计划状态
活跃,非招募阶段
第 1 阶段 第二阶段允许先接受免疫治疗
没有CRC 指导的试验
没有药物
AZD5069, AZD9150, MEDI4736, tremelimumab (treme)标签
MSS/ MMRp评论
PDL1 + Either a STAT3 inhibitor or a CXCR2 antagonist. MSS-CRC elegible during the initial phases of the trial. Side note: inclusion criteria includes higher than often allowed levels of bilirubin, ALT, and AST for those with liver mets
地点 | 位置状态 |
---|---|
美国 | |
研究网站 阿拉巴马州伯明翰 35294 |
活跃,非招募 |
研究网站 加利福尼亚州杜阿尔特 91010 |
活跃,非招募 |
研究网站 加利福尼亚州拉霍亚 92093 |
活跃,非招募 |
研究网站 加利福尼亚州洛杉矶 90024 |
活跃,非招募 |
研究网站 Los Angeles, California 90089 |
活跃,非招募 |
研究网站 Orange, California 92868-3298 |
活跃,非招募 |
研究网站 加利福尼亚州旧金山 94158 |
活跃,非招募 |
研究网站 科罗拉多州丹佛 80218 |
活跃,非招募 |
研究网站 Plantation, Florida 33324 |
活跃,非招募 |
研究网站 佛罗里达州萨拉索塔 34232 |
活跃,非招募 |
研究网站 印第安纳州拉斐特 47905 |
活跃,非招募 |
研究网站 Boston, Massachusetts 02111 |
活跃,非招募 |
研究网站 密歇根州底特律 48201 |
活跃,非招募 |
研究网站 蒙大拿州比林斯 59101 |
活跃,非招募 |
研究网站 Morristown, New Jersey 07960 |
活跃,非招募 |
研究网站 Cincinnati, Ohio 45267-2827 |
活跃,非招募 |
研究网站 德克萨斯州休斯顿 77030 |
活跃,非招募 |
研究网站 弗吉尼亚州费尔法克斯 22031 |
活跃,非招募 |
研究网站 华盛顿州西雅图 98109 |
活跃,非招募 |
比利时 | |
研究网站 Antwerpen 2020 |
活跃,非招募 |
研究网站 布鲁塞尔 1000 |
活跃,非招募 |
研究网站 布鲁塞尔 1200 |
活跃,非招募 |
研究网站 Edegem 2650 |
活跃,非招募 |
研究网站 Namur 5000 |
活跃,非招募 |
德国 | |
研究网站 柏林 12200 |
活跃,非招募 |
研究网站 Dresden 1307 |
活跃,非招募 |
研究网站 Frankfurt 60488 |
活跃,非招募 |
研究网站 汉堡 20246 |
活跃,非招募 |
研究网站 汉诺威 30625 |
活跃,非招募 |
研究网站 Jena 07743 |
活跃,非招募 |
研究网站 Köln 50670 |
活跃,非招募 |
研究网站 München 81675 |
活跃,非招募 |
意大利 | |
研究网站 米兰 20133 |
活跃,非招募 |
西班牙 | |
研究网站 巴塞罗那 08035 |
活跃,非招募 |
研究网站 Hospitalet deLlobregat 08907 |
活跃,非招募 |
研究网站 马德里 28040 |
活跃,非招募 |
研究网站 马德里 28041 |
活跃,非招募 |
研究网站 Toledo 45004 |
活跃,非招募 |
英国 | |
研究网站 Birmingham B15 2TH |
活跃,非招募 |
研究网站 伦敦 SE1 9RT |
活跃,非招募 |
研究网站 London SW3 6JB |
活跃,非招募 |
研究网站 曼彻斯特 M20 4BX |
活跃,非招募 |
研究网站 Surrey SM2 5PT |
活跃,非招募 |
研究网站 Taunton TA1 5DA |
活跃,非招募 |
纳入标准
主要纳入标准:
* Male and female patients must be at least 18 years of age.
