A PK Study to Compare GME751 (Proposed Pembrolizumab Biosimilar) and US-licensed and EU-authorized Keytruda® in Participants With Stage II and III Melanoma

• ClinicalTrials.gov Identifier: NCT06153238
• Recruitment Status: Not yet recruiting
• First Posted: December 1, 2023
• Last Update Posted: March 27, 2024
• Sponsor: Sandoz
• Information provided by (Responsible Party): Sandoz

Tracking Information

• First Submitted Date: October 11, 2023
• First Posted Date: December 1, 2023
• Last Update Posted Date: March 27, 2024
• Estimated Study Start Date: April 26, 2024
• Estimated Primary Completion Date: June 20, 2025 (Final data collection date for primary outcome measure)

Current Primary Outcome Measures (submitted: November 22, 2023)

• Area Under the Serum Concentration-time Curve from Time Zero to 42 Days (AUC0-42d) [ Time Frame: Day 1 (Postdose) through Day 42 ]
  The PK similarity (AUC0-42d) of GME751 compared with pembrolizumab 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 [ Time Frame: Week 19 through Week 24 ]
  The PK similarity (AUCtau_ss) of GME751 compared with pembrolizumab will be demonstrated in subjects with advanced melanoma in the adjuvant setting.

• Original Primary Outcome Measures: Same as current
• Current Secondary Outcome Measures: Not Provided
• Original Secondary Outcome Measures: Not Provided
• Current Other Pre-specified Outcome Measures: Not Provided
• Original Other Pre-specified Outcome Measures: Not Provided

Descriptive Information

• Brief Title: A PK Study to Compare GME751 (Proposed Pembrolizumab Biosimilar) and US-licensed and EU-authorized Keytruda® in Participants With Stage II and III Melanoma
• Official Title: A Randomized, Double-blind, Parallel-group Study to Compare Pharmacokinetics of GME751 (Proposed Pembrolizumab Biosimilar) and US-licensed and EU Authorized Keytruda® in Participants With Stage II and III Melanoma Requiring Adjuvant Treatment With Pembrolizumab
• Brief Summary: The purpose of this study is to investigate the pharmacokinetic (PK) similarity and efficacy, safety, and immunogenicity of GME751 compared with Keytruda® (pembrolizumab) in subjects with resected advanced melanoma requiring adjuvant treatment with pembrolizumab.

Detailed Description

Eligible subjects will be randomized in a 1:1:1 ratio to receive either GME751, Food and Drug Administration (FDA)-licensed pembrolizumab (Keytruda-US) or European Union (EU)-authorized pembrolizumab (Keytruda-EU). The maximum study duration for a participant will be approximately 28 weeks including screening.

Treatment duration is 24 weeks (4 treatment cycles, each of 6 weeks duration). However, subject should discontinue study participation in case of disease recurrence, unacceptable toxicity or other reasons.

Participants who are benefiting from treatment with pembrolizumab without signs of recurrence or unacceptable toxicity will be eligible for continued pembrolizumab treatment via most suitable option based on the respective country regulations.

• Study Type: Interventional
• Study Phase: Phase 1
• Study Design: Allocation: Randomized; Intervention Model: Parallel Assignment; Masking: Double (Participant, Investigator); Primary Purpose: Treatment
• Condition: Melanoma

Intervention

• Drug: GME751
  400 mg Q6W, i.v. infusion, over 24 weeks period
• Drug: Keytruda - EU
  400 mg Q6W, i.v. infusion, over 24 weeks period
• Drug: Keytruda - US
  400 mg Q6W, i.v. infusion, over 24 weeks period

Study Arms

• Experimental: GME751
  Subjects will receive GME751 via intravenous (IV) infusion.
  Intervention: Drug: GME751
• Active Comparator: Keytruda - EU
  Subjects will receive Keytruda-EU via intravenous (IV) infusion.
  Intervention: Drug: Keytruda - EU
• Active Comparator: Keytruda - US
  Subjects will receive Keytruda-US via intravenous (IV) infusion.
  Intervention: Drug: Keytruda - US

• Publications *: Not Provided

Recruitment Information

• Recruitment Status: Not yet recruiting
• Estimated Enrollment (submitted: November 22, 2023): 318
• Original Estimated Enrollment: Same as current
• Estimated Study Completion Date: June 20, 2025
• Estimated Primary Completion Date: June 20, 2025 (Final data collection date for primary outcome measure)

Eligibility Criteria

Inclusion Criteria:

• At least 18 years of age
• Advanced Melanoma
• Completely removed melanoma by surgery performed within 13 weeks of randomization
• Adequate organ function
• Subject has an Eastern Cooperative Oncology Group (ECOG) performance status score of 0 or 1

Exclusion Criteria:

• Known history or evidence of ocular or uveal melanoma
• Known history of hypersensitivity (grade ≥3) to pembrolizumab or its excipients
• Known History of auto-immune disease
• Received live vaccine ≤30 days before the first study treatment
• Prior treatment with anti-PD-1 agents or agent against another stimulatory or co-inhibitory T cell receptor
• Active autoimmune disease that has necessitated chronic systemic treatment within 2 years before the first study treatment

Other protocol-defined inclusion/exclusion criteria apply

Sex/Gender

• Sexes Eligible for Study: All

• Ages: 18 Years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Contacts

Contact: Clinical Disclosure Representative; +49 8024 / 908 0; sandoz.disclosure@sandoz.com

• Listed Location Countries: Not Provided

Administrative Information

• NCT Number: NCT06153238
• Other Study ID Numbers: CGME751A12101
• Has Data Monitoring Committee: No

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: Undecided

• Current Responsible Party: Sandoz
• Original Responsible Party: Same as current
• Current Study Sponsor: Sandoz
• Original Study Sponsor: Same as current
• Collaborators: Not Provided
• Investigators: Not Provided
• PRS Account: Sandoz
• Verification Date: March 2024