Phase I/II, Open-Label, Multicenter Study to Evaluate the Safety, Tolerability, and Preliminary Efficacy of Durvalumab Monotherapy or Durvalumab in Combination with Tremelimumab in Pediatric Patients with Advanced Solid Tumors and Hematological Malignancies - D419EC00001

Astra Zeneca0 个研究点目标入组 7 人开始时间: 待定最近更新: 2024年4月15日

试验速览

阶段: 2 期
状态: 已完成
发起方
入组人数: 7

研究概览入排标准研究者记录与标识符相似试验

研究概览

简要总结

暂无简介。

研究设计

研究类型: Interventional

入排标准

年龄范围: 0 至 17（—）

入选标准

•Patients must have pathologically confirmed relapsed or refractory advanced
•solid tumour malignancy or haematological malignancies including lymphoma and
•acute leukaemia. Any number of prior treatment regimens allowed. A select group
•of first-line patients may be eligible for screening and enrolment. These
•patients will be enrolled based on investigator assessment as patients for whom
•no curative standard of care treatment options exist or such therapies are not
•If available, patients must provide a diagnostic tumor sample taken *3 years
•prior to screening for evaluation of PD-L1 status.
•Lansky play performance scale >=50 for patients >=1 and <16 years of age and
•Karnofsky performance status score >=50 for patients >=16 years of age (patients
•<1 year of age are exempt from this criterion)
•Patients must have measurable/evaluable disease as defined by methods used in
•common clinical practice.
•No prior exposure to immune checkpoint inhibitors or genetically engineered
•cellular therapies including, but not limited to, other anti- CTLA-4,
•anti-PD-1, anti-PD-L1, anti-PD-L2 antibodies and antibodies of CAR-T or other
•cell therapies, excluding therapeutic anticancer vaccines.
•Exposure to other investigational agents may be permitted after discussion with
•the Sponsor or designee.

排除标准

•History of allogeneic organ transplantation (exceptions may be allowed for
•HL, NHL, ALL and AML, after discussion with Sponsor or designee). Patients who
•have previously received an autologous bone marrow transplant may be eligible
•Active or prior documented autoimmune or inflammatory disorders (including
•inflammatory bowel disease, diverticulitis, celiac disease or other serious GI
•chronic conditions associated with diarrhea, systemic lupus erythematosus,
•Wegener syndrome; myasthenia gravis, Graves' disease, rheumatoid arthritis,
•hypophysitis, uveitis, etc) autoimmune myocarditis, and autoimmune pneumonitis.
•The following are exceptions to this criterion:
•* Patients with vitiligo or alopecia
•* Patients with hypothyroidism (eg, following Hashimoto syndrome) stable on
•hormone replacement
•* Psoriasis that does not require systemic therapy
•* Patients with celiac disease controlled by diet alone.
•Uncontrolled intercurrent illness, including but not limited to, ongoing or
•active infection, symptomatic congestive heart failure, cardiac arrhythmia,
•ILD, or psychiatric illness or social situations that would
•limit compliance with study requirements, substantially increase risk of
•incurring AEs from IP, or compromise the ability of the patient to give written
•informed consent.
•History of primary immunodeficiency.
•Active infection including tuberculosis, hepatitis B, hepatitis C, or HIV.
•Patients with a past or resolved HBV infection are eligible. Patients positive
•for hepatitis C virus (HCV) antibody are eligible only if polymerase chain
•reaction is negative for HCV ribonucleic acid (RNA).
•Any unresolved toxicity NCI CTCAE version 5.0 Grade >=2 from previous
•anticancer therapy with the exception of alopecia, vitiligo, lymphopenia and
•the laboratory values defined in the inclusion criteria
•* Patients with Grade >=2 neuropathy will be evaluated on a case-bycase basis
•and may be included after consultation with the Study Physician.
•* Patients with toxicity not reasonably expected to be exacerbated by treatment
•with durvalumab or tremelimumab (eg, hearing loss, gastrostomy tube) may be
•included after consultation with the Study
•Patients with clinically active brain metastases (known or suspected) or
•spinal cord compression, and choloromas are excluded, unless these conditions
•have been previously treated and are considered stable.
•History of leptomeningeal carcinomatosis, or involvement of any other
•anatomic area that, in the opinion of the Investigator, may cause significant
•symptoms if an inflammatory reaction occurs.

研究者

发起方

Astra Zeneca

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