Study to Assess MEDI4736 With Either AZD9150 or AZD5069 in Advanced Solid Tumors & Relapsed Metastatic Squamous Cell Carcinoma of Head & Neck

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
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阿拉巴马州伯明翰 35294
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加利福尼亚州杜阿尔特 91010
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加利福尼亚州拉霍亚 92093
活跃,非招募
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加利福尼亚州洛杉矶 90024
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Los Angeles, California 90089
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Orange, California 92868-3298
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加利福尼亚州旧金山 94158
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科罗拉多州丹佛 80218
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Plantation, Florida 33324
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佛罗里达州萨拉索塔 34232
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印第安纳州拉斐特 47905
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Boston, Massachusetts 02111
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密歇根州底特律 48201
活跃,非招募
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蒙大拿州比林斯 59101
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Morristown, New Jersey 07960
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Cincinnati, Ohio 45267-2827
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德克萨斯州休斯顿 77030
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弗吉尼亚州费尔法克斯 22031
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华盛顿州西雅图 98109
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比利时
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Antwerpen 2020
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布鲁塞尔 1000
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布鲁塞尔 1200
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Edegem 2650
活跃,非招募
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Namur 5000
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德国
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柏林 12200
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Dresden 1307
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Frankfurt 60488
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汉堡 20246
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汉诺威 30625
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Jena 07743
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Köln 50670
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München 81675
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意大利
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米兰 20133
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西班牙
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巴塞罗那 08035
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Hospitalet deLlobregat 08907
活跃,非招募
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马德里 28040
活跃,非招募
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马德里 28041
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Toledo 45004
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英国
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Birmingham B15 2TH
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伦敦 SE1 9RT
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London SW3 6JB
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曼彻斯特 M20 4BX
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Surrey SM2 5PT
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Taunton TA1 5DA
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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.

NCT ID

NCT02499328

添加审判日期

2015-07-16

更新日期

2025-04-27