A Study to Evaluate Similarity of ABP 206 Compared With OPDIVO® (Nivolumab) in Subjects With Resected Melanoma

Melanoma Clinical Trial

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05907122
• Other study ID #: 20220083
• Status: Recruiting
• Phase: Phase 3
• Start date: July 26, 2023
• Est. completion date: July 30, 2025

Study information

• Verified date: May 2024
• Source: Amgen
• Contact: Amgen Call Center
• Phone: 1-800-772-6436
• Email: medinfo[@]amgen.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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 information / eligibility

• Status: Recruiting
• Enrollment: 249
• Est. completion date: July 30, 2025
• Est. primary completion date: July 30, 2025
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 99 Years

Eligibility

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

Related Conditions & MeSH terms

• Melanoma

Intervention

Drug:
• ABP 206
ABP 206 will be given intravenously over a period of 30 minutes, every 4 weeks (Q4W) for a total of 12 months.
• FDA-licensed Nivolumab
FDA-licensed Nivolumab will be given intravenously over a period of 30 minutes, Q4W for a total of 12 months.
• EU-authorized Nivolumab
FDA-licensed Nivolumab will be given intravenously over a period of 30 minutes, Q4W for a total of 12 months.

Locations

Country	Name	City	State
Argentina	Fundación CENIT	Caba
Argentina	CIMMDP	Mar del Plata
Argentina	Instituto de Oncologia de Rosario	Rosario
Argentina	ISIS Clinica Especializada	Santa Fe
Argentina	Clínica Viedma	Viedma	Río Negro
Bosnia and Herzegovina	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
Brazil	Hospital de Cancer de Barretos	Barretos	São Paulo
Brazil	Centro de Tratamento Oncologico	Belém	Pará
Brazil	Hospital Sirio Libanes - Brasilia	Brasilia	Distrito Federal
Brazil	Instituto de Oncologia do Parana	Curitiba
Brazil	CEPON-Centro de Pesquisas Oncológicas	Florianopolis	Santa Catarina
Brazil	Centro de Oncologia Leonardo da Vinci -ATO Oncologia	Fortaleza	Ceará
Brazil	PUCRS - Hospital São Lucas	Porto Alegre	Rio Grande Do Sul
Brazil	Hospital Sao Rafael	Salvador	Bahia
Brazil	Fac Med de Sao Jose do Rio Preto	São José do Rio Preto	São Paulo
Brazil	Hospital e Maternidade Brasil	Sao Paulo	São Paulo
Chile	Centro de Estudios Clínicos SAGA SpA	Santiago
Chile	Oncocentro APYS	Viña Del Mar
Croatia	KBC "Sestre milosrdnice"	Zagreb	Grad Zagreb
Croatia	University Hospital Centre Zagreb	Zagreb	Grad Zagreb
France	CHU de Bordeaux - Hopital Saint André	Bordeaux	Gironde
France	Hopital Ambroise Paré - Dermatologie	Boulogne Billancourt cedex	Hauts-de-Seine
France	Hôpital F Mitterrand - Dermatology	Dijon	Côte-d'Or
France	CHU de Poitiers	Poitiers	Haute-Vienne
Georgia	ISR-GEO Med Res Clin Healthycore	Tbilisi
Georgia	JSC KE Nat Ctr of Exp and Clin Surg	Tbilisi
Georgia	LLC "Todua Clinic"	Tbilisi
Germany	Charité - Universitätsmedizin Berlin KöR	Berlin
Germany	Goethe University Hospital	Frankfurt/Main	Hessen
Germany	SRH Wald-Klinikum Gera gGmbH	Gera	Thüringen
Germany	University Hospital Cologne AöR	Köln	Nordrhein-Westfalen
Italy	Istituto dei Tumori "Giovanni Paolo II"	Bari
Italy	ASST Papa Giovanni XXIII	Bergamo
Italy	Istituto Romagnolo Per Lo Studio Dei Tumori Dino Amadori IRST S.R.L	Meldola	Forli
Italy	Ospedale San Raffaele, 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
Japan	NHO Kagoshima Medical Center	Kagoshima-Shi	Kagosima [Kagoshima]
Japan	Shizuoka Cancer Center - Dermatology	Koto-Ku	Tôkyô [Tokyo]
