EUCTR2019-002328-33-CZ进行中（未招募）1 期
A Multi-Centre, Open-label Phase 2a Trial of the Combination of VB10.16 and Atezolizumab in Patients with Advanced or Recurrent, Non-resectable HPV16-Positive Cervical Cancer
VACCIBODY A.S.0 个研究点目标入组 50 人开始时间: 2019年10月21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
- 50
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. Has persistent, recurrent, or metastatic non-resectable squamous cell carcinoma, adeno-squamous carcinoma, or adenocarcinoma of the cervix, who has failed or is not eligible for treatment with systemic chemotherapy, radiotherapy or other standard-of-care anticancer treatment.
- •2. Tumour must be HPV16 positive. Provision of an archival tumour tissue sample not older than 2 years or new biopsy for analysing HPV16 status is mandatory.
- •3. Must have a biopsy (archived or new) available for PD-L1 assessment at Screening.
- •4. Has measurable disease as assessed by the local site investigator/radiology as per RECIST 1.1.
- •5. Has recovered from the effects of surgery, radiation therapy, or chemoradiotherapy.
- •6. Has an Eastern Cooperative Oncology Group (ECOG) performance status (PS) of 0 to 1 at Screening.
- •7. Is aged 18 years or older.
- •8. Has life expectancy of at least 6 months in the best judgement of the investigator.
- •9. Is willing and able to sign a written informed consent form.
- •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 40
- •F.1.3 Elderly (>=65 years) no
- •F.1.3.1 Number of subjects for this age range 10
排除标准
- •1. Patients who, in the investigator’s opinion, have progressed rapidly on their previous anticancer treatment (e.g., did not achieve any response [CR, PR, or SD]).
- •2. Has brain metastases (unless they have received prior treatment and are controlled and stable for at least 6 weeks before study enrolment) or leptomeningeal spread of disease.
- •3. Has positive serological test for:
- •-hepatitis C virus (HCV) and has not been treated; patients who are HCV-RNA negative would be eligible.
- •- hepatitis B virus (HBV) surface antigen (HBsAg); patients with positive HBV core antibody must have negative surface antibody and negative HBV viral load (HBV DNA) to be eligible.
- •- human immunodeficiency virus (HIV).
- •4. Has other concomitant or prior malignant disease, except for: a) adequately treated basal cell carcinoma or other non-melanomatous skin cancer, or low-grade urothelial cancer; b) other malignancies treated with curative intent, without disease recurrence and in complete remission with treatment completed 2 years or more before study entry.
- •5. Has an active, known or suspected autoimmune disease. Patients who required systemic immunosuppression within the past 3 months before enrolment or who have a documented history of clinically severe autoimmune disease that requires systemic steroids or immunosuppressive agents. (Exceptions include: patients with vitiligo; hypothyroidism stable on hormone replacement; type 1 diabetes; Grave’s disease; Hashimoto’s disease; alopecia areata; psoriasis; eczema; exceptions require discussion with the medical monitor).
- •6. Is receiving systemic immunosuppression including systemic steroids or the use of immunosuppressive agents (e.g., cyclosporine, azathioprine, methotrexate or tumour necrosis factor alfa [TNF-a]) for any concurrent condition. All systemically administered corticosteroids must be discontinued >2 weeks prior to the first study vaccine administration.
- •7. Has known allergy to aminoglycosides (especially kanamycin) or any study treatment component.
- •8. Has history of toxic shock syndrome.
- •Please refer to section 8.2 of the protocol for the full criteria.
研究者
相似试验
进行中（未招募）
1 期
A Phase 2 study for the Combination of VB10.16 and Atezolizumab in Patients with Advanced Cervical CancerEUCTR2019-002328-33-DEYKODE THERAPEUTICS ASA50
进行中（未招募）
1 期
A Phase 2 study for the Combination of VB10.16 and Atezolizumab in Patients with Advanced Cervical CancerAdvanced or recurrent non-resectable HPV16-positive cervical cancer, who failed or are not eligible for current standard of careMedDRA version: 21.1Level: LLTClassification code 10008229Term: Cervical cancerSystem Organ Class: 100000004864EUCTR2019-002328-33-NOykode Therapeutics ASA50
进行中（未招募）
1 期
A Phase 2 study for the Combination of VB10.16 and Atezolizumab in Patients with Advanced Cervical CancerAdvanced or recurrent non-resectable HPV16-positive cervical cancer, who failed or are not eligible for current standard of careMedDRA version: 21.1Level: LLTClassification code 10008229Term: Cervical cancerSystem Organ Class: 100000004864EUCTR2019-002328-33-BEykode Therapeutics ASA50
进行中（未招募）
1 期
A Phase 2 study for the Combination of VB10.16 and Atezolizumab in Patients with Advanced Cervical CancerAdvanced or recurrent non-resectable HPV16-positive cervical cancer, who failed or are not eligible for current standard of careMedDRA version: 21.1Level: LLTClassification code 10008229Term: Cervical cancerSystem Organ Class: 100000004864EUCTR2019-002328-33-BGykode Therapeutics A.S.50
进行中（未招募）
1 期
A Phase 2 study for the Combination of VB10.16 and Atezolizumab in Patients with Advanced Cervical CancerAdvanced or recurrent non-resectable HPV16-positive cervical cancer, who failed or are not eligible for current standard of careMedDRA version: 21.1Level: LLTClassification code 10008229Term: Cervical cancerSystem Organ Class: 100000004864EUCTR2019-002328-33-PLykode Therapeutics ASA50