* Has an Eastern Cooperative Oncology Group (ECOG) PS score of 0 or 1.
* Has measurable disease, defined as at least 1 lesion that can be accurately measured in at least 1 dimension (longest diameter to be recorded) with a minimum size of 10 mm by computerised tomography (CT) scan, except lymph nodes which must have minimum short axis size of 15 mm (CT scan slice thickness no greater than 5 mm in both cases). Indicator lesions must not have been previously treated with surgery, radiation therapy, or radiofrequency ablation unless there is documented progression after therapy.
* Has undergone ≤3 previous regimens (depending on treatment arm) of cytoreductive therapies including, but not limited to, platinum-based compounds, taxanes, or 5-fluorouracil. for B7 & B8, no prior systemic treatments should have been received for RM SCCHN
* Adequate organ and marrow function
* Female subjects of childbearing potential and male subjects with partners of childbearing potential should ensure use of a highly effective method of birth control as defined in study protocol
* Additional inclusion for part A: Has a histological confirmation of a solid malignancy (other than HCC) that is refractory to standard therapy or for which no standard of care regimen currently exists.
* Addition inclusion for Part A (A6) Has a histological confirmation of castrate-resistant prostate cancer
* Additional inclusion for Part B:Has histologically and/or cytologically confirmed SCCHN that is RM and not amendable to curative therapy by surgery or radiation. Squamous cell carcinoma of the head and neck originating from the following sites is eligible: oral cavity, oropharynx, larynx, or hypopharynx. Has at least 1 SCCHN tumour lesion (TL) amenable to biopsy and must have failed, refused, or has been found to be ineligible for least 1 prior platinum-based chemotherapy for RM-SCCHN Additional inclusion criteria for Arms B1 & B2: must have had prior exposure to anti PDL-1 antibody
* Arms B1-B6: Has undergone 1-3 previous regimens of cytoreductive chemo-therapies Arm B7 & B8: with no prior exposure to anti-PD-(L)1 therapies and have received no prior systemic treatment for RM SCCHN
钥匙
排除标准
排除标准:
- Spinal cord compression unless asymptomatic and not requiring steroids for at least 4 weeks before the start of study treatment. - Presently has a second malignancy other than SCCHN, or history of treatment for invasive cancer other than SCCHN in the past 3 years. Exceptions are: Previously treated in-situ carcinoma (ie, noninvasive) Cervical carcinoma stage 1B or less Noninvasive basal cell and squamous cell skin carcinoma Radically treated prostate cancer (prostatectomy or radiotherapy) with normal prostate-specific antigen, and not requiring ongoing antiandrogen hormonal therapy
* Patients must have completed any previous cancer-related treatments before enrolment. Any concurrent chemotherapy [Chemotherapy washout within 21 days or 5 half-lives (whichever is shorter) from enrolment], radiotherapy, immunotherapy, or biologic, or hormonal therapy for cancer excludes the patient (concurrent use of hormones for noncancer-related conditions [eg, insulin for diabetes and hormone replacement therapy] is acceptable),
* Experiencing CTCAE grade >1 events, experienced immune-related grade ≥3AEs with prior immunotherapy
* Has active or prior autoimmune disease within the past 2 years
* Has active or prior inflammatory bowel disease or primary immunodeficiency
* Undergone an organ transplant that requires use of immunosuppressive treatment
* Abnormalities in rhythm, conduction or morphology of resting 12-lead ECG
* uncontrolled comorbid conditions
* Received a live attenuated vaccine within 30 days of first study dose, unable to take oral medications
* History of allergic reactions to study compounds or excepients Additional exclusion criteria Part A: Patients with clinically active brain metastases and prior exposure to AZD9150, AZD5069, MEDI4736, or any other anti PD (L)1 antibody.
Additional exclusion criteria Part B: Patients with brain metastases (known or suspected) Additional exclusion criteria Part B: treatment arms B3, B4, B5, B6, B7 and B8: prior exposure to AZD9150, AZD5069, MEDI4736, or any other anti PD (L)1 antibody.