EUCTR2021-000615-23-FR进行中（未招募）1 期
Randomized phase III trial of standard immunotherapy (IO) by checkpoint inhibitors, versus reduced dose intensity of IO in patients with metastatic cancer in response after 6 months of standard IO - MOIO
ICANCER0 个研究点目标入组 646 人开始时间: 2021年6月14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
- 646
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
- •1.Patients must have signed a written informed consent form prior to any trial specific procedures.
- •2.Patient aged =18 years old.
- •3.Initial metastatic disease histologically confirmed including : lung cancer, renal cell cancer, head and neck cancer, bladder cancer, triple negative breast cancer, Merkel cancer, hepatocellular carcinoma and melanoma.
- •4.Patients in partial or complete response after 6 months of standard immunotherapy (whatever the line of therapy) according to the RECIST (confirmed by local radiological assessment). For metastatic melanoma only patients in partial response.
- •5.Eligible to maintain the same standard IO treatment.
- •6.Patient with ECOG performance status =1.
- •7.Patients with brain metastases are allowed, provided they are stable according to the following definitions: treated with surgery or stereotactic radiosurgery and without evidence of progression prior to randomization and have no evidence of new or enlarging brain metastases.
- •8.Patients treated by IO previously combined with chemotherapy are allowed.
- •9.Patients with TKI-IO or pemetrexed-IO or bevacizumab-IO are allowed.
- •10.Evidence of post-menopausal status, or negative urinary or serum pregnancy test for pre-menopausal patients.
- •11.Both sexually active women of childbearing potential and males (and their female partners) patients must agree to use adequate contraception method for the duration of the study treatment and after completing treatment according to the most recent version of the IO SmPC.
- •12.Patient is willing and able to comply with the protocol for the duration of the trial including undergoing treatment and scheduled visits, and examinations including follow-up.
- •13.Patient must be affiliated to a Social Security System.
- •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 250
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range 396
排除标准
- •1.Metastatic melanoma in complete response.
- •2.Metastatic renal cell carcinoma with IMDC favourable-risk treated TKI/IO combination.
- •3.Hematologic malignancies (leukaemia, myeloma, lymphoma…)
- •4.Active infection requiring systemic therapy.
- •5.Patients enrolled in another therapeutic study within 30 days before the inclusion in and during MOIO study.
- •6.Patient unable to comply with study obligations for geographic, social, or physical reasons, or who is unable to understand the purpose and procedures of the study.
- •7.Person deprived of their liberty or under protective custody or guardianship.
研究者
相似试验
进行中（未招募）
1 期
Study comparing the standard administration of immunotherapy (IO) versus the same agent administered each three months in patients with locally advanced or metastatic cancer in response after 6 months of standard IOCTIS2024-513707-14-00nicancer646
进行中（未招募）
1 期
A trial testing lenalidomide and dexamethasone after standard radiotherapy in patients with solitary bone plasmacytoma who are at a high risk of relapseEUCTR2015-001355-76-GBniversity College London140
招募中
3 期
Phase 3 Clinical Trial to evaluate the Immunogenicity and Safety of Covid19 Recombinant RBD Protein Vaccine (Noora Vaccine) as a Booster Vaccine after injection of existing Vaccines in IRAIRCT20210620051639N3Bagheiat-allah University of Medical Sciences10,300
终止
3 期
Phase III trial of an immunotherapy for Stage III (AJCC) melanoma based on cultured autologous dendritic cells presenting autologous tumour cell antigensStage III B/C (AJCC) MelanomaCancer - Malignant melanomaACTRN12605000590662Queensland Institute of Medical Research (QIMR)200
已完成
3 期
A phase III randomised, double-blind trial of immunotherapy with a polyvalent melanoma vaccine (C-VAX) plus bacille Calmette-Guerin (BCG) versus placebo plus BCG as a post surgical treatment for stage IV melanomaStage IV melanomaMalignant neoplasm of skinCancerISRCTN72807124Department of Health (UK)