OncoMatch/Clinical Trials/NCT02813135
European Proof-of-Concept Therapeutic Stratification Trial of Molecular Anomalies in Relapsed or Refractory Tumors
Is NCT02813135 recruiting? Yes, currently enrolling (Jun 2026). This Phase 1/2 trial studies multiple treatments for pediatric cancer.
Treatment: Ribociclib · Topotecan · Temozolomide · Everolimus · Adavosertib · Carboplatin · Olaparib · Irinotecan · Vistusertib · Nivolumab · Cyclophosphamide · Selumetinib · Enasidenib · Lirilumab · Fadraciclib · Cytarabine · Dexamethasone · Ceralasertib · Futibatinib · Capmatinib · Avelumab · Peposertib · Capivasertib · Vinorelbine — This proof-of-concept platform trial is designed to cover the targeting of several survival pathways in oncogenesis that are currently not adequately employed for pediatric patients in Europe (Geoerger 2017; Geoerger 2019). The aims of the trial are: 1. To determine the recommended phase II dose (RP2D) of a specific anticancer agent and/or a relevant combination in a pediatric population, to document its tolerability and 2. To explore first signals of activity in a molecularly enriched study population.
Check if I qualifyExtracted eligibility criteria
Treatments studied
Immunotherapy
Targeted therapy
Chemotherapy
Other
Demographics
Prior therapy
Must have received: standard therapy — relapsed/refractory
has progressed despite standard therapy, or for which no effective standard therapy exists
Cannot have received: systemic anticancer therapy
Systemic anticancer therapy within 21 days of the first study dose or 5 times its half-life, whichever is less
Cannot have received: myeloablative therapy with autologous hematopoietic stem cell rescue
Previous myeloablative therapy with autologous hematopoietic stem cell rescue within 8 weeks of the first study drug dose
Cannot have received: allogeneic stem cell transplant
Allogeneic stem cell transplant within 3 months prior to the first study drug dose. Patients receiving any agent to treat or prevent graft-versus host disease (GVHD) post bone marrow transplant are not eligible for this trial.
Cannot have received: radiotherapy (non-palliative)
Radiotherapy (non-palliative) within 21 days prior to the first dose of drug (or within 6 weeks for therapeutic doses of MIBG or craniospinal irradiation)
Cannot have received: major surgery
Exception: gastrostomy, ventriculo-peritoneal shunt, endoscopic ventriculostomy, tumor biopsy and insertion of central venous access devices are not considered major surgery, but for these procedures, a 48 hour interval must be maintained before the first dose of the investigational drug is administered
Major surgery within 21 days of the first dose
Lab requirements
Blood counts
Peripheral ANC ≥ 1000/μL (unsupported); Platelet count ≥ 100,000/μL (unsupported); Hemoglobin ≥ 8.0 g/dL (transfusion is allowed); Leukemia patients are excluded from hematological criteria
Kidney function
Serum creatinine ≤ 1.5 x ULN for age
Liver function
Total bilirubin ≤ 1.5 x ULN; ALT/SGPT ≤ 2.5 x ULN; AST/SGOT ≤ 2.5 x ULN except in patients with documented tumor involvement of the liver who must have AST/SGOT and ALT/SGPT ≤ 5 x ULN
Cardiac function
Shortening fraction >29% (>35% for children < 3 years) and LVEF ≥50% at baseline, as determined by echocardiography (mandatory only for patients who have received cardiotoxic therapy). Absence of QTc prolongation (QTc > 450 msec on baseline ECG, using the Fridericia correction [QTcF formula]) or other clinically significant ventricular or atrial arrhythmia.
Adequate organ function: Hematologic criteria (Leukemia patients are excluded from hematological criteria): Peripheral ANC ≥ 1000/μL (unsupported); Platelet count ≥ 100,000/μL (unsupported); Hemoglobin ≥ 8.0 g/dL (transfusion is allowed). Cardiac function: Shortening fraction >29% (>35% for children < 3 years) and LVEF ≥50% at baseline, as determined by echocardiography (mandatory only for patients who have received cardiotoxic therapy). Absence of QTc prolongation (QTc > 450 msec on baseline ECG, using the Fridericia correction [QTcF formula]) or other clinically significant ventricular or atrial arrhythmia. Renal and hepatic function: Serum creatinine ≤ 1.5 x ULN for age; Total bilirubin ≤ 1.5 x ULN; ALT/SGPT ≤ 2.5 x ULN; AST/SGOT ≤ 2.5 x ULN except in patients with documented tumor involvement of the liver who must have AST/SGOT and ALT/SGPT ≤ 5 x ULN.
Structured fields extracted by AI. May contain errors — verify against the official protocol.
Frequently asked questions
Is NCT02813135 currently recruiting?
Yes, this trial is currently recruiting patients.
Are there prior therapy exclusions?
Yes. Prior systemic anticancer therapy, myeloablative therapy with autologous hematopoietic stem cell rescue, allogeneic stem cell transplant disqualifies patients from enrollment.
Is there an age limit?
Yes. Patients must be 18 years or younger.
Could you qualify for this trial?
Enter your biomarker results to see how this trial's eligibility criteria match your specific cancer profile.
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