CTIS2023-509307-33-00进行中（未招募）1 期
A Phase 1/2 Open-Label, Umbrella Platform Design Study of MK-2870 With Pembrolizumab (MK-3475) and Chemotherapy in Participants With 1L LocallyAdvanced Unresectable/Metastatic Gastroesophageal Adenocarcinoma (Gastric Adenocarcinoma, Gastroesophageal Junction Adenocarcinoma, and EsophagealAdenocarcinoma): Substudy 06C - MK-3475-06C
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 入组人数
- 96
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+（—）
- 性别
- All
入选标准
- •Has histologically and/or cytologically confirmed diagnosis of previously untreated locally advanced unresectable or metastatic 1L gastroesophageal adenocarcinoma, Is not expected to require tumor resection during the treatment course, Has gastroesophageal adenocarcinoma that is not human epidermal growth factor receptor 2 (HER2)/neu positive, Has provided an archival tumor tissue sample or most recently obtained core, or incisional, or excisional biopsy for a tumor lesion, Participants who have adverse events (AEs) due to previous anticancer therapies must have recovered to = Grade 1 or baseline. Participants with endocrine-related AEs who are adequately treated with hormone replacement therapy are eligible, Has adequate organ function, Has measurable disease per Response Evaluation Criteria in Solid Tumors Version 1.1 (RECIST 1.1) as determined by the local site investigator/radiology assessment and verified by blind independent review committee (BICR), Has Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1 within 3 days prior to the first dose of study intervention, Has a life expectancy of at least 6 months
排除标准
- •Has had previous therapy for locally advanced unresectable or metastatic gastric/GEJ/esophageal adenocarcinoma, Has received prior treatment with a topoisomerase 1 inhibitor-based ADC and/or a topoisomerase 1 inhibitor-based chemotherapy, Has received prior systemic anticancer therapy including investigational agents within 4 weeks before the first dose of study intervention, Has received prior therapy with an anti-Programmed Cell Death Protein 1 (PD-1), anti-Programmed Cell Death-Ligand 1 (PD-L1), anti-Programmed Cell Death-Ligand 2 (PD-L2) agent or with an agent directed to another stimulatory or co-inhibitory T-cell receptor (TCR), Has received prior radiotherapy within 2 weeks of start of study intervention, or has radiation related toxicities, requiring corticosteroids, Has received a live or live-attenuated vaccine within 30 days before the first dose of study intervention, Has received a strong inducer/inhibitor of CYP3A4 that cannot be discontinued, Has received an investigational agent or has used an investigational device within 4 weeks prior to study intervention administration, Has diagnosis of immunodeficiency or is receiving chronic systemic steroid therapy or any other form of immunosuppressive therapy within 7 days prior to the first dose of study intervention, Has known additional malignancy that is progressing or has required active treatment within the past 3 years, Has known active central nervous system (CNS) metastases and/or carcinomatous meningitis, Has experienced weight loss >20% over 3 months before the first dose of study intervention, Has Severe hypersensitivity (=Grade 3) to pembrolizumab, sacituzumab tirumotecan, or other biologic therapy, chemotherapy (ie, oxaliplatin, fluorouracil, capecitabine), leucovorin, levoleucovorin, or any of their excipients, Has active autoimmune disease that has required systemic treatment in the past 2 years, Has history of (noninfectious) pneumonitis/interstitial lung disease that required steroids or has current pneumonitis/interstitial lung disease, Has an active infection requiring systemic therapy, Has concurrent active hepatitis B (defined as Hepatitis B surface antigen [HBsAg] reactive) and/or hepatitis C (defined as anti-hepatitis C virus [HCV] Ab positive and detectable HCV ribonucleic acid [RNA] infection or a known history of hepatitis B and/or C infection, Has history or current evidence of any condition, therapy, laboratory abnormality, or other circumstance that might confound the results of the study or interfere with the participant's ability to cooperate with the requirements of the study, Has GI obstruction, poor oral intake, or difficulty in taking oral medication, Has poorly controlled diarrhea, Has had a major surgery or significant traumatic injury within 4 weeks before the first dose of study intervention, Has history of allogeneic tissue/solid organ transplant, Has a history of documented severe dry eye syndrome, severe Meibomian gland disease and/or blepharitis, or corneal disease that prevents/delays corneal healing, Have not adequately recovered from major surgery or have ongoing surgical complications, Has Grade >2 peripheral neuropathy, Has active inflammatory bowel disease requiring immunosuppressive medication or previous history of inflammatory bowel disease, Has uncontrolled, significant cardiovascular disease or cerebrovascular disease within 6 months preceding study intervention, Has accumulation of pleural, ascitic, or pericardial fluid req
研究者
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