Phase Ib /II Clinical Trial of Nivolumab Monotherapy and Nivolumab in Combination with Ipilimumab in Pediatric Subjects with High Grade Primary CNS Malignancies - CA209-908 Pediatric Primary CNS

Bristol-Myers Squibb0 个研究点目标入组 6 人开始时间: 待定最近更新: 2024年2月28日

试验速览

阶段: 2 期
状态: 招募中
发起方
入组人数: 6

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: 2 至 64（—）

入选标准

•Prior to study participation, written informed consent from participants, or in the case of minors, written permission (informed consent) from parents or legally acceptable representatives.
•Males and Females, ages >= 6 months to < 22 years old
•Participants must have received standard of care therapy, and there must be no potentially-curative treatment available, in one of the following cohorts:
•1. newly diagnosed (by MRI or histology) DIPG that has been treated with radiation therapy (RT) (Cohort 1)
•2. histologically confirmed recurrent or progressive non-brainstem HGG previously treated with surgical resection and RT (with or without chemotherapy) (Cohort 2)
•3. histologically confirmed medulloblastoma that has relapsed or is resistant to at least one line of prior therapy including surgery, RT, and chemotherapy (regardless of age) (Cohort 3)
•4. histologically confirmed ependymoma that has relapsed or is resistant to at least one line of prior therapy including surgical resection and RT (regardless of age) (Cohort 4)
•5. histologically-confirmed other high grade CNS malignancy which is recurrent or progressive after at least one line of prior therapy (Cohort 5)
•If first recurrence of the CNS tumor is documented by MRI, an interval of at least 12 weeks after the end of prior radiation therapy is required unless there is either histopathologic confirmation of recurrent tumor, or new enhancement on MRI outside of the radiotherapy treatment field (Cohorts 2-5).
•A tumor sample must be available (from resection at time of recurrence, or otherwise archive sample from previous resection) for submission to central laboratory. This is not required for DIPG (Cohort 1).
•Substantial recovery (ie, no ongoing safety issues) from surgical resection prior to first dose of study therapy.
•Adequate wash-out interval since last administration of other treatment for CNS malignancies
•Able to taper (preferably discontinue) steroids. Participants must be receiving not more than 0.05 mg/kg dexamethasone per day (or equivalent) for intracranial mass effect at study entry.
•Participants who have received high-dose chemotherapy with autologous hematopoietic cell transplantation must be at least 6 months post-hematopoietic cell transplantation and they must have a CD4 count of at least 200.
•Lansky play score (LPS) for =< 16 years of age or Karnofsky performance scale (KPS) for > 16 years of age must be >= 60.
•Women of child-bearing potential must have a negative pregnancy test within 24 hours of starting treatment, and should not be breastfeeding. Women of childbearing potential, or male subjects who are sexually active with women of child-bearing potential must agree to the contraceptive requirements of the study.

排除标准

•Participants with active, known, or suspected autoimmune disease.
•Participants with a condition requiring systemic treatment with either corticosteroids or other immunosuppressive medications within 14 days of study drug administration.
•Participants who cannot undergo magnetic resonance imaging (MRI) with contrast enhancement.
•Specific blood test results indicating impaired haematological, liver or kidney function
•Participants cannot test positive for Hepatitis B/C
•Participants must not have HIV or AIDs
•Unable to taper steroids due to ongoing mass effect
•Participants with low-grade gliomas or tumors of unknown malignant potential
•Evidence of > Grade 1 recent CNS hemorrhage on the baseline MRI scan.
•Participants with bulky tumor on imaging are ineligible; bulky tumor is defined as:
•i) Tumor with any evidence of uncal herniation or severe midline shift
•ii) Tumor with diameter of > 6 cm in one dimension on contrast-enhanced MRI
•iii) Tumor that in the opinion of the investigator, shows significant mass effect.
•Prior treatment with any antibody or drug specifically targeting T-cell co-stimulation or checkpoint pathways.
•Prior allogeneic hematopoietic cell transplantation (unless MM approval in advance).
•Participants who are receiving any other anti-cancer or investigational drug therapy or non-palliative radiation therapy.
•Any serious or uncontrolled medical disorder that may increase the risk associated with study participation or study drug administration, impair the ability of the participant to receive protocol therapy, or interfere with the interpretation of study results.
•Patients cannot be incarcerated or detained for a psychiatric or physical illness
•History of allergy or hypersensitivity to study drug components or to any monoclonal antibody.

研究者

发起方

Bristol-Myers Squibb

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