Clinical trial NCT06054555: A Study to Evaluate ABP 206 Compared With OPDIVO® (Nivolumab) in Subjects With Unresectable or Metastatic Melanoma
Official 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
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: PHASE3
Conditions: Melanoma
Keywords: Treatment-naive
Unresectable melanoma
Metastatic melanoma
Lead sponsor: Amgen
Sponsor class: INDUSTRY
First posted: 2023-09-26
Enrollment: 620
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 assess the efficacy, safety, and immunogenicity of ABP 206 compared with Nivolumab in Subjects with Treatment-Naïve Unresectable or Metastatic Melanoma.

Detailed description: Eligible subjects will be randomized (1:1) to receive investigational product (ABP 206 or nivolumab).

All subjects will be treated until disease progression, unacceptable toxicity, or subject withdrawal of consent for a maximum of 24 months of treatment.

The total duration of study participation for each subject will be approximately 26 months.

Eligibility criteria: Key Inclusion Criteria:

* 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 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.

Primary outcomes:
measure: Objective response by Week 49
timeFrame: Week 49
measure: Objective response at Week 17
timeFrame: Week 17
measure: Progression-free survival (PFS)
timeFrame: From Randomization until Follow-up or End of treatment (EOT) or Early termination (ET) (Approximately 105 Weeks)
measure: Overall survival (OS)
timeFrame: From Randomization until Follow-up or EOT or ET (Approximately 105 Weeks)
measure: Duration of response (DOR)
timeFrame: From Randomization until Follow-up or EOT or ET (Approximately 105 Weeks)
Secondary outcomes:
measure: Number of subjects with treatment-emergent adverse events
timeFrame: Week 1 until Week 105
measure: Number of subjects with treatment-emergent serious adverse events
timeFrame: Week 1 until Week 105
measure: Number of subjects with treatment-emergent adverse events of interest
timeFrame: Week 1 until Week 105
measure: Number of subjects with anti-drug antibodies
timeFrame: Predose on Week 1 (Baseline), Weeks 9, 17, 29, 41, 53, 65, 77, 89, 101 and Week 105
measure: Serum concentrations of ABP 206 and nivolumab (Ctrough)
timeFrame: Predose on Week 1 (Baseline), Weeks 9, 17, 29, 41, 53, 65, 77, 89, 101 and Week 105
Other outcomes:
Locations:
city: Long Beach
country: United States
facility: Cancer and Blood Specialty clinic
state: California
city: Fort Wayne
country: United States
facility: Fort Wayne Medical Oncology and Hematology - Office of Clinical Research
state: Indiana
city: Baton Rouge
country: United States
facility: Our Lady of the Lake Physicians Group-Medical Oncology-Woman's Pavilion
state: Louisiana
city: Baltimore
country: United States
facility: University of Maryland Medical Center-Greenebaum Cancer Ctr
state: Maryland
city: Springfield
country: United States
facility: Oncology Hematology Associates
state: Missouri
city: East Syracuse
country: United States
facility: Hematology-Oncology Associates-CNY
state: New York
city: Buenos Aires
country: Argentina
facility: Fundación CENIT
state: Ciudad Autónoma De Buenos Aire
city: Mar del Plata
country: Argentina
facility: Centro De Investigaciones Medicas Mar Del Plata (CIMMDP) - Rheumatology
state: Río Negro
city: Viedma
country: Argentina
facility: Clínica Viedma
state: Río Negro
city: Rosario
country: Argentina
facility: Instituto de Oncologia de Rosario
state: Santa Fe
city: Santa Fe
country: Argentina
facility: ISIS Clinica Especializada
city: Sarajevo
country: Bosnia and Herzegovina
facility: Clinical Center University of Sarajevo - Clinic of Oncology
state: Kanton Sarajevo
