NL-OMON49259
Completed
Not Applicable
An exploratory tumor biopsy-driven study to understand the relationship between biomarkers and indicators of clinical response in immunomodulatory treatment naïve unresectable stage III/IV melanoma patients receiving REGN2810 (anti-PD-1) - Regeneron R2810-ONC-1606<br>(0456/0086)
Overview
- Phase
- Not Applicable
- Intervention
- Not specified
- Conditions
- Not specified
- Sponsor
- Regeneron Pharmaceuticals, Inc.
- Enrollment
- 8
- Status
- Completed
- Last Updated
- 2 years ago
Overview
Brief Summary
No summary available.
Investigators
Eligibility Criteria
Inclusion Criteria
- •1\. Histologically confirmed diagnosis of stage III (unresectable) or stage IV
- •cutaneous (non\-acral lentiginous) with at least 1 lesion that is measurable by
- •RECIST 1\.1 criteria and accessible for biopsies. , 2\. Eastern Cooperative
- •Oncology Group (ECOG) performance status (PS) of 0 or 1 (ECOG PS 1 definition:
- •Restricted in physically strenuous activity but ambulatory and able to carry
- •out work of a light or sedentary nature, eg, light house work, office work).,
- •3\. \*18 years old, 4\. Hepatic function:, a. Total bilirubin \*1\.5 x upper limit
- •of normal, b. Transaminases \*3 x ULN, c. Alkaline phosphatase (ALP) \*2\.5 x ULN,
- •5\. Serum creatinine \*1\.5 x ULN or estimated glomerular filtration rate \>50
- •mL/min/1\.73m^2, 6\. Bone marrow function:, a. Hemoglobin \*9\.0 g/dL, b. Absolute
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\. Prior treatment with an agent that blocks
- •the PD\-1/PD\-L1 pathway., 3\. Prior treatment with other immune modulating
- •anti\-cancer agents., 4\. Untreated or active brain metastases or spinal cord
- •compression. , 5\. Immunosuppressive corticosteroid doses, 6\. History of human
- •immunodeficiency virus (HIV)., 7\. Uncontrolled chronic hepatitis B or C., 8\.
- •History of pneumonitis within the last 5 years., 9\. Grade 3 or 4 hypercalcemia
- •at time of enrollment., 10\. Any systematic anticancer treatment,
- •investigational or standard of care, within 30 days of the initial
Outcomes
Primary Outcomes
Not specified
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