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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)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03002376
Recruitment Status : Active, not recruiting
First Posted : December 23, 2016
Last Update Posted : June 20, 2019
Sponsor:
Collaborator:
Sanofi
Information provided by (Responsible Party):
Regeneron Pharmaceuticals

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

Condition or disease Intervention/treatment Phase
Melanoma Drug: REGN2810 Phase 1

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 47 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
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)
Actual Study Start Date : April 10, 2017
Actual Primary Completion Date : March 5, 2019
Estimated Study Completion Date : October 22, 2019

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Biopsy Melanoma

Arm Intervention/treatment
Experimental: REGN2810
REGN2810 treatment
Drug: REGN2810
REGN2810 treatment
Other Names:
  • cemiplimab
  • Libtayo




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


Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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


Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03002376


Locations
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Korea, Republic of
Seoul National University Hospital
Seoul, Korea, Republic of, 03080
Asan Medical Center
Seoul, Korea, Republic of, 05505
Samsung Medical Center
Seoul, Korea, Republic of, 135-710
Severance Hospital-Yonsei University College of Medicine
Seoul, Korea, Republic of
Netherlands
Radboud University Medical Center
Nijmegen, Netherlands, 6500 HB
Serbia
Military Medical Academy
Belgrade, Serbia, 11000
United Kingdom
Guy's Hospital and St. Thomas NHS Foundation Trust
London, United Kingdom
Churchill Hospital
Oxford, United Kingdom, 0X3 7LE
Sponsors and Collaborators
Regeneron Pharmaceuticals
Sanofi
Investigators
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Study Director: Clinical Trial Management Regeneron Pharmaceuticals

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Responsible Party: Regeneron Pharmaceuticals
ClinicalTrials.gov Identifier: NCT03002376     History of Changes
Other Study ID Numbers: R2810-ONC-1606
2016-002755-16 ( EudraCT Number )
First Posted: December 23, 2016    Key Record Dates
Last Update Posted: June 20, 2019
Last Verified: June 2019

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Melanoma
Neuroendocrine Tumors
Neuroectodermal Tumors
Neoplasms, Germ Cell and Embryonal
Neoplasms by Histologic Type
Neoplasms
Neoplasms, Nerve Tissue
Nevi and Melanomas
Cemiplimab
Antineoplastic Agents, Immunological
Antineoplastic Agents