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Nivolumab in Combination With Metronomic Chemotherapy in Paediatrics Refractory / Relapsing Solid Tumors

NCT03585465 · Status: ACTIVE_NOT_RECRUITING · Phase: PHASE1/PHASE2 · Type: INTERVENTIONAL · Enrollment: 63

Last updated 2026-03-18

No results posted yet for this study

Summary

The study is a two-stage trial:

1. First stage (closed - 16 patients recruited in France):

Phase I feasibility trial to evaluate the safety of the combination of Nivolumab + metronomic chemotherapy considering three possible metronomic chemotherapy regimens
2. Second stage (opened - 86 patients expected in France and Belgium):

Phase II randomized controlled balanced 1:1 open-label trial comparing the efficacy of the metronomic chemotherapy regimen selected at the end of the previous stage (arm C: cyclophosphamide, capecitabine, vinblastine), with or without nivolumab.
3. "Trans-MetroPD1" ancillary sub-study is partially implemented since April 2022, and proposed to patients participating to second stage

Conditions

  • Childhood Solid Tumor

Interventions

DRUG

Vinblastine

* Experimentals Arm A or C (First stage): 2 mg/m2/day IV, weekly per cycle, 28 days cycle * Experimental Arms Metronomic or Metronomic+Nivolumab (second stage): see C

DRUG

Cyclophosphamide

* Arm A (First stage): 30 mg/m2/day PO, D1-4// D8-11// D15-18// D22-25 per cycle, 28 days cycle * Arm C (First stage): 30 mg/m2/day PO, D1-D4// D15-D18 per cycle, 28 days cycle * Metronomic or Metronomic+Nivolumab Arm (second stage): see C

DRUG

Capecitabine

* Arm B (First stage): 400 to 600 mg/m2/day PO, all days per cycle, 28 days cycle * Arm C (First stage): 400 to 600 mg/m2/day PO, D8-D11// D22-D25 per cycle, 28 days cycle * Metronomic or Metronomic+Nivolumab Arm (second stage): see C

DRUG

Nivolumab

* Arm A, B or C (First stage): 3 mg/kg IV, D1 \& D15 per cycle, 28 days cycle * Metronomic+Nivolumab Arm (second stage): 3 mg/kg IV, D1 \& D15 per cycle, 28 days cycle

Sponsors & Collaborators

  • Anticancer Fund, Belgium

    collaborator OTHER

  • Bristol-Myers Squibb

    collaborator INDUSTRY

  • CTD-CNO

    collaborator UNKNOWN

  • ECS-Progastrin SA

    collaborator INDUSTRY

  • Centre Oscar Lambret

    lead OTHER

Principal Investigators

  • Pierre LEBLOND, MD · Centre Oscar Lambret

  • Nicolas ANDRE, MD · CHU La Timone

  • Leen WILLEMS, MD · University Hospital, Ghent

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
0 Years
Max Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2019-03-26
Primary Completion
2025-12-31
Completion
2027-01-31

Countries

  • Belgium
  • France

Study Locations

More Related Trials

Entities

Drugs
Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03585465 on ClinicalTrials.gov