Companion Study for Patients Who Completed Participation in a REGN2810 (Anti-PD-1) Clinical Study
NCT ID: NCT02520245
Last Updated: 2016-11-07
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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WITHDRAWN
PHASE1
INTERVENTIONAL
2015-08-31
2023-11-30
Brief Summary
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Detailed Description
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Conditions
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Study Design
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NA
SINGLE_GROUP
TREATMENT
NONE
Study Groups
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Open-Label
REGN2810
Patients will receive REGN2810 by intravenous (IV) infusion
Interventions
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REGN2810
Patients will receive REGN2810 by intravenous (IV) infusion
Eligibility Criteria
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Inclusion Criteria
2. Developed documented progressive disease after first demonstrating clinical benefit from their initial treatment
3. Eastern Cooperative Oncology Group (ECOG) performance status ≤ 1
4. ≥18 years old
5. Hepatic function:
* Total bilirubin ≤ 1.5 x upper limit of normal (ULN; if liver metastases ≤ 3 x ULN)
* Transaminases ≤ 3 x ULN (or ≤ 5.0 x ULN, if liver metastases)
* Alkaline phosphatase (ALP) ≤ 2.5 x ULN (or ≤ 5.0 x ULN, if liver metastases)
* For patients with hepatic metastases or hepatic malignancies, exclude patients with concomitant 3 x ULN ≤ aspartate aminotransferase (AST) and/or alanine aminotransferase (ALT) ≤ 5 x ULN and 1.5 x ULN ≤ total bilirubin ≤ 3 x ULN
6. Renal function: Serum creatinine ≤ 1.5 x ULN
7. Bone marrow function:
* Hemoglobin ≥ 9.0 g/dL
* Absolute neutrophil count (ANC) ≥ 1.5 x 10\^9/L
* Platelet count ≥ 75 x 10\^9/L
Patients must have completed participation in any REGN2810 clinical study.
Exclusion Criteria
1. Ongoing or recent (within 5 years) evidence of significant autoimmune disease that required treatment with systemic immunosuppressive treatments, which may suggest risk for irAEs.
2. 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.
3. Patients who developed ≥ Grade 2 uveitis in a prior REGN2810 protocol
4. Immunosuppressive corticosteroid doses (\> 10 mg prednisone daily or equivalent) within 4 weeks prior to the first dose of REGN2810
5. Active infection requiring therapy, including known infection with human immunodeficiency virus, or active infection with hepatitis B or hepatitis C virus.
6. History of pneumonitis within the last 5 years.
7. Any investigational or antitumor treatment within 30 days prior to the initial administration of REGN2810.
8. History of documented allergic reactions or acute hypersensitivity reaction attributed of Grade ≥ 3 severity during or directly following an REGN2810 infusion
9. Known allergy to doxycycline or tetracycline. (precaution due to presence of trace components in REGN2810)
10. Breast-feeding
11. Positive serum pregnancy test
12. 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.
13. Acute or chronic psychiatric problems that, under the evaluation of the investigator, make the patient ineligible for participation
14. Unwilling to practice adequate contraception during the study until 6 months after the last dose of study drug
18 Years
ALL
No
Sponsors
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Regeneron Pharmaceuticals
INDUSTRY
Responsible Party
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Principal Investigators
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Clinical Trial Management
Role: STUDY_DIRECTOR
Regeneron Pharmaceuticals
Locations
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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
Countries
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Other Identifiers
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R2810-ONC-1425
Identifier Type: -
Identifier Source: org_study_id