A Study to Evaluate ABP 206 Compared With OPDIVO® (Nivolumab) in Subjects With Unresectable or Metastatic Melanoma

Melanoma Clinical Trial

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT06054555
• Other study ID #: 20210031
• Secondary ID: 2023-503288-40
• Status: Recruiting
• Phase: Phase 3
• Start date: November 2, 2023
• Est. completion date: January 25, 2027

Study information

• Verified date: May 2024
• Source: Amgen
• Contact: Amgen Call Center
• Phone: 866-572-6436
• Email: medinfo[@]amgen.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 620
• Est. completion date: January 25, 2027
• Est. primary completion date: January 25, 2027
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 99 Years

Eligibility

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 RECIST (version 1.1).
• Tumor tissue from the resected site of disease 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.

Related Conditions & MeSH terms

• Melanoma

Intervention

Drug:
• 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.
• Nivolumab
Nivolumab will be given intravenously over a period of 30 or 60 minutes, Q4W for a total of 24 months.

Locations

Country	Name	City	State
Bosnia and Herzegovina	University Clinical Center of Republic of Srpska	Banja Luka	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
Canada	Dr. Everett Chalmers Hospital	Fredericton	New Brunswick
Croatia	Klinicki bolnicki centar Osijek	Osijek	Osjecko-baranjska Županija
Croatia	Poliklinika Anova	Zagreb	Grad Zagreb
Croatia	University Hospital Centre Zagreb	Zagreb	Grad Zagreb
Czechia	FN Hradec Kralove	Hradec Kralove
Czechia	Vseobecna fakultni nemocnice v Praze	Praha 2
Estonia	East Tallinn Central Hospital	Tallinn
Estonia	Tartu University Hospital	Tartu
France	C.H.R.U Hopital Claude Huriez - Dermatologie	Lille	Nord
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
Georgia	Multprofil Clinic Consilium Medulla	Tbilisi
Germany	University Hospital Cologne AöR	Köln	Nordrhein-Westfalen
Italy	ASST Papa Giovanni XXIII	Bergamo
Italy	AOU Careggi	Firenze
Italy	IEO - Istituto Europeo di Oncologia, IRCCS	Milano
Italy	Ospedale San Raffaele, IRCCS	Milano
Italy	Azienda Ospedaliera Universitaria Federico II	Napoli
Italy	Fondazione IRCCS Policlinico San Matteo	Pavia
Italy	IRCCS IFO, Istituto Nazionale dei Tumori Regina Elena (IRE)	Roma
Italy	Istituto Dermopatico dell'Immacolata (IDI) - IRCCS	Roma
Italy	AOU Senese, Policlinico Le Scotte	Siena
Italy	PO Ospedale San Vincenzo	Taormina	Messina
Italy	Ospedale di Circolo e Fondazione Macchi, ASST Sette Laghi	Varese
Lithuania	National Cancer Institute	Vilnius
Malaysia	Hospital Canselor Tuanku Muhriz UKM	Kuala Lumpur	Wilayah Persekutuan Kuala Lump
Malaysia	Pantai Hospital Kuala Lumpur	Kuala Lumpur	Wilayah Persekutuan Kuala Lump
Malaysia	Hospital Universiti Sains Malaysia	Kubang Kerian	Kelantan
Malaysia	Sarawak General Hospital	Kuching	Sarawak
Malaysia	Hospital Pulau Pinang	Pulau Pinang	Pahang
Malaysia	Institut Kanser Negara	Putrajaya	Selangor
Mexico	Neurociencias Estudios Clínicos SC	Culiacan	Sinaloa
Mexico	Boca Clinical Trials México	Guadalajara
Mexico	Centro Inmuno Oncolog de Occidente	Guadalajara	Jalisco
Mexico	Cent de Estud y Prev del Cancer AC	Juchitan	Oaxaca
Mexico	Preparaciones Oncologicas SC	Leon	Guanajuato
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
Portugal	Hospital da Luz	Lisboa
Portugal	Hospital de São Francisco Xavier	Lisboa
Portugal	Instituto Portugues de Oncologia de Lisboa Francisco Gentil	Lisboa
Romania	Institutul Oncologic Prof Dr Ion Chiricuta Cluj-Napoca	Cluj-Napoca	Cluj
Romania	Medisprof	Cluj-Napoca
Romania	Centrul de Oncologie Sf. Nectarie	Craiova	Dolj
Romania	Radiotherapy Center Cluj	Floresti	Cluj
Romania	Centrul de Oncologie Euroclinic	Iasi
Romania	Spitalul Clinic Judetean De Urgenta Sibiu	Sibiu
Romania	Oncocenter-Oncologie Clinica	Timisoara	Timis
Serbia	Vojvodina Institute for Oncology	Sremska Kamenica	Vojvodina
Spain	Institut Català d'Oncologia-Hospital Universitari Germans Trias i Pujol	Badalona	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 Regional Universitario de Malaga	Málaga
Spain	Hospital Jerez Puerta Del Sur	Sevilla
Spain	Hospital Universitario Virgen De La Macarena	Sevilla	Andalucía
Spain	Consorcio Hospital General Universitario de Valencia	Valencia
Thailand	King Chulalongkorn Memorial Hospital [Medical Oncology]	Bangkok	Krung Thep Maha Nakhon [Bangko
Thailand	Ramathibodi Hospital, Mahidol University	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	Songkhla
United States	University of Maryland Medical Center-Greenebaum Cancer Ctr	Baltimore	Maryland
United States	Our Lady of the Lake Physician Grp MO	Baton Rouge	Louisiana
United States	Hematology-Oncology Associates-CNY	East Syracuse	New York
United States	Ft Wayne Med Oncology Hematology	Fort Wayne	Indiana
United States	Oncology Hematology Associates	Springfield	Missouri

Sponsors (1)

Lead Sponsor	Collaborator
Amgen

Countries where clinical trial is conducted

United States,  Bosnia and Herzegovina,  Canada,  Croatia,  Czechia,  Estonia,  France,  Georgia,  Germany,  Italy,  Lithuania,  Malaysia,  Mexico,  Portugal,  Romania,  Serbia,  Spain,  Thailand, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Objective response by Week 49		Week 49
Primary	Objective response at Week 17		Week 17
Primary	Progression-free survival (PFS)		From Randomization until Follow-up or End of treatment (EOT) or Early termination (ET) (Approximately 105 Weeks)
Primary	Overall survival (OS)		From Randomization until Follow-up or EOT or ET (Approximately 105 Weeks)
Primary	Duration of response (DOR)		From Randomization until Follow-up or EOT or ET (Approximately 105 Weeks)
Secondary	Number of subjects with treatment-emergent adverse events		Week 1 until Week 105
Secondary	Number of subjects with treatment-emergent serious adverse events		Week 1 until Week 105
Secondary	Number of subjects with treatment-emergent adverse events of interest		Week 1 until Week 105
Secondary	Number of subjects with anti-drug antibodies		Predose on Week 1 (Baseline), Weeks 9, 17, 29, 41, 53, 65, 77, 89, 101 and Week 105
Secondary	Serum concentrations of ABP 206 and nivolumab (trough)		Predose on Week 1 (Baseline), Weeks 9, 17, 29, 41, 53, 65, 77, 89, 101 and Week 105

External Links

•   AmgenTrials clinical trials website