2024-516982-35-00尚未招募3 期
A Phase 3, Open-label, Multicenter, Randomized Trial of Trastuzumab Deruxtecan with Bevacizumab Verus Bevacizumab Monotherapy as First-line Maintenance Therapy in HER2-Expressing Ovarian Cancer (DESTINY-Ovarian01/ENGOT-ov89/GEICO144-O/GOG-3112)
适应症
试验速览
- 阶段
- 3 期
- 状态
- 尚未招募
- 入组人数
- 182
- 试验地点
- 104
- 主要终点
- Progression Free Survival by Blinded Independent Central Review (BICR) in the HER2 IHC 3+/2+ population Time from randomization to time of objective radiographic disease progression as assessed by BICR based on RECIST v1.1 or death due to any cause.
研究概览
简要总结
To evaluate the safety and tolerability of T-DXd in combination with bevacizumab (for Safety Run-in phase). To compare the efficacy of T-DXd in combination with bevacizumab (Arm A) versus bevacizumab monotherapy (Arm B) as measured by PFS, as assessed by BICR in the HER2 IHC 3+/2+ population (for Randomized phase).
研究设计
- 分配方式
- Randomized
- 主要目的
- Randomized Phase
- 盲法
- None
入排标准
- 年龄范围
- 18 years 至 65+ years（18-64 Years, 65+ Years）
- 性别
- Female
- 接受健康志愿者
- 是
入选标准
- •Sign and date the tissue pre-screening informed consent form (ICF), prior to HER2 central testing. Sign and date the main ICF, prior to the start of any trial- specific qualification procedures. Consent to optional PGx prior to any PGx procedures. For participants in the safety run-in phase, a safety run-in ICF needs to be signed and dated prior to the start of any trial-specific qualification procedures.
- •Adults ≥18 years of age on the day of signing the ICF. Follow local regulatory requirements if the legal age of consent for trial participation is >18 years old.
- •Has histologically confirmed diagnosis of epithelial high-grade ovarian, fallopian tube or primary peritoneal carcinoma (including but not limiting to serous, endometrioid, clear cell, carcinosarcoma, mucinous).
- •Is newly diagnosed FIGO Stage III or IV.
- •Has HER2 expression per IHC scoring (3+/2+/1+) guidelines by prospective central testing. For participants in the safety run-in phase, HER2 expression assessed by either local (require using IHC scoring [IHC 3+/2+/1+] guidelines) or central assessment (if available) is acceptable. Submission of the pathology report is required for participants enrolled based on local HER2 IHC results.
- •Has adequate tumor tissue sample available for assessment of HER2 by central laboratory. Tumor tissue block or sufficient tissue slides are required for HER2 testing and retrospective HRD status determination. #Participants in the safety run-in phase who are enrolled based on local HER2 IHC results are recommended to provide tumor tissue sample from the same specimen for central assessment.
- •Has a local HRD or breast cancer gene (BRCA) test result available. Participants with BRCA wildtype will have a local HRD test results, as applicable.
- •Has received standard of care bevacizumab in combination with front line platinum based chemotherapy as per approved indication and clinical guidelines and is eligible to continue single agent bevacizumab maintenance per standard of care and investigator discretion. Note: Participants should receive up to 6 cycles of bevacizumab in combination with front line platinum-based chemotherapy.
排除标准
- •Has ovarian, fallopian tube, or peritoneal cancer of non-epithelial origin.
- •Has a history of (non-infectious) ILD/pneumonitis that required steroids, has current ILD/pneumonitis, or where suspected ILD/pneumonitis cannot be ruled out by imaging at screening.
- •Clinically severe pulmonary compromise resulting from intercurrent pulmonary illnesses including, but not limited to, any underlying pulmonary disorder (ie pulmonary emboli within three months of the trial enrollment, severe asthma, severe COPD, restrictive lung disease, pleural effusion etc.), and any autoimmune, connective tissue or inflammatory disorders with potential pulmonary involvement (ie Rheumatoid arthritis, Sjogren's, sarcoidosis etc.), or prior pneumonectomy.