Japan	Kumamoto University Hospital - Dermatology	Kumamoto
Japan	Nagoya City University Hospital - Dermatology	Nagoya	Aiti [Aichi]
Japan	Niigata Cancer Center Hospital	Niigata
Japan	Osaka International Cancer Institute - Dermatological Oncology	Osaka-shi	Ôsaka [Osaka]
Japan	Sapporo Medical University Hospital	Sapporo-Shi	Hokkaidô [Hokkaido]
Japan	Keio University Hospital - Dermatology	Shinjuku-ku	Tôkyô [Tokyo]
Korea, Republic of	Inje University Haeundae Paik Hospital	Busan	Busan Gwang'yeogsi [Pusan-Kwan
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	Severance Hospital, Yonsei University Health System	Seoul	Seoul Teugbyeolsi [Seoul-T'ukp
Malaysia	Hospital Canselor Tuanku Muhriz UKM	Kuala Lumpur	Wilayah Persekutuan Kuala Lump
Malaysia	Hospital Kuala Lumpur	Kuala Lumpur	Wilayah Persekutuan Kuala Lump
Malaysia	Hospital Universiti Sains Malaysia	Kubang Kerian	Kelantan
Malaysia	Hospital Umum Sarawak	Kuching	Sarawak
Malaysia	Hospital Pulau Pinang	Pulau Pinang	Pahang
Malaysia	Institut Kanser Negara	Putrajaya	Selangor
Mexico	Centro Inmuno Oncolog de Occidente	Guadalajara	Jalisco
Mexico	Centro De Atenc E Inv Clín En Onco	Merida	Yucatán
Mexico	Oncare Viaducto Napoles	Mexico City
Mexico	I CAN ONCOLOGY CENTER SA de CV	Monterrey	Nuevo León
Mexico	Clinica Integral Internac Oncologia	Puebla
Mexico	Ctro At Inv Cardio Potosi	San Luis Potosi	San Luis Potosí
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
Netherlands	Amphia Ziekenhuis - Molengracht	Breda	Noord-Brabant
Romania	Arensia - Iob	Bucuresti
Romania	Arensia - Iocn	Cluj-Napoca	Cluj
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	Vojvodina Institute for Oncology	Sremska Kamenica	Vojvodina
South Africa	Rondebosch Oncology Centre	Cape Town	Western Cape
South Africa	Medical Oncology Cent of Rosebank	Johannesburg	Gauteng
South Africa	Cape Town Oncology Trials	Kraaifontein	Western Cape
South Africa	Wits Clinical Research	Parktown, Johannesburg	Gauteng
South Africa	Mary Potter Oncology Centre	Pretoria	Gauteng
Spain	Institut Català d'Oncologia-Hospital Universitari Germans Trias i Pujol	Badalona	Barcelona
Spain	Hospital Clinic De Barcelona	Barcelona
Spain	Hospital de La Santa Creu i Sant Pau	Barcelona
Spain	Hospital Universitari Vall D Hebron	Barcelona
Spain	Hospital San Pedro de Alcántara	Caceres	Cáceres
Spain	H.U.V.Arrixaca	El Palmar	Murcia, Región De
Spain	M.D. Anderson Center Madrid	Madrid,	Madrid
Spain	Hospital Jerez Puerta Del Sur	Sevilla
Spain	Hospital Universitario Virgen De La Macarena	Sevilla	Andalucía
Spain	Consorcio Hospital General Universitario de Valencia	Valencia
Taiwan	Taipei Medical University - Shuang Ho Hospital Ministry of Health and Welfare	New Taipei City	Taipei
Taiwan	China Medical University Hospital - Internal Medicine	Taichung	Taichung Municipality
Taiwan	Taipei Municipal Wanfang Hospital - Managed by Taipei Medical University	Taipei
Thailand	King Chulalongkorn Memorial Hospital [Medical Oncology]	Bangkok	Krung Thep Maha Nakhon [Bangko
Thailand	Siriraj Hospital	Bangkok	Krung Thep Maha Nakhon [Bangko
Thailand	Khon Kaen University, Srinagarind Hospital	Khonkaen	Khon Kaen
Thailand	Prince of Songkla University - Faculty of Medicine	Songkhla
United States	University of Maryland Medical Center-Greenebaum Cancer Ctr	Baltimore	Maryland
United States	St. Vincent Frontier Cancer Crt	Billings	Montana
United States	Cancer and Blood Specialty Clinic	Long Beach	California
United States	AdventHealth	Orlando	Florida
United States	The Lundquist Institute - Main	Torrance	California

