CTIS2023-505005-16-00进行中（未招募）1 期
A Randomized, Phase 2 Study of Pembrolizumab And Chemotherapy With or Without MK-4830 as Neoadjuvant Treatment for High-Grade Serous Ovarian Cancer - MK-4830-002
适应症
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 入组人数
- 98
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
- 18 至 65+（—）
入选标准
- •Has histologically-confirmed International Federation of Gynecology and Obstetrics (FIGO) Stage III or Stage IV HGSOC, primary peritoneal cancer, or fallopian tube cancer., Is a candidate for carboplatin and paclitaxel chemotherapy, to be administered in the neoadjuvant and adjuvant setting., Is a candidate for interval debulking surgery., Is able to provide archival tissue or newly obtained core, incisional, or excisional biopsy of a tumor lesion., Has adequate organ functions.
排除标准
- •Has a non-HGSOC histology., Has known active Central Nervous System (CNS) metastases and/or carcinomatous meningitis., Has severe hypersensitivity to pembrolizumab, carboplatin, paclitaxel (or docetaxel, if applicable),Avastin or biosimilar (if using) and/or any of their excipients., Has an active autoimmune disease that has required systemic treatment in past 2 years., Has an active infection requiring systemic therapy., Has a known history of human immunodeficiency virus (HIV) infection., Has a known history of hepatitis B or known active hepatitis C virus infection., Has received colony-stimulating factors within 4 weeks prior to receiving study intervention on Day 1of Cycle 1., Has had surgery <6 months prior to Screening to treat borderline ovarian tumors, early-stage OC, or early-stage fallopian tube cancer., Has a known psychiatric or substance abuse disorder that would interfere with the participant's ability to cooperate with the requirements of the study., Has current, clinically relevant bowel obstruction., Has a history of (noninfectious) pneumonitis/interstitial lung disease that required steroids or has current pneumonitis/interstitial lung disease., Has a history of hemorrhage, hemoptysis, or active gastrointestinal (GI) bleeding within 6 months prior to randomization., Has uncontrolled hypertension., Has had an allogenic tissue/solid organ transplant., Has either had major surgery within 3 weeks of randomization or has not recovered from any effects of any major surgery., Has a known additional malignancy that is progressing or has required active treatment within the past 3 years., Has received prior treatment for any stage of OC, including radiation or systemic anticancer therapy., Planned or has been administered intraperitoneal chemotherapy as first-line therapy., Has received prior therapy with an anti-programmed cell death 1 protein (PD-1), anti-programmed cell death 1 ligand 1 (PD-L1), anti-programmed cell death 1 ligand 2 (PD-L2), anti-immunoglobulin-like transcript 4 (ILT4), or anti-human leukocyte antigen (HLA)-G agent or with an agent directed to another stimulatory or coinhibitory T-cell receptor., Has received a live or live-attenuated vaccine within 30 days before the first dose of study intervention., Is currently participating in or has participated in a study of an investigational agent or has used an investigational device within 4 weeks before the first dose of study intervention., Has a diagnosis of immunodeficiency or is receiving chronic systemic steroid therapy (in dosing exceeding 10 mg daily of prednisone equivalent) or any other form of immunosuppressive therapy within 7 days prior the first dose of study medication.
研究者
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