cluj-Napoca
country: Romania
facility: Arensia - Iocn
state: Cluj
city: Bucuresti
country: Romania
facility: Arensia - Iob
city: Sremska Kamenica
country: Serbia
facility: Vojvodina Institute for Oncology
state: Vojvodina
city: Belgrade
country: Serbia
facility: Military Medical Academy
city: Belgrade
country: Serbia
facility: Specialized hospital Oncomed System
city: Beograd
country: Serbia
facility: Institute for Oncology and Radiology of Serbia
city: Kragujevac
country: Serbia
facility: University Clinical Center Kragujevac
city: Nis
country: Serbia
facility: University Clinical Center Nis
city: Johannesburg
country: South Africa
facility: Medical Oncology Cent of Rosebank
state: Gauteng
city: Parktown, Johannesburg
country: South Africa
facility: Wits Clinical Research
state: Gauteng
city: Pretoria
country: South Africa
facility: Mary Potter Oncology Centre
state: Gauteng
city: Cape Town
country: South Africa
facility: Rondebosch Oncology Centre
state: Western Cape
city: Kraaifontein
country: South Africa
facility: Cape Town Oncology Trials
state: Western Cape
city: Sevilla
country: Spain
facility: Hospital Universitario Virgen De La Macarena
state: Andalucía
city: Badalona
country: Spain
facility: Institut Català d'Oncologia-Hospital Universitari Germans Trias i Pujol
state: Barcelona
city: Caceres
country: Spain
facility: Hospital San Pedro de Alcántara
state: Cáceres
city: Madrid,
country: Spain
facility: M.D. Anderson Center Madrid
state: Madrid
city: El Palmar
country: Spain
facility: H.U.V.Arrixaca
state: Murcia, Región De
city: Barcelona
country: Spain
facility: Hospital de La Santa Creu i Sant Pau
city: Barcelona
country: Spain
facility: Hospital Universitari Vall D Hebron
city: Barcelona
country: Spain
facility: Hospital Clinic De Barcelona
city: Valencia
country: Spain
facility: Consorcio Hospital General Universitario de Valencia
city: Taichung
country: Taiwan
facility: China Medical University Hospital - Internal Medicine
state: Taichung Municipality
city: New Taipei City
country: Taiwan
facility: Taipei Medical University - Shuang Ho Hospital Ministry of Health and Welfare
state: Taipei
city: Taipei
country: Taiwan
facility: Taipei Municipal Wanfang Hospital - Managed by Taipei Medical University
city: Khonkaen
country: Thailand
facility: Khon Kaen University, Srinagarind Hospital
state: Khon Kaen
city: Bangkok
country: Thailand
facility: King Chulalongkorn Memorial Hospital [Medical Oncology]
state: Krung Thep Maha Nakhon [Bangko
city: Bangkok
country: Thailand
facility: Siriraj Hospital
state: Krung Thep Maha Nakhon [Bangko
city: Songkhla
country: Thailand
facility: Prince of Songkla University - Faculty of Medicine
city: Hanoi
country: Vietnam
facility: Vietnam National Cancer Hopsital
state: Ha Noi, Thu Do
city: Hanoi
country: Vietnam
facility: Hanoi Oncology Hospital
state: Ha Noi, Thu Do
city: Ho Chi Minh
country: Vietnam
facility: HCM Oncology Hospital
state: Ho Chi Minh, Thanh Pho [Sai Go
Study officials:
affiliation: Amgen
name: MD
role: STUDY_DIRECTOR
References: