EUCTR2020-004364-25-DE进行中（未招募）1 期
Randomized Phase II study comparing neo-epitope based vaccine OSE2101 (TEDOPI®) with or without anti-PD1 (Pembrolizumab) versus best supportive care as maintenance treatment in platinum-sensitive recurrent ovarian cancer patient with controlled disease after Platinum-based chemotherapy - TEDOVA
适应症
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 入组人数
- 180
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
- Female
入选标准
- •1)Signed and dated informed consent document for the study, willing and able to comply with protocol requirements, including:
- •a.HLA-A2 phenotype determination by genetic test (blood)
- •b.participation in translational research in HLA-A2 positive
- •c.authorization for long term follow up if HLA-A2 negative
- •2)Histologically proven non-mucinous epithelial ovarian cancer
- •3)Positive HLA-A2 phenotype
- •4)Age = 18 years
- •5)ECOG Performance Status (PS) 0-1
- •6)Clinical or radiological relapse of a platinum sensitive ovarian cancer regardless of the number of prior lines of platinum-based chemotherapy, as long as each prior line fulfilled the platinum sensitive criteria defined as complete response, partial response or stable disease according to RECIST 1.1 at the end of a platinum-based chemotherapy. Patient must have received at least 4 infusions of platinum during the last line of platinum-based chemotherapy
- •7)Previously treated with a PARP inhibitor or not eligible to PARPi (i.e ineligibility due to not complete or partial response to chemotherapy)
- •8)Prior therapy with bevacizumab or with contra-indication to bevacizumab (i.e arterial thromboembolic events, history of intestinal perforation, any other contra-indications according to the SmPC)
- •9)Patient may have received prior immune checkpoint inhibitor (ICI), such as anti-PD-(L)1 or anti-CTLA-4 antibody and had a relapse after receiving the ICI without concomitant chemotherapy for at least 6 months the(as treatment or maintenance)
- •10)Randomization must be within 8 weeks of last dose of chemotherapy
- •11)Adequate organ function:
- •- Adequate marrow function
- •- White blood cell (WBC) = 3000/ mm3
- •- Neutrophils = 1500/ mm3
- •- Platelets = 100 × 103/mm3 (in the absence of transfusion within 2 weeks from before randomization)
- •- Haemoglobin = 9 g/dL (in the absence of transfusion within 2 weeks from before randomization)
- •- Adequate other organ functions
- •- ALT and AST = 2.5 × ULN, unless liver metastases are presents in which case they must be = 5.0 × ULN
- •- Total bilirubin = 1.5× ULN (except Gilbert Syndrome: < 3.0 mg/dL)
- •- Serum creatinine = 1.5 × ULN or creatinine clearance (CrCl) = 40 mL/min (measured using the Cockcroft-Gault formula below):
- •Female CrCl=(140-age in years) × weight in kg × 0.85
- •72 × serum creatinine in mg/dL
- •12)Archival or fresh (if possible) tumor tissue must be available for evaluating relevant biomarkers.
- •13)Women of childbearing potential must have a negative serum or urine pregnancy test within 72 hours prior to treatment allocation, and have to use of highly effective contraception during the treatment period and for at least 180 days after the last dose of study treatment
- •14)Stated willingness to comply with all study procedures and availability for the duration of the study
- •15)For countries where this will apply to : a subject will be eligible for randomization in this study only if either affiliated to, or a beneficiary of, a social security category
- •Are the trial subjects under 18? no
- •Number of subjects for this age range:
- •F.1.2 Adults (18-64 years) no
- •F.1.2.1 Number of subjects for this age range 150
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range 30
排除标准
- •1)Patient with contra-indications to immune therapies
- •2)Ongoing immunotherapy (checkpoint inhibition, antigen immunotherapy that would be scheduled to continue concomitantly to the study)
- •3) Use of any following immunomodulatory agents in 30 days prior the first dose of study drug:
- •Systemic corticosteroids (at dose higher than 10 mg/day equivalent prednisone); if systemic corticoid use, corticoid must be stopped at least 7 days before study treatment start
- •Interferons
- •Interleukins
- •Life vaccine
- •4)Prior cancer vaccine therapy.
- •5)Patient eligible for cytoreductive surgery at the time of inclusion.
- •6)Patient with clinical, radiological or biological progression (according GCIG criteria) at the end of last chemotherapy.
- •7)Prior radiotherapy in 2 weeks of start of study intervention. Participants must have recovered from all radiation-related toxicities, not require corticosteroids, and not have had radiation pneumonitis. A 1-week washout is permitted for palliative radiation (=2 weeks of radiotherapy) to non-CNS disease.
- •8)Patient with active autoimmune disease that required systemic treatment in the past 2 years (i.e. with use of disease modifying agents, corticosteroids or immunosuppressive drugs). Replacement therapy (eg., thyroxine, insulin, or physiologic corticosteroid replacement therapy for adrenal or pituitary insufficiency etc.) is not considered a form of systemic treatment and allowed.
- •9)History of serious adverse reactions, including anaphylaxis and related symptoms as hives and respiratory difficulty following administration of any vaccines, or history of hypersensitivity, to any components of study vaccine
- •10)Prior history of other malignancies other than study disease (except for basal cell or squamous cell carcinoma of the skin or carcinoma in situ of the cervix or other in situ cancer considered as cured) unless the patient has been free of the disease for at least 5 years.
- •11)Immune-deficient status (patients with HIV, immunosuppressive treatment, haematological malignancies, and previous organ transplantation)
- •12)History of (non-infectious) pneumonitis/ interstitial lung disease required steroids or has current pneumonitis/ interstitial lung disease that requires steroids.
- •13)History of any chronic hepatitis as evidenced by:
- •Positive test for hepatitis B surface antigen
- •Positive test for qualitative hepatitis C viral load by PCR
- •Note: Subjects with positive hepatitis C antibody and negative quantitative hepatitis C by PCR are eligible. History of resolved hepatitis A virus infection is not an exclusion criteria
- •14)Uncontrolled or significant cardiovascular disease including, but not limited to,any of the following:
- •Myocardial infarction or stroke/transient ischemic attack in the past 6 months
- •Uncontrolled angina within the past 3 months
- •History of other clinically significant heart disease (eg, cardiomyopathy, congestive heart failure with New York Heart Association functional classification III-IV, pericarditis, significant pericardial effusion, or myocarditis)
- •Any history of clinically significant arrhythmias (such as ventricular tachycardia, ventricular fibrillation, or torsades de pointes)
- •QT interval corrected for heart rate using Fridericia’s formula (QTcF) prolongation > 480 msec
- •Cardiovascular disease-related requirement for daily supplemental oxygen therapy
- •15)Subjects with known or suspected CNS metastases, untreated CNS metastases, are excluded. However, subjects with controlled brain metasta
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