2024-516096-32-00招募中2 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 Study)
相关药物
试验速览
- 阶段
- 2 期
- 状态
- 招募中
- 入组人数
- 180
- 试验地点
- 39
- 主要终点
- Progression Free Survival (PFS) is the time from randomization to progression, assessed radiologically using RECIST 1.1 by the investigator, or death whatever the cause, whichever comes first. Patients alive and free of progression at the cut-off date will be censored at the last tumor assessment date.
研究概览
简要总结
To evaluate the benefit by the Progression Free Survival (PFS) according to RECIST 1.1 of maintenance OSE2101 alone or in combination with PD1 inhibition after platinum based chemotherapy in relapsed ovarian cancer.
研究设计
- 研究类型
- Interventional
入排标准
- 年龄范围
- 18 years 至 65+ years（65+ Years, 18-64 Years）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •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
- •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 (as treatment or maintenance)
- •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
- •Archival or fresh (if possible) tumor tissue must be available for evaluating relevant biomarkers.
- •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
- •Stated willingness to comply with all study procedures and availability for the duration of the study
- •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
- •Randomization must be within 8 weeks of the last dose of chemotherapy
- •Histologically proven non-mucinous epithelial ovarian cancer
- •Positive HLA-A2 phenotype
- •Age ≥ 18 years
- •ECOG Performance Status (PS) 0-1
- •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 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
- •Previously treated with a PARP inhibitor or not eligible to PARPi (i.e ineligibility due to not complete or partial response to chemotherapy)
- •Prior therapy with bevacizumab or with contra-indication to bevacizumab (i.e arterial thromboembolic events, history of intestinal perforation, any other contra-indication according the SmPC)
排除标准
- •Patient with contra-indications to immune therapies
- •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.
- •Immune-deficient status (patients with HIV, immunosuppressive treatment, haematological malignancies, and previous organ transplantation)
- •History of (non-infectious) pneumonitis/ interstitial lung disease that required steroids or has current pneumonitis / interstitial lung disease that requires steroids.
- •History of any chronic hepatitis as evidenced by: • Positive test for hepatitis B surface antigen • Positive test for qualitative hepatitis C viral load (by polymerase chain reaction [PCR])
- •Uncontrolled or significant cardiovascular disease including, but not limited to, any of the following: • Myocardial infarction or stroke/transient ischemic attack within 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
- •Subjects with known or suspected CNS metastases, untreated CNS metastases, are excluded. However, subjects with controlled brain metastases will be allowed to enroll. Controlled brain metastases are defined as no radiographic progression for at least 4 weeks following radiation and/or surgical treatment (or 4 weeks of observation if no intervention is clinically indicated), and off of steroids for at least 2 weeks, and no new or progressive neurological signs and symptoms.
- •Any major surgery within 4 weeks of study drug administration. Subjects must have recovered from the effects of major surgery or significant traumatic injury at least 14 days before date of randomization.
- •Patients who has severe hypersensitivity (Grade 3 or higher) to pembrolizumab and/or any of its excipients (refer to the IB for a list of excipients).
- •Patients who has an active infection requiring systemic therapy.
- •Any acute medical condition that in the opinion of the investigator may obscure the ability to observe the safety or activity of the study vaccine treatment
- •Ongoing immunotherapy (checkpoint inhibition, antigen immunotherapy that would be scheduled to continue concomitantly to the study)
- •Any mental or psychiatric condition that, in the opinion of the investigator, is likely to compromise the ability to adhere to the protocol schedule
- •Life expectancy of less than 12 weeks
- •Pregnant or breastfeeding women
- •Concurrent participation in any other investigational study
- •Use of any of the following immunomodulatory agents within 30 days prior to 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 • Live vaccine
- •Prior cancer vaccine therapy
- •Patient eligible for cytoreductive surgery at the time of inclusion
- •Patient with clinical, radiological or biological progression (according GCIG criteria) at the end of last chemotherapy
- •Prior radiotherapy within 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
- •Patient with active autoimmune disease that has 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 is allowed
- •History of serious adverse reactions, including anaphylaxis and related symptoms such as hives and respiratory difficulty following administration of any vaccines, or a history of hypersensitivity, specifically to any components of study vaccine
结局指标
主要结局
Progression Free Survival (PFS) is the time from randomization to progression, assessed radiologically using RECIST 1.1 by the investigator, or death whatever the cause, whichever comes first. Patients alive and free of progression at the cut-off date will be censored at the last tumor assessment date.
