Companion Study for Patients Who Completed Participation in a REGN2810 (Anti-PD-1) Clinical Study
Study Details
Study Description
Brief Summary
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.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
| Phase 1 |
Study Design
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| Experimental: Open-Label
|
Drug: REGN2810
Patients will receive REGN2810 by intravenous (IV) infusion
|
Outcome Measures
Primary Outcome Measures
- Overall survival, from the first dose of study drug administered in the parent REGN2810 clinical study to death or date of last censoring [up to 8 years]
- Safety measured by the number of patients with AEs, AEs leading to discontinuation, SAEs, drug-related AEs, Immune-related adverse events (irAEs), and death as outcome. [up to 8 years]
Safety includes the number of patients with AEs, AEs leading to discontinuation, SAEs, drug-related AEs, Immune-related adverse events (irAEs), and death as outcome.
Secondary Outcome Measures
- Response duration (time from best overall response of partial or complete response, to time to first documented disease progression) [up to 8 years]
- Duration of disease control (time from best overall response of SD as well as PR and CR to time to first do documented disease progression) [up to 8 years]
Eligibility Criteria
Criteria
The target population for this study is patients who have participated in any REGN2810 clinical study.
Inclusion Criteria for Patients Receiving Re-treatment:
-
Tolerated prior treatment with REGN2810 with no unacceptable toxicity (except select reversible irAEs) requiring discontinuation of REGN2810
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Developed documented progressive disease after first demonstrating clinical benefit from their initial treatment
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Eastern Cooperative Oncology Group (ECOG) performance status ≤ 1
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≥18 years old
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Hepatic function:
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Total bilirubin ≤ 1.5 x upper limit of normal (ULN; if liver metastases ≤ 3 x ULN)
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Transaminases ≤ 3 x ULN (or ≤ 5.0 x ULN, if liver metastases)
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Alkaline phosphatase (ALP) ≤ 2.5 x ULN (or ≤ 5.0 x ULN, if liver metastases)
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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
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Renal function: Serum creatinine ≤ 1.5 x ULN
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Bone marrow function:
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Hemoglobin ≥ 9.0 g/dL
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Absolute neutrophil count (ANC) ≥ 1.5 x 10^9/L
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Platelet count ≥ 75 x 10^9/L
Inclusion Criteria for Patients who Will not Receive Re-treatment:
Patients must have completed participation in any REGN2810 clinical study.
Exclusion Criteria:
A patient who meets any of the following criteria will be excluded from receiving re-treatment with REGN2810:
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Ongoing or recent (within 5 years) evidence of significant autoimmune disease that required treatment with systemic immunosuppressive treatments, which may suggest risk for irAEs.
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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.
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Patients who developed ≥ Grade 2 uveitis in a prior REGN2810 protocol
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Immunosuppressive corticosteroid doses (> 10 mg prednisone daily or equivalent) within 4 weeks prior to the first dose of REGN2810
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Active infection requiring therapy, including known infection with human immunodeficiency virus, or active infection with hepatitis B or hepatitis C virus.
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History of pneumonitis within the last 5 years.
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Any investigational or antitumor treatment within 30 days prior to the initial administration of REGN2810.
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History of documented allergic reactions or acute hypersensitivity reaction attributed of Grade ≥ 3 severity during or directly following an REGN2810 infusion
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Known allergy to doxycycline or tetracycline. (precaution due to presence of trace components in REGN2810)
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Breast-feeding
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Positive serum pregnancy test
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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.
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Acute or chronic psychiatric problems that, under the evaluation of the investigator, make the patient ineligible for participation
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Unwilling to practice adequate contraception during the study until 6 months after the last dose of study drug
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | City of Hope National Medical Center | Duarte | California | United States | |
| 2 | Sarah Cannon Research Institute at HealthONE | Denver | Colorado | United States | |
| 3 | Washington University School of Medicine Siteman Cancer Center | St. Louis | Missouri | United States | |
| 4 | Laura & Isaac Perlmutter Cancer Center | New York | New York | United States | |
| 5 | University Hospitals Case Medical Center | Cleveland | Ohio | United States | |
| 6 | Stephenson Cancer Center | Oklahoma City | Oklahoma | United States | |
| 7 | Providence Portland Medical Center | Portland | Oregon | United States | |
| 8 | Sarah Cannon Research Institute | Nashville | Tennessee | United States | |
| 9 | START South Texas Accelerated Research Therapeutics | San Antonio | Texas | United States |
Sponsors and Collaborators
- Regeneron Pharmaceuticals
Investigators
- Study Director: Clinical Trial Management, Regeneron Pharmaceuticals
Study Documents (Full-Text)
None provided.More Information
Publications
None provided.- R2810-ONC-1425