MelanomaPhase 1NCT06153238
A PK Study to Compare GME751 (Proposed Pembrolizumab Biosimilar) and US-licensed and EU-authorized Keytruda® in Participants With Stage II and III Melanoma
A Phase 1 study testing GME751, Keytruda - EU and Keytruda - US in people with Melanoma, run by Sandoz at 61 sites in 18 countries.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Melanoma
- What is being tested?
- GME751, Keytruda - EU and Keytruda - US
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 322 participants
- Where
- 61 sitesin 18 countries
- Study dates
- 15 May 2024to 5 May 2026
- Phase
- Phase 1
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
61 sites in 18 countries.
61 sites in 18 countries
Brazil12 sites
Sandoz Investigational Site
Barretos
Sandoz Investigational Site
Belo Horizonte
Sandoz Investigational Site
Canoas
Sandoz Investigational Site
Caxias do Sul
Sandoz Investigational Site
Curitiba
Sandoz Investigational Site
Florianópolis
Sandoz Investigational Site
Fortaleza
Sandoz Investigational Site
Itajaí
Sandoz Investigational Site
Porto Alegre
Sandoz Investigational Site
Porto Velho
Sandoz Investigational Site
Salvador
Sandoz Investigational Site
São José do Rio Preto
Spain9 sites
Sandoz Investigational Site
Badalona
Sandoz Investigational Site
Barcelona
Sandoz Investigational Site
Cáceres
Sandoz Investigational Site
Madrid
Sandoz Investigational Site
Murcia
Sandoz Investigational Site
Santiago de Compostela
Sandoz Investigational Site
Seville
Sandoz Investigational Site
Valencia
Sandoz Investigational Site
Zaragoza
Malaysia6 sites
Sandoz Investigational Site
George Town
Sandoz Investigational Site
Johor Bahru
Sandoz Investigational Site
Kuala Lumpur
Sandoz Investigational Site
Kuching
Sandoz Investigational Site
Malacca
Sandoz Investigational Site
Putrajaya
Bosnia and Herzegovina4 sites
Sandoz Investigational Site
Banja Luka
Sandoz Investigational Site
Mostar
Sandoz Investigational Site
Sarajevo
Sandoz Investigational Site
Tuzla
Mexico4 sites
Sandoz Investigational Site
Mexico City
Sandoz Investigational Site
Oaxaca City
Sandoz Investigational Site
San Luis Potosí City
Sandoz Investigational Site
Veracruz
United States3 sites
Sandoz Investigational Site
Clermont, Florida, 34711
Sandoz Investigational Site
Orange, California, 92868
Sandoz Investigational Site
Orange City, Florida, 32763
Germany3 sites
Sandoz Investigational Site
Mainz
Sandoz Investigational Site
Münster
Sandoz Investigational Site
Tübingen
Serbia3 sites
Sandoz Investigational Site
Belgrade
Sandoz Investigational Site
Kamenitz
Sandoz Investigational Site
Niš
France2 sites
Sandoz Investigational Site
Besançon
Sandoz Investigational Site
Nantes
Georgia2 sites
Sandoz Investigational Site
Batumi
Sandoz Investigational Site
Tbilisi
Italy2 sites
Sandoz Investigational Site
Catanzaro
Sandoz Investigational Site
Rozzano
Lithuania2 sites
Sandoz Investigational Site
Klaipėda
Sandoz Investigational Site
Vilnius
Romania2 sites
Sandoz Investigational Site
Bucharest
Sandoz Investigational Site
Cluj-Napoca
South Africa2 sites
Sandoz Investigational Site
Johannesburg
Sandoz Investigational Site
Phoenix
Turkey (Türkiye)2 sites
Sandoz Investigational Site
Ankara
Sandoz Investigational Site
Yüreğir
About this study
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
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.
Read the 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.
- Conditions
- Melanoma
- Being tested
- GME751, Keytruda - EU, Keytruda - US
- Medical subject headings
- Melanoma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
GME751Drug
400 mg Q6W, i.v. infusion, over 24 weeks period
Keytruda - EUDrug
400 mg Q6W, i.v. infusion, over 24 weeks period
Keytruda - USDrug
400 mg Q6W, i.v. infusion, over 24 weeks period
| Study group | Role | What they receive |
|---|---|---|
| GME751 | Experimental | Subjects will receive GME751 via intravenous (IV) infusion. Receives: Drug: GME751 |
| Keytruda - EU | Active comparator | Subjects will receive Keytruda-EU via intravenous (IV) infusion. Receives: Drug: Keytruda - EU |
| Keytruda - US | Active comparator | Subjects will receive Keytruda-US via intravenous (IV) infusion. Receives: Drug: Keytruda - US |
What is being measured
The primary outcome is the main question the study is designed to answer.
Area Under the Serum Concentration-time Curve from Time Zero to 42 Days (AUC0-42d)
The PK similarity (AUC0-42d) of GME751 compared with pembrolizumab will be demonstrated in subjects with advanced melanoma in the adjuvant setting.
Measured: Day 1 (Postdose) through Day 42
Area Under the Serum Concentration-time Curve Over the Dosing Interval at Steady State
The PK similarity (AUCtau_ss) of GME751 compared with pembrolizumab will be demonstrated in subjects with advanced melanoma in the adjuvant setting.
Measured: Week 19 through Week 24
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Dec 2023
- Study start15 May 2024
- Primary completion5 May 2026
- Study completion5 May 2026
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for MelanomaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 322 participants (actual)
Sponsor and investigators
- Lead sponsor
- Sandoz
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06153238
- Sponsor's protocol ID
- CGME751A12101
- Status last verified
- Jul 2026
- First submitted
- 11 Oct 2023
- Last updated
- 7 Jul 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 7 Jul 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT06153238
- Acronym / sponsor ID
- CGME751A12101
- Conditions
- Melanoma
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 322 participants (actual)
- Lead sponsor
- SandozIndustry (pharma, biotech, devices)
- Study start
- 15 May 2024 (actual)
- Primary completion
- 5 May 2026 (actual)
- Study completion
- 5 May 2026 (actual)
- First posted
- 1 Dec 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| GME751 | Experimental | Drug: GME751Subjects will receive GME751 via intravenous (IV) infusion. |
| Keytruda - EU | Active comparator | Drug: Keytruda - EUSubjects will receive Keytruda-EU via intravenous (IV) infusion. |
| Keytruda - US | Active comparator | Drug: Keytruda - USSubjects will receive Keytruda-US via intravenous (IV) infusion. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (7 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| GME751400 mg Q6W, i.v. infusion, over 24 weeks period | Drug | GME751 |
| Keytruda - EU400 mg Q6W, i.v. infusion, over 24 weeks period | Drug | Keytruda - EU |
| Keytruda - US400 mg Q6W, i.v. infusion, over 24 weeks period | Drug | Keytruda - US |
Primary outcome
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.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 Jul 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
61 sites in 18 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing GME751, Keytruda - EU and Keytruda - US in people with Melanoma, run by Sandoz at 61 sites in 18 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 7 Jul 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 61 sites in Brazil, Spain, Malaysia, Bosnia and Herzegovina, Mexico and 13 more countries. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Area Under the Serum Concentration-time Curve from Time Zero to 42 Days (AUC0-42d) (time frame: Day 1 (Postdose) through Day 42). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 7 Jul 2026.