NL-OMON49259已完成不适用
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)
适应症
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 8
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional
入排标准
- 年龄范围
- 18 至 64（—）
入选标准
- •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
- •neutrophil count (ANC) *1.5 x 10^9/L, c. Platelet count *75 x 10^9/L, 7.
- •Willing and able to comply with clinic visits and study-related procedures, 8.
- •Provide signed informed consent, 9. Able to understand and complete
- •study-related questionnaires, 10. Anticipated life expectancy >12 weeks
排除标准
- •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
- •administration of REGN2810 or planned to occur during the study period (Patients
- •receiving bisphosphonates or denosumab are not excluded)., 11. History of
- •documented allergic reactions or acute hypersensitivity reaction attributed to
- •antibody treatments., 12. Known allergy to doxycycline or tetracycline, 13.
- •Concurrent malignancy other than melanoma and/or history of malignancy other
- •melanoma within 3 years of date of first planned dose of REGN2810, except for
- •with negligible risk of metastasis or death, such as adequately treated basal
- •carcinoma (BCC) of the skin, carcinoma in situ of the cervix, or ductal
- •carcinoma in situ
- •of the breast, or history of prostate adenocarcinoma treated with curative
- •intent at least
- •3 years prior and with undetectable PSA for at least 3 years prior to
- •enrollment. Patients
- •with hematologic malignancies (e.g., chronic lymphocytic leukemia, CLL) are
- •excluded., 14. Any acute or chronic psychiatric problems that, in the opinion
- •of the investigator, make
- •the patient ineligible for participation., 15. Patients with a history of solid
- •organ transplant., 16. Any medical co-morbidity, clinical laboratory finding,
- •or concomitant medication that, in the opinion of the investigator, renders the
- •patient an unsuitable candidate for tumor biopsies due to high safety risks.,
- •17. Any medical co-morbidity, physical examination finding, or metabolic
- •dysfunction, or clinical laboratory abnormality that, in the opinion of the
- •investigator, renders the patient unsuitable for participation in a clinical
- •trial due to high safety risks and/or potential to affect interpretation of
- •results of the study., 18. Inability to undergo any response assessment by
- •contrast-enhanced radiologic imaging., 19. Pregnant or breastfeeding women, 20.
- •Sexually active men or women of childbearing potential who are unwilling to
- •highly effective contraception prior to the initial dose, during the study, and
- •for at least 6
- •months after the last dose. , 21. Prior treatment with idelalisib, 22.
- •Radiation therapy within 2 weeks prior to enrollment and not recovered to
- •baseline from
- •any AE due to radiation., See protocol section 6.2.2. for more detailed
- •information
研究者
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