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临床试验/EUCTR2017-002474-39-DE
EUCTR2017-002474-39-DE进行中（未招募）1 期

An open-label first-in-human phase 1/2a study to evaluate safety, feasibility and efficacy of multiple dosing with individualised VB10.NEO or VB10.NEO and bempegaldesleukin (NKTR-214) immunotherapy in patients with locally advanced or metastatic melanoma, NSCLC, clear renal cell carcinoma, urothelial cancer or squamous cell carcinoma of headand neck, who did not reach complete responses with current standard of care immune checkpoint blockade

ykode Therapeutics AS0 个研究点目标入组 101 人开始时间: 2017年8月4日最近更新:
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试验速览

阶段
1 期
状态
进行中（未招募）
发起方
入组人数
101
研究概览入排标准研究者记录与标识符相似试验

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

  • •For patients with melanoma:
  • •1. Have histologically confirmed locally advanced or metastatic melanoma not amenable to local treatment
  • •2. Patients must be on CPI (i.e. anti-programmed cell death protein 1 [anti-PD-1] or anti-programmed cell death protein ligand 1[anti-PD-L1]) or must initiate treatment with CPI (e.g. nivolumab or pembrolizumab) as part of their cancer treatment as prescribed by the treating physician
  • •For patients with lung cancer:
  • •1. Have histologically confirmed locally advanced or metastatic NSCLC not amenable to local treatment
  • •2. Patients must have been on CPI (i.e. anti-PD1 or anti-PD-L1) for at least 12 weeks before screening and must be on CPI treatment as part of their cancer treatment as prescribed by the treating physician, n, e.g. nivolumab, pembrolizumab, atezolizumab or durvalumab.
  • •For patients with renal cancer:
  • •1. Have histologically confirmed locally advanced or metastatic clear RCC not amenable to local treatment
  • •2. Patients must have been on CPI (i.e. anti-PD1 or anti-PD-L1) for at least 12 weeks before screening and must be on CPI treatment as part of their cancer treatment as prescribed by the treating physician, e.g. nivolumab
  • •For patients with urothelial carcinoma:
  • •1. Have histologically confirmed locally advanced or metastatic urothelial carcinoma not amenable to local treatment
  • •2. Patients must have been on CPI (i.e. anti-PD1 or anti-PD-L1) for at least 12 weeks before screening and must be on CPI treatment as part of their cancer treatment as prescribed by the treating physician, e.g. nivolumab, pembrolizumab or atezolizumab
  • •Inclusion criteria for patients with head and neck cancer:
  • •1. Have histologically confirmed locally advanced or metastatic SCCHN not amenable to local treatment.
  • •2. Patients must be on CPI (i.e. anti-PD-1 or anti-PD-L1) or must initiate treatment with CPI at screening as part of their cancer treatment as prescribed by the treating physician, e.g. nivolumab or pembrolizumab.
  • •Inclusion criteria for patients in all arms:
  • •3. 18 years or older
  • •4. Patients who have been on CPI for longer than 12 weeks at screening need to be per RECIST:
  • •a. in partial response or
  • •b. stable disease or
  • •c. in progression, i.e. in case of a mixed response to CPI treatment, provided that at least 1 lesion shows measurable regression and who, according to the investigator, have a clinical benefit of continued immunotherapy.
  • •5. Adequate tumour specimen (at least 1 core biopsy) must be available for exome sequencing, preferably a newly acquired FF sample. Archival FFPE samples from biopsies or resected tumour material taken < 4 months before screening can be accepted.
  • •Inclusion criteria 6 was deleted.
  • •Inclusion criteria 7 was deleted.
  • •8. Measurable disease per RECIST v1.1. Preferably 2 tumour sites should be available, one for biopsy and one for RECIST assessment.
  • •9. ECOG performance status = 1
  • •10. Life expectancy of at least 6 months in the best judgement of the investigator
  • •11. Willing and able to sign a written informed consent form (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 70
  • •F.1.3 Elderly (>=65 years) yes
  • •F.1.3.1 Number of subjects for this age range 21

排除标准

  • •1. Ocular melanoma
  • •2. Brain metastases (unless treated, controlled, stable for at least 6 weeks) or leptomeningeal spread of disease
  • •3. Positive serological test for hepatitis B or C virus surface antigen or HIV
  • •4. Other concomitant or prior malignant disease except for adequately treated basal cell carcinoma or other non-melanomatous skin cancer, low-grade urothelial cancer or other malignancies treated with curative intent within 2 or more years pre-study entry and in complete remission at study entry
  • •5. Immune disorder requiring the continued use (> 7 days) of high-dose systemic steroids or immunosuppressive agents for any concurrent condition, or a documented history of clinically significant autoimmune disease, as assessed by the investigator. Systemically administered corticosteroids must be discontinued > 4 weeks prior to first study vaccine administration.
  • •Exclusion criteria 6 deleted.
  • •7. Known allergy to aminoglycosides or to any of the IMP’s components/excipients
  • •Exclusion criteria 8 deleted.
  • •9. History of toxic shock syndrome
  • •10. Evidence or history of clinically significant cardiac disease including congestive heart failure, unstable angina, acute myocardial infarction or cerebrovascular accident within the last 6 months, and symptomatic arrhythmia requiring therapy
  • •11. Ongoing toxicity from prior therapy that is > Grade 2 for skin toxicities and > Grade 1 for all other toxicities, or that is progressing in severity, except toxicities not considered a safety risk
  • •12. History of life-threatening organ toxicity of Grade 4 related to CPI exposure, excluding endocrinopathies
  • •13. Acute infections
  • •14. Active lesions/rashes or any implantable devices within 2cm of the site of vaccination
  • •15. Current participation in a clinical trial (allowed if not exposed to IMP)
  • •16. Planned vaccination against infections within 30 days before start of treatment.
  • •17. Previous transplantations
  • •18. Inadequate bone marrow function: Platelet count < 50,000 cells/µL
  • •19. Patients requiring therapeutic anticoagulation due to medical condition are eligible but have to be excluded in case of not sufficiently manageable anticoagulation treatment or history of severe bleeding episodes due to therapeutic anticoagulation
  • •20. Inadequate liver function:
  • •Serum total bilirubin >1.5 x ULN for the institution; patients with Gilbert’s Syndrome >3 x ULN
  • •AST or ALT >3 x ULN; patients with liver metastases > 5 x ULN
  • •By the investigator's judgement, patients exceeding the above limits as an effect of CPI treatment should be excluded; patients exceeding the above limits due to the course of malignancy may be enrolled
  • •21. Inadequate renal function:
  • •Estimated CrCl of =30 mL/min
  • •Proteinuria >100 mg/dL
  • •22. Clinically significant uncorrected electrolyte abnormalities that are CTCAE Grade 3 or higher for both low and high values
  • •23. Female patients of childbearing potential not willing to use a highly effective form of contraception during treatment and for at least 6 months after the last dose of VB10.NEO or NKTR-214
  • •24. Pregnancy or intention to become pregnant during the study period (serum/urine pregnancy test: screening, day of vaccination, prior to treatment start)
  • •25. Nursing women
  • •26. Evidence of any other medical conditions that may interfere with study participation, affect patient compliance or place the patient at high risk from treatment-related complications
  • •Exclusion criteria for patients enrolled to arm 5B:

研究者

发起方
ykode Therapeutics AS

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