EUCTR2011-005014-12-DE进行中（未招募）不适用
A Phase 1/2 Study to Evaluate the Safety, Tolerability, Immune Response, and Clinical Efficacy of Cancer Peptide Vaccine S-488210 in Patients with Unresectable Locoregionally Recurrent and/or Metastatic Head and Neck Squamous Cell Carcinoma (HNSCC)
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 入组人数
- 92
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional clinical trial of medicinal product
入排标准
- 性别
- All
入选标准
- •1. Confirmed to be HLA-A*02:01-positive (Phase 1 part only)
- •2. Has unresectable locoregionally recurrent and/or metastatic HNSCC after failure of platinum based chemotherapy (including patients who are intolerant to platinum based chemotherapy due to adverse or toxic effects)For patients who can be treated with radiotherapy according to national guidelines, radiotherapy treatment, including hyperfractionation radiotherapy or radiotherapy with concurrent systemic therapy, must be completed before enrollment.
- •3. Has previously received platinum based chemotherapy containing either cisplatin or carboplatin as monotherapy or in combination with radiation
- •4. Has histologically confirmed squamous cell carcinoma of the oral cavity, oropharynx, hypopharynx, or larynx
- •5. Has the presence of measurable disease as defined by response evaluation criteria in solid tumors (RECIST) that is confirmed on imaging within 4 weeks before enrollment
- •6. Has an ECOG PS of 0 or 1 within 2 weeks before enrollment
- •7. Has an expected life span of at least 3 months from the time of enrollment
- •8. Is willing and able to provide a tumor tissue sample
- •9. Is a male or female patient aged >/ = 18 years at enrollment
- •10. Has been informed of the full nature and purpose of the study, including possible risks and side effects, and has been given ample time and opportunity to read and understand this information, and has signed the ICF
- •Are the trial subjects under 18? no
- •Number of subjects for this age range:
- •F.1.2 Adults (18-64 years) yes
- •F.1.2.1 Number of subjects for this age range 46
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range 46
排除标准
- •1. Has been treated with 3 or more chemotherapy regimens
- •2. Is human immunodeficiency virus positive, hepatitis B surface antigen
- •positive, hepatitis C virus positive, or has other positive laboratory tests
- •suggestive of active infection
- •3. Has human papilloma virus-positive tumor (Phase 2 only)
- •4. Has any other malignant disease within the past 3 years, except for
- •cervical carcinoma in situ or skin cancers other than melanoma
- •5. Has brain metastasis
- •6. Has received any of the following within 28 days of enrollment: anti malignant tumor drugs, immunosuppressants, corticosteroids, radiation therapy, immunotherapy, thermotherapy, and/or major surgery
- •7. Has an uncontrolled systemic or active infection
- •8. Has uncontrolled comorbidities such as hepatic insufficiency, renal insufficiency, heart failure, chronic obstructive pulmonary disease, bleeding disorders, or metabolic disease
- •9. Has an autoimmune disease including rheumatoid arthritis, systemic lupus erythematosus, or psoriasis
- •10. Has a current drug allergy or a past history of drug allergy
- •11. Has a past history of hypersensitivity to vaccines (eg, prophylactic vaccination)
- •12. Has received any systemic radiation therapy within 28 days of enrollment
- •13. Has inadequate bone marrow function, hepatic, or renal function test values that meet the following criteria within 2 weeks before enrollment:
- •- White blood cell count <2000/mm^3 or >20 000/mm^3
- •- Platelet count <50 000/mm^3
- •- Aspartate aminotransferase or alanine aminotransferase >5 × the upper limit of the reference range
- •- Total bilirubin >3 × the upper limit of the reference range
- •- Serum creatinine >3 × the upper limit of the reference range
- •14. Is a female who is breastfeeding or pregnant, or who might be pregnant
- •15. Cannot or does not intend to use adequate means of contraception (barrier contraceptives [male condom, female condom, or diaphragm with a spermicidal gel]; hormonal contraceptives [implants, injectables, combination oral contraceptives, transdermal patches, or contraceptive rings]; or intrauterine devices) from enrollment until 12 weeks after final study drug administration
- •16. Has previously received a URLC10-, a CDCA1-, or a KOC1-derived
- •peptide vaccine
- •17. Has received another investigational product (including clinical study
- •drugs) within 28 days of enrollment, or still has adverse effects
- •attributable to a previous investigational product at the time of
- •18. Is considered inappropriate for the safe conduct of this study in the
- •opinion of the coordinating investigator
- •19. Has previously been genotyped for HLA status (Phase 2 part only)
研究者
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