JPRN-jRCT2080225362已完成1 期
Safety Study of Bintrafusp alfa in Combination with Other Anti-cancer Therapies in Participants with Locally Advanced or Advanced Cervical Cancer
适应症
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 24
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional
入排标准
- 年龄范围
- >= 18age old 至 ot applicable（—）
- 性别
- Female
入选标准
- •Criteria for participants enrolling into Cohort 1:
- •1. Study participants have documented persistent, recurrent, or metastatic squamous cell carcinoma, adenosquamous carcinoma, or adenocarcinoma of the cervix
- •2. Study participants have not been treated with systemic chemotherapy and are not amenable to curative treatment
- •3. Prior radiation with or without radio-sensitizing chemotherapy is allowed
- •- Criteria for participants enrolling into Cohort 2:
- •1. Participants have documented evidence of cervical adenocarcinoma, squamous cell carcinoma, or adenosquamous carcinoma International Federation of Gynecology and Obstetrics (FIGO) 2018 Stages 1B2 to 4A
- •2. Participants have not received prior chemotherapy or radiotherapy for cervical cancer
- •- Criteria for all participants:
- •1. Archival tumor tissue sample or newly obtained core or excisional biopsy is required
- •2. Participants who have Eastern Cooperative Oncology Group (ECOG) Performance status (PS) of 0 to 1
- •3. Participants have a life expectancy greater than or equal to 12 weeks
- •4. Participants have adequate hematological, hepatic, renal and coagulation function as defined in the protocol
- •5. Participants with known Human immunodeficiency virus (HIV) infections are eligible if the criteria described in the protocol are met
- •6. Participants with Hepatitis B virus (HBV) and/or Hepatitis C virus (HCV) infections are eligible if the criteria described in the protocol are met
- •7. Other protocol defined inclusion criteria could apply
排除标准
- •- Criteria for all participants:
- •1. Participants with active central nervous system (CNS) metastases causing clinical symptoms or metastases that require therapeutic intervention are excluded.
- •2. Participants with a history of treated CNS metastases (by surgery or radiation therapy) are not eligible unless they have fully recovered from treatment, demonstrated no progression for at least 4 weeks, and are not using steroids for at least 7 days prior to the start of study intervention
- •3. Participants that received any organ transplantation, including allogeneic stem-cell transplantation, but with the exception of transplants that do not require immuno-suppression
- •4. Participants with significant acute or chronic infections
- •5. Participants with active autoimmune disease that might deteriorate when receiving an immuno-stimulatory agent
- •6. Participants with clinically significant cardiovascular/cerebrovascular disease including: cerebral vascular accident/stroke, myocardial infarction, unstable angina, congestive heart failure, or serious cardiac arrhythmia
- •7. Participants with history of bleeding diathesis or recent major bleeding events
- •8. Participant that has received prior cancer treatment with any other immunotherapy or checkpoint inhibitors or any other immunemodulating monoclonal antibody (mAb)
- •- Criteria for Cohort 1A
- •1. Participants with inadequately controlled hypertension
- •2. Prior history of hypertensive crisis or hypertensive encephalopathy
- •3. Participants with significant vascular disease within 6 months prior to Screening
- •4. Participants with history of hemoptysis within 1 month prior to Screening
- •5. Current use of full-dose oral or parenteral anticoagulants or thrombolytic agents for therapeutic purposes
- •6. Core biopsy or other minor surgical procedure, excluding placement of a vascular access device, within 7 days prior to the first dose of bevacizumab
- •7. Participants with a history of abdominal or trache-oesophageal fistula or gastrointestinal (GI) perforation within 6 months prior to Screening
- •8. Participants with clinical signs of GI obstruction or requirement for routine parenteral hydration, parenteral nutrition, or tube feeding
- •9. Participants with evidence of abdominal free air not explained by paracentesis or recent surgical procedure
- •10. Participants with serious, non-healing wound, active ulcer, or untreated bone fracture
- •11. Participants with proteinuria
- •- Other protocol defined exclusion criteria could apply
研究者
相似试验
已完成
1 期
Bintrafusp Alfa Combination Therapy in Participants With Cervical Cancer (INTR@PID 046)Cervical CancerNCT04551950EMD Serono Research & Development Institute, Inc.25
进行中（未招募）
1 期
A phase II trial assessing Bintrafusp alfa, a bifunctional fusion protein targeting TGF-ß and PD-L1, in a pre-operative setting for resectable and untreated head and neck squamous cell carcinomaEUCTR2019-004052-11-FRICANCER59
已完成
3 期
M7824 Versus Pembrolizumab as a First-line (1L) Treatment in Participants With Programmed Death-ligand 1 (PD-L1) Expressing Advanced Non-small Cell Lung Cancer (NSCLC)Non-small Cell Lung CancerNCT03631706EMD Serono Research & Development Institute, Inc.304
终止
2 期
Bintrafusp Alfa With Chemotherapy for Tyrosine Kinase Inhibitor-Resistant EGFR-Mutant Non-small Cell Lung CancerStage IVB Lung Cancer AJCC v8Unresectable Lung Non-Squamous Non-Small Cell CarcinomaLocally Advanced Lung Non-Squamous Non-Small Cell CarcinomaMetastatic Lung Non-Squamous Non-Small Cell CarcinomaStage III Lung Cancer AJCC v8Stage IIIA Lung Cancer AJCC v8Stage IIIB Lung Cancer AJCC v8Stage IIIC Lung Cancer AJCC v8Stage IV Lung Cancer AJCC v8Stage IVA Lung Cancer AJCC v8NCT04971187M.D. Anderson Cancer Center3
进行中（未招募）
1 期
eoadjuvant Bintrafusp alfa in patients with resectable biliary tract cancer (NEOBIL)Treatment-naive subjects with a diagnosis of resectable biliary tract cancer, confirmed by histopathologyMedDRA version: 20.0Level: PTClassification code 10004593Term: Bile duct cancerSystem Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps)MedDRA version: 21.0Level: LLTClassification code 10004597Term: Bile duct cancer resectableSystem Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps)MedDRA version: 20.0Level: LLTClassification code 10004598Term: Bile duct carcinomaSystem Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps)MedDRA version: 20.0Level: LLTClassification code 10007289Term: Carcinoma bile ductSystem Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps)MedDRA version: 21.0Level: LLTClassification code 10004601Term: Bile duct carcinoma resectableSystem Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps)EUCTR2020-002605-25-DEAIO-Studien-gGmbH24