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

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ClinicalTrials.gov Identifier: NCT06054555
Recruitment Status : Recruiting
First Posted : September 26, 2023
Last Update Posted : May 9, 2024
Sponsor:
Information provided by (Responsible Party):
Amgen

Study Description
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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.

Condition or disease Intervention/treatment Phase
Melanoma Drug: ABP 206 Drug: Nivolumab Phase 3

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.

Study Design
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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 620 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
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.
Primary Purpose: Treatment
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
Actual Study Start Date : November 2, 2023
Estimated Primary Completion Date : January 25, 2027
Estimated Study Completion Date : January 25, 2027

Resource links provided by the National Library of Medicine

MedlinePlus Genetics related topics: Melanoma
MedlinePlus related topics: Melanoma
Drug Information available for: Nivolumab

Arms and Interventions
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Arm Intervention/treatment
Experimental: ABP 206
Subjects will receive Dose A of ABP 206 via intravenous (IV) infusion.
 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.
Active Comparator: Nivolumab
Subjects will receive Dose A of Nivolumab via IV infusion.
 Drug: Nivolumab
Nivolumab will be given intravenously over a period of 30 or 60 minutes, Q4W for a total of 24 months.
Other Name: OPDIVO®


Outcome Measures
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Primary Outcome Measures :
  1. Objective response by Week 49 [ Time Frame: Week 49 ]
  2. Objective response at Week 17 [ Time Frame: Week 17 ]
  3. Progression-free survival (PFS) [ Time Frame: From Randomization until Follow-up or End of treatment (EOT) or Early termination (ET) (Approximately 105 Weeks) ]
  4. Overall survival (OS) [ Time Frame: From Randomization until Follow-up or EOT or ET (Approximately 105 Weeks) ]
  5. Duration of response (DOR) [ Time Frame: From Randomization until Follow-up or EOT or ET (Approximately 105 Weeks) ]

Secondary Outcome Measures :
  1. Number of subjects with treatment-emergent adverse events [ Time Frame: Week 1 until Week 105 ]
  2. Number of subjects with treatment-emergent serious adverse events [ Time Frame: Week 1 until Week 105 ]
  3. Number of subjects with treatment-emergent adverse events of interest [ Time Frame: Week 1 until Week 105 ]
  4. 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 ]
  5. 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 ]

Eligibility Criteria
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Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 99 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.

Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT06054555


Contacts
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Contact: Amgen Call Center 866-572-6436 medinfo@amgen.com

Locations
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Sponsors and Collaborators
Amgen
Investigators
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Study Director: MD Amgen
More Information
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Additional Information:

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Responsible Party: Amgen
ClinicalTrials.gov Identifier: NCT06054555    
Other Study ID Numbers: 20210031
2023-503288-40 ( EudraCT Number )
First Posted: September 26, 2023    Key Record Dates
Last Update Posted: May 9, 2024
Last Verified: May 2024
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes
Plan Description: De-identified individual patient data for variables necessary to address the specific research question in an approved data sharing request.
Supporting Materials: Study Protocol
Statistical Analysis Plan (SAP)
Informed Consent Form (ICF)
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.
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.
URL: http://www.amgen.com/datasharing

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Amgen:
Treatment-naive
Unresectable melanoma
Metastatic melanoma
Additional relevant MeSH terms:
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Melanoma
Neuroendocrine Tumors
Neuroectodermal Tumors
Neoplasms, Germ Cell and Embryonal
Neoplasms by Histologic Type
Neoplasms
Neoplasms, Nerve Tissue
Nevi and Melanomas
 Skin Neoplasms
Neoplasms by Site
Skin Diseases
Nivolumab
Antineoplastic Agents, Immunological
Antineoplastic Agents
Immune Checkpoint Inhibitors
Molecular Mechanisms of Pharmacological Action