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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Open-Label | Experimental |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| REGN2810 | Drug | Patients will receive REGN2810 by intravenous (IV) infusion |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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. | 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. | up to 8 years |
| Measure | Description | Time Frame |
|---|---|---|
| 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) |
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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
Developed documented progressive disease after first demonstrating clinical benefit from their initial treatment
Eastern Cooperative Oncology Group (ECOG) performance status ≤ 1
≥18 years old
Hepatic function:
Renal function: Serum creatinine ≤ 1.5 x ULN
Bone marrow function:
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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| Name | Affiliation | Role |
|---|---|---|
| Clinical Trial Management | Regeneron Pharmaceuticals | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| City of Hope National Medical Center | Duarte | California | United States | |||
| Sarah Cannon Research Institute at HealthONE |
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| up to 8 years |
| 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 |
| ID | Term |
|---|---|
| C000627974 | cemiplimab |
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