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Trial record 31 of 38 for:    cemiplimab

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

Tracking Information
First Submitted Date  ICMJE December 20, 2016
First Posted Date  ICMJE December 23, 2016
Last Update Posted Date June 20, 2019
Actual Study Start Date  ICMJE April 10, 2017
Actual Primary Completion Date March 5, 2019   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: December 20, 2016)
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 ]
Original Primary Outcome Measures  ICMJE Same as current
Change History Complete list of historical versions of study NCT03002376 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE
 (submitted: December 20, 2016)
  • Correlation between baseline tumor characteristics and the change in tumor volume following treatment in REGN2810 [ Time Frame: Baseline up to week 24 ]
  • Incidence of Adverse Event (AEs) in patients treated with REGN2810 [ Time Frame: Baseline through treatment with REGN2810 (up to 48 weeks) and follow up ]
  • REGN2810 serum concentrations [ Time Frame: Baseline up to 6 weeks following last dose of REGN2810 ]
  • Anti-REGN2810 antibody levels [ Time Frame: Baseline up to 6 weeks following last dose of REGN2810 ]
  • The progression-free survival (PFS) in patients treated with REGN2810 [ Time Frame: Baseline up to 6 weeks following last dose of REGN2810 ]
  • The overall response rate in patients treated with REGN2810 [ Time Frame: Baseline up to 6 weeks following last dose of REGN2810 ]
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE 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  ICMJE 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)
Brief Summary This study is being conducted to compare the relationship of patient response to treatment to changes in tumor environment.
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 1
Study Design  ICMJE Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE Melanoma
Intervention  ICMJE Drug: REGN2810
REGN2810 treatment
Other Names:
  • cemiplimab
  • Libtayo
Study Arms  ICMJE Experimental: REGN2810
REGN2810 treatment
Intervention: Drug: REGN2810
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Active, not recruiting
Actual Enrollment  ICMJE
 (submitted: June 18, 2019)
47
Original Estimated Enrollment  ICMJE
 (submitted: December 20, 2016)
30
Estimated Study Completion Date  ICMJE October 22, 2019
Actual Primary Completion Date March 5, 2019   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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

Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Korea, Republic of,   Netherlands,   Serbia,   United Kingdom
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT03002376
Other Study ID Numbers  ICMJE R2810-ONC-1606
2016-002755-16 ( EudraCT Number )
Has Data Monitoring Committee No
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Regeneron Pharmaceuticals
Study Sponsor  ICMJE Regeneron Pharmaceuticals
Collaborators  ICMJE Sanofi
Investigators  ICMJE
Study Director: Clinical Trial Management Regeneron Pharmaceuticals
PRS Account Regeneron Pharmaceuticals
Verification Date June 2019

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP