EUCTR2020-002766-14-FR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
Gustave Roussy0 个研究点目标入组 800 人开始时间: 2020年8月21日最近更新:
适应症
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 发起方
- 入组人数
- 800
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional clinical trial of medicinal product
入排标准
- 性别
- All
入选标准
- •1.Age = 18 years.
- •2.Patients must have histologically or cytologically confirmed progressive metastatic or recurrent solid tumor (as defined below for each tumor type).
- •3.Evidence of disease progression prior to trial entry.
- •4.To be enrolled in this study, only the tumor types and settings described below are allowed:
- •4.1.1 – Cohort 1A: Urothelial Bladder Cancer
- •4.1.2– Cohort 1B: Gastric or gastro-esophageal junction adenocarcinoma
- •4.1.3– Cohort 1C: Head and Neck Cancer
- •4.1.4– Cohort 1D: Biliary Tract Cancer
- •4.1.5- Cohort 1E Others
- •4.2 - Cohorts 2: Platinum-sensitive urothelial bladder cancer
- •4.3 - Cohort 3: Clear cell Renal Cell Carcinoma
- •5.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.
- •6.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.
- •7.Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1 with no deterioration from registration date.
- •8.Estimated life expectancy of greater than 12 weeks.
- •9.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):
- •oAbsolute neutrophil count (ANC) = 1500 cells/µL (without granulocyte colony-stimulating factor support within 2 weeks before cycle 0 day 1).
- •oLymphocyte count = 500/µL.
- •oPlatelet count = 100.000/µL (without platelets transfusion within 2 weeks before Cycle 0 Day 1).
- •oHemoglobin = 9g/dL (patients are not allowed to be transfused with RBC or receive erythropoietic treatment to meet this criterion).
- •oTotal bilirubin = 1.5 ULN (subjects with documented/suspected Gilbert’s disease or liver metastases may be enrolled with bilirubin = 3 × ULN).
- •oAspartate aminotransferase (AST) or Alanine aminotransferase (ALT) = 2.5 x upper normal limit (ULN) or = 5 × ULN in case of liver involvement.
- •oAlbumin = 28g/L.
- •oSerum creatinine = 1.5 x ULN or creatinine clearance = 40 mL/min (according to Cockroft and Gault formula).
- •oInternational normalized ratio (INR) and activated partial thromboplastin time (aPTT) = 1.5 x ULN. This applies only to patients who do not receive therapeutic anticoagulation; patients receiving therapeutic anticoagulation (such as low-molecular weight heparin or warfarin) should be on stable dose.
- •10.Women of childbearing potential must have a negative serum ß-HCG pregnancy test within 7 days prior to the administration of the first study treatment.
- •11.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.
- •12.Participant must agree to not breastfeed during the study or for 180 days after the last dose of study treatment.
- •13.Participant must agree to not donate blood during the study or for 90 days after the last dose of study treatment.
- •14.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 the
排除标准
- •1.Participation in another clinical study with an investigational product simulteanously and/or during the last 4 weeks
- •2.Receipt of the last dose of anti-cancer therapy 28 days prior to the first dose of study drug, or five half lives of the previous agent, whichever is the shorter.
- •3.Prior radiation therapy encompassing >20% of the bone marrow within 2 weeks prior to Cycle 0 Day 1; or any radiation therapy within 1 week prior to Cycle 0 Day 1.
- •4.History of another primary malignancy within 5 years prior to Cycle 0 Day 1 except for:
- •5.Treatment with systemic corticosteroids or other immunosuppressive medications within 7 days prior to Cycle 0 Day 1, or anticipated requirements for systemic immunosuppressive medications during the trial:
- •6.Acute toxicities from previous therapies that have not resolved to Grade = 1, with the exception of alopecia.
- •7.Any prior Grade =3 immune-related adverse event (irAE) while receiving any previous immunotherapy agent, or any unresolved irAE > Grade 1.
- •8.Participant must not have received a platelet transfusion = 4 weeks prior to Cycle 0 Day 1.
- •9.Participants must not have received colony stimulating factors within 4 weeks prior to Cycle 0 Day 1.
- •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
- •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
- •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:
- •19.Psychiatric illness/social situations that would limit compliance with study requirements or compromise the ability of the subject to give written informed consent.
- •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 eligible only if polymerase chain reaction (PCR) is negative for HCV RNA.
- •24.Active tuberculosis.
- •25.Administration of attenuated or live vaccine within 2 weeks prior to Cycle 0 Day 1 or anticipation that such a live attenuated vaccine will be required during the study.
- •26.Major surgical procedure within 20 days prior ty Cycle 0 Day 1 with recovery from any s
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