EUCTR2018-003118-42-GB进行中（未招募）1 期
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
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 入组人数
- 228
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional clinical trial of medicinal product
入排标准
- 性别
- All
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 tolerable.
- •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 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.
- •Are the trial subjects under 18? yes
- •Number of subjects for this age range: 228
- •F.1.2 Adults (18-64 years) no
- •F.1.2.1 Number of subjects for this age range
- •F.1.3 Elderly (>=65 years) no
- •F.1.3.1 Number of subjects for this age range
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-by case basis and may be included after consultation with the Study
- •- 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 Physician.
- •Patients with clinically active brain metastases (known or suspected), 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
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