NCT02999646已完成不适用
Personalized and Cell-based Antitumor Immunization MVX-ONCO-1 in Advanced Head and Neck Squamous Cell Carcinoma. A Single Arm, Open Label, Multicenter Phase II Trial.
Maxivax SA4 个研究点 分布在 1 个国家目标入组 16 人开始时间: 2018年7月25日最近更新:
适应症
干预措施
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 16
- 试验地点
- 4
- 主要终点
- Overall Survival at 26 weeks (OS)
研究概览
简要总结
The purpose of this trial is to determine the efficacy of the immunotherapy with MVX-ONCO-1 in patients with advanced head and neck squamous cell carcinoma. MVX-ONCO-1 consists of dead tumor cells from the patient itself and genetically modified cells within a capsule. The whole treatment takes 9 weeks. At weeks 1, 2, 3, 4, 6 and 8, the tumor cells are injected underneath the skin and two capsules are implanted for a week. At weeks 2, 3, 4, 5, 7 and 9 the capsules are removed again. The patients are then followed-up for 5 years.
详细描述
Patients with advanced HNSCC after platinum-based palliative chemotherapy have a poor prognosis, with no well-defined standard treatment and a survival between 6 to 9 months.
MVX-ONCO-1 is a patient specific, cell-based, active immunotherapy, where the patient's immune response to tumor cells is stimulated and/or increased by triggering an immune response against the patients' cancer cells.
Rationale for this trial is:
- HNSCC: there is a clear medical need in this patient population,
- Relapsing HNSCC often have accessible tumor tissue,
- HNSCC is considered an immunogenic tumor.
This phase II study is a first step towards a potentially innovative immunotherapy for HNSCC.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •for pre-registration:
- •Written informed consent according to ICH/GCP regulations before pre-registration
- •Histologically confirmed diagnosis of head and neck squamous carcinoma (oral cavity, pharynx, larynx), Stage III/IV in recurrent or metastatic stage. Patients with local relapse for whom a curative treatment is available cannot be enrolled. Furthermore, all patients should have no other therapeutic option left.
- •At least one line of prior anticancer therapy for recurrent or metastatic disease. Patients with locally advanced disease experiencing local relapse within 6 months of last dose of curative intended, platinum-based chemo-radiation with or without prior surgery can also be included.
- •Primary tumor and/or metastasis amenable for partial/total surgery or tap
- •Measurable or evaluable disease according to RECIST 1.1 criteria
- •Patients age ≥ 18 years
- •WHO performance status 0-2
- •Adequate hematological values: neutrophils ≥1x10^9/L, platelets ≥70x10^9/L
- •Adequate hepatic function: bilirubin ≤2 x ULN; AST and ALT and AP ≤2.5 x ULN (except for patients with liver metastasis: ≤5 x ULN)
- •Adequate renal function (creatinine clearance >40mL/min/1.73m^2, calculated according to the corrected formula of Cockcroft-Gault
- •Women with child-bearing potential are using effective contraception, are not pregnant and agree not to become pregnant after pre-registration, during trial treatment and during the 6 months thereafter. A negative blood pregnancy test before inclusion into the trial is required for all women with child-bearing potential
- •Men agree not to father a child during trial treatment and during 6 months thereafter
排除标准
- •for pre-registration:
- •Known or suspected CNS metastases or active leptomeningeal disease
- •History of hematologic or primary solid tumor malignancy, unless in remission for at least 3 years from registration with the exception of T1-2 prostate cancer Gleason score <6 (PSA<10 ng/mL), adequately treated cervical carcinoma in situ or localized non-melanoma skin cancer
- •Participated in any other investigational study or received an experimental therapeutic procedure considered to interfere with the study in the 4 preceding weeks of the pre-registration
- •Concomitant use of other anti-cancer drugs
- •Planned radiotherapy (other than symptom control)
- •Severe or uncontrolled cardiovascular disease uncontrolled hypertension (sustained systolic blood pressure > 150 mm Hg and/or diastolic > 100 mm Hg despite antihypertensive therapy)
- •History of cerebrovascular accident or intracranial hemorrhage within 6 months prior to pre-registration
- •Any history of HIV
