Companion Study for Patients Who Completed Participation in a REGN2810 (Anti-PD-1) Clinical Study

Withdrawn before enrolling · Phase 1

Conditions studied: Advanced Malignancies

In brief

This study has been designed to collect long-term follow-up information for patients who received REGN2810 in other clinical studies and to allow re-treatment for eligible patients.

Key facts

Study ID

NCT02520245

Run by

Regeneron Pharmaceuticals

People needed

0

Starts

2015-08-01

Expected to finish

2023-11-01

Last updated by the study team

2016-11-07

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may not qualify if…

• A patient who meets any of the following criteria will be excluded from receiving re-treatment with REGN2810:
• Ongoing or recent (within 5 years) evidence of significant autoimmune disease that required treatment with systemic immunosuppressive treatments, which may suggest risk for irAEs.
• Patients who experienced an irAE in while participating in another REGN2810 protocol who were unable to have their corticosteroid dose reduced to <10 mg per day prednisone equivalent within 12 weeks of toxicity.
• Patients who developed ≥ Grade 2 uveitis in a prior REGN2810 protocol
• Immunosuppressive corticosteroid doses (> 10 mg prednisone daily or equivalent) within 4 weeks prior to the first dose of REGN2810
• Active infection requiring therapy, including known infection with human immunodeficiency virus, or active infection with hepatitis B or hepatitis C virus.
• History of pneumonitis within the last 5 years.
• Any investigational or antitumor treatment within 30 days prior to the initial administration of REGN2810.
• History of documented allergic reactions or acute hypersensitivity reaction attributed of Grade ≥ 3 severity during or directly following an REGN2810 infusion
• Known allergy to doxycycline or tetracycline. (precaution due to presence of trace components in REGN2810)
• Breast-feeding
• Positive serum pregnancy test
• History within the last 5 years of an invasive malignancy other than the one treated in this study, with the exception of resected/ablated basal or squamous-cell carcinoma of the skin or carcinoma in situ of the cervix, or other local tumors considered cured by local treatment.
• Acute or chronic psychiatric problems that, under the evaluation of the investigator, make the patient ineligible for participation
• Unwilling to practice adequate contraception during the study until 6 months after the last dose of study drug

Where it is running

• City of Hope National Medical Center — Duarte, California, United States
• Sarah Cannon Research Institute at HealthONE — Denver, Colorado, United States
• Washington University School of Medicine Siteman Cancer Center — St Louis, Missouri, United States
• Laura & Isaac Perlmutter Cancer Center — New York, New York, United States
• University Hospitals Case Medical Center — Cleveland, Ohio, United States
• Stephenson Cancer Center — Oklahoma City, Oklahoma, United States
• Providence Portland Medical Center — Portland, Oregon, United States
• Sarah Cannon Research Institute — Nashville, Tennessee, United States
• START South Texas Accelerated Research Therapeutics — San Antonio, Texas, United States

Full record on ClinicalTrials.gov

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