city: Banja Luka
country: Bosnia and Herzegovina
facility: University Clinical Center of Republic of Srpska
state: Republika Srpska
city: Mostar
country: Bosnia and Herzegovina
facility: University Clinical Hospital Mostar - Clinic for Lung Diseases
city: Tuzla
country: Bosnia and Herzegovina
facility: University Clinical Center Tuzla - Oncology, Hematology and Radio
city: Zenica
country: Bosnia and Herzegovina
facility: Cantonal hospital Zenica - Oncology
city: Fredericton
country: Canada
facility: Dr. Everett Chalmers Hospital - Oncology
state: New Brunswick
city: Moncton
country: Canada
facility: American University of Beirut Medical Center - Haematology
state: New Brunswick
city: La Serena
country: Chile
facility: IC La Serena Research
state: Coquimbo
city: Estacion Central
country: Chile
facility: Icegclinic Research & Care
state: Santiago
city: Valparaiso
country: Chile
facility: Oncocentro APYS
state: Valparaíso
city: Temuco
country: Chile
facility: Centro de Investigacion y Desarrollo Oncologico
city: Zagreb
country: Croatia
facility: University Hospital Centre Zagreb - Oncology department
state: Grad Zagreb
city: Zagreb
country: Croatia
facility: Poliklinika Anova
state: Grad Zagreb
city: Osijek
country: Croatia
facility: Klinicki bolnicki centar Osijek
state: Osjecko-baranjska Županija
city: Hradec Kralove
country: Czechia
facility: FN Hradec Kralove - Klinika onkologie a radioterap
city: Praha 2
country: Czechia
facility: Vseobecna fakultni nemocnice v Praze - Dermatovenerologicka
city: Tartu
country: Estonia
facility: Tartu University Hospital
state: Tartumaa
city: Tallinn
country: Estonia
facility: East Tallinn Central Hospital
city: Poitiers
country: France
facility: CHU de Poitiers
state: Haute-Vienne
city: Rennes
country: France
facility: Centre Hospitalier De Saint Malo
state: Ille-et-Vilaine
city: Lille
country: France
facility: C.H.R.U Hopital Claude Huriez - Dermatologie
state: Nord
city: Batumi
country: Georgia
facility: High Technology Hospital MedCenter LTD
state: Ajaria
city: Tbilisi
country: Georgia
facility: LLC "Todua Clinic"
city: Tbilisi
country: Georgia
facility: LTD "Israel-Georgian Medical Research Clinic Healthycore"
city: Tbilisi
country: Georgia
facility: JSC KE Nat Ctr of Exp and Clin Surg
city: Tbilisi
country: Georgia
facility: LTD "Multprofile Clinic Consilium Medulla" - Oncology
city: Frankfurt/Main
country: Germany
facility: Goethe University Frankfurt
state: Hessen
city: Köln
country: Germany
facility: University Hospital of Cologne
state: Nordrhein-Westfalen
city: Szeged
country: Hungary
facility: Pécsi Tudományegyetem - Pszichiátriai És Pszichoter
city: Crema
country: Italy
facility: Ospedale Maggiore Di Crema - Oncologia e Day Hospital oncologico
state: Cremona
city: Meldola
country: Italy
facility: IRST Dino Amadori (IRST IRCCS) - UNK
state: Forli
city: Taormina
country: Italy
facility: PO Ospedale San Vincenzo - Oncologia Medica
state: Messina
city: Rozzano
country: Italy
facility: Istituto Clinico Humanitas
state: Milano
city: Alessandria
country: Italy
facility: AO Ss Antonio, Biagio e Arrigo
city: Bari
country: Italy
facility: AUO Consorziale-Policlinico Bari
city: Bari
country: Italy
facility: Istituto dei Tumori "Giovanni Paolo II"
city: Bergamo
country: Italy
facility: ASST Papa Giovanni XXIII - Oncologia
city: Firenze
country: Italy
facility: AOU Careggi
city: Milano
country: Italy
facility: IRCCS Ca'Granda Maggiore Policlinic
city: Milano
country: Italy
facility: Ospedale San Raffaele, IRCCS
city: Napoli
country: Italy
facility: AOU Luigi Vanvitelli
city: Napoli
country: Italy
facility: Azienda Ospedaliera Universitaria Federico II
city: Napoli
country: Italy
