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NCT06153238 · ClinicalTrials.gov registry record · Phase 1

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 of Melanoma, sponsored by Sandoz.

Active
Registry status
Phase 1
Development phase
322
Enrollment target
20
Study locations

NCT06153238 is a Phase 1 study of Melanoma that is active but no longer recruiting, run by Sandoz. The registered enrollment target is 322 participants, below the 705-participant average among 266 other Melanoma trials with a reported enrollment target (54% lower). The trial reports 20 study locations across 3 states.

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The verdict

NCT06153238, a Phase 1 study of Melanoma, is active but no longer recruiting, sponsored by Sandoz.

ACTIVE NOT RECRUITING
Registry status
Phase 1
Development phase
322 participants
Enrollment target
20
Study locations

Study 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.

Conditions Studied

Melanoma

Interventions

  • DRUG GME751
  • DRUG Keytruda - EU
  • DRUG Keytruda - US

Study Locations (20)

Other

  • Sandoz Investigational Site - Banja Luka
  • Sandoz Investigational Site - Mostar
  • Sandoz Investigational Site - Sarajevo
  • Sandoz Investigational Site - Tuzla
  • 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
  • Sandoz Investigational Site - Besançon

Florida

  • Sandoz Investigational Site - Clermont
  • Sandoz Investigational Site - Orange City

California

  • Sandoz Investigational Site - Orange

Trial Details

FieldValue
Enrollment Target 322 participants
Start Date 2024-05-15
Est. Completion 2026-06
Phase Phase 1

Sponsor

Sandoz

29 total trials

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Full Details on ClinicalTrials.gov ↗

What the Registry Record Tells You About NCT06153238

The ClinicalTrials.gov registry entry for NCT06153238 describes a study currently listed as active not recruiting, categorized as Phase 1. The registered enrollment target is 322 participants, a figure that helps gauge the scale of data the investigators plan to collect, below the 705-participant average among 266 other Melanoma trials with a reported enrollment target (54% lower). The listed sponsor is Sandoz, which has 29 total studies on file at ClinicalTrials.gov.

The record links to 1 condition, with Melanoma appearing as the primary indexed condition, and to 3 interventions - of which GME751 is the first listed.

NCT06153238 reports 20 study locations spanning 3 distinct geographic areas - top geographies include Other, Florida, California.

Frequently Asked Questions

What is clinical trial NCT06153238 about?

NCT06153238 is a clinical study titled "A PK Study to Compare GME751 (Proposed Pembrolizumab Biosimilar) and US-licensed and EU-authorized Keytruda® in Participants With Stage II and III Melanoma". 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.

What is the current status of trial NCT06153238?

This trial is currently active not recruiting. It is a Phase 1 study. The enrollment target is 322 participants. The study started on 2024-05-15. Estimated completion is 2026-06.

What conditions does trial NCT06153238 study?

This clinical trial studies the following conditions: Melanoma.

What interventions are being tested in trial NCT06153238?

The interventions under investigation include: GME751 (DRUG), Keytruda - EU (DRUG), Keytruda - US (DRUG).

Who is sponsoring clinical trial NCT06153238?

This trial is sponsored by Sandoz, which has 29 total clinical trials registered on ClinicalTrials.gov.

Where is trial NCT06153238 being conducted?

This trial has 20 study locations across California, Florida. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.

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