ACTRN12616001019493已完成2 期
Single arm, open label, signal seeking, phase IIa trial of the activity of Durvalumab (MEDI4736) in combination with Tremelimumab in patients with advanced rare or neglected cancers.
适应症
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 112
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional
- 分配方式
- Non-randomised trial
- 主要目的
- Treatment
- 盲法
- Open (masking not used)
入排标准
- 年龄范围
- 18 Years 至 o limit（—）
- 性别
- All
入选标准
- •To be eligible for treatment in a substudy, patients must continue to meet all of the inclusion criteria and none of the exclusion criteria specified for entry into molecular screening at the time of registration to a treatment substudy. In addition, they must meet all the inclusion criteria and none of the exclusion criteria in the substudy addendum at the time of registration.
- •1.Confirmation of molecular eligibility by the molecular tumour board;
- •2.Received and failed all standard anticancer therapy or have documented unsuitability for any further standard therapy, if standard therapy exists;
- •3.Clinical or radiological progression on or following last anticancer therapy;
- •4.Adequate organ system function per addendum definitions
- •5.Meet any additional inclusion criteria specified in the relevant substudy addendum;
- •6.Signed, written informed consent to participation in the specific treatment substudy.
- •Inclusion criteria specific to this sub-study:
- •1.ECOG performance status of 0 or 1
- •2.Sufficient and accessible tumor tissue for PD-L1 testing and exploratory objectives
- •3.Adequate liver function. See protocol definition.
- •4.Serum creatinine CL greater than 40 mL/min by the Cockcroft-Gault formula (Cockcroft and Gault 1976) or by 24-hour urine collection for determination of creatinine clearance.
排除标准
- •Exclusion criteria will include those relevant for screening but also include:
- •1. Contraindications to investigational product, as listed in the substudy addendum and outlined in the Investigator Brochure appended to each substudy module;
- •2. Known history of hypersensitivity to active or inactive components of investigational product;
- •3. Previous treatment with the same agent or same class of agent;
- •4. Treatment with any of the following anti-cancer therapies prior to the first dose of study treatment:
- •o Radiation therapy, surgery or tumour embolization within 14 days prior to the first dose of study treatment. Palliative radiotherapy (for analgesia) is acceptable only if the irradiated field does not include target lesions;
- •o Immunotherapy within 28 days prior to the first dose of study treatment;
- •o Chemotherapy, biologic therapy, or hormonal therapy within 14 days or 5 half-lives of a drug prior to the first dose of study treatment or until recovery from previous therapy (whichever is longer);
- •5. Administration of any investigational treatment within 30 days or 5 half-lives (whichever is longer) prior to receiving the first dose of study treatment;
- •6. Any additional exclusion criteria specified in the relevant substudy addendum.
- •Exclusion Criteria specific to the sub-study:
- •1. Involvement in the planning and/or conduct of the study (applies to both AstraZeneca staff and/or staff at the study site)
- •2. Patients with cutaneous melanoma, non-small cell lung cancer, squamous cell carcinoma of the head and neck, bladder cancer, thymoma, thymic carcinoma or pancreatic cancer
- •3. Patients who are eligible for other clinical studies involving durvalumab and/or tremelimumab
- •4. Eligible for participation in another MoST substudy based on identification of an actionable mutation. Patients who have previously participated in another MoST substudy may subsequently participate in this study, all other inclusion and exclusion criteria being satisfied
- •5. Participation in another clinical study with an investigational product during the last 4 weeks prior to study enrolment
- •6. Any previous treatment with a PD1 or PD-L1 inhibitor, including durvalumab or an anti-CTLA-4, including tremelimumab
- •7. Any unresolved toxicity (>CTCAE grade 2) from previous anti-cancer therapy. Subjects with irreversible toxicity that is not reasonably expected to be exacerbated by the investigational product may be included (e.g., hearing loss, peripherally neuropathy)
- •8. Mean QT interval corrected for heart rate (QTc) =470 ms calculated from 3
- •electrocardiograms (ECGs) using Fredericia’s Correction
- •9. Prolonged use of moderate to high doses of immunosuppressive medication before the first dose of durvalumab or tremelimumab. Exceptions include intranasal and inhaled corticosteroids or systemic corticosteroids at physiological doses (eg: <=10 mg/day of prednisone); use of dexamethasone up to 4mg /day within 14 days of initial treatment for patients with brain tumours.
- •10. Any prior Grade =3 immune-related adverse event (irAE) while receiving any previous immunotherapy agent, or any unresolved irAE >Grade 1
- •11. Active autoimmune disease or prior documented autoimmune disease requiring systemic treatment within the past 2 years NOTE: Subjects with vitiligo, Grave’s disease, or psoriasis not requiring systemic treatment (within the past 2 years) are not excluded.
- •12. Active or prior documented inflammatory bowel disease requiring systemic treatment within t
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