- •Has a BRCA mutation as per local test.
- •Participant to receive PARP inhibitor as maintenance per standard of care and investigator discretion. Reasons for which the participant is not eligible for PARP inhibitor will be recorded in the eCRF as follows: • HRD negative • HRD positive with SD as best response after platinum • HRD positive non-serous histology • HRD tested, but inconclusive • HRD positive but safety concern (safety concern to be specified).
- •Has a history of severe hypersensitivity reactions to either the drug substances or inactive ingredients in the drug products and other monoclonal antibodies.
- •Previous Cerebral-Vascular Accident, Transient Ischemic Attack or Sub- Arachnoids Hemorrhage within 6 months prior to randomization.
- •Has evidence of bleeding diathesis or significant coagulopathy (in the absence of anticoagulation therapy).
- •Has a history of hemorrhagic disorders, abdominal fistula, gastrointestinal perforation, or active gastrointestinal bleeding within 6 months before randomization.
- •Evidence of active or ongoing bowel obstruction.
- •Has lung-specific intercurrent clinically significant illnesses including, but not limited to, any underlying pulmonary disorder (eg, pulmonary emboli within 3 months of the trial randomization, severe asthma, severe chronic obstructive pulmonary disease, restrictive lung disease, pleural effusion, pneumonectomy, etc.).
结局指标
主要结局
Progression Free Survival by Blinded Independent Central Review (BICR) in the HER2 IHC 3+/2+ population Time from randomization to time of objective radiographic disease progression as assessed by BICR based on RECIST v1.1 or death due to any cause.
Progression Free Survival by Blinded Independent Central Review (BICR) in the HER2 IHC 3+/2+ population Time from randomization to time of objective radiographic disease progression as assessed by BICR based on RECIST v1.1 or death due to any cause.
次要结局
- Overall Survival in the HER2 IHC 3+/2+ population Time interval from the date of randomization to the date of death due to any cause.
- Progression Free Survival by BICR in the HER2 IHC 3+/2+/1+ population. Time from randomization to time of objective radiographic disease progression as assessed by BICR based on RECIST v1.1 or death due to any cause.
- Overall Survival in the HER2 IHC 3+/2+/1+ population Time interval from the date of randomization to the date of death due to any cause.
- Progression Free Survival by the investigator in HER2 IHC 3+/2+ population Time from randomization to time of objective radiographic disease progression as assessed by the investigator based on RECIST v1.1 or death due to any cause.
- Progression Free Survival by the investigator in HER2 IHC 3+/2+/1+ population Time from randomization to time of objective radiographic disease progression as assessed by the investigator based on RECIST v1.1 or death due to any cause.
研究者
Clinical Trial Office
Scientific
Daiichi Sankyo Europe GmbH
研究点 (104)
Loading locations...
相似试验
招募中
2 期
Safety and preliminary effectiveness of BNT327, an investigational therapy for patients with non-small cell lung cancer in combination with chemotherapy following chemoimmunotherapyNon-small Cell Lung Cancer2024-518279-80-00BioNTech SE10
进行中（未招募）
3 期
DESTINY-Breast11 will compare trastuzumab deruxtecan (T-DXd) alone or in sequence with other medications, known as THP, with standard of care treatment (ddAC-THP) and determine its safety and efficacy in patients with HER2-positive early breast cancer.2023-505210-18-00AstraZeneca AB280
已完成
3 期
Pembrolizumab with Lenvatinib versus Docetaxel for Metastatic NSCLC after Platinum Doublet Chemotherapy and Immunotherapy2022-501439-18-00Merck Sharp & Dohme LLC206
招募中
2 期
A Phase I/II study of DYP688 treatment alone in patients with eye cancer and other
types of cancers of the skin and mucosal membranes in the body.2023-509451-14-00Novartis Pharma AG27
招募中
2 期
A clinical study to learn about the effects of a virus that transfers the gene for human Ornithine Transcarbamylase (OTC) in adults with late-onset OTC deficiency in the long termOrnithine transcarbamylase deficiency2022-501146-30-00Ultragenyx Pharmaceutical Inc.4