NL-OMON41308已完成不适用
An open Phase I Study of immunization with the recNY-ESO-1 + AS15 Antigen-Specific Cancer Immunotherapeutic in patients with NY-ESO-1-positive unresectable and progressive metastatic cutaneous melanoma. - NYESO1-AS15-MEL-001 (MET)
适应症
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 6
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 99（—）
入选标准
- •1. Male or female patient with histologically proven, measurable metastatic cutaneous melanoma, and with documented progressive disease within the 12 weeks before the first administration of study treatment.
- •2. Written informed consent for NY-ESO-1 expression screening and gene profiling on
- •resected tumor tissue and for the complete study has been obtained from the patient prior to shipment of the sample for expression testing and prior to the performance of any other protocol-specific procedure.
- •3. Patient is > or = 18 years of age at the time the informed consent form is signed.
- •4. The patient*s tumor shows expression of NY-ESO-1, as determined by real-time
- •quantitative reverse transcription polymerase chain reaction (RT-PCR) analysis or
- •any updated technique on fresh tissue sample(s).
- •5. Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1.
- •6. The patient has normal organ functions, including hemoglobin, leukocytes, lymphocytes, platelets, serum creatinine, serum total bilirubin, lactate dehydrogenase, ASAT, and ALAT.
- •7. Female patients of non-childbearing potential may be enrolled in the study.
- •8. Female patient of childbearing potential may be enrolled in the study if adequate contraception is being practiced and pregnancy tests are negative.
- •9. In the view of the investigator, the patient can and will comply with the requirements of the protocol.
排除标准
- •1. The patient has at any time received systemic chemotherapy, biochemotherapy or
- •anti-CTLA-4 monoclonal antibody for metastatic disease.
- •2. The patient is scheduled to receive any other anticancer treatments than those
- •specified in the protocol, including but not limited to (bio-)chemotherapeutic,
- •immunomodulating agents and radiotherapy.
- •3. The patient received any cancer immunotherapy containing a NY-ESO-1 antigen or
- •any cancer immunotherapy for his/her metastatic disease.
- •4. The patient requires concomitant treatment (more than 7 consecutive days) with
- •systemic corticosteroids, or any other immunosuppressive agents.
- •5. Use of any investigational or non-registered product (drug or vaccine) other than the ASCI within 30 days preceding the first ASCI administration, or planned use during the study period.
- •6. The patient has (had) previous or concomitant malignancies at other sites (including carcinoma in situ), except effectively treated non-melanoma skin cancers or
- •carcinoma in situ of the cervix or effectively treated malignancy that has been in
- •remission for over 5 years and is highly likely to have been cured.
- •7. The patient has an allergy to any component of the study investigational product or has a history of previous allergic reactions to vaccinations.
- •8. The patient has an autoimmune disease such as, but not limited to, multiple sclerosis, lupus, and inflammatory bowel disease. Patients with vitiligo are not excluded.
- •9. The patient has a family history of congenital or hereditary immunodeficiency.
- •10. The patient is known to be positive for the Human Immunodeficiency Virus (HIV).
- •11. The patient has an uncontrolled bleeding disorder.
- •12. The patient has a family history of congenital or hereditary immunodeficiency.
- •13. The patient has psychiatric or addictive disorders that may compromise his/her
- •ability to give informed consent, or to comply with the trial procedures.
- •14. The patient has concurrent severe medical problems, unrelated to the malignancy, that would significantly limit full compliance with the study or expose the patient to unacceptable risk.
- •15. For female patients: the patient is pregnant or lactating.
研究者
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