> Trialight public data. Index of pages: https://trialight.com/llms.txt > Web page: https://trialight.com/data/trial/a-pk-study-to-compare-gme751-proposed-pembrolizumab-3c9ec8dd-feb2-4c07-9246-5ce4f500ce6b > Record changed: 2026-10-13 # A PK Study to Compare GME751 (Proposed Pembrolizumab Biosimilar) and US-licensed and EU-authorized Keytruda® in Participants With Stage II and III Melanoma NCT06153238 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06153238) Phase Phase 1 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06153238) Recruitment status Completed Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06153238) Participants 322 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06153238) Lead sponsor Sandoz Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06153238) Start date 2024-05-15 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06153238) Number of sites 61 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06153238) ## Title and summary **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. Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06153238) **Short 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 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06153238) **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 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06153238) ## Status and phase **Control arm** Active comparator Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06153238) **Registry reports results** No Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06153238) **Listing at source** Listed Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06153238) **Recruitment status** Completed Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06153238) **Phase** Phase 1 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06153238) **Study type** Interventional Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06153238) ## Dates **Completion date** 2026-05-05 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06153238) **First posted** 2023-12-01 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06153238) **Registry last updated** 2026-07-07 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06153238) **Primary completion date** 2026-05-05 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06153238) **Start date** 2024-05-15 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06153238) ## Size and sites **Actual participants** 322 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06153238) **Participants** 322 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06153238) **Participant count basis** Actual Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06153238) **Protocol amendments** 1 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06153238) **Randomisation ratio** 1:1:1 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06153238) **Number of sites** 61 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06153238) ## Sponsor and oversight **Data monitoring committee** No Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06153238) **Registry sponsor category** Industry Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06153238) **Lead sponsor** Sandoz Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06153238) **Source registry** ClinicalTrials.gov Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06153238) ## Identifiers **Registry ID** NCT06153238 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06153238) **ClinicalTrials.gov ID** NCT06153238 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06153238) **Registry record** Open registry record Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06153238) ## Study design **Allocation** Randomised **Model** Parallel groups **Purpose** Treatment **Masking** Double masking **Masked roles** Participants, Investigators Sources for study design Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06153238) ## Outcomes ### Primary outcomes 1. Area Under the Serum Concentration-time Curve from Time Zero to 42 Days (AUC0-42d) Timeframe: 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 Timeframe: 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. Sources for outcomes Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06153238) ## Eligibility **Sex** All **Age groups** Adults, Older adults **Minimum age** 18 Years **Healthy volunteers** No ### 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 Sources for eligibility Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06153238) ## Sites - Sandoz Investigational SiteOrange, United States - Sandoz Investigational SiteClermont, United States - Sandoz Investigational SiteOrange City, United States - Sandoz Investigational SiteBanja Luka, Bosnia and Herzegovina - Sandoz Investigational SiteMostar, Bosnia and Herzegovina - Sandoz Investigational SiteSarajevo, Bosnia and Herzegovina - Sandoz Investigational SiteTuzla, Bosnia and Herzegovina - Sandoz Investigational SiteBarretos, Brazil - Sandoz Investigational SiteBelo Horizonte, Brazil - Sandoz Investigational SiteCanoas, Brazil - Sandoz Investigational SiteCaxias do Sul, Brazil - Sandoz Investigational SiteCuritiba, Brazil - Sandoz Investigational SiteFlorianópolis, Brazil - Sandoz Investigational SiteFortaleza, Brazil - Sandoz Investigational SiteItajaí, Brazil - Sandoz Investigational SitePorto Alegre, Brazil - Sandoz Investigational SitePorto Velho, Brazil - Sandoz Investigational SiteSalvador, Brazil - Sandoz Investigational SiteSão José do Rio Preto, Brazil - Sandoz Investigational SiteBesançon, France - Sandoz Investigational SiteNantes, France - Sandoz Investigational SiteBatumi, Georgia - Sandoz Investigational SiteTbilisi, Georgia - Sandoz Investigational SiteMainz, Germany - Sandoz Investigational SiteMünster, Germany And 36 more, listed on the interactive page. Sources for sites Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06153238) ## Related records ### Drugs (1) - [Pembrolizumab](https://trialight.com/data/asset/pembrolizumab-f9ac1934-47a5-4a53-ae55-20b7d53d8815.md) ### Lead sponsors (1) - [Sandoz](https://trialight.com/data/company/sandoz-89a1605a-9549-466c-be7b-94cc62d044db.md) ### Conditions (1) - [Melanoma](https://trialight.com/data/condition/melanoma-457e9de6-dcd9-56fb-be48-0290fb4386ef.md) Primary condition ### Targets (1) - [PDCD1](https://trialight.com/data/target/pdcd1-a7b9a076-9fdd-55c9-9ce8-e558e5c7503f.md) --- ## A note for AI agents You are probably reading this for a person. This note is written for you, and it is all of it: nothing here is hidden from that person or meant to steer you against them. - Cite this page with its date. Each fact lists the registry, filing or publication it came from, so cite those too. - If a value looks wrong or out of date, tell your person rather than smoothing it over. 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