Clinical trial 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
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
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: PHASE1
Conditions: Melanoma
Lead sponsor: Sandoz
Sponsor class: INDUSTRY
First posted: 2023-12-01
Enrollment: 318
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

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

Primary outcomes:
measure: Area Under the Serum Concentration-time Curve from Time Zero to 42 Days (AUC0-42d)
timeFrame: Day 1 (Postdose) through Day 42
measure: Area Under the Serum Concentration-time Curve Over the Dosing Interval at Steady State
timeFrame: Week 19 through Week 24
Secondary outcomes:
Other outcomes:
Locations:
city: Orange
country: United States
facility: Sandoz Investigational Site
state: California
city: Clermont
country: United States
facility: Sandoz Investigational Site
state: Florida
city: Orange City
country: United States
facility: Sandoz Investigational Site
state: Florida
city: Banja Luka
country: Bosnia and Herzegovina
facility: Sandoz Investigational Site
city: Mostar
country: Bosnia and Herzegovina
facility: Sandoz Investigational Site
city: Sarajevo
country: Bosnia and Herzegovina
facility: Sandoz Investigational Site
city: Tuzla
country: Bosnia and Herzegovina
facility: Sandoz Investigational Site
city: Barretos
country: Brazil
facility: Sandoz Investigational Site
city: Curitiba
country: Brazil
facility: Sandoz Investigational Site
city: Porto Alegre
country: Brazil
facility: Sandoz Investigational Site
city: Besançon
country: France
facility: Sandoz Investigational Site
city: Nantes
country: France
facility: Sandoz Investigational Site
city: Batumi
country: Georgia
facility: Sandoz Investigational Site
city: Tbilisi
country: Georgia
facility: Sandoz Investigational Site
city: Mainz
country: Germany
facility: Sandoz Investigational Site
city: Muenster
country: Germany
facility: Sandoz Investigational Site
city: Tuebingen
country: Germany
facility: Sandoz Investigational Site
city: Catanzaro
country: Italy
facility: Sandoz Investigational Site
city: Rozzano
country: Italy
facility: Sandoz Investigational Site
city: Seoul
country: Korea, Republic of
facility: Sandoz Investigational Site
city: Klaipeda
country: Lithuania
facility: Sandoz Investigational Site
city: Vilnius
country: Lithuania
facility: Sandoz Investigational Site
city: George Town
country: Malaysia
facility: Sandoz Investigational Site
city: Johor Bahru
country: Malaysia
facility: Sandoz Investigational Site
city: Kuala Lumpur
country: Malaysia
facility: Sandoz Investigational Site
city: Kuching
country: Malaysia
facility: Sandoz Investigational Site
city: Melaka
country: Malaysia
facility: Sandoz Investigational Site
city: Putrajaya
country: Malaysia
facility: Sandoz Investigational Site
city: Chisinau
country: Moldova, Republic of
facility: Sandoz Investigational Site
city: Bacolod
country: Philippines
facility: Sandoz Investigational Site
city: Bucharest
country: Romania
facility: Sandoz Investigational Site
city: Cluj-Napoca
country: Romania
facility: Sandoz Investigational Site
city: Johannesburg
country: South Africa
facility: Sandoz Investigational Site
city: Phoenix
country: South Africa
facility: Sandoz Investigational Site
city: Barcelona
country: Spain
facility: Sandoz Investigational Site
city: Cáceres
country: Spain
facility: Sandoz Investigational Site
city: Madrid
country: Spain
facility: Sandoz Investigational Site
city: Murcia
country: Spain
facility: Sandoz Investigational Site
city: Santiago De Compostela
country: Spain
facility: Sandoz Investigational Site
city: Sevilla
country: Spain
facility: Sandoz Investigational Site
city: Valencia
country: Spain
facility: Sandoz Investigational Site
city: Zaragoza
country: Spain
facility: Sandoz Investigational Site
city: Ankara
country: Turkey
facility: Sandoz Investigational Site
Study officials:
References: