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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)

Primary Purpose

Melanoma

Status
Completed
Phase
Phase 1
Locations
International
Study Type
Interventional
Intervention
REGN2810
Sponsored by
Regeneron Pharmaceuticals
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Melanoma

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Seoul National University Hospital
  • Asan Medical Center
  • Samsung Medical Center
  • Severance Hospital-Yonsei University College of Medicine
  • Radboud University Medical Center
  • Military Medical Academy
  • Guy's Hospital and St. Thomas NHS Foundation Trust
  • Churchill Hospital

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

REGN2810

Arm Description

REGN2810 treatment

Outcomes

Primary Outcome Measures

Correlation between changes in the tumor microenvironment and the change in tumor volume following REGN2810 treatment versus baseline

Secondary Outcome Measures

Correlation between baseline tumor characteristics and the change in tumor volume following treatment in REGN2810
Incidence of Adverse Event (AEs) in patients treated with REGN2810
REGN2810 serum concentrations
Anti-REGN2810 antibody levels
The progression-free survival (PFS) in patients treated with REGN2810
The overall response rate in patients treated with REGN2810

Full Information

First Posted
December 20, 2016
Last Updated
April 16, 2020
Sponsor
Regeneron Pharmaceuticals
Collaborators
Sanofi
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1. Study Identification

Unique Protocol Identification Number
NCT03002376
Brief Title
An Exploratory Tumor Biopsy-driven Study to Understand the Relationship Between Biomarkers and Clinical Response in Melanoma Patients Receiving REGN2810 (Anti-PD-1)
Official Title
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)
Study Type
Interventional

2. Study Status

Record Verification Date
April 2020
Overall Recruitment Status
Completed
Study Start Date
April 10, 2017 (Actual)
Primary Completion Date
March 5, 2019 (Actual)
Study Completion Date
March 19, 2020 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Regeneron Pharmaceuticals
Collaborators
Sanofi

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Melanoma

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 1
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
47 (Actual)

8. Arms, Groups, and Interventions

Arm Title
REGN2810
Arm Type
Experimental
Arm Description
REGN2810 treatment
Intervention Type
Drug
Intervention Name(s)
REGN2810
Other Intervention Name(s)
cemiplimab, Libtayo
Intervention Description
REGN2810 treatment
Primary Outcome Measure Information:
Title
Correlation between changes in the tumor microenvironment and the change in tumor volume following REGN2810 treatment versus baseline
Time Frame
Baseline up to week 24
Secondary Outcome Measure Information:
Title
Correlation between baseline tumor characteristics and the change in tumor volume following treatment in REGN2810
Time Frame
Baseline up to week 24
Title
Incidence of Adverse Event (AEs) in patients treated with REGN2810
Time Frame
Baseline through treatment with REGN2810 (up to 48 weeks) and follow up
Title
REGN2810 serum concentrations
Time Frame
Baseline up to 6 weeks following last dose of REGN2810
Title
Anti-REGN2810 antibody levels
Time Frame
Baseline up to 6 weeks following last dose of REGN2810
Title
The progression-free survival (PFS) in patients treated with REGN2810
Time Frame
Baseline up to 6 weeks following last dose of REGN2810
Title
The overall response rate in patients treated with REGN2810
Time Frame
Baseline up to 6 weeks following last dose of REGN2810

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Clinical Trial Management
Organizational Affiliation
Regeneron Pharmaceuticals
Official's Role
Study Director
Facility Information:
Facility Name
Seoul National University Hospital
City
Seoul
ZIP/Postal Code
03080
Country
Korea, Republic of
Facility Name
Asan Medical Center
City
Seoul
ZIP/Postal Code
05505
Country
Korea, Republic of
Facility Name
Samsung Medical Center
City
Seoul
ZIP/Postal Code
135-710
Country
Korea, Republic of
Facility Name
Severance Hospital-Yonsei University College of Medicine
City
Seoul
Country
Korea, Republic of
Facility Name
Radboud University Medical Center
City
Nijmegen
ZIP/Postal Code
6500 HB
Country
Netherlands
Facility Name
Military Medical Academy
City
Belgrade
ZIP/Postal Code
11000
Country
Serbia
Facility Name
Guy's Hospital and St. Thomas NHS Foundation Trust
City
London
Country
United Kingdom
Facility Name
Churchill Hospital
City
Oxford
ZIP/Postal Code
0X3 7LE
Country
United Kingdom

12. IPD Sharing Statement

Learn more about this trial

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

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