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

• ClinicalTrials.gov Identifier: NCT05907122
• Recruitment Status: Recruiting
• First Posted: June 18, 2023
• Last Update Posted: May 9, 2024
• Sponsor: Amgen
• Information provided by (Responsible Party): Amgen

Tracking Information

• First Submitted Date: June 8, 2023
• First Posted Date: June 18, 2023
• Last Update Posted Date: May 9, 2024
• Actual Study Start Date: July 26, 2023
• Estimated Primary Completion Date: July 30, 2025 (Final data collection date for primary outcome measure)

Current Primary Outcome Measures (submitted: June 8, 2023)

• Area Under the Serum Concentration-time Curve from Time Zero to 28 Days (AUC0-28d) [ Time Frame: Day 1 (Postdose) through Day 28 ]
  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) [ Time Frame: Week 17 through Week 21 ]
  The PK similarity (AUCtau_ss) of ABP 206 compared with nivolumab will be demonstrated in subjects with advanced melanoma in the adjuvant setting.

• Original Primary Outcome Measures: Same as current

Current Secondary Outcome Measures (submitted: March 20, 2024)

• Maximum Observed Serum Concentration Following the First Dose (Cmax_dose 1) [ Time Frame: Week 1 (Baseline) through Week 9, Week 17 to 29, Week 41, and Week 53 (End of Study) ]
  The comparison of PK (Cmax_dose 1) of ABP 206 with nivolumab will be determined in subjects with advanced melanoma in the adjuvant setting.
• Maximum Observed Serum Concentration at Steady State (Cmax_ss) [ Time Frame: Week 1 (Baseline) through Week 9, Week 17 to 29, Week 41, and Week 53 (End of Study) ]
  The comparison of PK (Cmax_ss) of ABP 206 with nivolumab will be determined in subjects with advanced melanoma in the adjuvant setting.
• Serum Concentrations at Predose (Ctrough) [ Time Frame: Week 1 (Baseline) through Week 9, Week 17 to 29, Week 41, and Week 53 (End of Study) ]
  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 [ Time Frame: Week 1 (First dose of study drug) through Week 53 (End of Study) ]
  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 [ Time Frame: Week 1 (First dose of study drug) through Week 53 (End of Study) ]
  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 [ Time Frame: Week 1 (First dose of study drug) through Week 53 (End of Study) ]
  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) [ Time Frame: Predose on Week 1 (Baseline), Weeks 5, 9, 17, 21, 29, 41, and at Week 53 (End of Study) ]
  The immunogenicity of ABP 206 compared with nivolumab will be assessed in subjects with advanced melanoma in the adjuvant setting.
• Recurrence-free Survival (RFS) [ Time Frame: Randomization through 12 months (or until RFS criteria is met) ]
  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 to reach Cmax following the first dose (Tmax_dose 1) [ Time Frame: Week 1 (Baseline) through Week 9, Week 17 to 29, Week 41, and Week 53 (End of Study) ]
  The comparison of PK (Tmax_dose 1) of ABP 206 with nivolumab will be determined in subjects with advanced melanoma in the adjuvant setting.
• Time to reach Cmax at steady state (Tmax_ss) [ Time Frame: Week 1 (Baseline) through Week 9, Week 17 to 29, Week 41, and Week 53 (End of Study) ]
  The comparison of PK (Tmax_SS) of ABP 206 with nivolumab will be determined in subjects with advanced melanoma in the adjuvant setting.
• Serum Concentrations (Ctrough) [ Time Frame: At Week 5 (Pre-dose), and at Weeks 17 and 21 (Pre-dose) ]
  The comparison of PK (Ctrough) of ABP 206 with nivolumab will be determined in subjects with advanced melanoma in the adjuvant setting.

Original Secondary Outcome Measures (submitted: June 8, 2023)

• Maximum Observed Serum Concentration Following the First Dose (Cmax_dose 1) [ Time Frame: Week 1 (Baseline) through Week 9, Week 17 to 29, Week 41, and Week 53 (End of Study) ]
  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) [ Time Frame: Week 1 (Baseline) through Week 9, Week 17 to 29, Week 41, and Week 53 (End of Study) ]
  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) [ Time Frame: Week 1 (Baseline) through Week 9, Week 17 to 29, Week 41, and Week 53 (End of Study) ]
  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 [ Time Frame: Week 1 (First dose of study drug) through Week 53 (End of Study) ]
  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 [ Time Frame: Week 1 (First dose of study drug) through Week 53 (End of Study) ]
  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 [ Time Frame: Week 1 (First dose of study drug) through Week 53 (End of Study) ]
  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) [ Time Frame: Predose on Week 1 (Baseline), Weeks 5, 9, 17, 29, 41, and on Week 53 (End of Study) ]
  The immunogenicity of ABP 206 compared with nivolumab will be assessed in subjects with advanced melanoma in the adjuvant setting.
• Recurrence-free Survival (RFS) [ Time Frame: Randomization through 12 months (or until RFS criteria is met) ]
  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).

• Current Other Pre-specified Outcome Measures: Not Provided
• Original Other Pre-specified Outcome Measures: Not Provided

Descriptive Information

• 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
• 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.

• Study Type: Interventional
• Study Phase: Phase 3

Study Design

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

• Condition: 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.
• Drug: FDA-licensed Nivolumab
  FDA-licensed Nivolumab will be given intravenously over a period of 30 minutes, Q4W for a total of 12 months.
  Other Name: OPDIVO®
• Drug: EU-authorized Nivolumab
  FDA-licensed Nivolumab will be given intravenously over a period of 30 minutes, Q4W for a total of 12 months.
  Other Name: OPDIVO®

Study Arms

• Experimental: ABP 206
  Subjects will receive Dose A of ABP 206 via intravenous (IV) infusion.
  Intervention: Drug: ABP 206
• Active Comparator: FDA-licensed Nivolumab
  Subjects will receive Dose A of FDA-licensed Nivolumab via IV infusion.
  Intervention: Drug: FDA-licensed Nivolumab
• Active Comparator: EU-authorized Nivolumab
  Subjects will receive Dose A of EU-authorized Nivolumab via IV infusion.
  Intervention: Drug: EU-authorized Nivolumab

• Publications *: Not Provided

Recruitment Information

• Recruitment Status: Recruiting
• Estimated Enrollment (submitted: June 8, 2023): 249
• Original Estimated Enrollment: Same as current
• Estimated Study Completion Date: July 30, 2025
• Estimated Primary Completion Date: July 30, 2025 (Final data collection date for primary outcome measure)

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

Sex/Gender

• Sexes Eligible for Study: All

• Ages: 18 Years to 99 Years (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Contacts

Contact: Amgen Call Center; 1-800-772-6436; medinfo@amgen.com

• Listed Location Countries: 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, United States
• Removed Location Countries: India, Israel

Administrative Information

• NCT Number: NCT05907122
• Other Study ID Numbers: 20220083
• Has Data Monitoring Committee: Yes

U.S. FDA-regulated Product

• Studies a U.S. FDA-regulated Drug Product: Yes
• Studies a U.S. FDA-regulated Device Product: No

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
• Supporting Materials: Statistical Analysis Plan (SAP)
• Supporting Materials: 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

• Current Responsible Party: Amgen
• Original Responsible Party: Same as current
• Current Study Sponsor: Amgen
• Original Study Sponsor: Same as current
• Collaborators: Not Provided

Investigators

• Study Director: MD; Amgen

• PRS Account: Amgen
• Verification Date: May 2024