计划状态
活跃，非招募阶段
第 1 阶段允许先接受免疫治疗
是CRC 指导的试验
是药物
LGK974, PDR001标签
MSS/ MMRp评论
Porcupine (Wnt) inhibitor (LGK974) + PD1 (PDR001). BRAF mutant colorectal cancer specifically being recruited.
Phase I is expected to be Jan. 2019
| 地点 | 位置状态 |
|---|---|
| 美国 | |
|
UCLA School of Medicine 加利福尼亚州洛杉矶 90024 |
活跃，非招募 |
|
Sidney Kimmel Comprehensive Cancer Center Johns Hopkins Baltimore, Maryland 21287-0013 |
活跃，非招募 |
|
Dana Farber Cancer Institute SC-7 马萨诸塞州波士顿 02215 |
活跃，非招募 |
|
University of Michigan Comprehensive Cancer Center Onc Dept. Ann Arbor, Michigan 48109-0944 |
活跃，非招募 |
|
Karmanos Cancer Institute Wayne St 密歇根州底特律 48201 |
活跃，非招募 |
|
University of Texas/MD Anderson Cancer Center MD Anderson 2 德克萨斯州休斯顿 77030-4009 |
活跃，非招募 |
| 加拿大 | |
|
Novartis Investigative Site Montreal, Quebec H2W 1T8 |
活跃，非招募 |
| 法国 | |
|
Novartis Investigative Site Villejuif 94800 |
活跃，非招募 |
| 德国 | |
|
Novartis Investigative Site Essen 45147 |
活跃，非招募 |
| 意大利 | |
|
Novartis Investigative Site Milano, MI 20133 |
活跃，非招募 |
|
Novartis Investigative Site 那不勒斯 80131 |
活跃，非招募 |
| 荷兰 | |
|
Novartis Investigative Site Rotterdam 3075 EA |
活跃，非招募 |
|
Novartis Investigative Site 乌特勒支 3584CX |
活跃，非招募 |
| 西班牙 | |
|
Novartis Investigative Site 巴塞罗那，加泰罗尼亚 08035 |
活跃，非招募 |
|
Novartis Investigative Site 巴塞罗那，加泰罗尼亚 08036 |
活跃，非招募 |
|
Novartis Investigative Site Hospitalet de LLobregat, Catalunya 08907 |
活跃，非招募 |
|
Novartis Investigative Site Valencia, Comunidad Valenciana 46010 |
活跃，非招募 |
|
Novartis Investigative Site 马德里 28009 |
活跃，非招募 |
|
Novartis Investigative Site 马德里 28040 |
活跃，非招募 |
|
Novartis Investigative Site 马德里 28050 |
活跃，非招募 |
纳入标准
纳入标准
Diagnosis of locally advanced or metastatic cancer that has progressed despite standard therapy or for which no effective standard therapy exists and histological confirmation of one of the following diseases indicated below:
Single Agent Dose escalation part:documented B-RAF mutant colorectal cancer or pancreatic adenocarcinoma. In addition, tumors of any histological origin with documented genetic alterations upstream in the Wnt signaling pathway are eligible with prior agreement with Novartis.
Single Agent Dose expansion part: documented B-RAF mutant colorectal cancer with documented RNF43 mutation and/or RSPO fusion or pancreatic adenocarcinoma with documented RNF43 mutation. In addition, patients with tumors of any histological origin with documented genetic alterations upstream in the Wnt signaling pathway (e.g. RNF43 or RSPO fusion) are eligible with prior agreement with Novartis
LGK974 with PDR001: Dose escalation: patients with the following cancers that were previously treated with anti-PD-1 therapy and whose best response on that therapy was progressive disease (i.e. primary refractory): melanoma, lung SCC, HNSCC. Patients with esophageal SCC, cervical SCC or TNBC who are either naïve or primary refractory to prior anti-PD-1 therapy.
LGK974 with PDR001: Dose expansion: patients with:
cutaneous melanoma that was primary refractory to prior anti-PD-1 therapy, defined as a best response of progressive disease or stable disease for 4 months. Patients with BRAF V600-mutant melanoma must have also received and been failed by prior systemic therapy with a BRAF V600 inhibitor, with or without a MEK inhibitor.
排除标准
排除标准：
Impaired cardiac function
Impairment of gastrointestinal function or gastrointestinal disease that may significantly alter the absorption of LGK974 (e.g., ulcerative diseases, uncontrolled nausea, vomiting, diarrhea, malabsorption syndrome, small bowel resection)
Brain metastases that have not been adequately treated
Malignant disease other than that being treated in this study
Laboratory abnormalities as specified in the protocol
Osteoporosis, osteopenia
Bone fractures within the past year
Pathologic bone fracture
Active, known or suspected autoimmune disease or severe hypersensitivity reactions to other monoclonal antibodies
Other protocol-defined inclusion/exclusion criteria may apply
