A Study to Evaluate Similarity of ABP 206 Compared With OPDIVO® (Nivolumab) in Subjects With Resected Melanoma
- Conditions
- Melanoma
- Interventions
- Registration Number
- NCT05907122
- Lead Sponsor
- Amgen
- 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.
Recruitment & Eligibility
- Status
- ACTIVE_NOT_RECRUITING
- Sex
- All
- Target Recruitment
- 256
- 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
- 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
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description FDA-licensed Nivolumab FDA-licensed Nivolumab Subjects will receive Dose A of FDA-licensed Nivolumab via IV infusion. EU-authorized Nivolumab EU-authorized Nivolumab Subjects will receive Dose A of EU-authorized Nivolumab via IV infusion. ABP 206 ABP 206 Subjects will receive Dose A of ABP 206 via intravenous (IV) infusion.
- Primary Outcome Measures
Name Time Method Area Under the Serum Concentration-time Curve from Time Zero to 28 Days (AUC0-28d) Day 1 (Postdose) through Day 28 The PK similarity (AUC0-28d) of ABP 206 compared with nivolumab will be demonstrated in subjects with advanced melanoma in the adjuvant setting.
Area Under the Serum Concentration-time Curve Over the Dosing Interval at Steady State (AUCtau_SS) Week 17 through Week 21 The PK similarity (AUCtau_ss) of ABP 206 compared with nivolumab will be demonstrated in subjects with advanced melanoma in the adjuvant setting.
- Secondary Outcome Measures
Name Time Method Number of Subjects With Anti-drug Antibodies (ADAs) Predose on Week 1 (Baseline), Weeks 5, 9, 17, 21, 29, 41, and at Week 53 (End of Study) The immunogenicity of ABP 206 compared with nivolumab will be assessed in subjects with advanced melanoma in the adjuvant setting.
Serum Concentrations at Predose (Ctrough) Week 1 (Baseline) through Week 9, Week 17 to 29, Week 41, and Week 53 (End of Study) The PK similarity (Ctrough) of ABP 206 compared with nivolumab determined in subjects with advanced melanoma in the adjuvant setting.
Recurrence-free Survival (RFS) Randomization through 12 months (or until RFS criteria is met) The RFS is assessed to compare the efficacy of ABP 206 with nivolumab in subjects with advanced melanoma in the adjuvant setting. The RFS is defined as the time between the date of randomization and the date of first recurrence (local, regional, distant metastasis) or death (whatever the cause), or date of last visit/contact with disease assessments (for subjects who remain alive and whose disease has not recurred).
Time to reach Cmax at steady state (Tmax_ss) Week 1 (Baseline) through Week 9, Week 17 to 29, Week 41, and Week 53 (End of Study) The comparison of PK (Tmax_SS) of ABP 206 with nivolumab will be determined in subjects with advanced melanoma in the adjuvant setting.
Serum Concentrations (Ctrough) At Week 5 (Pre-dose), and at Weeks 17 and 21 (Pre-dose) The comparison of PK (Ctrough) of ABP 206 with nivolumab will be determined in subjects with advanced melanoma in the adjuvant setting.
Number of Subjects With Treatment-Emergent Adverse Events Week 1 (First dose of study drug) through Week 53 (End of Study) The safety (treatment-emergent adverse events) of ABP 206 compared with nivolumab will be assessed in subjects with advanced melanoma in the adjuvant setting.
Maximum Observed Serum Concentration Following the First Dose (Cmax_dose 1) Week 1 (Baseline) through Week 9, Week 17 to 29, Week 41, and Week 53 (End of Study) The comparison of PK (Cmax_dose 1) of ABP 206 with nivolumab will be determined in subjects with advanced melanoma in the adjuvant setting.
Maximum Observed Serum Concentration at Steady State (Cmax_ss) Week 1 (Baseline) through Week 9, Week 17 to 29, Week 41, and Week 53 (End of Study) The comparison of PK (Cmax_ss) of ABP 206 with nivolumab will be determined in subjects with advanced melanoma in the adjuvant setting.
