EUCTR2019-001420-34-DK进行中（未招募）1 期
ImmunoBreast - A phase II study to investigate the efficacy and safety of ALECSAT treatment as an add-on therapy to carboplatin and gemcitabine in patients with locally advanced or metastatic triple-negative breast cancer”
Henrik Ditzel0 个研究点目标入组 20 人开始时间: 2019年6月18日最近更新:
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 发起方
- 入组人数
- 20
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. Have signed informed consent to study participation. The patient may also provide consent for Future Biomedical Research (FBR). However, the patient may participate in the main study without participating in FBR.
- •2. Female patients aged 18 years and older
- •3. Have locally advanced inoperable breast which cannot be treated with curative intent OR have metastatic breast cancer.
- •4. Have a histologically or cytologically TNBC (defined by absence of HER2 and estrogen receptor (ER) expression on primary tumor) confirmed by local pathologist. Patients initially diagnosed with hormone receptor–positive and/or HER2-positive breast cancer must have confirmation of TNBC in a tumor biopsy obtained from a local recurrence or distant metastasis site.
- •5. Able and willing to provide a fresh tumor biopsy from a local recurrence or distant metastasis site.
- •6. Eligible for chemotherapy with carboplatin and gemcitabine.
- •7. WHO Performance status 0-1.
- •8. Has received no more than two prior regimens for locally advanced or metastatic breast cancer. Prior therapy with checkpoint inhibitors (anti–PD-1, anti–PD-L1, anti–PD-L2, or anti-CTLA-4) agent is allowed.
- •9. Have measurable disease based on RECIST 1.1 as determined by local radiology review.
- •10. Have life expectancy =3 months at time of enrollment.
- •11. Women of child-bearing potential must have a negative pregnancy test at screening and agree to use acceptable methods of contraception during the study.
- •12. Demonstrate adequate organ function, within 10 days prior to the start of study treatment, as defined:
- •Hematological:
- •Absolute neutrophil count (ANC) =1,500/µL,
- •Lymphocyte count >0.3 x 109/L.
- •Platelets =100,000/µL.
- •Creatinine =1.5 × ULN OR measured creatinine clearance (GFR can also be used in place of creatinine or CrCl) =30 mL/min for patient with creatinine levels >1.5 × institutional ULN)
- •Total bilirubin =1.5 ×ULN
- •ASAT and ALT =2.5 × ULN (=5 × ULN for patients with liver metastases),
- •Albumin =3.0 g/dL
- •Are the trial subjects under 18? no
- •Number of subjects for this age range:
- •F.1.2 Adults (18-64 years) yes
- •F.1.2.1 Number of subjects for this age range 15
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range 5
排除标准
- •1. Previously treated with carboplatin / gemcitabine.
- •2. Prior therapy with ALECSAT or other cellular immunotherapies.
- •3. Is currently participating in a clinical study and receiving an investigational agent or has participated in a clinical study and received an investigational agent within 4 weeks prior to inclusion or during the trial.
- •4. Has not recovered (e.g., to =Grade 1 or to baseline) from AEs due to a previously administered therapy (alopecia excluded). Prior to inclusion, the patient must have recovered adequately from any toxicity and/or complications associated with any recent procedure.
- •5. Has an active autoimmune disease that has required systemic treatment in the past 2 years (e.g., with use of disease modifying agents, corticosteroids, or immunosuppressive drugs).
- •6. Has a diagnosis of immunodeficiency or is receiving systemic steroid therapy or any other form of immunosuppressive therapy within 7 days prior to inclusion.
- •7. Positive blood tests for anti-HIV-1/2; HBsAg, anti-HBc, Anti-HCV or being positive in a Treponema Pallidum test (syphilis).
