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

Primary Purpose

Melanoma

Status
Recruiting
Phase
Phase 3
Locations
International
Study Type
Interventional
Intervention
ABP 206
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 Treatment-naive, Unresectable melanoma, Metastatic melanoma

Eligibility Criteria

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

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.

Sites / Locations

  • Oncology Hematology AssociatesRecruiting
  • Dr. Everett Chalmers HospitalRecruiting
  • LLC "Todua Clinic"Recruiting
  • ISR-GEO Med Res Clin HealthycoreRecruiting
  • JSC KE Nat Ctr of Exp and Clin SurgRecruiting
  • Multprofil Clinic Consilium MedullaRecruiting
  • Hospital Universitario Virgen De La MacarenaRecruiting
  • Hospital Jerez Puerta Del SurRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

ABP 206

Nivolumab

Arm Description

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

Subjects will receive Dose A of Nivolumab via IV infusion.

Outcomes

Primary Outcome Measures

Objective response by Week 49
Objective response at Week 17
Progression-free survival (PFS)
Overall survival (OS)
Duration of response (DOR)

Secondary Outcome Measures

Number of subjects with treatment-emergent adverse events
Number of subjects with treatment-emergent serious adverse events
Number of subjects with treatment-emergent adverse events of interest
Number of subjects with anti-drug antibodies
Serum concentrations of ABP 206 and nivolumab (trough)

Full Information

First Posted
September 20, 2023
Last Updated
October 18, 2023
Sponsor
Amgen
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1. Study Identification

Unique Protocol Identification Number
NCT06054555
Brief Title
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

2. Study Status

Record Verification Date
October 2023
Overall Recruitment Status
Recruiting
Study Start Date
September 20, 2023 (Actual)
Primary Completion Date
January 25, 2027 (Anticipated)
Study Completion Date
January 25, 2027 (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 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Melanoma
Keywords
Treatment-naive, Unresectable melanoma, Metastatic 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
620 (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
Nivolumab
Arm Type
Active Comparator
Arm Description
Subjects will receive Dose A of 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 or 60 minutes, every 4 weeks (Q4W) for a total of 24 months.
Intervention Type
Drug
Intervention Name(s)
Nivolumab
Other Intervention Name(s)
OPDIVO®
Intervention Description
Nivolumab will be given intravenously over a period of 30 or 60 minutes, Q4W for a total of 24 months.
Primary Outcome Measure Information:
Title
Objective response by Week 49
Time Frame
Week 49
Title
Objective response at Week 17
Time Frame
Week 17
Title
Progression-free survival (PFS)
Time Frame
From Randomization until Follow-up or End of treatment (EOT) or Early termination (ET) (Approximately 105 Weeks)
Title
Overall survival (OS)
Time Frame
From Randomization until Follow-up or EOT or ET (Approximately 105 Weeks)
Title
Duration of response (DOR)
Time Frame
From Randomization until Follow-up or EOT or ET (Approximately 105 Weeks)
Secondary Outcome Measure Information:
Title
Number of subjects with treatment-emergent adverse events
Time Frame
Week 1 until Week 105
Title
Number of subjects with treatment-emergent serious adverse events
Time Frame
Week 1 until Week 105
Title
Number of subjects with treatment-emergent adverse events of interest
Time Frame
Week 1 until Week 105
Title
Number of subjects with anti-drug antibodies
Time Frame
Predose on Week 1 (Baseline), Weeks 9, 17, 29, 41, 53, 65, 77, 89, 101 and Week 105
Title
Serum concentrations of ABP 206 and nivolumab (trough)
Time Frame
Predose on Week 1 (Baseline), Weeks 9, 17, 29, 41, 53, 65, 77, 89, 101 and Week 105

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
99 Years
Accepts Healthy Volunteers
No
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 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.
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
Oncology Hematology Associates
City
Springfield
State/Province
Missouri
ZIP/Postal Code
65807-5287
Country
United States
Individual Site Status
Recruiting
Facility Name
Dr. Everett Chalmers Hospital
City
Fredericton
State/Province
New Brunswick
ZIP/Postal Code
E3B 5N5
Country
Canada
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
Multprofil Clinic Consilium Medulla
City
Tbilisi
ZIP/Postal Code
0186
Country
Georgia
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
Hospital Jerez Puerta Del Sur
City
Sevilla
ZIP/Postal Code
41009
Country
Spain
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 ABP 206 Compared With OPDIVO® (Nivolumab) in Subjects With Unresectable or Metastatic Melanoma

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