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GME751 Pembrolizumab BioSimilar& Keytruda Particip w/ Stage II & III Melanoma Tx w /Pembro

Cancer
Warren A Chow
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
Melanoma skin

Study Description

Eligibility

  1. APOL1 genotype of G1/G1, G2/G2, or G1/G2
  2. Proteinuric kidney disease

Key

  1. Solid organ or bone marrow transplant
  2. Uncontrolled hypertension
  3. History of diabetes mellitus
  4. Known underlying cause of kidney disease including but not limited to sickle cell disease

Other protocol defined Inclusion/Exclusion criteria apply.

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