Number of Subjects With Treatment-Emergent Serious Adverse Events Week 1 (First dose of study drug) through Week 53 (End of Study) The safety (treatment-emergent serious adverse events) of ABP 206 compared with nivolumab will be assessed in subjects with advanced melanoma in the adjuvant setting.
Number of Subjects With Treatment-emergent Adverse Events-of-interest Week 1 (First dose of study drug) through Week 53 (End of Study) The safety (treatment-emergent adverse events-of-interest) of ABP 206 compared with nivolumab will be assessed in subjects with advanced melanoma in adjuvant setting.
Time to reach Cmax following the first dose (Tmax_dose 1) Week 1 (Baseline) through Week 9, Week 17 to 29, Week 41, and Week 53 (End of Study) The comparison of PK (Tmax_dose 1) of ABP 206 with nivolumab will be determined in subjects with advanced melanoma in the adjuvant setting.
Trial Locations
- Locations (110)
Cancer and Blood Specialty Clinic
🇺🇸Long Beach, California, United States
The Lundquist Institute - Main
🇺🇸Torrance, California, United States
AdventHealth
🇺🇸Orlando, Florida, United States
University of Maryland Medical Center-Greenebaum Cancer Ctr
🇺🇸Baltimore, Maryland, United States
St. Vincent Frontier Cancer Crt
🇺🇸Billings, Montana, United States
Clínica Viedma
🇦🇷Viedma, Río Negro, Argentina
Fundación CENIT
🇦🇷Caba, Argentina
CIMMDP
🇦🇷Mar del Plata, Argentina
Instituto de Oncologia de Rosario
🇦🇷Rosario, Argentina
ISIS Clinica Especializada
🇦🇷Santa Fe, Argentina
University Clinical Centre of the Republic of Srpska - Gastroenterology
🇧🇦Banjaluka, Republika Srpska, Bosnia and Herzegovina
University Clinical Hospital Mostar
🇧🇦Mostar, Bosnia and Herzegovina
Clinical Center University of Sarajevo
🇧🇦Sarajevo, Bosnia and Herzegovina
University Clinical Center Tuzla
🇧🇦Tuzla, Bosnia and Herzegovina
Cantonal hospital Zenica
🇧🇦Zenica, Bosnia and Herzegovina
Hospital Sao Rafael
🇧🇷Salvador, Bahia, Brazil
Centro de Oncologia Leonardo da Vinci -ATO Oncologia
🇧🇷Fortaleza, Ceará, Brazil
Hospital Sirio Libanes - Brasilia
🇧🇷Brasilia, Distrito Federal, Brazil
Centro de Tratamento Oncologico
🇧🇷Belém, Pará, Brazil
Hospital Sao Lucas da PUCRS
🇧🇷Porto Alegre, Rio Grande Do Sul, Brazil
CEPON - Centro de Pesquisas Oncológicas
🇧🇷Florianopolis, Santa Catarina, Brazil
Hospital de Cancer de Barretos
🇧🇷Barretos, São Paulo, Brazil
Hospital e Maternidade Brasil
🇧🇷Sao Paulo, São Paulo, Brazil
Fac Med de Sao Jose do Rio Preto
🇧🇷São José do Rio Preto, São Paulo, Brazil
Instituto de Oncologia do Parana
🇧🇷Curitiba, Brazil
Instituto Nacional de Câncer - INCA
🇧🇷Rio de Janeiro, Brazil
Centro de Estudios Clínicos SAGA SpA
🇨🇱Santiago, Chile
Oncocentro APYS
🇨🇱Viña Del Mar, Chile
University Hospital Centre Zagreb
🇭🇷Zagreb, Grad Zagreb, Croatia
KBC "Sestre milosrdnice"
🇭🇷Zagreb, Grad Zagreb, Croatia
CHU de Poitiers
🇫🇷Poitiers, Haute-Vienne, France
Hopital Ambroise Paré - Dermatologie