Progression Free Survival (PFS) is the time from randomization to progression, assessed radiologically using RECIST 1.1 by the investigator, or death whatever the cause, whichever comes first. Patients alive and free of progression at the cut-off date will be censored at the last tumor assessment date.
次要结局
- Objective response is defined using the RECIST 1.1. The best overall response is defined as the best radiological response observed over the whole treatment period before progression or subsequent anti-cancer treatment. Proportion of parti
- Safety will be assessed based on NCI CTC-AE version 5.0
- Time to subsequent first treatment (TTST-1) is defined as time from randomization to initiation of first subsequent treatment (including treatment change due to toxicity or investigator's decision). Deaths will be counted as events. Patients alive and not receiving a subsequent treatment will be censored at the last assessment date.
- Time to subsequent second treatment (TTST-2) is defined as time from randomization to initiation of second subsequent treatment (including treatment change due to toxicity or investigator's decision). Deaths will be counted as events. Patients alive and not receiving a subsequent treatment will be censored at the last assessment date.
- Overall survival is defined as time from randomization to the date of death, whatever the cause. Patients alive at the cut-off date will be censored at the last date they are known to be alive.
研究者
Alexandra LEARY
Scientific
Asso De Recherche Cancers Gynecologiques
研究点 (39)
Loading locations...
相似试验
进行中（未招募）
1 期
Evaluation of two maintenance therapies (OSE2101 alone or in combination with pembrolizumab) versus best supportive care in patient with platinum-sensitive recurrent ovarian cancer1st or 2nd platinum-sensitive recurrent ovarian cancer with controlled disease after platinum based chemotherapy.MedDRA version: 20.0Level: PTClassification code 10033128Term: Ovarian cancerSystem Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps)MedDRA version: 21.1Level: PTClassification code 10066697Term: Ovarian cancer recurrentSystem Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps)EUCTR2020-004364-25-DEARCAGY-GINECO180
进行中（未招募）
1 期
Randomized Phase 2 study comparing pathological responses observed on colorectal cancer metastases resected after preoperative treatment combining cetuximab with FOLFOX or FOLFIRI in RAS and B-RAF WT tumors.Potentialy or borderline resecable metastatic colorectal cancer(RAS and B-RAF W-T) at diagnosis and for whom a multidisciplinary meeting recommended chemotherapy first in a curative intent.EUCTR2012-005249-19-BECliniques universitaires Saint-Luc60
进行中（未招募）
1 期
Randomized Phase 2 study comparing pathological responses observed on colorectal cancer metastases resected after preoperative treatment combining bevacizumab with FOLFOX or FOLFIRI.Resecable Metastatic Cororectal Cancer.EUCTR2012-005376-34-BECliniques universitaires Saint-Luc60
已完成
2 期
A phase II randomised study comparing the clinical benefit between Paclitaxel (Taxol) and oral Vinorelbine (Navelbine) in patients with stage IIIBw - IV non-small cell lung cancer (NSCLC), performance status (PS) 2on-Small Cell Lung CancerCancer - Lung - Non small cellNon-Small Cell Lung CancerACTRN12610000020088Hellenic Cooperative Oncology Group92
已完成
2 期
A randomised phase II study comparing the activity and toxicity profiles of Carboplatin plus pegylated Liposomal Doxorubicin (CLD) versus Carboplatin plus Paclitaxel (CP) in potentially platinum sensitive ovarian cancer patientsplatinum sensitive ovarian cancerCancer - Ovarian and primary peritonealACTRN12609000436279Hellenic Cooperative Oncology Group201