2023-503519-13-00招募中2 期
A Phase 2, Randomized, Open-label Study of Relatlimab in Combination with Nivolumab in Participants with Advanced Hepatocellular Carcinoma who are Naive to IO Therapy but Progressed on Tyrosine Kinase Inhibitors (RELATIVITY-073)
试验速览
- 阶段
- 2 期
- 状态
- 招募中
- 入组人数
- 109
- 试验地点
- 18
- 主要终点
- Overall response rate (ORR) assessed by blinded independent central review (BICR) using Response Evaluation Criteria in Solid Tumors (RECIST) v1.1
研究概览
简要总结
To evaluate the efficacy of relatlimab in combination with nivolumab relative to nivolumab monotherapy in IO therapy-naive participants after prior treatment with TKI therapy
入排标准
- 年龄范围
- 18 years 至 65+ years（18-64 Years, 65+ Years）
- 接受健康志愿者
- 是
入选标准
- •Male and female participants must be ≥ 18 years at the time of informed consent.
- •Participants with histologic confirmed advanced/metastatic 2L or 3L HCC.
- •Participants with pre-treatment tumor tissue sample with evaluable LAG-3 expression level by IHC. Participants with indeterminate or unevaluable LAG-3 status results will not be permitted to receive study treatment or randomize to a treatment arm.
- •Participants who have experienced progression that was demonstrated radiographically on or after one or two prior TKI therapies without prior exposure to IO agents.
- •Child-Pugh score of 5 or 6 points (ie, Child-Pugh A).
- •Eastern Cooperative Oncology Group (ECOG) performance status 0 or 1
排除标准
- •Women who are pregnant or breastfeeding
- •Untreated symptomatic central nervous system metastases or leptomeningeal metastases.
- •Participants with uncontrolled or significant cardiovascular disease.
- •Prior organ allograft or allogeneic bone marrow transplantation.
- •Participants with an active, known or suspected autoimmune disease. Participants with type I diabetes mellitus, hypothyroidism only requiring hormone replacement, skin disorders (such as vitiligo, psoriasis, or alopecia) not requiring systemic treatment, or conditions not expected to recur in the absence of an external trigger are permitted to enroll.
- •Participants with symptomatic severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) infection.
结局指标
主要结局
Overall response rate (ORR) assessed by blinded independent central review (BICR) using Response Evaluation Criteria in Solid Tumors (RECIST) v1.1
Overall response rate (ORR) assessed by blinded independent central review (BICR) using Response Evaluation Criteria in Solid Tumors (RECIST) v1.1
次要结局
- Incidence of Adverse Events (AEs), Serious Adverse Events (SAEs), death and AEs leading to discontinuation
- Incidence of clinically significant changes in clinical laboratory results: Hematology, Clinical Chemistry and Urinalysis tests
- Disease control rate (DCR), Duration of response (DOR) and Progression-free survival assessed by BICR per RECIST v1.1
- ORR, DCR, DOR and PFS assessed by investigator per RECIST v1.1
- Overall survival (OS)
研究者
GSM-CT
Scientific
Bristol Myers Squibb International Corporation
研究点 (18)
Loading locations...
相似试验
进行中（未招募）
2 期
A Study of Relatlimab Plus Nivolumab Versus Nivolumab Alone in Participants With Advanced MelanomaMelanomaNCT03470922Bristol-Myers Squibb714
已完成
2 期
A Study of Relatlimab Plus Nivolumab in Combination With Chemotherapy vs. Nivolumab in Combination With Chemotherapy as First Line Treatment for Participants With Stage IV or Recurrent Non-small Cell Lung Cancer (NSCLC)Recurrent Non-small Cell Lung CancerMetastatic Non-small Cell Lung CancerNon-small Cell Lung CancerNCT04623775Bristol-Myers Squibb468
终止
3 期
A Study of Nivolumab-relatlimab Fixed-dose Combination Versus Regorafenib or TAS-102 in Participants With Later-lines of Metastatic Colorectal CancerColorectal NeoplasmsNCT05328908Bristol-Myers Squibb769
撤回
2 期
An Investigational Immuno-therapy Study of Relatlimab Plus Nivolumab Compared to Various Standard-of-Care Therapies in Previously Treated Participants With Recurrent, Advanced or Metastatic Gastric Cancer or Gastroesophageal Junction AdenocarcinomaCancer of the StomachGastroesophageal JunctionGastric CancerStomach CancerNCT03704077Bristol-Myers Squibb
招募中
2 期
Nivolumab Alone or Plus Relatlimab or Ipilimumab for Patients With Locally-Advanced Unresectable or Metastatic Basal Cell CarcinomaBasal Cell CarcinomaNCT03521830Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins57