EUCTR2018-003719-23-GB进行中（未招募）1 期
A Phase 2 Multi-Center Randomized Trial to Assess Early Intervention with Adjuvant Nivolumab in Non- Small Cell Lung Cancer Participants with ctDNA detected Minimal Residual Disease after Surgical Resection - CheckMate 9T
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 入组人数
- 340
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
- •Inclusion Criteria prior to Surgery:
- •- Suspected or histologically confirmed Stage IIA to IIIB NSCLC with disease that is considered resectable
- •- Must be deemed eligible for complete resection and must agree to undergo standard of care surgery for complete resection of NSCLC
- •- Treatment naive (no previous systemic treatment)
- •Inclusion Criteria prior to Treatment Randomization:
- •- Must have undergone complete surgical resection of their Stage IIA to IIIB NSCLC
- •- Must have adequately recovered from surgery at the time of randomization
- •- Minimal residual disease (MRD) positive results as detected by ctDNA
- •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 160
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range 180
排除标准
- •Exclusion Criteria prior to Surgery:
- •- Participants with known EGFR mutations which are sensitive to available targeted inhibitor therapy
- •- Active, known or suspected autoimmune disease
- •- Participants with a condition requiring systemic treatment with either corticosteroids (> 10 mg daily prednisone equivalent) or other immunosuppressive medications within 14 days of randomization
- •Exclusion Criteria prior to Treatment Randomization:
- •- Must continue to meet Exclusion Criteria prior to Surgery
- •- Must have no evidence of metastatic disease after surgery
- •- Received a live/attenuated vaccine within 30 days of first treatment
研究者
相似试验
进行中（未招募）
1 期
An Investigational Immuno-therapy Study of Nivolumab Given After Surgery in Non-Small Cell Lung Cancer (NSCLC) Participants with Minimal Residual Disease After Surgical RemovalEUCTR2018-003719-23-FRBristol-Myers Squibb International Corporation340
进行中（未招募）
不适用
A multicenter randomized phase II Trial assessing the activity of Gemcitabine - Oxaliplatin chemotherapy alone or in combination with Cetuximab in patients with advanced biliary cancer - BINGOadenocarcinoma of the biliary tract ( gallbladder, intra and/ or extrahepatic bile ducts, ampulla of Vater)EUCTR2007-001200-20-DEMedizinische Hochschule Hannover100
进行中（未招募）
不适用
A Multicenter, Randomized Phase II Trial Assessing the Activity of Gemcitabine – Oxaliplatin Chemotherapy Alone or in Combination with Cetuximab in Patients with Advanced Biliary Cancer - BINGOadenocarcinoma of the biliary tract ( gallbladder, intra and/ or extrahepatic bile ducts, ampulla of Vater)EUCTR2007-001200-20-FRInstitut Gustave Roussy100
进行中（未招募）
1 期
A randomized, multi-center phase II trial to assess the efficay of 5-azacytidine added to standard primery therapy in elderly patients with newly diagnosed AML. - AML-AZAThe disease under investigation is newly diagnosed Acute Myeloid Leucemia (AML) in elderly patients.MedDRA version: 13.1Level: PTClassification code 10000880Term: Acute myeloid leukaemiaSystem Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps)EUCTR2008-004583-40-DEniversitaetsklinikum Muenster234
招募中
2 期
A multicenter phase II randomized trial to evaluate systemic therapy versus systemic therapy in combination with stereotactic radiotherapy in patients with metastatic colorectal cancerBowel cancerrectum cancer1001799010017991colon cancerNL-OMON52282niversitair Medisch Centrum Utrecht105