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临床试验/NL-OMON54526
NL-OMON54526招募中2 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 phase 1/2a of BMS-986016 alone or in combination with nivolumab

Bristol-Myers Squibb0 个研究点目标入组 26 人开始时间: 待定最近更新:
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适应症

试验速览

阶段
2 期
状态
招募中
发起方
入组人数
26
研究概览入排标准研究者记录与标识符相似试验

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

年龄范围
12 至 99（—）

入选标准

  • •-For Dose escalation: subjects with cervical, ovarian, bladder and CRC, head
  • •and neck, gastric and hepatocellular cancer naive to immuno-oncology agents;
  • •1st line melanoma and NSCLC; 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/out anti-CTLA-4.
  • •-For Dose Expansion: all of the above in escalation except for cervical,
  • •ovarian bladder and CRC
  • •-Progressed, or been intolerant to, at least one standard treatment regimen
  • •-Received any number of prior treatment regimens
  • •-ECOG performance status of 0 or 1
  • •-At least 1 lesion with measurable disease at baseline
  • •-Availability of an existing tumor biopsy sample (or consent to allow
  • •pre-treatment tumor biopsy if sample not available

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

研究者

发起方
Bristol-Myers Squibb

相似试验

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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)
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Safety Study of Anti-LAG-3 With and Without Anti-PD-1 in the Treatment of Solid Tumorseoplasms by siteMedDRA version: 21.1Level: PTClassification code: 10061873Term: Non-small cell lung cancer Class: 100000004864MedDRA version: 21.1Level: PTClassification code: 10067821Term: Head and neck cancer Class: 100000004864MedDRA version: 21.1Level: PTClassification code: 10067946Term: Renal cell carcinoma Class: 100000004864MedDRA version: 21.1Level: PTClassification code: 10017758Term: Gastric cancer Class: 100000004864MedDRA version: 21.1Level: LLTClassification code: 10053571Term: Melanoma Class: 10029104MedDRA version: 21.1Level: LLTClassification code: 10065147Term: Malignant solid tumor Class: 10029104MedDRA version: 20.0Level: PTClassification code: 10005003Term: Bladder cancer Class: 100000004864MedDRA version: 20.0Level: PTClassification code: 10073071Term: Hepatocellular carcinoma Class: 100000004864
CTIS2023-508067-70-00Bristol Myers Squibb International Corporation2,000
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