An Exploratory Tumor Biopsy-driven Study to Understand the Relationship Between Biomarkers and Clinical Response in Melanoma Patients Receiving REGN2810 (Anti-PD-1)

Phase 1

Completed

• Conditions: Melanoma
• Interventions: Drug: REGN2810

• Registration Number: NCT03002376
• Lead Sponsor: Regeneron Pharmaceuticals

Brief Summary

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

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2016-12-20
• Study First Submitted QC: 2016-12-20
• Study First Posted: 2016-12-23
• Study Start: 2017-04-10
• Primary Completion: 2019-03-05
• Study Completion: 2020-03-19
• Status Verified: 2020-04
• Last Update Submitted: 2020-04-16
• Last Update Posted: 2020-04-20

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 47

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
REGN2810	REGN2810	REGN2810 treatment

Primary Outcome Measures

Name	Time	Method
Correlation between changes in the tumor microenvironment and the change in tumor volume following REGN2810 treatment versus baseline	Baseline up to week 24

Secondary Outcome Measures

Name	Time	Method
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

Trial Locations

Locations (8)

Seoul National University Hospital; 🇰🇷 Seoul, Korea, Republic of

Asan Medical Center; 🇰🇷 Seoul, Korea, Republic of

Samsung Medical Center; 🇰🇷 Seoul, Korea, Republic of

Severance Hospital-Yonsei University College of Medicine; 🇰🇷 Seoul, Korea, Republic of

Radboud University Medical Center; 🇳🇱 Nijmegen, Netherlands

Churchill Hospital; 🇬🇧 Oxford, United Kingdom

Guy's Hospital and St. Thomas NHS Foundation Trust; 🇬🇧 London, United Kingdom

Military Medical Academy; 🇷🇸 Belgrade, Serbia