NCT03002376

Brief Summary

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

Trial Health

90
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
47

participants targeted

Target at P50-P75 for phase_1

Timeline
Completed

Started Apr 2017

Typical duration for phase_1

Geographic Reach
4 countries

8 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

December 20, 2016

Completed
3 days until next milestone

First Posted

Study publicly available on registry

December 23, 2016

Completed
4 months until next milestone

Study Start

First participant enrolled

April 10, 2017

Completed
1.9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 5, 2019

Completed
1 year until next milestone

Study Completion

Last participant's last visit for all outcomes

March 19, 2020

Completed
Last Updated

April 20, 2020

Status Verified

April 1, 2020

Enrollment Period

1.9 years

First QC Date

December 20, 2016

Last Update Submit

April 16, 2020

Conditions

Melanoma

Outcome Measures

Primary Outcomes (1)

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

    Baseline up to week 24

Secondary Outcomes (6)

  • 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

  • +1 more secondary outcomes

Study Arms (1)

REGN2810

EXPERIMENTAL

REGN2810 treatment

Drug: REGN2810

Interventions

REGN2810DRUG

REGN2810 treatment

Also known as: cemiplimab, Libtayo
REGN2810

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (8)

Radboud University Medical Center

Nijmegen, 6500 HB, Netherlands

Location

Military Medical Academy

Belgrade, 11000, Serbia

Location

Seoul National University Hospital

Seoul, 03080, South Korea

Location

Asan Medical Center

Seoul, 05505, South Korea

Location

Samsung Medical Center

Seoul, 135-710, South Korea

Location

Severance Hospital-Yonsei University College of Medicine

Seoul, South Korea

Location

Guy's Hospital and St. Thomas NHS Foundation Trust

London, United Kingdom

Location

Churchill Hospital

Oxford, 0X3 7LE, United Kingdom

Location

MeSH Terms

Conditions

Melanoma

Interventions

cemiplimab

Condition Hierarchy (Ancestors)

Neuroendocrine TumorsNeuroectodermal TumorsNeoplasms, Germ Cell and EmbryonalNeoplasms by Histologic TypeNeoplasmsNeoplasms, Nerve TissueNevi and MelanomasSkin NeoplasmsNeoplasms by SiteSkin DiseasesSkin and Connective Tissue Diseases

Study Officials

  • Clinical Trial Management

    Regeneron Pharmaceuticals

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
phase 1
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

December 20, 2016

First Posted

December 23, 2016

Study Start

April 10, 2017

Primary Completion

March 5, 2019

Study Completion

March 19, 2020

Last Updated

April 20, 2020

Record last verified: 2020-04

Locations

NL(1)SE(1)KR(4)GB(2)