- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03492489
Expanded Access Protocol for Cemiplimab in Metastatic or Locally Advanced Cutaneous Squamous Cell Carcinoma
July 30, 2019 updated by: Regeneron Pharmaceuticals
An Open-Label, Expanded Access Protocol of Cemiplimab in Patients With Metastatic or Locally Advanced Cutaneous Squamous Cell Carcinoma Who Are Not Candidates for Surgery
The objective of this program is to provide access to cemiplimab (REGN2810) to patients with metastatic cutaneous squamous cell carcinoma (mCSCC) or locally advanced cutaneous squamous cell carcinoma (laCSCC) who are not candidates for surgery prior to cemiplimab (REGN2810) being commercially available.
Study Overview
Status
No longer available
Conditions
Intervention / Treatment
Study Type
Expanded Access
Expanded Access Type
- Intermediate-size Population
- Treatment IND/Protocol
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years and older (Adult, Older Adult)
Accepts Healthy Volunteers
N/A
Genders Eligible for Study
All
Description
Key Inclusion Criteria:
- Histologically confirmed diagnosis of invasive Cutaneous Squamous Cell Carcinoma (CSCC)
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 ≤2.5 x ULN (or ≤5.0 x ULN, if liver or bone metastases) Patients with hepatic metastases: If transaminase levels (AST and/or ALT) are >3 x but ≤5 x ULN, total bilirubin must be ≤1.5 x ULN. If total bilirubin is >1.5 x but ≤3 x ULN, both transaminases (AST and ALT) must be ≤3 x ULN
- Renal function: serum creatinine ≤1.5 x ULN or estimated creatinine clearance (CrCl) >30 mL/min
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 not candidates for surgery include the examples below, but are not limited to:
- Metastatic disease (distant or nodal)
- Recurrence in the same location and curative resection is unlikely
- Significant local invasion that precludes complete resection
- Surgery may result in severe disfiguration or dysfunction
- Other conditions deemed to be contraindicating for surgery
Key Exclusion Criteria:
- Ongoing or recent (within 5 years) evidence of significant autoimmune disease that required treatment with systemic immunosuppressive treatments, which may suggest risk for immune-related adverse events (irAEs). The following are not exclusionary: vitiligo, childhood asthma that has resolved, type 1 diabetes, residual hypothyroidism that required only hormone replacement, or psoriasis that does not require systemic treatment
- Prior treatment with other immune modulating agents that was (a) within fewer than 4 weeks (28 days) prior to the first dose of cemiplimab (REGN2810), or (b) associated with immune-mediated adverse events (AEs) that were ≥ Grade 1 within 90 days prior to the first dose of cemiplimab (REGN2810), or (c) associated with toxicity that resulted in discontinuation of the immune-modulating agent
- Continuous immunosuppressive corticosteroid treatment (doses >10 mg prednisone daily or equivalent) within 2 weeks prior to the first dose of cemiplimab (REGN2810)Note: Patients who require brief course of steroids (eg, as prophylaxis for imaging studies) are not excluded
- Active uncontrolled infection requiring therapy, including infection with human immunodeficiency virus, or active infection with hepatitis B virus (HBV) or hepatitis C virus (HCV)
- History of pneumonitis within the last 5 years
Note: Other protocol defined Inclusion/Exclusion criteria may apply
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Collaborators
Investigators
- Study Director: Medical Affairs, Regeneron Pharmaceuticals
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Registration Dates
First Submitted
March 30, 2018
First Submitted That Met QC Criteria
March 30, 2018
First Posted (Actual)
April 10, 2018
Study Record Updates
Last Update Posted (Actual)
August 1, 2019
Last Update Submitted That Met QC Criteria
July 30, 2019
Last Verified
July 1, 2019
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- R2810-ONC-17103
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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