EUCTR2018-002108-15-IT进行中（未招募）1 期
Phase 1/2 Study of BMS-986310 Administered Alone and in Combination with Nivolumab in Participants with Advanced Solid Tumors - NA
适应症
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 入组人数
- 280
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
- •Patients with measurable disease per RECIST v1.1 and have at least
- •one lesion accessible for biopsy.
- •ECOG performance status less than or equal to 1
- •Part 1 and Sub-study B:
- •i) Part 1 participants must have advanced or metastatic disease where
- •no other standard of care treatment option is possible.
- •ii) Sub-study B participants must have advanced or metastatic disease
- •where no other standard of care treatment is possible, in one of the
- •following tumor types: Renal cell carcinoma, Melanoma, colorectal
- •cancer (CRC) microsatellite instability (MSI)-High (determined by
- •Clinical Laboratory Improvement Amendments (CLIA) validated assay,
- •testing methodology must be provided), Bladder cancer, Squamous Cell
- •Carcinoma of the Head and Neck (SCCHN), and they must have had
- •disease progression on an anti-PD-(L)1 based regimen as their most
- •recent prior therapy
- •Sub-study A:
- •i) Participants must be newly diagnosed, no prior history of treatment
- •for bladder cancer
- •ii) Participants must not meet criteria for standard of care neoadjuvant
- •therapy and must be candidates for SOC surgical resection of primary
- •iii) Histologically confirmed muscle-Invasive bladder cancer (MIBC) pure
- •or mixed histology urothelial carcinoma
- •Part 2 - Patients with relapsed / refractory solid tumors where no other
- •standard of care treatment option is available
- •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 168
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range 112
排除标准
- •- History of severe adverse drug reactions to nonsteroidal anti-inflammatory drugs (NSAIDs), or those with adverse reactions to an NSAID that is currently prescribed
- •- Participants with an active, known or suspected autoimmune disease.
研究者
相似试验
进行中（未招募）
1 期
An investigational immunotherapy study of BMS-986310 administered alone and in combination with Nivolumab inpatients with advanced solid tumorsAdvanced Solid TumorsMedDRA version: 20.0Level: LLTClassification code 10065252Term: Solid tumorSystem Organ Class: 100000004864EUCTR2018-002108-15-BEBristol-Myers Squibb International Corporation280
进行中（未招募）
1 期
Study of BMS-986179 Administered alone and in Combination with Nivolumab (BMS- 936558) in Subjects with Advanced Solid TumorsSolid tumorsMedDRA version: 20.0 Level: LLT Classification code 10065252 Term: Solid tumor System Organ Class: 100000004864EUCTR2016-000603-91-DEBristol-Myers Squibb International Corporation246
进行中（未招募）
1 期
A Phase 1/2 Study of BMS-986408 with and without Nivolumab or Nivolumab and Ipilimumab in Participants with Solid TumorsAdvanced Solid TumoursMedDRA version: 21.0Level: LLTClassification code: 10049280Term: Solid tumour Class: 10029104CTIS2022-500823-61-00Bristol-Myers Squibb International Corporation136
招募中
1 期
A Phase 1/2 Study of BMS-986449 with and without Nivolumab in Participants with Solid TumorsAdvanced, metastatic, solid malignancyMedDRA version: 20.0Level: LLTClassification code: 10025648Term: Malignant mast cell tumors unspecified site extranodal and solid organ sites Class: 10029104CTIS2023-503484-42-00Bristol-Myers Squibb Services Unlimited Company98
进行中（未招募）
1 期
A Phase 1/2a Study of BMS-986205 Administered in Combination with Nivolumab (anti-PD-1 Monoclonal Antibody) and in Combination with Both Nivolumab and Ipilimumab (anti-CTLA-4 Monoclonal Antibody) in Advanced CancersAdvanced Malignant TumorsMedDRA version: 20.0Level: LLTClassification code 10048683Term: Advanced cancerSystem Organ Class: 100000004864EUCTR2015-004914-79-PLBristol-Myers Squibb International Corporation907