ACTRN12618000954224招募中2 期
A phase II study of Avelumab + stereotactic ablative body radiosurgery (SABR) for metastatic castration-resistant prostate cancer (mCRPC). To assess radiographic progression-free survival (rPFS).
适应症
试验速览
- 阶段
- 2 期
- 状态
- 招募中
- 入组人数
- 25
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional
- 分配方式
- Non-randomised trial
- 主要目的
- Treatment
- 盲法
- Open (masking not used)
入排标准
- 年龄范围
- 18 Years 至 o limit（—）
- 性别
- Male
入选标准
- •1.18 years of age.
- •2.Willing and able to provide informed written consent.
- •3.Life expectancy of at least 6 months.
- •4.Adenocarcinoma of the prostate diagnosed histologically without small cell differentiation.
- •5.Prior surgical orchiectomy or maintained on luteinizing hormone-releasing hormone (LHRH) agonist/antagonist therapy
- •6.Prior treatment with 1 of the following agents: CYP17 inhibitors (including abiraterone acetate (ABI), TAK-700, TOK-001 and ketoconazole), enzalutamide or other experimental anti-androgens (e.g. ARN-509, TOK-001).
- •7.Prior treatment with up to 1 line of systemic chemotherapy for mCRPC is permitted.
- •8.Evidence of biochemical or imaging progression in the setting of surgical or medical castration. PD for study entry is defined by one of the following three criteria:
- •a.PSA progression: minimum of two rising PSA values from a baseline measurement with an interval of 1 week between each measurement.
- •b.Soft tissue or visceral disease progression as per RECIST 1.1 criteria
- •c.Bone progression: 2 new lesions on bone scan.
- •9.Radiographic evidence of metastatic disease documented with bone scan or CT scan. Patients with any number of metastatic sites are permitted to enrol.
- •10.Adequate organ function laboratory values:
- •a.Absolute neutrophil count (ANC) at 1.5 x 109/L
- •b.Platelets at 100 x 109/L
- •c.Hemoglobin at 9 g/dL
- •d.Creatinine at 1.5 X upper limit of normal (ULN) OR at 60 mL/min calculated creatinine clearance for subject with creatinine levels greater than 1.5 X ULN
- •e.Serum total bilirubin at 1.5 X ULN OR direct bilirubin at ULN for participants with total bilirubin levels greater than 1.5 ULN
- •f.Aspartate aminotransferase (AST) (SGOT) and alanine aminotransferase (ALT) (SGPT) at 2.5 X ULN OR at 5 X ULN for participants with liver metastases
- •g.International normalised ratio (INR)/activated partial prothrombin time (aPTT) at 1.5 X ULN unless subject is receiving anticoagulant therapy as long as prothrombin time (PT) or partial prothrombin time (PTT) is within therapeutic range of intended use of anticoagulants.
- •11.Eastern cooperative oncology group (ECOG) performance status 0-1.
- •12.Be willing and able to comply with all study requirements, including treatment, attending assessments and follow-up.
- •13.Participants should agree to use a highly efficient method of contraception starting with the first dose of study therapy through 120 days after the last dose of study therapy.
排除标准
- •1.Subjects for whom urgent treatment with cytotoxic chemotherapy is indicated (e.g., symptomatic metastases).
- •2.Subjects with active, known or suspected autoimmune disease except type I diabetes mellitus, hypothyroidism only requiring hormone replacement and skin disorders (such as vitiligo, psoriasis, or alopecia) not requiring systemic treatment.
- •3.Subjects with a condition requiring systemic treatment with either corticosteroids or other immunosuppressive medications within 14 days of randomization. Use of inhaled, intranasal, and topical steroids is acceptable.