🇫🇷Boulogne Billancourt cedex, Hauts-de-Seine, France
ISR-GEO Med Res Clin Healthycore
🇬🇪Tbilisi, Georgia
LLC "Todua Clinic"
🇬🇪Tbilisi, Georgia
JSC KE Nat Ctr of Exp and Clin Surg
🇬🇪Tbilisi, Georgia
University Hospital Cologne AöR
🇩🇪Köln, Nordrhein-Westfalen, Germany
SRH Wald-Klinikum Gera gGmbH
🇩🇪Gera, Thüringen, Germany
Charité - Universitätsmedizin Berlin KöR
🇩🇪Berlin, Germany
Istituto Romagnolo Per Lo Studio Dei Tumori Dino Amadori IRST S.R.L
🇮🇹Meldola, Forli, Italy
Istituto dei Tumori "Giovanni Paolo II"
🇮🇹Bari, Italy
ASST Papa Giovanni XXIII
🇮🇹Bergamo, Italy
Ospedale San Raffaele, IRCCS
🇮🇹Milano, Italy
Istituto Europeo di Oncologia IRCCS
🇮🇹Milano, Italy
Azienda Ospedaliera Universitaria Federico II
🇮🇹Napoli, Italy
Fondazione IRCCS Policlinico San Matteo
🇮🇹Pavia, Italy
Istituto Dermopatico dell'Immacolata (IDI) - IRCCS
🇮🇹Roma, Italy
Azienda ospedaliero Universitaria Senese - Policlinico Le Scotte
🇮🇹Siena, Italy
ASST Sette Laghi - Ospedale di Circolo Fondazione Macchi
🇮🇹Varese, Italy
Nagoya City University Hospital - Dermatology
🇯🇵Nagoya, Aiti [Aichi], Japan
Sapporo Medical University Hospital
🇯🇵Sapporo-Shi, Hokkaidô [Hokkaido], Japan
NHO Kagoshima Medical Center
🇯🇵Kagoshima-Shi, Kagosima [Kagoshima], Japan
Shizuoka Cancer Center - Dermatology
🇯🇵Koto-Ku, Tôkyô [Tokyo], Japan
Keio University Hospital - Dermatology
🇯🇵Shinjuku-ku, Tôkyô [Tokyo], Japan
Kumamoto University Hospital - Dermatology
🇯🇵Kumamoto, Japan
Niigata Cancer Center Hospital
🇯🇵Niigata, Japan
Osaka International Cancer Institute - Dermatological Oncology
🇯🇵Osaka-shi, Ôsaka [Osaka], Japan
Inje University Haeundae Paik Hospital
🇰🇷Busan, Busan Gwang'yeogsi [Pusan-Kwan, Korea, Republic of
Severance Hospital, Yonsei University Health System
🇰🇷Seoul, Seoul Teugbyeolsi [Seoul-T'ukp, Korea, Republic of
Asan Medical Center
🇰🇷Seoul, Seoul Teugbyeolsi [Seoul-T'ukp, Korea, Republic of
Samsung Medical Center
🇰🇷Seoul, Seoul Teugbyeolsi [Seoul-T'ukp, Korea, Republic of
Hospital Universiti Sains Malaysia
🇲🇾Kubang Kerian, Kelantan, Malaysia
Hospital Pulau Pinang
🇲🇾Pulau Pinang, Pahang, Malaysia
Hospital Umum Sarawak
🇲🇾Kuching, Sarawak, Malaysia
Institut Kanser Negara
🇲🇾Putrajaya, Selangor, Malaysia
Hospital Canselor Tuanku Muhriz UKM
🇲🇾Kuala Lumpur, Wilayah Persekutuan Kuala Lump, Malaysia
Hospital Kuala Lumpur
🇲🇾Kuala Lumpur, Wilayah Persekutuan Kuala Lump, Malaysia
Centro Inmuno Oncolog de Occidente
🇲🇽Guadalajara, Jalisco, Mexico
I CAN ONCOLOGY CENTER SA de CV
🇲🇽Monterrey, Nuevo León, Mexico
Ctro At Inv Cardio Potosi
🇲🇽San Luis Potosi, San Luis Potosí, Mexico
Centro De Atenc E Inv Clín En Onco
🇲🇽Merida, Yucatán, Mexico
Centro de Inv Medica Aguascalientes
🇲🇽Aguascalientes, Mexico
Oncare Viaducto Napoles
🇲🇽Mexico City, Mexico
Clinica Integral Internac Oncologia
🇲🇽Puebla, Mexico
Althian Research Management Center
🇲🇽San Pedro Garza Garcia, Mexico
Centro Medico Zambrano Hellion
🇲🇽San Pedro Garza García, Mexico
Clinical Research Institute S.C.