Sponsors (1)

Lead Sponsor	Collaborator
Amgen

Countries where clinical trial is conducted

United States,  Argentina,  Bosnia and Herzegovina,  Brazil,  Chile,  Croatia,  France,  Georgia,  Germany,  Italy,  Japan,  Korea, Republic of,  Malaysia,  Mexico,  Netherlands,  Romania,  Serbia,  South Africa,  Spain,  Taiwan,  Thailand, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Area Under the Serum Concentration-time Curve from Time Zero to 28 Days (AUC0-28d)	The PK similarity (AUC0-28d) of ABP 206 compared with nivolumab will be demonstrated in subjects with advanced melanoma in the adjuvant setting.	Day 1 (Postdose) through Day 28
Primary	Area Under the Serum Concentration-time Curve Over the Dosing Interval at Steady State (AUCtau_SS)	The PK similarity (AUCtau_ss) of ABP 206 compared with nivolumab will be demonstrated in subjects with advanced melanoma in the adjuvant setting.	Week 17 through Week 21
Secondary	Maximum Observed Serum Concentration Following the First Dose (Cmax_dose 1)	The comparison of PK (Cmax_dose 1) of ABP 206 with nivolumab will be determined in subjects with advanced melanoma in the adjuvant setting.	Week 1 (Baseline) through Week 9, Week 17 to 29, Week 41, and Week 53 (End of Study)
Secondary	Maximum Observed Serum Concentration at Steady State (Cmax_ss)	The comparison of PK (Cmax_ss) of ABP 206 with nivolumab will be determined in subjects with advanced melanoma in the adjuvant setting.	Week 1 (Baseline) through Week 9, Week 17 to 29, Week 41, and Week 53 (End of Study)
Secondary	Serum Concentrations at Predose (Ctrough)	The PK similarity (Ctrough) of ABP 206 compared with nivolumab determined in subjects with advanced melanoma in the adjuvant setting.	Week 1 (Baseline) through Week 9, Week 17 to 29, Week 41, and Week 53 (End of Study)
Secondary	Number of Subjects With Treatment-Emergent Serious Adverse Events	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.	Week 1 (First dose of study drug) through Week 53 (End of Study)
Secondary	Number of Subjects With Treatment-Emergent Adverse Events	The safety (treatment-emergent adverse events) of ABP 206 compared with nivolumab will be assessed in subjects with advanced melanoma in the adjuvant setting.	Week 1 (First dose of study drug) through Week 53 (End of Study)
Secondary	Number of Subjects With Treatment-emergent Adverse Events-of-interest	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.	Week 1 (First dose of study drug) through Week 53 (End of Study)
Secondary	Number of Subjects With Anti-drug Antibodies (ADAs)	The immunogenicity of ABP 206 compared with nivolumab will be assessed in subjects with advanced melanoma in the adjuvant setting.	Predose on Week 1 (Baseline), Weeks 5, 9, 17, 21, 29, 41, and at Week 53 (End of Study)
Secondary	Recurrence-free Survival (RFS)	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).	Randomization through 12 months (or until RFS criteria is met)
Secondary	Time to reach Cmax following the first dose (Tmax_dose 1)	The comparison of PK (Tmax_dose 1) of ABP 206 with nivolumab will be determined in subjects with advanced melanoma in the adjuvant setting.	Week 1 (Baseline) through Week 9, Week 17 to 29, Week 41, and Week 53 (End of Study)
Secondary	Time to reach Cmax at steady state (Tmax_ss)	The comparison of PK (Tmax_SS) of ABP 206 with nivolumab will be determined in subjects with advanced melanoma in the adjuvant setting.	Week 1 (Baseline) through Week 9, Week 17 to 29, Week 41, and Week 53 (End of Study)
Secondary	Serum Concentrations (Ctrough)	The comparison of PK (Ctrough) of ABP 206 with nivolumab will be determined in subjects with advanced melanoma in the adjuvant setting.	At Week 5 (Pre-dose), and at Weeks 17 and 21 (Pre-dose)

External Links

•   AmgenTrials clinical trials website