- •4.Prior therapy with anti- PD-1, anti- PD-L1/L2, anti-CD137, or anti-Cytotoxic T lymphocyte-associated antigen 4 (CTLA-4) antibody or any other antibody or drug specifically targeting T-cell co-stimulation or checkpoint pathways
- •5.Has had previous high dose radiotherapy (biological equivalent of 30Gy in 10 fractions) to an area to be treated, which includes vertebral bodies
- •6.Other severe acute or chronic medical conditions including colitis, inflammatory bowel disease, pneumonitis, pulmonary fibrosis or psychiatric conditions including recent (within the past year) or active suicidal ideation or behaviour; or laboratory abnormalities that may increase the risk associated with study participation or study treatment administration or may interfere with the interpretation of study results and, in the judgment of the investigator, would make the patient inappropriate for entry into this study
- •7.Prior organ transplantation including allogenic stem-cell transplantation
- •8.Known prior severe hypersensitivity to investigational product or any component in its formulations, including known severe hypersensitivity reactions to monoclonal antibodies (NCI CTCAE v4.03 Grade 3)
- •9.Clinically significant (i.e., active) cardiovascular disease: cerebral vascular accident/stroke (less than 6 months prior to enrollment), myocardial infarction (less than 6 months prior to enrollment), unstable angina, congestive heart failure (= New York Heart Association Classification Class II), or serious cardiac arrhythmia requiring medication
- •10.Initiation or discontinuation of bisphosphonates or denosumab within the previous 28 days.
- •11.Brain metastases or active epidural disease.
- •12.Active concurrent malignancy (with the exception of non-melanomatous skin cancer or other superficial cancers not requiring treatment e.g. non-muscle invasive bladder cancer).
- •13.Evidence of interstitial lung disease or active, non-infectious pneumonitis.
- •14.Known human immunodeficiency virus (HIV) or active Hepatitis B or C.
- •15.Has received a live vaccine within 30 days of registration.
- •16.Has a known history of active TB (Bacillus Tuberculosis).
- •17.Has had prior chemotherapy, targeted small molecule therapy, radiation therapy or radioisotopes (such as Strontium-89 or Radium-223) 28 days prior to starting study drug
- •18.Persisting toxicity related to prior therapy (NCI CTCAE v. 4.03 Grade greater than 1); however, alopecia, sensory neuropathy Grade 2, or other Grade 2 not constituting a safety risk based on investigator’s judgment are acceptable
- •19.Has known psychiatric or substance abuse disorders that would interfere with cooperation with the requirements of the study.
- •20.Is expecting to father children within the projected duration of the study, starting with the screening visit through 120 days after the last dose of study treatment.
研究者
相似试验
尚未招募
2 期
A pilot study of Nivolumab with stereotactic ablative radiation therapy after induction chemotherapy in cholangiocarcinoma.ocally Advanced, recurrent or metastatic cholangiocarcinoma.biliary tractLBCTR2020124689American University of Beirut40
进行中（未招募）
1 期
Avelumab in combination with Axitinib in patients with advanced Thymic tumoursHistologically confirmed advanced Thymoma B3 or Thymic carcinoma inoperable (Masaoka Stage IIIb or IV).MedDRA version: 21.1Level: PTClassification code 10055108Term: Thymic cancer metastaticSystem Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps)EUCTR2017-004048-38-ITISTITUTO EUROPEO DI ONCOLOGIA33
招募中
2 期
A Phase II, single arm Study of avelumab in combination with Axitinib in Patients with unresectable/metastatic Gastrointestinal Stromal Tumor after failure of standard therapy - AXAGIST2024-519176-95-00Narodowy Instytut Onkologii Im. Marii Sklodowskiej-Curie Panstwowy Instytut Badawczy58
进行中（未招募）
1 期
A Phase II, single arm Study of avelumab In combination with Axitinib in Patients With unresectable/metastatic Gastrointestinal Stromal Tumor after failure of standard therapy - AXAGISTGIST - unresectable/metastatic Gastrointestinal Stromal Tumor after failure of standard therapyMedDRA version: 20.0Level: LLTClassification code 10062427Term: Gastrointestinal stromal tumorSystem Organ Class: 100000004864EUCTR2018-003998-96-PLCentrum Onkologii – Instytut im. Marii Sklodowskiej - Curie17
招募中
不适用
Phase II trial of avelumab and gemcitabine in advanced leiomyosarcomaKCT0003308Gachon University Gil Medical Center38