🇲🇽Tlalnepantla de Baz, Mexico
IMSP Institutul Oncologic, ARENSIA
🇲🇩Chisinau, Moldova, Republic of
Amphia Ziekenhuis (Amphia Hospital Breda) - Locatie Molengracht
🇳🇱Breda, Noord-Brabant, Netherlands
Arensia - Iocn
🇷🇴Cluj-Napoca, Cluj, Romania
Arensia - Iob
🇷🇴Bucuresti, Romania
Vojvodina Institute for Oncology
🇷🇸Sremska Kamenica, Vojvodina, Serbia
Military Medical Academy
🇷🇸Belgrade, Serbia
Specialized hospital Oncomed System
🇷🇸Belgrade, Serbia
Institute for Oncology and Radiology of Serbia
🇷🇸Beograd, Serbia
University Clinical Center Kragujevac
🇷🇸Kragujevac, Serbia
University Clinical Center Nis
🇷🇸Nis, Serbia
Medical Oncology Cent of Rosebank
🇿🇦Johannesburg, Gauteng, South Africa
Wits Clinical Research
🇿🇦Parktown, Johannesburg, Gauteng, South Africa
Mary Potter Oncology Centre
🇿🇦Pretoria, Gauteng, South Africa
Rondebosch Oncology Centre
🇿🇦Cape Town, Western Cape, South Africa
Cape Town Oncology Trials
🇿🇦Kraaifontein, Western Cape, South Africa
Hospital Universitario Virgen De La Macarena
🇪🇸Sevilla, Andalucía, Spain
Institut Català d'Oncologia-Hospital Universitari Germans Trias i Pujol
🇪🇸Badalona, Barcelona, Spain
Hospital San Pedro de Alcántara
🇪🇸Caceres, Cáceres, Spain
M.D. Anderson Center Madrid
🇪🇸Madrid,, Madrid, Spain
H.U.V.Arrixaca
🇪🇸El Palmar, Murcia, Región De, Spain
Hospital de La Santa Creu i Sant Pau
🇪🇸Barcelona, Spain
Hospital Universitari Vall D Hebron
🇪🇸Barcelona, Spain
Hospital Clinic De Barcelona
🇪🇸Barcelona, Spain
Consorcio Hospital General Universitario de Valencia
🇪🇸Valencia, Spain
China Medical University Hospital - Internal Medicine
🇨🇳Taichung, Taichung Municipality, Taiwan
Taipei Medical University - Shuang Ho Hospital Ministry of Health and Welfare
🇨🇳New Taipei City, Taipei, Taiwan
Taipei Municipal Wanfang Hospital - Managed by Taipei Medical University
🇨🇳Taipei, Taiwan
Khon Kaen University, Srinagarind Hospital
🇹🇭Khonkaen, Khon Kaen, Thailand
King Chulalongkorn Memorial Hospital [Medical Oncology]
🇹🇭Bangkok, Krung Thep Maha Nakhon [Bangko, Thailand
Siriraj Hospital
🇹🇭Bangkok, Krung Thep Maha Nakhon [Bangko, Thailand
Prince of Songkla University - Faculty of Medicine
🇹🇭Songkhla, Thailand
Vietnam National Cancer Hopsital
🇻🇳Hanoi, Ha Noi, Thu Do, Vietnam
Hanoi Oncology Hospital
🇻🇳Hanoi, Ha Noi, Thu Do, Vietnam
HCM Oncology Hospital
🇻🇳Ho Chi Minh, Ho Chi Minh, Thanh Pho [Sai Go, Vietnam