facility: Azienda Sanitaria Locale Napoli 1 Centro (ASL Napoli 1) - Ospedale del Mare
city: Pavia
country: Italy
facility: Fondazione IRCCS Policlinico San Matteo
city: Reggio Emilia
country: Italy
facility: Arcispedale Santa Maria Nuova
city: Roma
country: Italy
facility: Fondazione Policlinico Universitario Campus Bio-medico - Oncologia Medica
city: Roma
country: Italy
facility: IRCCS IFO, Istituto Nazionale dei Tumori Regina Elena (IRE)
city: Roma
country: Italy
facility: Istituto Dermopatico dell'Immacolata (IDI) - IRCCS - Oncologia
city: Roma
country: Italy
facility: Osp Isola Tiberina-Gemelli Isola
city: Siena
country: Italy
facility: AOU Senese, Policlinico Le Scotte
city: Varese
country: Italy
facility: Ospedale di Circolo, Presidio di Varese - Oncologia
city: Amman
country: Jordan
facility: Al Khalidi Hospital and Medical Center - Research
state: 'Ammān
city: Amman
country: Jordan
facility: The Speciality Hospital (TSH) / Advanced Clinical Center
state: 'Ammān
city: Amman
country: Jordan
facility: King Hussein Cancer Center
city: Irbid
country: Jordan
facility: Pharmaceutical Research Center (KAUH)
city: Busan
country: Korea, Republic of
facility: Inje University Haeundae Paik Hospital - Oncology
state: Busan Gwang'yeogsi [Pusan-Kwan
city: Suwon-si
country: Korea, Republic of
facility: The Catholic University of Korea, St. Vincent's Hospital
state: Gyeonggido [Kyonggi-do]
city: Seoul
country: Korea, Republic of
facility: Severance Hospital, Yonsei University Health System - Division of Medical Oncology, Department of In
state: Seoul Teugbyeolsi [Seoul-T'ukp
city: Seoul
country: Korea, Republic of
facility: Asan Medical Center - Oncology
state: Seoul Teugbyeolsi [Seoul-T'ukp
city: Seoul
country: Korea, Republic of
facility: Samsung Medical Center
state: Seoul Teugbyeolsi [Seoul-T'ukp
city: Seoul
country: Korea, Republic of
facility: The Catholic University of Korea, Seoul St. Mary's Hospital - Hematology and Oncology
state: Seoul Teugbyeolsi [Seoul-T'ukp
city: Achrafieh
country: Lebanon
facility: Saint George Hospital University Medical Center
state: Beirut
city: Tripoli
country: Lebanon
facility: Nini Hospital
state: Loubnâne Ech Chemâli
city: Saida
country: Lebanon
facility: Hammoud Hospital University Medical Center (HHUMC) - Hemato-Oncology
state: Loubnâne Ej Jnoûbi
city: Beirut
country: Lebanon
facility: Ain Wazein Hospital - internal medicine
city: Beirut
country: Lebanon
facility: Hotel Dieu de France Hospital - Oncology
city: Vilnius
country: Lithuania
facility: National Cancer Institute - Conservative Tumour Therapy
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: Sarawak General Hospital
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: Pantai Hospital Kuala Lumpur
state: Wilayah Persekutuan Kuala Lump
city: Kuala Lumpur
country: Malaysia
facility: Hospital Kuala Lumpur - Surgery
state: Wilayah Persekutuan Kuala Lump
city: Ciudad de Mexico
country: Mexico
facility: Health Pharma Professional Research S.A de C.V.
state: Distrito Federal
city: Leon, Guanajuato
country: Mexico
facility: Preparaciones Oncologicas SC
state: Guanajuato
city: Guadalajara
country: Mexico
facility: Centro de Inm Onc de Occ Sa de Cv
state: Jalisco
city: Monterrey
country: Mexico
facility: iCan Oncology Center Centro Medico AVE
state: Nuevo León
city: Monterrey
country: Mexico
facility: Centro Medico Zambrano Hellion TecSalud
state: Nuevo León
city: Juchitan
country: Mexico
facility: Centro de Estudios y Prevención del Cancer AC
state: Oaxaca
city: San Luis Potosi
country: Mexico
facility: Hospital Angeles Centro Médico San Luis Potosí - Cardiologia
state: San Luis Potosí
city: Culiacan
country: Mexico
facility: Neurosciences Hospital Angeles Culiacán - Neurociencias Estudios Clínicos S.C.
