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An Exploratory Tumor Biopsy-driven Study to Understand the Relationship Between Biomarkers and Clinical Response in Melanoma Patients Receiving REGN2810 (Anti-PD-1)
An Exploratory Tumor Biopsy-driven Study to Understand the Relationship Between Biomarkers and Clinical Response in Melanoma Patients Receiving REGN2810 (Anti-PD-1)

NCT03002376

CompletedPhase 1

Sponsor: Regeneron Pharmaceuticals

Conditions: Melanoma

Interventions: REGN2810

Countries: Netherlands, Serbia, South Korea, United Kingdom

This study is being conducted to compare the relationship of patient response to treatment to changes in tumor environment.

Eligibility overview

Sex: ALL

Age: 18 Years to —

Healthy volunteers: No

Study type: INTERVENTIONAL

Eligibility criteria
Key Inclusion Criteria:

* Histologically confirmed diagnosis of stage III (unresectable) or stage IV cutaneous melanoma (non-acral lentiginous) with at least 1 lesion that is measurable by RECIST 1.1 criteria and accessible for biopsies
* Eastern Cooperative Oncology Group (ECOG) performance status (PS) of 0 or 1
* Adequate hepatic function
* Adequate renal function
* Adequate bone marrow function
* Willing and able to comply with clinic visits and study-related procedures
* Provide signed informed consent
* Able to understand and complete study-related questionnaires
* Anticipated life expectancy \>12 weeks

Key Exclusion Criteria:

* Ongoing or recent (within 5 years) evidence of significant autoimmune disease that required treatment with systemic immunosuppressive treatments, which may suggest risk for immune-related adverse events (irAEs).
* Prior treatment with an agent that blocks the programmed death-1/ programmed death-ligand 1 (PD-1/PD-L1 pathway)
* Prior treatment with other immune modulating anti-cancer agents, except for remote treatment (\>6 months) in adjuvant setting.
* Untreated or active brain metastases or spinal cord compression
* Immunosuppressive corticosteroid doses (\>10 mg prednisone daily or equivalent) within 4 weeks prior to the first dose of REGN2810

Other protocol-defined inclusion/exclusion criteria will apply
Locations (8)
  • Nijmegen, Netherlands
  • Belgrade, Serbia
  • Seoul, South Korea
  • Seoul, South Korea
  • Seoul, South Korea
  • Seoul, South Korea
  • London, United Kingdom
  • Oxford, United Kingdom