INFORM2 Study Uses Nivolumab and Entinostat in Children and Adolescents With High-risk Refractory Malignancies

Sponsor
University Hospital Heidelberg
Study ID
NCT03838042
Phase
PHASE1/PHASE2
Status
Recruiting
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Conditions

  • CNS Tumor
  • Solid Tumor

Eligibility Criteria

Sex
ALL
Age
2 Years - 21 Years
Healthy Volunteers
Not accepted

Interventions

  • Nivolumab and Entinostat — DRUG
    Patients entering phase I will receive one week entinostat without nivolumab (priming phase) before receiving the combination treatment of nivolumab and entinostat.

Study Details

The aim of this trial is to determine preliminary activity of the combination treatment with nivolumab and entinostat in children and adolescents with high risk refractory/relapsed/progressive tumors harboring a high mutational load, focal MYC(N) amplification or ATRT-MYC subgroup as well as tumors with high tumor infiltrating lymphocytes (TILs) or a tertiary lymphoid structure (TLS).

Key Dates

Start date
May 26, 2020
Status verified
Feb 2024
Primary completion
Jun 30, 2026
Completion
Jun 30, 2027

Study Design

Enrollment
91 participants (estimated)
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT

Arms

  • Experimental: Nivolumab and Entinostat
    Combination Study of Nivolumab and Entinostat

Primary Outcome Measure

Phase I: Dose Limiting Toxicity (DLT) of the combination treatment. [ Time Frame: 5 weeks ]

Central Contacts

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