ACTRN12618000686202已完成2 期
A Phase II randomised trial comparing immune priming by low dose oral cyclophosphamide plus olaparib versus priming by olaparib alone, prior to combination therapy with olaparib plus durvalumab, versus single agent olaparib alone, in asymptomatic platinum-sensitive recurrent ovarian, fallopian tube or primary peritoneal cancers with homologous recombination repair defects (SOLACE2).
适应症
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 114
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomised controlled trial
- 主要目的
- Treatment
- 盲法
- Open (masking not used)
入排标准
- 年龄范围
- 18 Years 至 o limit（—）
- 性别
- Female
入选标准
- •1. Women, aged 18 years and older, with histologically confirmed high-grade serous carcinoma of the ovary, fallopian tube or primary peritoneum.
- •2. Undergone prior adequate debulking surgery, as appropriate, and 1 line of platinum-based chemotherapy. Patients who received bevacizumab or hormonal therapy as part of first-line treatment are eligible.
- •3. Known germline BRCA1 and BRCA2 status. Both BRCA mutant and BRCA wild-type patients are eligible, but they must have normalisation of CA125 to less than upper limit of normal (ULN), defined as 35 units/mL, by the end of first-line chemotherapy.
- •4. CA125 progression after first-line treatment, occurring 6 months or more following the last dose of chemotherapy. Participants must have raised CA125 readings twice the ULN (greater than or equal to 70 kU/L) on 2 occasions at least 1 week apart. The following circumstances are also considered eligible:
- •If CA125 is less than 70 kU/L, patient must have evaluable disease on imaging (RECIST measurable or non-measurable);
- •In the absence of RECIST measurable disease, CA125 progression (greater than or equal to 70 kU/L) after first-line treatment occurring 4 months or more following last dose of chemotherapy is allowed.
- •5. No indication for immediate chemotherapy or secondary debulking surgery.
- •6. ECOG performance status of 0-1.
- •7. Confirmation of the availability of tumour tissue (FFPE) for translational studies (a cell pellet from ascites or pleural fluid is not acceptable). If no tissue is available, patients will not be eligible for this study.
- •8. Adequate bone marrow function (measured within 28 days prior to registration and with values within the ranges specified below):
- •Absolute neutrophil count equal to or greater than 1.5 x 109 /L
- •Platelet count equal to or greater than 100 x 109 /L
- •Haemoglobin equal to or greater than 100 g/L with no blood transfusion in the past 28 days
- •Peripheral blood smear must not show any features suggestive of myelodysplastic syndrome/acute myeloblastic leukaemia.
- •9. Adequate liver function, as follows:
- •Total bilirubin equal to or less than 1.5 x institutional upper limit of normal (ULN)
- •Alkaline phosphatase (ALP), equal to or less than 2.5 x ULN (or equal to or less than 5 x ULN if liver metastases AST (SGOT), ALT (SGPT are present)
- •10. Adequate renal function, as follows:
- •Serum creatinine equal to or less than 1.5 x ULN, or
- •Creatinine clearance greater than 50mL/min (Cockcroft-Gault Formula)
- •11. Willing and able to comply with all study requirements, including treatment, timing and/or nature of required assessments.
- •12. Signed, written informed consent prior to any study specific procedures.
排除标准
- •1. Previous randomisation in the present study.
- •2. Any previous treatment with a PARP inhibitor, including olaparib.
- •3. Any previous treatment with durvalumab, or any other anti-PD-1, anti-PD-L1, anti-PD-L2, anti-CTLA-4 antibodies or any other antibody or drug specifically targeting T cell co-stimulation or immune checkpoint pathways.
- •4. Concomitant use of known strong CYP3A inhibitors (e.g. itraconazole, telithromycin, clarithromycin, protease inhibitors boosted with ritonavir or cobicistat, indinavir, saquinavir, nelfinavir, boceprevir, telaprevir) or moderate CYP3A inhibitors (e.g. ciprofloxacin, erythromycin, diltiazem, fluconazole, verapamil). The required washout period prior to starting olaparib is 2 weeks.
- •5. Concomitant use of known strong (e.g. phenobarbital, enzalutamide, phenytoin, rifampicin, rifabutin, rifapentine, carbamazepine, nevirapine and St John’s Wort) or moderate CYP3A inducers (e.g. bosentan, efavirenz, modafinil). The required washout period prior to starting olaparib is 5 weeks for enzalutamide or phenobarbital and 3 weeks from the last study dose for other agents.).
- •6. Treatment with any investigational product during the last 14 days (or a longer period depending on the defined characteristics of the agents used).
- •7. Patients receiving any systemic anti-cancer treatment (including endocrine therapy, chemotherapy or VEGF-targeted agents) or radiotherapy (except for palliative reasons), within 14 days from the last dose prior to study treatment (or a longer period depending on the defined characteristics of the agents used).
- •8. Patients who are unable to swallow orally administered medication or have gastrointestinal disorders likely to interfere with absorption of the study medication (e.g. including but not limited to partial bowel obstruction or chronic malabsorption syndrome, Crohn’s disease and ulcerative colitis).
- •9. Suspected brain or leptomeningeal metastases, untreated brain metastases or current clinical or radiological progression of known brain metastases, or requirement for steroid therapy for brain metastases. Patients with treated brain metastases are eligible if they have been stable and off steroids for equal to or greater than 3 weeks.
- •10. Patients with known haemorrhagic cystitis.
- •11. No history of other active malignancy.
- •12. History of known or suspected auto-immune disease other than vitiligo, type 1 diabetes, residual hypothyroidism due to an autoimmune condition requiring only hormone replacement, or psoriasis not requiring systematic treatment within the last 2 years.
- •13. Prior allogeneic organ transplant, double umbilical cord blood transplantation, inflammatory bowel disease (e.g. Crohn’s disease, ulcerative colitis), pneumonitis, tuberculosis, or primary immunodeficiency.
- •14. Patients with prior diagnosis of myelodysplastic syndrome or acute myeloid leukaemia. Any abnormal blood films at baseline need to be reviewed to exclude these conditions.
- •15. Current or prior use of immunosuppressive medication within 28 days before the first dose of durvalumab, with the exception of intranasal and inhaled corticosteroids or systemic corticosteroids at physiological doses, which are not to exceed 10 mg/day of prednisone or an equivalent corticosteroid. In the case of short term use of systemic corticosteroids (less than 24 hours within 28 days) of greater than 10 mg/day of prednisone or an equivalent corticosteroid, the required washout period prior to starting the first dose of d
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