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NCT06153238 | RECRUITING | Melanoma

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

Sandoz

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.

Condition or disease

Melanoma

Intervention/treatment

GME751

Keytruda - EU

Keytruda - US

Phase

PHASE1

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
Estimated Enrollment : 318 participants
Masking : DOUBLE
Primary Purpose : TREATMENT
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
Actual Study Start Date : 2024-05-15
Estimated Primary Completion Date : 2026-07
Estimated Study Completion Date : 2026-07

Information not available for Arms and Intervention/treatment

Ages Eligible for Study: 18 Years
Sexes Eligible for Study: ALL
Accepts Healthy Volunteers:
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
A PK Study to Compare GME751 (Proposed Pembrolizumab Biosimilar) and US-licensed and EU-authorized Keytruda® in Participants With Stage II and III Melanoma

Location Details

NCT06153238

Please Choose a site

How to Participate

Want to participate in this study, select a site at your convenience, send yourself email to get contact details and prescreening steps.

Locations

RECRUITING

United States, California

Sandoz Investigational Site

Orange, California, United States, 92868

RECRUITING

United States, Florida

Sandoz Investigational Site

Clermont, Florida, United States, 34711

RECRUITING

United States, Florida

Sandoz Investigational Site

Orange City, Florida, United States, 32763

RECRUITING

Bosnia and Herzegovina,

Sandoz Investigational Site

Banja Luka, Bosnia and Herzegovina,

RECRUITING

Bosnia and Herzegovina,

Sandoz Investigational Site

Mostar, Bosnia and Herzegovina,

RECRUITING

Bosnia and Herzegovina,

Sandoz Investigational Site

Sarajevo, Bosnia and Herzegovina,

RECRUITING

Bosnia and Herzegovina,

Sandoz Investigational Site

Tuzla, Bosnia and Herzegovina,

RECRUITING

Brazil,

Sandoz Investigational Site

Barretos, Brazil,

RECRUITING

Brazil,

Sandoz Investigational Site

Curitiba, Brazil,

RECRUITING

Brazil,

Sandoz Investigational Site

Porto Alegre, Brazil,

WITHDRAWN

France,

Sandoz Investigational Site

Besançon, France,

RECRUITING

France,

Sandoz Investigational Site

Nantes, France,

RECRUITING

Georgia,

Sandoz Investigational Site

Batumi, Georgia,

RECRUITING

Georgia,

Sandoz Investigational Site

Tbilisi, Georgia,

RECRUITING

Germany,

Sandoz Investigational Site

Mainz, Germany,

RECRUITING

Germany,

Sandoz Investigational Site

Muenster, Germany,

RECRUITING

Germany,

Sandoz Investigational Site

Tue, Germany,

RECRUITING

Italy,

Sandoz Investigational Site

Catanzaro, Italy,

RECRUITING

Italy,

Sandoz Investigational Site

Rozzano, Italy,

RECRUITING

Korea, Republic of,

Sandoz Investigational Site

Seoul, Korea, Republic of,

RECRUITING

Lithuania,

Sandoz Investigational Site

Klaipeda, Lithuania,

RECRUITING

Lithuania,

Sandoz Investigational Site

Vilnius, Lithuania,

RECRUITING

Malaysia,

Sandoz Investigational Site

George Town, Malaysia,

RECRUITING

Malaysia,

Sandoz Investigational Site

Johor Bahru, Malaysia,

RECRUITING

Malaysia,

Sandoz Investigational Site

Kuala Lumpur, Malaysia,

RECRUITING

Malaysia,

Sandoz Investigational Site

Kuching, Malaysia,

RECRUITING

Malaysia,

Sandoz Investigational Site

Melaka, Malaysia,

RECRUITING

Malaysia,

Sandoz Investigational Site

Putrajaya, Malaysia,

RECRUITING

Moldova, Republic of,

Sandoz Investigational Site

Chisinau, Moldova, Republic of,

RECRUITING

Philippines,

Sandoz Investigational Site

Bacolod, Philippines,

RECRUITING

Romania,

Sandoz Investigational Site

Bucharest, Romania,

RECRUITING

Romania,

Sandoz Investigational Site

Cluj-Napoca, Romania,

RECRUITING

South Africa,

Sandoz Investigational Site

Johannesburg, South Africa,

RECRUITING

South Africa,

Sandoz Investigational Site

Phoenix, South Africa,

RECRUITING

Spain,

Sandoz Investigational Site

Barcelona, Spain,

RECRUITING

Spain,

Sandoz Investigational Site

Cáceres, Spain,

RECRUITING

Spain,

Sandoz Investigational Site

Madrid, Spain,

RECRUITING

Spain,

Sandoz Investigational Site

Murcia, Spain,

RECRUITING

Spain,

Sandoz Investigational Site

Santiago de Compostela, Spain,

RECRUITING

Spain,

Sandoz Investigational Site

Sevilla, Spain,

RECRUITING

Spain,

Sandoz Investigational Site

Valencia, Spain,

RECRUITING

Spain,

Sandoz Investigational Site

Zaragoza, Spain,

RECRUITING

Turkey,

Sandoz Investigational Site

Ankara, Turkey,