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

UCI Specialty Area: Cancer
Principal Investigator: Warren A Chow
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
A Study On:
Melanoma skin

Study Description

The purpose of the study is to demonstrate similarity of PK between the proposed pembrolizumab biosimilar GME751, Keytruda-EU and Keytruda-US in participants with stage IIB, IIC or III melanoma who underwent complete resection of the tumor and, if applicable, dissection of affected lymph nodes, and require adjuvant treatment with pembrolizumab.

• The study duration for a participant will be approximately 28 weeks including screening.

• The treatment duration will be approximately 24 weeks (4 treatment cycles, each of 6 weeks duration).

• Participants will come to the study site every 6 weeks for treatment and for a final assessment. In Cycle 1 and Cycle 4, additional visits will be required for PK blood sampling.

Eligibility

  • Completely surgically resected (including sentinel node if applicable) stage IIB, IIC or III(A-D) cutaneous melanoma, classified per AJCC 8th edition (Keung and Gershenwald 2018)
  • Disease-free status (no loco-regional relapse or distant metastasis, no clinical evidence for brain metastases) as supported by surgical or pathological reports and post-surgical tumor imaging
  • Minimum 2 to maximum 13 weeks from final surgical resection to first study treatment with adequate wound healing (as per the Investigator’s judgement) from the surgery
  • Adverse effects resulting from prior radiotherapy or other antineoplastic therapy must have resolved to CTCAE grade 1 (or lower)
  • ECOG performance status of 0 or 1
  • Albumin tested within 10 days before first study treatment ≥25 g/L
  • Adequate organ function as per the Investigator’s clinical judgement and safety laboratory values that are specified below and were tested within 10 days before first study treatment.
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University of California, Irvine - Study Information Sheet

UCI Center for Clinical Research Potential Participant Database

Lead Researcher
Maheswari Senthil, MD
UCI Center for Clinical Research

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