EUCTR2017-002054-37-GB进行中（未招募）1 期
Pilot Study of Nivolumab in Pediatric Patients with Hypermutant Cancer - Pilot Study of Nivolumab in Pediatric Patients with Hypermutant Cancer
适应症
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 入组人数
- 50
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
- •1. Patient and LAR must be willing and able to provide written informed
- •consent/assent for the trial as per local requirements
- •2. patient must have completed and verified a sufficient TMB level or
- •have proof of RRD diagnosed in the appropriate lab
- •3. patients must be = 12 months and < 25 years of age at the time of
- •Part I/II enrollment
- •3. Recurrent of relapse pediatric cancer patients suspected to be
- •hypermutant.
- •4. patients must have had histologic verification of malignancy at the
- •time of initial diagnosis or at relapse
- •5. patients must be able to provide specimen of a tumor lesion.
- •5. patients must have either measurable or evaluable disease in
- •accordance with criteria as outlined in Section 10
- •6. patient's current disease state must be one for which there is no
- •known curative therapy or therapy proven to prolong survival with an
- •acceptable quality of life. Chemotherapy-naïve patients will be eligible in
- •cases where first-line therapy does not include chemotherapy
- •7. Karnofsky = 50% for patients > 16 years of age or Lansky = 50 for
- •patients = 16 years of age
- •8. patients must have fully recovered from the acute toxic effects of all
- •prior anti-cancer therapy.
- •a. Myelosuppressive chemotherapy: at least 21 days after the last dose
- •(42 days if prior nitrosourea)
- •b. Hematopoietic growth factors: at least 14 days after the last dose of a
- •long-acting growth factor or 7 days for short-acting growth factor. For
- •agents that have known adverse events occurring beyond 7 days after
- •administration, this period must be extended beyond the time during
- •which adverse events are known to occur.
- •c. Biologic (anti-neoplastic agent): at least 14 days after the last dose of
- •a biologic agent. For agents that have known adverse events occurring
- •beyond 14 days after administration, this period must be extended
- •beyond the time during which adverse events are known to occur.
- •d. Monoclonal antibodies: at least three (3) half-lives of the antibody
- •after the last dose of a monoclonal antibody.
- •e. Radiation Therapy (XRT): at least 14 days after local palliative XRT
- •(small port). At least 150 days must have elapsed if prior Total Body
- •Irradiation, craniospinal XRT or if = 50% radiation of pelvis. At least 42
- •days must have elapsed if other substantial BM radiation.
- •f. Stem Cell Infusion without Total Body Irradiation (TBI): no evidence of
- •active graft vs. host disease and at least 56 days must have elapsed
- •after transplant or stem cell infusion. Patients with prior allogeneic
- •transplants (including solid organ) are not eligible.
- •9. a. Adequate BM Function Defined as
- •i. Peripheral ANC =0.75 x 109/L or 750/mm3.
- •ii. Platelet count =75 x 109/L or 75,000/mm3.
- •iii. Hemoglobin = 90g/L (transfusion permitted).
- •iv. Patients with known BM metastatic disease or haematological
- •malignancies will be eligible for study provided they meet
- •haematological criteria.
- •b. Renal Function : serum creatinine based on age/gender as provided in
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排除标准
- •1. Women who are pregnant or breastfeeding and men who are sexually
- •active with women of childbearing potential who are not
- •willing to use effective contraception, or to practice abstinence if this is
- •the usual lifestyle and preferred contraception for the patient. **
- •? Pregnant or breast-feeding women will not be entered on this study
- •due to risks of fetal and teratogenic adverse events as there is yet no
- •available information regarding human fetal or teratogenic toxicities.
- •? WOCBP must have a negative pregnancy test every 4 weeks. During
- •Part II screening, WOCBP must have a negative serum pregnancy test.
- •WOCBP must have a negative serum or urine pregnancy test (minimum
- •sensitivity 25 IU/L or equivalent units of HCG) within 24 hours prior to
- •the start of nivolumab administration. WOCBP who are sexually active,
- •must be willing to adhere to effective contraception during treatment
- •and for 5 months after the last dose of nivolumab.
- •? Men who are sexually active with WOCBP must be willing to adhere to
- •effective contraception during treatment and for 7 months after the last
- •dose of nivolumab.
- •2. Concomitant Medications
- •a. Corticosteroids: Patients requiring systemic steroid therapy or any
- •other form of immunosuppressive therapy within seven (7) days prior to
- •first dose of trial therapy or while on trial are not eligible. The use of
- •physiologic doses of corticosteroids (up to 5mg/m2/day prednisone
- •equivalent) is permitted following discussion with the Study Chair or Co-
- •Note: Use of topical, ocular, intra-articular, intra-nasal or inhaled
- •corticosteroids will not render a patient ineligible. A brief course of
- •corticosteroids for prophylaxis (e.g. contrast dye allergy) or for
- •treatment of non-autoimmune conditions (e.g. delayed-type
- •hypersensitivity reaction caused by contact allergen) is permitted if
- •completed at least 7 days prior to initiation of therapy.
- •b. Investigational Drugs: Patients who are currently receiving another
- •investigational drug are not eligible.
- •c. Anti-cancer Agents: Patients who are currently receiving other anticancer
- •agents are not eligible.
- •3. Patients with a History of Autoimmune Disease
- •? Patients with a history of autoimmune disorder that has required
- •systemic treatment in the previous two (2) years are not eligible.
- •Asymptomatic laboratory abnormalities (e.g. ANA, rheumatoid factor,
- •altered thyroid function studies) will not render a patient ineligible in the
- •absence of a diagnosis of an autoimmune disorder. Replacement therapy
- •(e.g. thyroxine, insulin or physiologic corticosteroid replacement
- •therapy) is not considered a form of systemic treatment.
- •4. Infection: Patients who have an uncontrolled infection are not eligible.
- •5. HIV and/or Hepatitis B/C patients: Patients with known HIV/AIDS or
- •acute/chronic Hepatitis B or C are excluded.
- •6. Transplant patients: Patients who have received prior allogeneic Bone
- •Marrow (BM) transplants or prior solid organ transplantation are not
- •7. Non-Compliance: Patients who in the opinion of the investigator may
- •not be able to comply with the safety monitoring requirements of the
- •study are not eligible.
- •8. Previous anti-PD-1 and/or anti-PD-L1 therapy: Patients who have
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研究者
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