- •Known history of HTLV-1, HTLV-2, or active chronic Hepatitis C or Hepatitis B Virus infection or any uncontrolled active systemic infection requiring intravenous (iv) antimicrobial treatment
- •Known severe allergy to reagents in the study product (MVX-ONCO-1)
- •Systemic disease other than cancer that is not controlled by approved medication
- •Patient with active autoimmune disease
- •Chronic immunosuppressive treatment exceeding 20 mg/day of prednisone or an equivalent corticosteroid. Note: In acute situations prednison exceeding 20mg/day or equivalent(day is allowed during 7 days)
- •Women who are pregnant or breast feeding
- •Any other serious underlying medical, psychiatric, psychological, familial or geographical condition, which in the judgment of the investigator may interfere with the planned staging, treatment and follow-up, affect patient compliance or place the patient at high risk from treatment-related complications
- •Inclusion criteria for registration:
- •Primary tumor and/or metastasis amenable for partial/total surgery or tap and subsequent cell harvest > 26x10^6 cells
- •Measurable or evaluable disease according to RECIST 1.1 criteria
- •WHO performance status 0-2
- •Baseline QoL forms have been completed
- •Adequate hematological values: neutrophils ≥1x10^9/L, platelets ≥70x10^9/L
- •Adequate hepatic function: bilirubin ≤2 x ULN; AST and ALT and AP ≤ 2.5 x ULN (except for patients with liver metastasis: ≤5 x ULN)
- •Adequate renal function (creatinine clearance >40 mL/min/1.73m^2, calculated according to the corrected formula of Cockcroft-Gault
- •Women with child-bearing potential are using effective contraception, are not pregnant or lactating and agree not to become pregnant after registration, during trial treatment, and during the 6 months thereafter. A negative blood pregnancy
- •Exclusion criteria for registration:
- •Known or suspected CNS metastases or active leptomeningeal disease
- •Concomitant use of other anti-cancer drugs
- •Planned radiotherapy (other than symptom control)
- •Any one full cycle of anti-cancer chemotherapy treatment in the 3 preceding weeks of the registration
- •Systemic disease other than cancer, that is not controlled by approved medication
- •Chronic immunosuppressive treatment exceeding 20 mg/day of prednisone or an equivalent corticosteroid. Note: In acute situations prednisone exceeding 20 mg/day or equivalent is allowed during 7 days
- •Any other serious underlying medical, psychiatric, psychological, familial or geographical condition, which in the judgment of the investigator may interfere with the planned staging, treatment and follow-up, affect patient compliance or place the patient at high risk from treatment-related complications
- •Women who are pregnant or breastfeeding
研究组 & 干预措施
MVX-ONCO-1
Experimental
MVX-ONCO-1 vaccine treatment once weekly starting on week 1 for 4 weeks followed by two additional treatments 2 weeks apart (total 6 treatments over 8 weeks). Each treatment consists of two macrocapsules containing the MVX-1 cell line and lethally irradiated autologous tumor cells.
干预措施: MVX-ONCO-1 (Other)
结局指标
主要结局
Overall Survival at 26 weeks (OS)
时间窗: at 26 weeks from registration
The primary endpoint of the trial is Overall Survival (OS) at 26 weeks defined as percentage of patients alive 26 weeks from registration. Patients who are lost to follow-up with a date they were last known to be alive less than 26 weeks after registration will be counted as failures for this endpoint.
次要结局
- Time to subsequent therapy (TST)(assessed within 5 years)
- Disease control rate (DCR)(at 6, 13, 26, 39 and 52 weeks)
- Objective response rate (ORR)(at 6, 13, 26, 39 and 52 weeks)
- Progression-free survival according to iRECIST (iPFS)(assessed within 5 years)
- OS(assessed within 5 years)
- Adverse and serious adverse events(assessed within 5 years)
- Duration of response (DOR)(assessed within 5 years)
- Progression Free Survival (PFS)(assessed within 5 years)
- Best overall response(assessed within 5 years)
- Objective response according to iRECIST (iOR)(at 6, 13, 26, 39 and 52 weeks)
- PFS at 6, 13, 26, 39, and 52 weeks(at 6, 13, 26, 39, and 52 weeks)
- PFS under the first subsequent treatment(assessed within 5 years)
研究者
研究点 (4)
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