Actively Recruiting
INFORM2 Study Uses Nivolumab and Entinostat in Children and Adolescents With High-risk Refractory Malignancies
Led by University Hospital Heidelberg · Updated on 2024-02-07
91
Participants Needed
14
Research Sites
370 weeks
Total Duration
On this page
Sponsors
U
University Hospital Heidelberg
Lead Sponsor
G
German Cancer Research Center
Collaborating Sponsor
AI-Summary
What this Trial Is About
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).
CONDITIONS
Official Title
INFORM2 Study Uses Nivolumab and Entinostat in Children and Adolescents With High-risk Refractory Malignancies
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Children and adolescents aged 2 to 21 years with refractory, relapsed, or progressive high-risk CNS tumors or solid tumors
- CNS tumors include medulloblastoma, ependymoma, ATRT, ETMR, pediatric high grade glioma (including DIPG), or other pediatric embryonal CNS tumors
- Solid tumors include neuroblastoma, nephroblastoma, rhabdoid tumor, embryonal or alveolar rhabdomyosarcoma, other embryonal small round blue cell tumors including pediatric type (bone) sarcoma, or other pediatric type solid tumors
- Newly diagnosed high grade glioma in children and adolescents with constitutional mismatch repair deficiency syndrome after maximum safe surgical resection and no standard curative treatment option
- No standard of care treatment available
- Molecular analysis confirming biomarker status (high mutational load, MYC/N amplification, high TILs or TLS positive) performed in accredited laboratories
- Time between biopsy/resection and registration ≤ 24 weeks (or ≤ 36 weeks if therapy does not impact biomarker stratification)
- Measurable disease per RANO or RECIST v1.1 criteria
- Life expectancy greater than 3 months and sufficient general condition score (Lansky or Karnofsky ≥ 70)
- Hematology and biochemistry laboratory values within specified limits
- Normal ECG QTc interval (< 440 ms)
- Ability to swallow oral study medication
- Ability of patient or legal representative to understand the trial and give informed consent
- Negative pregnancy test for females of childbearing potential and agreement to use contraception
- Absence of conditions hampering compliance with study procedures
- No prior therapy with combination of immune checkpoint inhibitors and HDAC inhibitors
- Molecular analysis and biomarker status known before Phase I and Phase II enrollment
- Stratification into groups based on biomarker status for Phase II enrollment
You will not qualify if you...
- Neurologically unstable patients with CNS tumors or metastases despite treatment
- Patients with low-grade gliomas or tumors of unknown malignant potential
- Recent CNS hemorrhage greater than Grade 1 on baseline MRI
- Bulky CNS tumors with uncal herniation, severe midline shift, diameter >6 cm, or significant mass effect
- Previous allogeneic bone marrow, stem cell, or organ transplantation
- Diagnosis of immunodeficiency or prior/active autoimmune disease
- Evidence of interstitial lung disease
- Contraindications to oral agents or conditions affecting drug absorption
- Known HIV infection or active hepatitis B or C virus infection
- Clinically significant uncontrolled heart disease
- Major surgery within 21 days before first dose (except specific minor procedures with 48-hour interval)
- Recent anticancer therapy within 2 weeks or at least 5 half-lives before study drug administration
- Radiotherapy-induced pseudoprogression in CNS tumors
- Use of traditional herbal medicines that could interfere with study drugs
- History of hypersensitivity to investigational product or similar drugs
- Participation in other ongoing clinical trials
- Pregnant or lactating females
- Underlying medical conditions that could affect compliance or interpretation of treatment effects
- Systemic steroid or immunosuppressive therapy within 7 days prior to first dose (physiologic corticosteroids may be allowed after consultation)
- Previous enrollment in this trial
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 14 locations
1
Sydney Children's Hospital
Randwick, New South Wales, Australia, 2031
Actively Recruiting
2
Children's Hospital at Westmead
Westmead, New South Wales, Australia, 2145
Actively Recruiting
3
Royal Children's Hospital
Parkville, Victoria, Australia, 3052
Actively Recruiting
4
Perth Children's Hospital
Nedlands, Western Australia, Australia, 6009
Actively Recruiting
5
St. Anna Children's Hospital
Vienna, Austria, 1090
Actively Recruiting
6
Institut Curie
Paris, France, 75005
Actively Recruiting
7
Augsburg University Hospital
Augsburg, Germany, 86156
Actively Recruiting
8
Charité University Medicine Berlin
Berlin, Germany
Actively Recruiting
9
Essen University Hospital
Essen, Germany
Actively Recruiting
10
Hannover Medical School
Hanover, Germany
Actively Recruiting
11
Hopp Children's Cancer Center Heidelberg (KiTZ)
Heidelberg, Germany, 69120
Actively Recruiting
12
Prinses Máxima Centrum
Utrecht, Netherlands
Actively Recruiting
13
Karolinska Institute
Stockholm, Sweden
Actively Recruiting
14
Children's Hospital Zurich
Zurich, Switzerland, 8032
Actively Recruiting
Research Team
V
Venukah Schäfer
CONTACT
M
Melanie Heiß
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SINGLE_GROUP
Primary Purpose
TREATMENT
Number of Arms
1
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