CTIS2023-508067-70-00进行中（未招募）1 期
A Phase 1/2a Dose Escalation and Cohort Expansion Study of the Safety, Tolerability, and Efficacy of Anti-LAG-3 Monoclonal Antibody (BMS-986016) Administered Alone and in Combination with Anti-PD-1 Monoclonal Antibody (Nivolumab, BMS-936558) in Advanced Solid Tumors - CA224-020
适应症
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 入组人数
- 2,000
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
- 年龄范围
- 0 至 65+（—）
- 性别
- All
入选标准
- •For Dose escalation: subjects with cervical, ovarian, bladder and CRC, head and neck, gastric and hepatocellular cancer naive to immunooncology agents; 1st line melanoma and 1st line/2nd line NSCLC; Renal Cell Carcinoma naive to IO; NSCLC progressing while on or after therapy with anti-PD1/anti-PDL-1 and melanoma subjects progressed while-on or after treatment with anti-PD1 or anti-PDL1 with or without anti-CTLA-4., For Dose Expansion: all of the above in escalation except for cervical, ovarian and CRC, Progressed, or been intolerant to, at least one standard treatment regimen, except for subjects in 1st line cohorts., ECOG performance status of 0 to 2, At least 1 lesion with measurable disease at baseline, Availability of an existing tumor biopsy sample (and consent to allow pre-treatment tumor biopsy)
排除标准
- •Primary CNS tumors or solid tumors with CNS metastases as the only site of active disease, Autoimmune disease, Encephalitis, meningitis, or uncontrolled seizures in the year prior to informed consent, Uncontrolled CNS metastases
研究者
相似试验
进行中（未招募）
1 期
A Phase I/2a study of BMS-986156 given alone and in combination with nivolumab in subjects with advanced solid tumors.Advanced Solid TumorsMedDRA version: 19.0Level: LLTClassification code 10065252Term: Solid tumorSystem Organ Class: 100000004864EUCTR2015-002505-11-ESBristol-Myers Squibb International Corporation300
进行中（未招募）
1 期
Safety Study of Anti-LAG-3 With and Without Anti-PD-1 in the Treatment of Solid TumorsEUCTR2014-002605-38-ATBristol-Myers Squibb International Corporation2,000
进行中（未招募）
1 期
Safety Study of Anti-LAG-3 With and Without Anti-PD-1 in the Treatment of Solid Tumorseoplasms by siteMedDRA version: 21.1Level: LLTClassification code 10065147Term: Malignant solid tumorSystem Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps)MedDRA version: 21.1Level: PTClassification code 10017758Term: Gastric cancerSystem Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps)MedDRA version: 20.0Level: PTClassification code 10073071Term: Hepatocellular carcinomaSystem Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps)MedDRA version: 21.1Level: LLTClassification code 10053571Term: MelanomaSystem Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps)MedDRA 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 10067821Term: Head and neck cancerSystem Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps)MedDRA version: 21.1Level: PTClassification code 10067946Term: Renal cell carcinomaSystem Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps)MedDRA version: 20.0Level: PTClassification code 10005003Term: Bladder cancerSystem Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps)EUCTR2014-002605-38-DEBristol-Myers Squibb International Corporation2,000
进行中（未招募）
1 期
Safety Study of Anti-LAG-3 With and Without Anti-PD-1 in the Treatment of Solid Tumorseoplasms by siteMedDRA version: 21.1Level: LLTClassification code 10065147Term: Malignant solid tumorSystem Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps)MedDRA version: 21.1Level: PTClassification code 10017758Term: Gastric cancerSystem Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps)MedDRA version: 20.0Level: PTClassification code 10073071Term: Hepatocellular carcinomaSystem Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps)MedDRA version: 21.1Level: LLTClassification code 10053571Term: MelanomaSystem Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps)MedDRA 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 10067821Term: Head and neck cancerSystem Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps)MedDRA version: 21.1Level: PTClassification code 10067946Term: Renal cell carcinomaSystem Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps)MedDRA version: 20.0Level: PTClassification code 10005003Term: Bladder cancerSystem Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps)EUCTR2014-002605-38-GBBristol-Myers Squibb International Corporation2,000
进行中（未招募）
1 期
A Phase I/2a study of BMS-986156 given alone and in combination with nivolumab in subjects with advanced solid tumors.EUCTR2015-002505-11-NLBristol-Myers Squibb International Corporation380