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临床试验/NL-OMON53750
NL-OMON53750尚未招募2 期

A Randomized Clinical Trial Investigating Olaparib, Durvalumab (MEDI4736) and UV1 as Maintenance Therapy in BRCAwt Patients with Recurrent Ovarian Cancer - DOVACC

ordic Society of Gynaecological Oncology - Clinical Trial Unit, Department of Oncology, 9431, Rigshospitalet, Copenhagen University Hospital0 个研究点目标入组 20 人开始时间: 待定最近更新:
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适应症

试验速览

阶段
2 期
状态
尚未招募
发起方
入组人数
20
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

入排标准

入选标准

  • •1. Capable of giving signed informed consent which includes compliance with the
  • •requirements and restrictions listed in the informed consent form (ICF) and in
  • •the protocol.
  • •2. Histologically diagnosed epithelial ovarian, fallopian tube or primary
  • •peritoneal cancer.
  • •3. Radiological or histological confirmation of relapse disease >= 6 month after
  • •last chemotherapy
  • •4. Patients who are non-gBRCAmut or tBRCAwt
  • •5. Have completed at least two lines, but no more than 4 lines, of
  • •platinum-containing chemotherapy, which means that patients at first, second or
  • •third relapse with treatment free interval of more than 6 months are eligible.
  • •a. Subjects must have completed at least 4 cycles of the last
  • •platinum-containing chemotherapy
  • •6. Be either:
  • •a. PARPi naive
  • •b. Earlier treated with PARPi and not progressed during 6 months of PARPi
  • •7. Must have, in the opinion of the investigator, CR or PR on the
  • •post-treatment scan and no evidence of rising CA-125 level, following
  • •completion of the last chemotherapy course.
  • •8. Patient consents to Myriad myChoice HRD test.
  • •9. Must be included in the study within 10 weeks of completion of the final
  • •dose of platinum-containing chemotherapy.
  • •10. Age >=18 years
  • •11. Body weight > 30 kg
  • •12. Eastern Cooperative Oncology Group (ECOG) performance status 0-1
  • •13. Must have a life expectancy >= 16 weeks.
  • •14. Must have normal organ and bone marrow function measured within 28 days
  • •prior to administration of study treatment as defined below:
  • •- Haemoglobin >= 10.0 g/dL (6,2 mmol/L) with no blood transfusion in the past 28
  • •- Absolute neutrophil count (ANC) >= 1.5 x 10^9/L
  • •- Platelet count >= 100 x 10^9/L
  • •- Total bilirubin <= 1.5 x institutional upper limit of normal (ULN)
  • •- Aspartate aminotransferase (AST) (Serum Glutamic Oxaloacetic Transaminase
  • •(SGOT)) / Alanine aminotransferase (ALT) (Serum Glutamic Pyruvate Transaminase
  • •(SGPT)) <= 2.5 x institutional upper limit of normal unless liver metastases are
  • •present in which case, they must be <= 5x ULN
  • •- Must have creatinine clearance estimated of >= 51 mL/min using the
  • •Cockcroft-Gault equation or based on a urine test.
  • •15. Ability to swallow oral medications (tablets) without chewing, breaking,
  • •crushing, opening or otherwise altering the product formulation.
  • •16. Post-menopausal or evidence of non-childbearing status for women of
  • •childbearing potential: negative urine or serum pregnancy test within 28 days
  • •of study treatment and confirmed prior to treatment on day 1.

排除标准

  • •1. Previous immunotherapy (for example anti-PD-1/L1, including durvalumab).
  • •2. Other malignancy unless curatively treated with no evidence of disease for >=
  • •5 years except adequately treated non-melanoma skin cancer, curatively treated
  • •in situ cancer of the cervix, ductal carcinoma in situ (DCIS), Stage 1, grade 1
  • •endometrial carcinoma.
  • •3. Resting ECG indicating uncontrolled, potentially reversible cardiac
  • •conditions, as judged by the investigator (e.g., unstable ischemia,
  • •uncontrolled symptomatic arrhythmia, congestive heart failure, QTcF
  • •prolongation > 500 ms, electrolyte disturbances, etc.), or patients with
  • •congenital long QT syndrome.
  • •4. Patients with myelodysplastic syndrome/acute myeloid leukemia or with
  • •features suggestive of MDS/AML.
  • •5. Patients with symptomatic uncontrolled brain metastases. A scan to confirm
  • •the absence of brain metastases is not required. The patient can receive a
  • •stable dose of corticosteroids before and during the study if these were
  • •started at least 4 weeks prior to treatment. Patients with spinal cord
  • •compression unless considered to have received definitive treatment for this
  • •and evidence of clinically stable disease for 28 days.
  • •6. Patients considered a poor medical risk due to a serious, uncontrolled
  • •medical disorder, non-malignant systemic disease or active, uncontrolled
  • •infection. Examples include, but are not limited to, uncontrolled ventricular
  • •arrhythmia, recent (within 3 months) myocardial infarction, uncontrolled major
  • •seizure disorder, unstable spinal cord compression, superior vena cava
  • •syndrome, extensive interstitial bilateral lung disease on High Resolution
  • •Computed Tomography (HRCT) scan or any psychiatric disorder that prohibits
  • •obtaining informed consent.
  • •7. Disease progression during or within 4 weeks after PARPi therapy.
  • •8. Subject have received > 2 series of chemotherapy for relapse
  • •9. Concomitant treatment with bevacizumab within the last 3 weeks.
  • •10. Concomitant therapy with any other anticancer therapy or chronic use of
  • •systemic corticosteroids of more than 10mg prednisolone daily.
  • •11. 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 study
  • •treatment is 2 weeks.
  • •12. 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 study treatment is 5 weeks for
  • •enzalutamide or phenobarbital and 3 weeks for other agents
  • •13. Previous allogeneic bone marrow transplant or double umbilical cord blood
  • •transplantation
  • •14. Subjects being considered at poor medical condition due to a serious,
  • •uncontrolled medical disorder or non-malignant systemic disease.
  • •15. Major surgery or significant traumatic injury within 28 days of run-in
  • •16. Immunocompromised patients, e.g., patients who are known to be
  • •serologically positive for human immunodeficiency virus (HIV), patients with
  • •active hepatitis B (defined

研究者

发起方
ordic Society of Gynaecological Oncology - Clinical Trial Unit, Department of Oncology, 9431, Rigshospitalet, Copenhagen University Hospital

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