Clinical trial NCT03002376: 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
Overall status: COMPLETED
Phase: PHASE1
Conditions: Melanoma
Lead sponsor: Regeneron Pharmaceuticals
Sponsor class: INDUSTRY
Collaborators: name: Sanofi
First posted: 2016-12-23
Enrollment: 47
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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


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

Primary outcomes:
measure: Correlation between changes in the tumor microenvironment and the change in tumor volume following REGN2810 treatment versus baseline
timeFrame: Baseline up to week 24
Secondary outcomes:
measure: Correlation between baseline tumor characteristics and the change in tumor volume following treatment in REGN2810
timeFrame: Baseline up to week 24
measure: Incidence of Adverse Event (AEs) in patients treated with REGN2810
timeFrame: Baseline through treatment with REGN2810 (up to 48 weeks) and follow up
measure: REGN2810 serum concentrations
timeFrame: Baseline up to 6 weeks following last dose of REGN2810
measure: Anti-REGN2810 antibody levels
timeFrame: Baseline up to 6 weeks following last dose of REGN2810
measure: The progression-free survival (PFS) in patients treated with REGN2810
timeFrame: Baseline up to 6 weeks following last dose of REGN2810
measure: The overall response rate in patients treated with REGN2810
timeFrame: Baseline up to 6 weeks following last dose of REGN2810
Other outcomes:
Locations:
city: Seoul
country: Korea, Republic of
facility: Seoul National University Hospital
city: Seoul
country: Korea, Republic of
facility: Asan Medical Center
city: Seoul
country: Korea, Republic of
facility: Samsung Medical Center
city: Seoul
country: Korea, Republic of
facility: Severance Hospital-Yonsei University College of Medicine
city: Nijmegen
country: Netherlands
facility: Radboud University Medical Center
city: Belgrade
country: Serbia
facility: Military Medical Academy
city: London
country: United Kingdom
facility: Guy's Hospital and St. Thomas NHS Foundation Trust
city: Oxford
country: United Kingdom
facility: Churchill Hospital
Study officials:
affiliation: Regeneron Pharmaceuticals
name: Clinical Trial Management
role: STUDY_DIRECTOR
References: