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

Melanoma Clinical Trial

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)

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03002376
• Other study ID #: R2810-ONC-1606
• Secondary ID: 2016-002755-16
• Status: Completed
• Phase: Phase 1
• Start date: April 10, 2017
• Est. completion date: March 19, 2020

Study information

• Verified date: April 2020
• Source: Regeneron Pharmaceuticals
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 47
• Est. completion date: March 19, 2020
• Est. primary completion date: March 5, 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Melanoma

Intervention

Drug:
• REGN2810
REGN2810 treatment

Locations

Country	Name	City	State
Korea, Republic of	Asan Medical Center	Seoul
Korea, Republic of	Samsung Medical Center	Seoul
Korea, Republic of	Seoul National University Hospital	Seoul
Korea, Republic of	Severance Hospital-Yonsei University College of Medicine	Seoul
Netherlands	Radboud University Medical Center	Nijmegen
Serbia	Military Medical Academy	Belgrade
United Kingdom	Guy's Hospital and St. Thomas NHS Foundation Trust	London
United Kingdom	Churchill Hospital	Oxford

Sponsors (2)

Lead Sponsor	Collaborator
Regeneron Pharmaceuticals	Sanofi

Countries where clinical trial is conducted

Korea, Republic of,  Netherlands,  Serbia,  United Kingdom, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Correlation between changes in the tumor microenvironment and the change in tumor volume following REGN2810 treatment versus baseline		Baseline up to week 24
Secondary	Correlation between baseline tumor characteristics and the change in tumor volume following treatment in REGN2810		Baseline up to week 24
Secondary	Incidence of Adverse Event (AEs) in patients treated with REGN2810		Baseline through treatment with REGN2810 (up to 48 weeks) and follow up
Secondary	REGN2810 serum concentrations		Baseline up to 6 weeks following last dose of REGN2810
Secondary	Anti-REGN2810 antibody levels		Baseline up to 6 weeks following last dose of REGN2810
Secondary	The progression-free survival (PFS) in patients treated with REGN2810		Baseline up to 6 weeks following last dose of REGN2810
Secondary	The overall response rate in patients treated with REGN2810		Baseline up to 6 weeks following last dose of REGN2810