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A First-in-Human Study of Repeat Dosing with REGN2810, a Monoclonal, Fully Human Antibody to Programmed Death – 1 (PD-1), as Single Therapy and in Combination with Other Anti-Cancer Therapies in Patients with Advanced Malignancies

Clinical Trial Details

The trial is open to patients ≥ 18 years old who have been diagnosed with advanced cancer and who have failed standard therapy.  This is a phase 1 study to characterize the safety and tolerability of the investigational study drug REGN2810, which is manufactured by Regeneron Pharmaceuticals.

The primary objective of this study is to find a safe dose level of the investigational study drug, REGN2810 in combination with radiotherapy, cyclophosphamide, and radiotherapy plus cyclophosphamide and GM-CSF. Other objectives of this study are to measure the levels of REGN2810 in your blood and to collect any evidence of anti-tumor activity of REGN2810 when given alone or in combination with the other therapies. This drug is not yet approved.

REGN2810 is a type of drug called a monoclonal antibody.  REGN2810 is a fully human monoclonal anti - PD-1 antibody (a type of protein) that works by blocking the programmed death receptor 1 (PD-1), a cell receptor on immune cells that is involved in preventing the immune cells from destroying other cells. Blocking the receptor is expected to help the immune cells attack the cancer cells. This study is being conducted to test the safety of REGN2810 and to see if blocking PD-1 with REGN2810 will help the immune system attack the tumor, and to determine whether combining REGN2810 with radiotherapy and/or cyclophosphamide is safe enough and if it can help to improve tumor shrinkage.

Radiotherapy and lower doses of cyclophosphamide are therapies currently approved for the treatment of various cancers.

The study medication is given by intravenous infusion (given into a vein) every two weeks.

Key Eligibility: 
  • Open to patients ≥ 18 years old, who have been diagnosed with advanced cancer and who have failed standard line of therapies
  • At least one measurable lesion according to RECIST criteria for response assessment
  • Ability and willingness to comply with scheduled visits, treatment plans, laboratory tests and other study-related procedures
  • Detailed eligibility reviewed when you contact the study team

Contact

Sharanya Chandrasekhar
shc2043@med.cornell.edu

Primary Investigator

Silvia Formenti, M.D.

Protocol ID: 
WCMC IRB #1505016229; Sponsor Protocol #REGN2810-ONC-1423; ClinicalTrials.gov #NCT02383212

Status:

Open to Enrollment

AGE GROUP

Adult

DRUG/DEVICE

STUDY TYPE

PHASE