A phase 1/2 trial of EO2401, a novel microbial-derived peptide therapeutic vaccine, in combination with PD-1 check point blockade, for treatment of patients with locally advanced or metastatic adrenocortical carcinoma, or malignant pheochromocytoma/paraganglioma. - Spencer study

ENTEROME0 个研究点目标入组 72 人开始时间: 2021年1月22日最近更新: 2021年8月30日

适应症

试验速览

阶段: 1 期
状态: 进行中（未招募）
发起方: ENTEROME
入组人数: 72

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

•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 carcinoma.
•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 including mitotane and/or chemotherapy (other groups of systemic therapies utilized in e.g. clinical trials will also be assessed and counted if appropriate).
•b. In addition, for inclusion in Cohort 2B patients should not have received prior systemic therapy for their adrenocortical carcinoma.
•Note, adjuvant therapy for patients with complete resections should not be counted in the definitions above.
•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 including radionuclide therapy and/or chemotherapy (other groups of systemic therapies utilized in e.g. clinical trials will also be assessed and counted if appropriate).
•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 = 2 (see Section 12.2 [39]).
•7. Patients with a life expectancy > 4 months as judged by their treating physician.
•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:
•e) female, post-menopausal (serum follicle-stimulating hormone (FSH) level > 40 mIU/mL >),
•f) female and male, surgically sterile (e.g. bilaterally blocked or removed fallopian tubes, vas deferens),
•g) female of childbearing potential with a negative highly sensitive serum pregnancy test within 72 hours prior to first administration of study treatment and use of a highly effective contraception from signing the Informed Consent Form (ICF) through 5 months after the last study treatment dose administered; note, the male partner should in addition to the use of highly effective contraception by the female patient also use condoms,
•h) male patient with female partners of childbearing potential must use condoms from signing the ICF through 5 months after the last study treatment dose administered; in addition, male patients must ensure that their partners of childbearing potential also use highly effective contraception.
•Highly effective barrier and non-barrier contraception include:
•i) combined (estrogen and progesterone containing) hormonal contraception associated with inhibition of ovulation: oral, intravaginal, transdermal,
•ii) progestogen-only hormonal contraception associated with inhibition of o

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 trail is allowed provided tumor progression on this therapy has been demonstrated under therapeutic plasma level or at maximum individual tolerated dose and mitotane plasma level monitoring is maintained during the trial (mitotane might have been given in the adjuvant and/or established disease settings as long as progression on this therapy before trial inclusion has been documented). For patients with MPP, concurrent therapy with octreotide 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 ACC with more than three organs involved by disease, combined with high ki-67 expression in tumor (= 20%), and unresectable primary tumor.
•6. Patients with ACC and uncontrolled cortisol secretion (according to the judgement of the treating physician).
•7. Patients with MPP and uncontrolled blood pressure (according to the judgement of the treating physician).
•8. Patients with abnormal laboratory values according to the following list (note, lab ranges according to the performing laboratory's reference ranges):
•a. hemoglobin < 10 g/dL (6.2 mmol/L) (transfusion to correct the value is acceptable),
•b. white blood cell count decrease (< 3.0 × 109/L),
•c. absolute neutrophil count decrease (< 1.5 × 109/L),
•d. platelet count decrease (< 75 × 109/L),
•e. bilirubin > 1.5 x upper limit of normal (ULN) (note, benign hereditary hyperbilirubinemia, e.g. Gilbert's syndrome is permitted),
•f. alanine aminotransferase (ALT) > 3 x ULN; if disease metastatic to the liver > 5 x ULN,
•g. aspartate aminotransferase (AST) > 3 x ULN; if disease metastatic to the liver > 5 x ULN,
•h. serum creatinine increase (> 1.5 x ULN); however, if creatinine clearance (measured, or calculated according to the Cockcroft/Gault [40] formula; CCr={((l40–age) x weight)/(72xSCr)} x 0.85 (if female); C

研究者

发起方

ENTEROME

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