- •8. Patients who have been exposed to high risk contagious virus within a reasonable time prior to enrolment, e.g., by travelling in areas with known high risk of infection or known epidemics. This includes but is not limited to:
- •? West e virus (in season): Less than 28 days following return from affected area; less than 6 months following full recovery from known West e virus infection or symptoms suggestive of West e virus infection
- •? Dengue virus: Less than 28 days following return from affected area or cessation of symptoms (include high fever, joint pain, body pain, and/or rash) in case of confirmed Dengue virus infection; less than 6 months following full recovery from diagnosis of dengue hemorrhagic fever
- •? Zika virus: Less than 28 days following return from an affected area or after sexual contact with a male who has been diagnosed with Zika virus infection or with a male who travelled or lived in a Zika affected area during the three months prior to the sexual contact; less than 60 days following recovery of symptoms in case of confirmed Zika virus infection
- •? Ebola virus: Less than 60 days after return from an affected area; Patients previously diagnosed with Ebola virus should be excluded from the study
- •9. Patients from high incidence areas for Human T-Lymphotropic Virus type 1 (HTLV-1) or who has a parent from a high incidence area or who has had sexual contact with a partner from a high incidence area must be excluded unless tested negative for HTLV-1
- •10. Blood transfusion with whole blood or red blood cells within 48 hours prior to the donation of blood for ALECSAT production.
- •11. Has an active infection requiring systemic therapy.
- •12. Has a known additional malignancy that progressed or required active treatment within the last 5 years. Exceptions include basal cell carcinoma of the skin, squamous cell carcinoma of the skin that has undergone potentially curative therapy, and in situ cervical cancer.
- •13. Patients with symptomatic brain metastases. Patients previously treated or untreated for these conditions that are asymptomatic in the absence of corticosteroid and anticonvulsant therapy for at least 6 weeks and size no more than 20 mm are allowed to enroll. Radiotherapy for brain metastasis must have been completed at least 6 weeks prior to start of study treatment. Brain metastasis must be stable with verification by imaging (e.g. brai
研究者
相似试验
未知
2 期
DNK-651-3JPRN-jRCT2080223664DENKA SEIKEN CO.,LTD.500
进行中（未招募）
不适用
A Phase II trial evaluating the immunological and clinical efficay and safety of HER-2 Protein Autovac(TM) monotherapy in patients with metastatic breast cancer - NAFemale patients with histologically proven metastatic or locally advanced breast cancer who have HER-2 overexpression in the primary tumour and/or a metastatic lesion.EUCTR2004-000838-36-HUPharmexa A/S60
进行中（未招募）
不适用
A Phase II trial evaluating the immunological and clinical efficacy and safety of HER-2 Protein AutoVac(TM) and Stimulon® Adjuvant QS-21 monotherapy in patients with metastatic breast cancerEUCTR2005-000558-60-HUPharmexa A/S60
进行中（未招募）
1 期
A phase 2 bridging study to assess that the new formulation of ETVAX is not inferior to the previous formulatioHealthy volunteers (prevention of diarrheal disease due to infection with enterotoxigenic E. coli [ETEC])MedDRA version: 21.1Level: LLTClassification code 10054983Term: Prophylaxis against traveller's diarrheaSystem Organ Class: 100000004865MedDRA version: 20.1Level: LLTClassification code 10022665Term: Intestinal infection due to enterotoxigenic E. coliSystem Organ Class: 100000004862EUCTR2021-001541-13-SEScandinavian Biopharma Holding AB280
进行中（未招募）
不适用
A Phase II Study to Evaluate the Immunogenicity, Safety and Tolerability of a H1N1 Influenza Vaccine in Immunocompromised Adults Who Have Undergone Solid Organ Transplantation or Bone Marrow Transplantation and in Age-Matched Healthy Volunteers - Focetria TxVaccination for H1N1sw of immunocompromised adults who have undergone solid organ or bone marrow transplantation and of healthy adultsMedDRA version: 12.1Level: LLTClassification code 10022000Term: InfluenzaEUCTR2009-017052-27-DEMedizinische Hochschule Hannover