search
Back to results

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

Primary Purpose

Melanoma

Status
Recruiting
Phase
Phase 3
Locations
International
Study Type
Interventional
Intervention
ABP 206
FDA-licensed Nivolumab
EU-authorized Nivolumab
Sponsored by
Amgen
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Melanoma focused on measuring Pharmacokinetic similarity study, Adjuvant melanoma treatment, Advanced Melanoma

Eligibility Criteria

18 Years - 99 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • St. Vincent Frontier Cancer CrtRecruiting
  • Centro de Estudios Clínicos SAGA SpARecruiting
  • Oncocentro APYSRecruiting
  • KBC "Sestre milosrdnice"Recruiting
  • Hôpital F Mitterrand - DermatologyRecruiting
  • CHU de PoitiersRecruiting
  • LLC "Todua Clinic"Recruiting
  • ISR-GEO Med Res Clin HealthycoreRecruiting
  • JSC KE Nat Ctr of Exp and Clin SurgRecruiting
  • SRH Wald-Klinikum Gera gGmbHRecruiting
  • Charité - Universitätsmedizin Berlin KöRRecruiting
  • Istituto Romagnolo Per Lo Studio Dei Tumori Dino Amadori IRST S.R.LRecruiting
  • Istituto dei Tumori "Giovanni Paolo II"Recruiting
  • Azienda Ospedaliera Universitaria Federico IIRecruiting
  • Azienda ospedaliero Universitaria Senese - Policlinico Le ScotteRecruiting
  • Inje University Haeundae Paik HospitalRecruiting
  • Severance Hospital, Yonsei University Health SystemRecruiting
  • Asan Medical CenterRecruiting
  • Samsung Medical CenterRecruiting
  • Hospital Universiti Sains MalaysiaRecruiting
  • Hospital Pulau PinangRecruiting
  • Hospital Umum SarawakRecruiting
  • National Cancer InstituteRecruiting
  • UKM Medical CentreRecruiting
  • Hospital Kuala LumpurRecruiting
  • Amphia Ziekenhuis - MolengrachtRecruiting
  • Institute for Oncology and Radiology of SerbiaRecruiting
  • University Clinical Center KragujevacRecruiting
  • University Clinical Center NisRecruiting
  • Rondebosch Oncology CentreRecruiting
  • GVI Oncology,CapeGate Oncology CentRecruiting
  • Hospital Universitario Virgen De La MacarenaRecruiting
  • H.U.V.ArrixacaRecruiting
  • Hospital Clinic De BarcelonaRecruiting
  • Hospital de La Santa Creu i Sant PauRecruiting
  • Hospital Jerez Puerta Del SurRecruiting
  • King Chulalongkorn Memorial Hospital [Medical Oncology]Recruiting
  • Siriraj HospitalRecruiting

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Experimental

Active Comparator

Active Comparator

Arm Label

ABP 206

FDA-licensed Nivolumab

EU-authorized Nivolumab

Arm Description

Subjects will receive Dose A of ABP 206 via intravenous (IV) infusion.

Subjects will receive Dose A of FDA-licensed Nivolumab via IV infusion.

Subjects will receive Dose A of EU-authorized Nivolumab via IV infusion.

Outcomes

Primary Outcome Measures

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.
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.

Secondary Outcome Measures

Maximum Observed Serum Concentration Following the First Dose (Cmax_dose 1)
The PK similarity (Cmax_dose 1) of ABP 206 compared with nivolumab will be determined in subjects with advanced melanoma in the adjuvant setting.
Maximum Observed Serum Concentration at Steady State (Cmax_ss)
The PK similarity (Cmax_ss) of ABP 206 compared with nivolumab will be determined in subjects with advanced melanoma in the adjuvant setting.
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.
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.
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.
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.
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.
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).

Full Information

First Posted
June 8, 2023
Last Updated
October 12, 2023
Sponsor
Amgen
search

1. Study Identification

Unique Protocol Identification Number
NCT05907122
Brief Title
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

2. Study Status

Record Verification Date
October 2023
Overall Recruitment Status
Recruiting
Study Start Date
July 26, 2023 (Actual)
Primary Completion Date
July 30, 2025 (Anticipated)
Study Completion Date
July 30, 2025 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Amgen

4. Oversight

Studies a U.S. FDA-regulated Drug Product
Yes
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Melanoma
Keywords
Pharmacokinetic similarity study, Adjuvant melanoma treatment, Advanced Melanoma

