EUCTR2019-003396-19-DK进行中（未招募）1 期
A phase 1/2 trial of EO2401, a novel microbial-derived peptide therapeutic vaccine, in combination with PD-1 check point blockade, for treatment ofpatients with locally advanced or metastatic adrenocortical carcinoma, or malignant pheochromocytoma/paraganglioma
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 发起方
- Enterome
- 入组人数
- 120
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. For inclusion in Cohort 1 patients should have adrenocortical
- •carcinoma, or malignant pheochromocytoma/paraganglioma, as defined
- •below for Cohorts 2A and 3A.
- •2. For inclusion in Cohorts 2A and 2B patients should have histologically
- •confirmed (at primary diagnosis) unresectable locally advanced or
- •metastatic (ENSAT/AJCC] stage 3 = tumor has spread into nearby
- •tissues or lymph nodes, or stage 4 = metastatic disease) adrenocortical
- •a. In addition, for inclusion in Cohort 2 A patients should also have
- •received treatment with at least one line, but not more than two prior
- •lines, of systemic therapy for established locally advanced or metastatic
- •disease (i.e. non-adjuvant therapy), and should within these lines of
- •therapy for advanced/metastatic disease, or as neoadjuvant/adjuvant
- •therapy, have received mitotane therapy delivered at an adequate dose.
- •b. In addition, for inclusion in Cohort 2B patients should not have
- •received prior systemic therapy for established locally advanced or
- •metastatic disease (i.e. non-adjuvant therapy).
- •Note, for both Cohorts 2A and 2B, neoadjuvant/adjuvant therapy
- •(including mitotane with or without chemotherapy) for patients after
- •complete response to local therapy should not be counted in the
- •definitions above for line of therapy for established disease. Patients
- •who have received mitotane as neoadjuvant/adjuvant therapy, or
- •therapy for advanced/metastatic disease can continue mitotane during
- •study therapy provided definitions regarding eligibility of continued
- •mitotane therapy are fulfilled.
- •3. For inclusion in Cohorts 3A and 3B patients should have histologically
- •confirmed (at primary diagnosis) unresectable malignant (defined as
- •metastatic disease, i.e. presence of chromaffin tissue in non-chromaffin
- •organs pheochromocytoma/paraganglioma, and RECIST defined
- •progression should have been documented during a maximum of an
- •18months period.
- •a. In addition, for inclusion in Cohort 3A patients should also have
- •received treatment with at least two prior lines of systemic therapy if
- •the patients are eligible for radionuclide therapy, and at least one prior
- •line of systemic therapy if the patients are not eligible for radionuclide
- •b. In addition, for inclusion in Cohort 3B patients should not have
- •received prior systemic therapy for their malignant
- •pheochromocytoma/paraganglioma.
- •4. Patients with an age = 18 years old.
- •5. Patients who are human leukocyte antigen (HLA)-A2 positive.
- •6. Patients with an Eastern Cooperative Oncology Group (ECOG)
- •performance status = 1 with the specific meaning of ECOG 1 being
- •restricted in physically strenuous activity but ambulatory and able to
- •carry out work of a light or sedentary nature, e.g. light house-work,
- •office work.
- •7. Patients with a life expectancy > 4 months as judged by their treating
- •8. Patients with at least one measurable lesion according to RECIST 1.1
- •(see Section 12.1).
- •9. Males or non-pregnant, non-lactating, females who are:
- •a) female, post-menopausal (serum follicle-stimulating hormone (FSH)
- •level > 40 mIU/mL),
- 另有 7 项未显示
排除标准
- •1. Patients treated with dexamethasone > 2 mg/day or equivalent (i.e.
- •13 mg/day of prednisone, or 53 mg/day of hydrocortisone) within 14
- •days before the first EO2401 administration, unless required to treat an
- •adverse event. Note, inhaled steroids and adrenal replacement steroid
- •doses > 13 mg daily prednisone equivalents are permitted. Thus,
- •patients needing hydrocortisone replacement therapy due to prior or
- •ongoing mitotane therapy can receive hydrocortisone doses > 53
- •mg/day, i.e. also in the normally used range of 60-80 mg/day, and still
- •be included in the trial.
- •2. Patients with prior treatment with compounds targeting PD-1, PD-L1,
- •CTLA-4, or similar compounds where general resistance against
- •therapeutic vaccination approaches might have developed (e.g. defects
- •to the cellular antigen processing/presentation machinery, including
- •mutations in Janus kinas [JAK] 1, JAK2, and ß-2-microglobulin [B2M])
- •allowing tumor cells to avoid recognition and attack by immune cells.
- •3. Patients with prior exposure to EO2401, e.g. patients treated in
- •Cohorts 2B or 3B of the current trial cannot be re-enrolled for treatment
- •also in Cohorts 2A or 3A.
- •4. Patients treated with immunotherapy (meaning immunostimulatory or
- •immunosuppressive therapy; beside excluded, or allowed, compounds
- •per other inclusion/exclusion criteria specifications), radionuclide
- •therapy, radiotherapy, cytoreductive therapy, or received treatment with
- •any other investigational agent within 28 days before the first EO2401
- •administration. Note, for patients with ACC continued treatment with
- •mitotane during this trial is allowed provided patient is eligible (see
- •section6.9.2).
- •For patients with MPP, concurrent therapy with somatostatin, and
- •somatostatin analogues is allowed provided tumor progression on this
- •therapy has been demonstrated; concurrent therapy with
- •bisphosphonates (e.g. zoledronic acid) or denosumab is also allowed.
- •5. Patients with an initial diagnosis of ACC less than 9 months from start
- •of screening part 2.
- •6. Patients with ACC and any individual lesion according to RECIST 1.1
- •having a maximum diameter of more than 125 mm; irrespective if the
- •lesion is proposed as a target lesion, or not, according to RECIST 1.1.
- •7. Patients with ACC with more than three organs involved by disease.
- •8. Patients with ACC and uncontrolled hormonal secretion (according to
- •the judgement of the treating physician).
- •9. Patients with MPP and uncontrolled blood pressure (according to the
- •judgement of the treating physician).
- •10. Patients with abnormal laboratory values according to the following
- •a. lymphocyte count decreased, grade 2 (lymphocytes <800 - 500/mm3;
- •<0.8 - 0.5 x 109/L), or worse grade,
- •b. hemoglobin < 8 g/dL (9 mmol/L) i.e. anemia Grade 2 is acceptable if
- •judged by the Investigator as not constituting a safety risk in the
- •individual patient,
- •c. white blood cell count decrease (< 3.0 × 109/L),
- •d. absolute neutrophil count decrease (< 1.5 × 109/L),
- •e. platelet count decrease (< 75 × 109/L),
- •f. total bilirubin > 1.5 x upper limit of normal (ULN)
- 另有 8 项未显示
研究者
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