An open-label, multi-center, single arm, rollover study of GME751 (proposed pembrolizumab biosimilar) in participants who are eligible for continued pembrolizumab treatment after participation in CGME751A12101 or CGME751A12301 studies.

Status

Recruiting

Phases

Phase 3

Study type

Interventional

Source

EU CTIS

Registry ID

CTIS2024-513160-25-00

Acronym

CGME751A12302

Enrollment

Registered

2024-09-16

Start date

2024-10-30

Completion date

Unknown

Last updated

2025-10-13

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Melanoma and Non-small-cell lung cancer

Brief summary

Cohort A (Melanoma): SAEs up to 6 – 12 months (EOS/ED) after start of treatment in Study 302 Cohort B (NSCLC): SAEs up to 12- 24 months (EOS/ED) after start of treatment in Study 302

Interventions

DRUGPemetrexed STADA® 25 mg/ml Konzentrat zur Herstellung einer Infusionslösung

DRUGpembrolizumab

Eligibility

Sex/Gender

All

Age

18 Years to No maximum

Design outcomes

Primary

Measure	Time frame
Cohort A (Melanoma): SAEs up to 6 – 12 months (EOS/ED) after start of treatment in Study 302 Cohort B (NSCLC): SAEs up to 12- 24 months (EOS/ED) after start of treatment in Study 302	—

Countries

Lithuania, Romania, Spain

Outcome results

None listed

Source: EU CTIS · Data processed: Feb 4, 2026