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 Indicators of Clinical Response in Immunomodulatory Treatment-naïve Unresectable Stage III/IV Melanoma Patients Receiving REGN2810 (Anti-PD-1)

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

Study Overview

• Status: Completed
• Conditions: Melanoma
• Intervention / Treatment: Drug: REGN2810

• Study Type: Interventional
• Enrollment (Actual): 47
• Phase: Phase 1

Contacts and Locations

Study Locations

• Korea, Republic of
  • Seoul, Korea, Republic of, 135-710
    • Samsung Medical Center
  • Seoul, Korea, Republic of, 03080
    • Seoul National University Hospital
  • Seoul, Korea, Republic of, 05505
    • Asan Medical Center
  • Seoul, Korea, Republic of
    • Severance Hospital-Yonsei University College of Medicine
• Netherlands
  • Nijmegen, Netherlands, 6500 HB
    • Radboud University Medical Center
• Serbia
  • Belgrade, Serbia, 11000
    • Military Medical Academy
• United Kingdom
  • London, United Kingdom
    • Guy's Hospital and St. Thomas NHS Foundation Trust
  • Oxford, United Kingdom, 0X3 7LE
    • Churchill Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: REGN2810; REGN2810 treatment	Drug: REGN2810; REGN2810 treatment; Other Names: Libtayo; cemiplimab

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Correlation between changes in the tumor microenvironment and the change in tumor volume following REGN2810 treatment versus baseline	Baseline up to week 24

Secondary Outcome Measures

Outcome Measure	Time Frame
Correlation between baseline tumor characteristics and the change in tumor volume following treatment in REGN2810	Baseline up to week 24
Incidence of Adverse Event (AEs) in patients treated with REGN2810	Baseline through treatment with REGN2810 (up to 48 weeks) and follow up
REGN2810 serum concentrations	Baseline up to 6 weeks following last dose of REGN2810
Anti-REGN2810 antibody levels	Baseline up to 6 weeks following last dose of REGN2810
The progression-free survival (PFS) in patients treated with REGN2810	Baseline up to 6 weeks following last dose of REGN2810
The overall response rate in patients treated with REGN2810	Baseline up to 6 weeks following last dose of REGN2810

Collaborators and Investigators

• Sponsor: Regeneron Pharmaceuticals
• Collaborators: Sanofi

Study record dates

Study Major Dates

• Study Start (Actual): April 10, 2017
• Primary Completion (Actual): March 5, 2019
• Study Completion (Actual): March 19, 2020

Study Registration Dates

• First Submitted: December 20, 2016
• First Submitted That Met QC Criteria: December 20, 2016
• First Posted (Estimate): December 23, 2016

Study Record Updates

• Last Update Posted (Actual): April 20, 2020
• Last Update Submitted That Met QC Criteria: April 16, 2020
• Last Verified: April 1, 2020

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Neoplasms by Histologic Type; Neoplasms; Neuroectodermal Tumors; Neoplasms, Germ Cell and Embryonal; Neoplasms, Nerve Tissue; Neuroendocrine Tumors; Nevi and Melanomas; Melanoma; Antineoplastic Agents; Antineoplastic Agents, Immunological; Cemiplimab
• Other Study ID Numbers: R2810-ONC-1606; 2016-002755-16 (EudraCT Number)

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No