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Clinical Trials/NL-OMON48940
NL-OMON48940
Recruiting
Phase 2

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 sites6 target enrollmentStarted: TBDLast updated:
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Overview

Phase
Phase 2
Status
Recruiting
Enrollment
6
OverviewEligibility CriteriaInvestigatorsRecords & IdentifiersSimilar Trials

Overview

Brief Summary

No summary available.

Study Design

Study Type
Interventional

Eligibility Criteria

Ages
2 to 64 (—)

Inclusion Criteria

  • •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\).

Exclusion Criteria

  • •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:

Investigators

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