state: Sinaloa
city: Merida
country: Mexico
facility: Centro de Atención e Investigación Clínica en Oncología
state: Yucatán
city: Aguascalientes
country: Mexico
facility: Centro de Investigación Médica Aguascalientes (CIMA) - Oncology
city: Guadalajara
country: Mexico
facility: Boca Clinical Trials MÃ©xico
city: Mexico City
country: Mexico
facility: Oncare Cancer Center Viaducto CdMx
city: Puebla
country: Mexico
facility: ONCOCENTER PUEBLA - Dermatology
city: San Pedro Garza Garcia
country: Mexico
facility: Althian - Research Management Center
city: Tlalnepantla de Baz
country: Mexico
facility: Clinical Research Institute
city: Chisinau
country: Moldova, Republic of
facility: Arensia Exploratory Medicine - Moldova - IMSP Institutul Oncologic - Oncology
city: Breda
country: Netherlands
facility: Amphia Ziekenhuis - Molengracht
state: Noord-Brabant
city: Baguio City
country: Philippines
facility: Baguio General Hospital and Medical Center
state: Benguet
city: Iloilo City
country: Philippines
facility: The Medical City Iloilo
state: Iloilo
city: Pasig City
country: Philippines
facility: The Medical City - Neurology
state: Metropolitan Manila
city: Cagayan De Oro City
country: Philippines
facility: Cagayan de Oro Medical Center - Internal Medicine
state: Misamis Oriental
city: Makati City
country: Philippines
facility: Center for Skin Research, Testing and Product Development
state: National Capital Region
city: Manila/Ermita
country: Philippines
facility: Philippine General Hospital
state: National Capital Region
city: San Juan City
country: Philippines
facility: Cardinal Santos Madical Center
state: National Capital Region
city: Bacolod City
country: Philippines
facility: Riverside Medical Center
state: Negros Occidental
city: Cebu City
country: Philippines
facility: Cebu Doctors' University Hospital - Oncology
city: Setubal
country: Portugal
facility: Centro Hospitalar de Setúbal - Oncologia
state: Setúbal
city: Lisboa
country: Portugal
facility: Champalimaud Cancer Center
city: Lisboa
country: Portugal
facility: Unidade Local De Saude De Lisboa Ocidental E.P.E.
city: Lisboa
country: Portugal
facility: Hospital da Luz
city: Lisboa
country: Portugal
facility: Centro Hospitalar de Lisboa Norte E.P.E. - H. Santa Maria Serviço de Oncologia Médica
city: Lisboa
country: Portugal
facility: Instituto Portugues de Oncologia de Lisboa Francisco Gentil - Oncologia Medica
city: Porto
country: Portugal
facility: Instituto Português Oncologia Francisco Gentil do Porto - Oncologia Medica
city: Cluj-Napoca
country: Romania
facility: Institutul Oncologic Prof Dr Ion Chiricuta Cluj-Napoca
state: Cluj
city: Cluj-Napoca
country: Romania
facility: Medisprof - Medical Oncology
state: Cluj
city: Floresti
country: Romania
facility: Radiotherapy Center Cluj
state: Cluj
city: Craiova
country: Romania
facility: Oncolab - Medical Oncology
state: Dolj
city: Craiova
country: Romania
facility: Centrul de Oncologie Sf Nectarie - Medical Oncology
state: Dolj
city: Ploiesti
country: Romania
facility: Medical Center Gral
state: Prahova
city: Ploiesti
country: Romania
facility: Spitalul Municipal Ploiesti
state: Prahova
city: Timisoara
country: Romania
facility: Oncocenter- Oncologie Clinica - Medical Oncology
state: Timis
city: Bucuresti
country: Romania
facility: Memorial Healthcare International
city: Bucuresti
country: Romania
facility: Institutul Oncologic Prof Dr Alexandru Trestioreanu Bucuresti
city: Iasi
country: Romania
facility: Centrul de Oncologie Euroclinic
city: Sibiu
country: Romania
facility: Spitalul Clinic Judetean De Urgenta Sibiu
city: Sremska Kamenica
country: Serbia
facility: Institute for Oncology of Vojvodina, Clinic for Internal Oncology-Department of Soft Tissue, Skin, B
state: Vojvodina
city: Kragujevac
country: Serbia
facility: University Clinical Center of Kragujevac, Center for Internal Oncology
state: Šumadijski Okrug
city: Johannesburg
country: South Africa
facility: The Medical Oncology Centre of Rosebank
state: Gauteng
city: Parktown, Johannesburg
country: South Africa
facility: Wits Clinical Research
state: Gauteng
city: Pretoria
country: South Africa
facility: Steve Biko Academic Hospital
state: Gauteng
city: Pretoria
country: South Africa
