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

Regeneron Pharmaceuticals

Status and phase

Completed

Phase 1

Conditions

Melanoma

Treatments

Drug: REGN2810

Study type

Interventional

Funder types

Industry

Identifiers

2016-002755-16 (EudraCT Number)

R2810-ONC-1606

Details and patient eligibility

About

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

Enrollment

47 patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

Inclusion and exclusion 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