CTIS2024-514855-13-00进行中（未招募）1 期
An open label phase II basket trial exploring the efficacy and safety of the combination of Niraparib and Dostarlimab in patients with DNA repair-deficient or platinum-sensitive solid tumors (NIRADO) - 2020/3093 NIRADO
适应症
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 入组人数
- 112
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
- •1. Age = 18 years., 10. Adequate hematologic and organ function, defined by the following laboratory results obtained within 3 days prior to the first study treatment (Cycle 0 Day 1) (describes in the protocol and synopsis), 11. Women of childbearing potential must have a negative serum ß-HCG pregnancy test within 14 days prior to the administration of the first study treatment. Pregnancy testing must be repeated within 72 hours prior to the first dose and while on study., 12. Sexually active women of childbearing potential must agree to use a highly effective method of contraception supplemented by a barrier method, or to abstain from sexual activity during the study and for at least 180 days after the last study treatment administration., 13. Participant must agree to not breastfeed during the study or for 180 days after the last dose of study treatment., 14. Participant must agree to not donate blood during the study or for 90 days after the last dose of study treatment., 15. Sexually active males patients must agree to use condom during the study and for at least 180 days after the last study treatment administration. Also, it is recommended their women of childbearing potential partner use a highly effective method of contraception for the same duration., 16. Patient should understand, sign, and date the written informed consent form prior to any protocol-specific procedures performed., 17. Patient should be able and willing to comply with study visits and procedures as per protocol., 18. Patients must be affiliated to a social security system or beneficiary of an equivalent system., 2. Patients must have histologically or cytologically confirmed progressive metastatic or recurrent solid tumor (as defined below for each tumor type). Diagnosis must be stated in a pathology report and confirmed by the physician investigator., 3. Evidence of disease progression prior to trial entry., To be enrolled in this study, only the tumor types and settings described in the protocol and synopsis, 5. Patients must have progressed following standard of care or not eligible to effective standard therapy., 6. For all cohorts: representative archival formalin-fixed paraffin-embedded (FFPE) tumor specimens in paraffin blocks (preferred) or 20 (ideally) freshly cut and unstained slides, with an associated pathology report, for ancillary studies and/or central testing. If less than 20 slides are available, inclusion must be discussed with the Coordinating Investigator. In all cases, recovery of the most recent tumor block or biopsy is encouraged. If no material is available (blocks or slides), a biopsy will be mandatory at baseline (before the start of the treatment)., 7. At least one lesion, not previously irradiated, measurable according to RECIST v1.1) as =10 mm in the longest diameter (except lymph nodes which must have short axis = 15 mm) with computed tomography (CT) or magnetic resonance imaging (MRI) and suitable for repeated assessment., 8. Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1 with no deterioration from registration date., 9. Estimated life expectancy of greater than 12 weeks.
排除标准
- •1. Participation in another clinical study with an investigational product simultaneously and/or during the last 4 weeks (excepting observational or noninterventional clinical studies)., 10. Participant has had any known Grade 3 or 4 anemia, neutropenia or thrombocytopenia due to prior chemotherapy that persisted > 4 weeks and was related to the most recent treatment., 11. Participant must not have any known history of myelodysplastic syndrome (MDS) or acute myeloid leukemia (AML)., 12. History of severe allergic, anaphylactic, or other hypersensitivity reactions to chimeric or humanized antibodies or fusion proteins., 13. Known hypersensitivity or allergy to biopharmaceuticals produced in Chinese hamster ovary cells or to any component of the TSR-042 formulation, or to niraparib or its components., 14. History of autoimmune disease, including but not limited to myasthenia gravis, myositis, autoimmune hepatitis, systemic lupus erythematosus, rheumatoid arthritis, inflammatory bowel disease, vascular thrombosis associated with anti-phospholipid syndrome, Wegener’s granulomatosis, Sjögren’s syndrome, Guillain-Barré syndrome, multiple sclerosis, vasculitis or glomerulonephritis. o Patients with autoimmune hypothyroidism on a stable dose of thyroid replacement hormone are eligible. o Patients with controlled Type 1 diabetes mellitus on a stable insulin regimen are eligible., 15. Active or prior documented inflammatory bowel disease (e.g. Crohn’s disease, ulcerative colitis)., 16. History of interstitial lung disease, idiopathic pulmonary fibrosis, drug-induced pneumonitis, organizing pneumonia or evidence of active pneumonitis on screening chest CT scan., 17. History of allogeneic organ transplant or prior bone marrow transplantation of double umbilical cord blood transplantation., 18. Uncontrolled intercurrent illness including, but not limited to: o ongoing or active infection or severe infection requiring hospitalization or IV antibiotics within 2 weeks of starting treatment (with the exception of prophylactic antibiotics). o symptomatic congestive heart failure > NYHA II, superior vena cava syndrome, uncontrolled hypertension, unstable angina pectoris, cardiac arrhythmia, pericardial effusion, myocardial infarction within 90 days. o active peptic ulcer disease or gastritis. o active bleeding diatheses. o major seizure disorder, 19. Psychiatric illness/social situations that would limit compliance with study requirements or compromise the ability of the subject to give written informed consent., 2. Receipt of the last dose of anti-cancer therapy (chemotherapy, immunotherapy, endocrine therapy, targeted therapy, biologic therapy, tumor embolization, monoclonal antibodies, other investigational agent) 28 days prior to the first dose of study drug, or five half lives of the previous agent, whichever is the shorter., 20. Patients with known left ventricular ejection fraction (LVEF) < 40%; patients with known coronary artery disease, congestive heart failure not meeting the above criteria, or LVEF < 50% must be on a stable cardiologic treatment., 21. Known positive test for HIV., 22. Patients with active hepatitis B (defined as positive HBsAg test at screening) or hepatitis C (HCV).Patients with past hepatitis B virus (HBV) infection or resolved HBV infection (defined as having a negative HBsAg test and a positive antibody to hepatitis B core antigen anti-HBc) are eligible., 23. Patients positive for hepatitis C virus (HCV) antibody are eligi
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