facility: Curo-Oncology
state: Gauteng
city: Pretoria
country: South Africa
facility: Little Company Of Mary Hospital - Oncology
state: Gauteng
city: Bellville
country: South Africa
facility: Cape Gate Oncology Centre
state: Western Cape
city: Cape Town
country: South Africa
facility: Cancercare - Rondebosch Oncology
state: Western Cape
city: Sevilla
country: Spain
facility: Hospital Universitario Virgen de la Macarena - Oncología Médica
state: Andalucía
city: Badalona
country: Spain
facility: Institut Català d'Oncologia-Hospital Universitari Germans Trias i Pujol - Oncología Médica
state: Barcelona
city: Caceres
country: Spain
facility: Hospital San Pedro de Alcántara - Oncología
state: Cáceres
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 - Oncología Médica
city: Barcelona
country: Spain
facility: Hospital Universitario Vall d'Hebron - Oncología Médica
city: Madrid
country: Spain
facility: M.D. Anderson Center Madrid
city: Málaga
country: Spain
facility: Hospital Regional Universitario de Malaga - Servicio de Oncología
city: Sevilla
country: Spain
facility: Hospital Jerez Puerta Del Sur
city: Valencia
country: Spain
facility: Consorcio Hospital General Universitario de Valencia - Oncología
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: Changhua
country: Taiwan
facility: Changhua Christian Medical Foundation - Changhua Christian Hospital - Internal Medicine
city: Taipei
country: Taiwan
facility: Taipei Municipal Wanfang Hospital - Managed by Taipei Medical University - Hematology and Oncology
city: Chiangmai
country: Thailand
facility: Maharaj Nakorn Chiangmai Hospital - Medical Oncology
state: Chiang Mai
city: Khonkaen
country: Thailand
facility: Khon Kaen University, Srinagarind Hospital - Academic Clinical Research Office (ACRO)
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: Ramathibodi Hospital - Immunology and Rheumatology
state: Krung Thep Maha Nakhon [Bangko
city: Bangkok
country: Thailand
facility: Siriraj Hospital - Medical Oncology
state: Krung Thep Maha Nakhon [Bangko
city: Songkla
country: Thailand
facility: Prince of Songkla University
state: Songkhla
city: Yenimahalle/Ankara
country: Turkey
facility: Gazi University Medical Faculty - Gynecology
state: Ankara
city: Adana
country: Turkey
facility: Adana City Training and Research Hospital
city: Ankara
country: Turkey
facility: Gulhane Training and Research Hospital - Medical Oncology
city: Ankara
country: Turkey
facility: Ankara University Medical Faculty
city: Ankara
country: Turkey
facility: Ankara Liv Hospital
city: Ankara
country: Turkey
facility: Memorial Ankara Hastanesi
city: Ankara
country: Turkey
facility: Dr Abdurrahman Yurtaslan Training and Research Hospital - Medical Oncology
city: Bursa
country: Turkey
facility: Uludag University Medical Faculty
city: Gaziantep
country: Turkey
facility: Medical Point Gaziantep Hospital
city: Gaziantep
country: Turkey
facility: Gaziantep University Sahinbey Practise and Research Hospital - Internal Medicine- Endocrinology and
city: Istanbul
country: Turkey
facility: Koc Universitesi Hastanesi; Tıbbi Onkoloji
city: Istanbul
country: Turkey
facility: Bakirkoy Dr. Sadi Konuk Egt. Ars Hast.
city: Istanbul
country: Turkey
facility: Goztepe SuleymanYalcin Sehir Hast
city: Istanbul
country: Turkey
facility: Memorial Bahçelievler Hospital
city: Izmir
country: Turkey
facility: Izmir Medical Point Hastanesi
city: Kocaeli
country: Turkey
facility: Kocaeli University Research and Practice Hospital - Medical Oncology
city: Konya
country: Turkey
facility: Necmettin Erbakan University Meram Medical Faculty - Oncology
city: Sakarya
country: Turkey
facility: Sakarya Training and Research Hospital
city: Samsun
country: Turkey
facility: VM Medical Park Samsun Hospital - Medical oncology
city: Kyiv
country: Ukraine
facility: ARENSIA Exploratory Medicine LLC
state: Kyïv
city: Hanoi
country: Vietnam
facility: Hanoi Oncology Hospital
state: Ha Noi, Thu Do
city: Hanoi
country: Vietnam
facility: Vietnam National Cancer Hopsital
state: Ha Noi, Thu Do
city: Ho Chi Minh
country: Vietnam
facility: HCM Oncology Hospital - Medical Oncology
state: Ho Chi Minh, Thanh Pho [Sai Go
Study officials:
affiliation: Amgen
name: MD
role: STUDY_DIRECTOR
References: