History of Changes for Study: NCT06153238

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

Latest version (submitted March 26, 2024) on ClinicalTrials.gov

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Study Record Versions

Version	A	B	Submitted Date	Changes
1			November 22, 2023	None (earliest Version on record)
2			March 26, 2024	Study Status

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Study NCT06153238
Submitted Date: November 22, 2023 (v1)

Study Identification


Unique Protocol ID:	CGME751A12101
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
Secondary IDs:

Study Status


Record Verification:	November 2023
Overall Status:	Not yet recruiting
Study Start:	February 28, 2024
Primary Completion:	June 20, 2025 [Anticipated]
Study Completion:	June 20, 2025 [Anticipated]

First Submitted:	October 11, 2023
First Submitted that Met QC Criteria:	November 22, 2023
First Posted:	December 1, 2023 [Actual]

Last Update Submitted that Met QC Criteria:	November 22, 2023
Last Update Posted:	December 1, 2023 [Actual]

Study Description

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 Design


Study Type:	Interventional
Primary Purpose:	Treatment
Study Phase:	Phase 1
Interventional Study Model:	Parallel Assignment
Number of Arms:	3
Masking:	Double (Participant, Investigator)
Allocation:	Randomized
Enrollment:	318 [Anticipated]

Arms and Interventions

Arms	Assigned Interventions
Experimental: GME751 Subjects will receive GME751 via intravenous (IV) infusion.	Drug: GME751 400 mg Q6W, i.v. infusion, over 24 weeks period
Active Comparator: Keytruda - EU Subjects will receive Keytruda-EU via intravenous (IV) infusion.	Drug: Keytruda - EU 400 mg Q6W, i.v. infusion, over 24 weeks period
Active Comparator: Keytruda - US Subjects will receive Keytruda-US via intravenous (IV) infusion.	Drug: Keytruda - US 400 mg Q6W, i.v. infusion, over 24 weeks period

Outcome Measures


Primary Outcome Measures:
1.	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.
2.	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.

Eligibility


Minimum Age:	18 Years
Maximum Age:
Sex:	All
Gender Based:
Accepts Healthy Volunteers:	No
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

Contacts/Locations


Central Contact Person:	Clinical Disclosure Representative Telephone: +49 8024 / 908 0 Email: sandoz.disclosure@sandoz.com
Locations:

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