EUCTR2021-001060-23-BE进行中（未招募）1 期
A PHASE Ib/II OPEN-LABEL, MULTICENTER STUDYEVALUATING THE SAFETY, EFFICACY, ANDPHARMACOKINETICS OF MOSUNETUZUMAB INCOMBINATION WITH TIRAGOLUMAB WITH ORWITHOUT ATEZOLIZUMAB IN PATIENTS WITHRELAPSED OR REFRACTORY B-CELLNON-HODGKIN LYMPHOMA
F. Hoffman-La Roche Ltd0 个研究点目标入组 118 人开始时间: 2021年11月3日最近更新:
适应症
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 发起方
- 入组人数
- 118
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
- 性别
- All
入选标准
- •- Age >= 18 years
- •- Participants who have an Eastern Cooperative Oncology Group (ECOG) Performance Status of 0, 1, or 2
- •- Participants who have a life expectancy of at least 12 weeks that has relapsed or failed to respond to at least two prior systemic treatment regimens and for which no suitable therapy of curative intent or higher priority exists (e.g., standard chemotherapy, ASCT, CAR T cells).
- •- Participants who have histologically documented FL or DLBCL that expresses CD20 as determined by the local laboratory.
- •- Participants who have at least one bi-dimensionally measurable (>1.5 cm) nodal lesion, or at least one bi-dimensionally measurable (>1.0 cm) extranodal lesion
- •- Participants who have confirmed availability of a tumor tissue
- •- Participants with FL for whom a bone marrow biopsy and aspirate can be collected
- •- Participants with adequate hematologic and organ function
- •Are the trial subjects under 18? no
- •Number of subjects for this age range:
- •F.1.2 Adults (18-64 years) yes
- •F.1.2.1 Number of subjects for this age range 118
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range 118
排除标准
- •Participants who have received any of the following treatments prior to study entry:
- •o Treatment with mosunetuzumab or other CD20/CD3-directed bispecific antibodies
- •o Treatment with tiragolumab or other anti- T-cell immunoreceptor with immunoglobulin and immunoreceptor tyrosine-based inhibition motif (ITIM) domains agent
- •o Allogeneic stem Cell Transplant (SCT)
- •o Solid organ transplantation
- •- Participants who received any of the following treatments, whether investigational or approved, within the respective time periods prior to initiation of study treatment:
- •o Radiotherapy within 2 weeks prior to the first dose of study treatment If participants have received radiotherapy within 4 weeks prior to the first study treatment administration, participants must have at least one measurable lesion outside of the radiation field.
- •o Autologous SCT within 100 days prior to first study treatment
- •o Chimeric antigen receptor T-cell therapy within 30 days before first study treatment
- •o Use of monoclonal antibodies or antibody-drug conjugates for the treatment of lymphoma, within 4 weeks prior to first study treatment
- •o Use of radioimmunoconjugates within 12 weeks prior to first study treatment
- •o Systemic immunosuppressive medications within 2 weeks prior to first dose of study treatment
- •o Any other anti-cancer therapy, whether investigational or approved
- •o The Medical Monitor should be informed of any prior cancer immunotherapy not explicitly described in this protocol
- •- Participants who received a live, attenuated vaccine within 4 weeks before first dose of study treatment, or in whom it is anticipated that such a live attenuated vaccine will be required during the study period or within 5 months after the final dose of study treatment
- •- Participants with aggressive NHL who are currently eligible for autologous SCT
- •- Participants with current or past history of CNS lymphoma or leptomeningeal infiltration
- •- Participants with a history of severe allergic or anaphylactic reactions to humanized or murine monoclonal antibody therapy
- •- Participants with a contraindication to atezolizumab (specific to Arm 2 of the study ) or tocilizumab
- •- Participants in whom clinically significant toxicities from prior treatment have not resolved to Grade <= 1 (per National Cancer Institute Common Terminology Criteria for Adverse Events [NCI CTCAE] v5.0) prior to the first study drug administration
- •- Participants with treatment-emergent immune-mediated adverse events associated with prior immunotherapeutic agents
- •- Participants with evidence of any significant, concomitant disease that could affect compliance with the protocol or interpretation of results
- •- Participants who underwent recent major surgery within 4 weeks prior to first study treatment administration
研究者
相似试验
招募中
不适用
A PHASE Ib/II, OPEN-LABEL, MULTICENTER STUDY EVALUATING THE SAFETY, ACTIVITY, AND PHARMACOKINETICS OF GDC-6036 IN COMBINATION WITH OTHER ANTI-CANCER THERAPIES IN PATIENTS WITH PREVIOUSLY UNTREATED ADVANCED OR METASTATIC NON-SMALL CELL LUNG CANCER WITH A KRAS G12C MUTATIONL-OMON53747Roche Nederland B.V.5
进行中（未招募）
1 期
A Study Evaluating the Safety, Activity, and Pharmacokinetics of Divarasib in Combination with Other Anti-Cancer Therapies in Patients with Previously Untreated Advanced or Metastatic Non-Small Cell Lung Cancer with a KRAS G12C Mutationtreated Advanced or Metastatic Non-Small Cell Lung CancerMedDRA version: 21.1Level: PTClassification code 10061873Term: Non-small cell lung cancerSystem Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps)MedDRA version: 21.1Level: PTClassification code 10059515Term: Non-small cell lung cancer metastaticSystem Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps)EUCTR2022-003048-28-PLF. Hoffmann-La Roche Ltd60
进行中（未招募）
不适用
OPEN-LABEL, MULTICENTER, PHASE II STUDY OF FIRST- LINE BI-WEEKLY IRINOTECAN, OXALIPLATIN AND INFUSIONAL 5FU/LV (FOLFOXIRI) IN COMBINATION WITH BEVACIZUMAB IN PATIENTS WITH METASTATIC COLORECTAL CANCER. - FOIBEUCTR2006-001007-11-ITG.O.N.O. - GRUPPO ONCOLOGICO NORD OVEST
进行中（未招募）
不适用
MULTICENTER, OPEN-LABEL PHASE II STUDY TO EVALUATE THE EFFICACY OF A 2-CYCLE IMMUNOTHERAPY WITH THE TRI FUNCTIONAL BISPECIFIC ANTIBODY CATUMAXOMAB (ANTI EPCAM X ANTI-CD3) IN ADDITION TO SYSTEMIC CHEMOTHERAPY IN PATIENTS WITH PERITONEAL CARCINOMATOSIS FROM GASTRIC OR COLORECTAL ADENOCARCINOMA - PERCATPERITONEAL CARCINOMATOSIS FROM GASTRIC OR COLORECTAL ADENOCARCINOMAMedDRA version: 12.1Level: LLTClassification code 10068069Term: Peritoneal carcinomatosisMedDRA version: 12.1Level: LLTClassification code 10052360Term: Colorectal adenocarcinomaMedDRA version: 12.1Level: LLTClassification code 10017758Term: Gastric cancerEUCTR2010-022810-26-DEniversity Witten/Herdecke40
进行中（未招募）
1 期
Study to investigate the combination of Lanreotide Autogel 120mg and Temozolomid in patients with WITH PROGRESSIVE GASTRO-ENTERO-PANCREATIC NEUROENDOCRINE TUMOURSmetastatic functioning and non-functioning entero-pancreatic tumoursEUCTR2013-001697-17-ATIpsen Pharma GmbH65