NCT03002376CompletedPhase 1
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)
Regeneron Pharmaceuticals8 sites in 4 countries47 target enrollmentStarted: April 10, 2017Last updated:
Conditions
Interventions
Drugs
Trial Snapshot
- Phase
- Phase 1
- Status
- Completed
- Sponsor
- Regeneron Pharmaceuticals
- Enrollment
- 47
- Locations
- 8
- Primary Endpoint
- Correlation between changes in the tumor microenvironment and the change in tumor volume following REGN2810 treatment versus baseline
Study Overview
Brief Summary
This study is being conducted to compare the relationship of patient response to treatment to changes in tumor environment.
Study Design
- Study Type
- Interventional
- Allocation
- Na
- Intervention Model
- Single Group
- Primary Purpose
- Treatment
- Masking
- None
Eligibility Criteria
- Ages
- 18 Years to — (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
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
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
Arms & Interventions
REGN2810
Experimental
REGN2810 treatment
Intervention: REGN2810 (Drug)
Outcomes
Primary Outcomes
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 Outcomes
- The progression-free survival (PFS) in patients treated with REGN2810(Baseline up to 6 weeks following last dose of REGN2810)
- 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)
- Correlation between baseline tumor characteristics and the change in tumor volume following treatment in REGN2810(Baseline up to week 24)
- The overall response rate in patients treated with REGN2810(Baseline up to 6 weeks following last dose of REGN2810)
- Anti-REGN2810 antibody levels(Baseline up to 6 weeks following last dose of REGN2810)
Investigators
Study Sites (8)
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