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigator
Masking Description
The study is double-blinded; therefore, the investigators, study personnel (with the exception of the data monitoring committee, authorized unblinded sponsor and contract research organization staff, and unblinded site pharmacy staff), and the study subjects will remain blinded to treatment allocation. ABP 206 and nivolumab will be coded and labeled to protect blinding.
Allocation
Randomized
Enrollment
249 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
ABP 206
Arm Type
Experimental
Arm Description
Subjects will receive Dose A of ABP 206 via intravenous (IV) infusion.
Arm Title
FDA-licensed Nivolumab
Arm Type
Active Comparator
Arm Description
Subjects will receive Dose A of FDA-licensed Nivolumab via IV infusion.
Arm Title
EU-authorized Nivolumab
Arm Type
Active Comparator
Arm Description
Subjects will receive Dose A of EU-authorized Nivolumab via IV infusion.
Intervention Type
Drug
Intervention Name(s)
ABP 206
Intervention Description
ABP 206 will be given intravenously over a period of 30 minutes, every 4 weeks (Q4W) for a total of 12 months.
Intervention Type
Drug
Intervention Name(s)
FDA-licensed Nivolumab
Other Intervention Name(s)
OPDIVO®
Intervention Description
FDA-licensed Nivolumab will be given intravenously over a period of 30 minutes, Q4W for a total of 12 months.
Intervention Type
Drug
Intervention Name(s)
EU-authorized Nivolumab
Other Intervention Name(s)
OPDIVO®
Intervention Description
FDA-licensed Nivolumab will be given intravenously over a period of 30 minutes, Q4W for a total of 12 months.
Primary Outcome Measure Information:
Title
Area Under the Serum Concentration-time Curve from Time Zero to 28 Days (AUC0-28d)
Description
The PK similarity (AUC0-28d) of ABP 206 compared with nivolumab will be demonstrated in subjects with advanced melanoma in the adjuvant setting.
Time Frame
Day 1 (Postdose) through Day 28
Title
Area Under the Serum Concentration-time Curve Over the Dosing Interval at Steady State (AUCtau_SS)
Description
The PK similarity (AUCtau_ss) of ABP 206 compared with nivolumab will be demonstrated in subjects with advanced melanoma in the adjuvant setting.
Time Frame
Week 17 through Week 21
Secondary Outcome Measure Information:
Title
Maximum Observed Serum Concentration Following the First Dose (Cmax_dose 1)
Description
The PK similarity (Cmax_dose 1) of ABP 206 compared with nivolumab will be determined in subjects with advanced melanoma in the adjuvant setting.
Time Frame
Week 1 (Baseline) through Week 9, Week 17 to 29, Week 41, and Week 53 (End of Study)
Title
Maximum Observed Serum Concentration at Steady State (Cmax_ss)
Description
The PK similarity (Cmax_ss) of ABP 206 compared with nivolumab will be determined in subjects with advanced melanoma in the adjuvant setting.
Time Frame
Week 1 (Baseline) through Week 9, Week 17 to 29, Week 41, and Week 53 (End of Study)
Title
Serum Concentrations at Predose (Ctrough)
Description
The PK similarity (Ctrough) of ABP 206 compared with nivolumab determined in subjects with advanced melanoma in the adjuvant setting.
Time Frame
Week 1 (Baseline) through Week 9, Week 17 to 29, Week 41, and Week 53 (End of Study)
Title
Number of Subjects With Treatment-Emergent Serious Adverse Events
Description
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.
Time Frame
Week 1 (First dose of study drug) through Week 53 (End of Study)
Title
Number of Subjects With Treatment-Emergent Adverse Events
Description
The safety (treatment-emergent adverse events) of ABP 206 compared with nivolumab will be assessed in subjects with advanced melanoma in the adjuvant setting.
Time Frame
Week 1 (First dose of study drug) through Week 53 (End of Study)
Title
Number of Subjects With Treatment-emergent Adverse Events-of-interest
Description
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 Frame
Week 1 (First dose of study drug) through Week 53 (End of Study)
Title
Number of Subjects With Anti-drug Antibodies (ADAs)
Description
The immunogenicity of ABP 206 compared with nivolumab will be assessed in subjects with advanced melanoma in the adjuvant setting.
Time Frame
Predose on Week 1 (Baseline), Weeks 5, 9, 17, 29, 41, and on Week 53 (End of Study)
Title
Recurrence-free Survival (RFS)
Description
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 Frame
Randomization through 12 months (or until RFS criteria is met)

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
99 Years
Accepts Healthy Volunteers
No
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Amgen Call Center
Phone
866-572-6436
Email
medinfo@amgen.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
MD
Organizational Affiliation
Amgen
Official's Role
Study Director
Facility Information:
Facility Name
St. Vincent Frontier Cancer Crt
City
Billings
State/Province
Montana
ZIP/Postal Code
59102-6746
Country
United States
Individual Site Status
Recruiting
Facility Name
Centro de Estudios Clínicos SAGA SpA
City
Santiago
State/Province
Región Metropolitana De Santia
ZIP/Postal Code
7500653
Country
Chile
Individual Site Status
Recruiting
Facility Name
Oncocentro APYS
City
Viña Del Mar
ZIP/Postal Code
2520612
Country
Chile
Individual Site Status
Recruiting
Facility Name
KBC "Sestre milosrdnice"
City
Zagreb
State/Province
Grad Zagreb
ZIP/Postal Code
10000
Country
Croatia
Individual Site Status
Recruiting
Facility Name
Hôpital F Mitterrand - Dermatology
City
Dijon
State/Province
Côte-d'Or
ZIP/Postal Code
21000
Country
France
Individual Site Status
Recruiting
Facility Name
CHU de Poitiers
City
Poitiers
State/Province
Haute-Vienne
ZIP/Postal Code
21079
Country
France
Individual Site Status
Recruiting
Facility Name
LLC "Todua Clinic"
City
Tbilisi
ZIP/Postal Code
0112;
Country
Georgia
Individual Site Status
Recruiting
Facility Name
ISR-GEO Med Res Clin Healthycore
City
Tbilisi
ZIP/Postal Code
0112
Country
Georgia
Individual Site Status
Recruiting
Facility Name
JSC KE Nat Ctr of Exp and Clin Surg
City
Tbilisi
ZIP/Postal Code
0159
Country
Georgia
Individual Site Status
Recruiting
Facility Name
SRH Wald-Klinikum Gera gGmbH
City
Gera
State/Province
Thüringen
ZIP/Postal Code
07548
Country
Germany
Individual Site Status
Recruiting
Facility Name
Charité - Universitätsmedizin Berlin KöR
City
Berlin
ZIP/Postal Code
10117
Country
Germany
Individual Site Status
Recruiting
Facility Name
Istituto Romagnolo Per Lo Studio Dei Tumori Dino Amadori IRST S.R.L
City
Meldola
State/Province
Forli-Cesena
ZIP/Postal Code
47014
Country
Italy
Individual Site Status
Recruiting
Facility Name
Istituto dei Tumori "Giovanni Paolo II"
City
Bari
ZIP/Postal Code
70124
Country
Italy
Individual Site Status
Recruiting
Facility Name
Azienda Ospedaliera Universitaria Federico II
City
Napoli
ZIP/Postal Code
80131
Country
Italy
Individual Site Status
Recruiting
Facility Name
Azienda ospedaliero Universitaria Senese - Policlinico Le Scotte
City
Siena
ZIP/Postal Code
53100
Country
Italy
Individual Site Status
Recruiting
Facility Name
Inje University Haeundae Paik Hospital
City
Busan
State/Province
Busan Gwang'yeogsi [Pusan-Kwan
ZIP/Postal Code
48108
Country
Korea, Republic of
Individual Site Status
Recruiting
Facility Name
Severance Hospital, Yonsei University Health System
City
Seoul
State/Province
Seoul Teugbyeolsi [Seoul-T'ukp
ZIP/Postal Code
03722
Country
Korea, Republic of
Individual Site Status
Recruiting
Facility Name
Asan Medical Center
City
Seoul
State/Province
Seoul Teugbyeolsi [Seoul-T'ukp
ZIP/Postal Code
05505
Country
Korea, Republic of
Individual Site Status
Recruiting
Facility Name
Samsung Medical Center
City
Seoul
State/Province
Seoul Teugbyeolsi [Seoul-T'ukp
ZIP/Postal Code
6351
Country
Korea, Republic of
Individual Site Status
Recruiting
Facility Name
Hospital Universiti Sains Malaysia
City
Kubang Kerian
State/Province
Kelantan
ZIP/Postal Code
16150
Country
Malaysia
Individual Site Status
Recruiting
Facility Name
Hospital Pulau Pinang
City
Pulau Pinang
State/Province
Pahang
Country
Malaysia
Individual Site Status
Recruiting
Facility Name
Hospital Umum Sarawak
City
Kuching
State/Province
Sarawak
Country
Malaysia
Individual Site Status
Recruiting
Facility Name
National Cancer Institute
City
Putrajaya
State/Province
Selangor
ZIP/Postal Code
62250
Country
Malaysia
Individual Site Status
Recruiting
Facility Name
UKM Medical Centre
City
Kuala Lumpur
State/Province
Wilayah Persekutuan Kuala Lump
ZIP/Postal Code
56000
Country
Malaysia
Individual Site Status
Recruiting
Facility Name
Hospital Kuala Lumpur
City
Kuala Lumpur
State/Province
Wilayah Persekutuan Kuala Lump
Country
Malaysia
Individual Site Status
Recruiting
Facility Name
Amphia Ziekenhuis - Molengracht
City
Breda
State/Province
Noord-Brabant
ZIP/Postal Code
4818 CK
Country
Netherlands
Individual Site Status
Recruiting
Facility Name
Institute for Oncology and Radiology of Serbia
City
Beograd
Country
Serbia
Individual Site Status
Recruiting
Facility Name
University Clinical Center Kragujevac
City
Kragujevac
ZIP/Postal Code
34000
Country
Serbia
Individual Site Status
Recruiting
Facility Name
University Clinical Center Nis
City
Nis
ZIP/Postal Code
18108
Country
Serbia
Individual Site Status
Recruiting
Facility Name
Rondebosch Oncology Centre
City
Cape Town
State/Province
Western Cape
ZIP/Postal Code
7700
Country
South Africa
Individual Site Status
Recruiting
Facility Name
GVI Oncology,CapeGate Oncology Cent
City
Kraaifontein
State/Province
Western Cape
ZIP/Postal Code
7570
Country
South Africa
Individual Site Status
Recruiting
Facility Name
Hospital Universitario Virgen De La Macarena
City
Sevilla
State/Province
Andalucía
ZIP/Postal Code
41009
Country
Spain
Individual Site Status
Recruiting
Facility Name
H.U.V.Arrixaca
City
El Palmar
State/Province
Murcia, Región De
ZIP/Postal Code
30120
Country
Spain
Individual Site Status
Recruiting
Facility Name
Hospital Clinic De Barcelona
City
Barcelona
ZIP/Postal Code
08036
Country
Spain
Individual Site Status
Recruiting
Facility Name
Hospital de La Santa Creu i Sant Pau
City
Barcelona
ZIP/Postal Code
08041
Country
Spain
Individual Site Status
Recruiting
Facility Name
Hospital Jerez Puerta Del Sur
City
Sevilla
ZIP/Postal Code
41009
Country
Spain
Individual Site Status
Recruiting
Facility Name
King Chulalongkorn Memorial Hospital [Medical Oncology]
City
Bangkok
State/Province
Krung Thep Maha Nakhon [Bangko
ZIP/Postal Code
10330
Country
Thailand
Individual Site Status
Recruiting
Facility Name
Siriraj Hospital
City
Bangkok
State/Province
Krung Thep Maha Nakhon [Bangko
ZIP/Postal Code
10700
Country
Thailand
Individual Site Status
Recruiting

12. IPD Sharing Statement

Plan to Share IPD
Yes
IPD Sharing Plan Description
De-identified individual patient data for variables necessary to address the specific research question in an approved data sharing request.
IPD Sharing Time Frame
Data sharing requests relating to this study will be considered beginning 18 months after the study has ended and either 1) the product and indication have been granted marketing authorization in both the US and Europe or 2) clinical development for the product and/or indication discontinues and the data will not be submitted to regulatory authorities. There is no end date for eligibility to submit a data-sharing request for this study.
IPD Sharing Access Criteria
Qualified researchers may submit a request containing the research objectives, the Amgen product(s) and Amgen study/studies in scope, endpoints/outcomes of interest, statistical analysis plan, data requirements, publication plan, and qualifications of the researcher(s). In general, Amgen does not grant external requests for individual patient data for the purpose of re-evaluating safety and efficacy issues already addressed in the product labelling. Requests are reviewed by a committee of internal advisors. If not approved, a Data Sharing Independent Review Panel will arbitrate and make the final decision. Upon approval, information necessary to address the research question will be provided under the terms of a data-sharing agreement. This may include anonymized individual patient data and/or available supporting documents, containing fragments of analysis code where provided in analysis specifications. Further details are available at the URL below.
IPD Sharing URL
http://www.amgen.com/datasharing
Links:
URL
http://www.amgentrials.com
Description
AmgenTrials clinical trials website

Learn more about this trial

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

We'll reach out to this number within 24 hrs