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Spartalizumab and Low-dose PAzopanib in Refractory or Relapsed Solid TumOrs of Pediatric and Adults

Study acronym: SPARTO
StatusActive, Not Recruiting
PhasePhase 1/2
Started2022-05-17
View on ClinicalTrials.gov ↗

Amendment history

2026-01-13
Recruiting→Active, Not Recruiting Study Status, Study Design, Contacts/Locations v3
Trial statusRecruiting→Active, Not Recruiting
Primary completion dateestimated 2026-11-17→confirmed 2025-08-26
Enrollment targetestimated 59→confirmed 80
Study sites9→13
2024-04-08
Not Yet Recruiting→Recruiting Study Identification, Study Status, Study Description, Eligibility, Contacts/Locations v2
Trial statusNot Yet Recruiting→Recruiting
Primary completion date2026-10-01→2026-11-17
Completion date2027-10-01→2027-11-17
Start dateestimated 2022-04-01→confirmed 2022-05-17
Eligibility criteria+413 characters
[...] lymphoid structure (TLS). Age ≥5 and <18 years at inclusion, patients 18 years and older may be included after discussion with the Sponsor if they have a pediatric recurrent/refacractory malignancy. Performance status: Karnofsky performance status (for pati [...] cal requirements. For adults patients: Pre-screening phase: young adults (≥ 18 to 35 years old) with refractory or recurrent solid tumor (includ [...] egional or national guidelines. Screening phase (Cohort 2): young adults without standard established therapeutic alternatives [...] d tumor characterized by the presence of mature TLS Age ≥ 18 and ≤ 35 ye [...] [...]
Study description-18 characters
[...] cy of immunotherapy in some selected pediatric patients and young adults. PDR001 (also referred to as spartalizumab) is a huma [...] nib in refractory or relapsed solid tumors of pediatric and young adults is proposed. This study will include 2 separate cohor [...] th four potential candidate doses (2, 3, 4 and 6 mg/kg). the young adult cohort will consist of a phase II study combining paz [...]
Study sitesdetails revised at 9 of 9 sites
Study title-6 characters
Spartalizumab and Low-dose PAzopanib in Refractory or Relapsed Solid TumOrs of Pediatric and Young Adults
2022-03-09
Study Status, Sponsor/Collaborators, Study Description, Study Design, Arms and Interventions, Outcome Measures, Contacts/Locations v1
Study sites0→9
InterventionsSpartalizumab and low-dose Pazopanib (Drug)→Low-dose Pazopanib in Adult Cohort (Drug), Low-dose Pazopanib in Pediatric Cohort (Drug), Spartalizumab in Adult cohort (Drug)…
Secondary endpoints23 entries, revised
Incidence of Treatment-Emergent Adverse Events [Safety endpointsand Tolerability] in pediatric and adult cohorts Incidence of Treatment-Emergent Adverse Events [Safety endpointsand Tolerability]in pediatric and adult cohorts Incidence of Treatment-Emergent Adverse Events [Safety endpointsand Tolerability]in pediatric and adult cohorts Incidence of Treatment-Emergent Adverse Events [Safety endpointsand in pediatric ans adult cohorts Safety endpoints Tolerability]in pediatric and adult cohorts Incidence of Treatment-Emergent Adverse Events [Safety endpointsand Tolerability]in pediatric and adult [...] [...]
Study description+15 characters
[...] as those described in the next sections. For these reasons, wethe investigators proposed to combine immunotherapy and low dose of pazopanib [...]
Collaborators3 entries, revised
Novartis Pharma S.A.S.
2022-01-13
Original filing
Immunotherapies have revolutionized medical oncology following the remarkable and, in some cases, unprecedented outcomes observed in certain groups of patients with cancer. However results in adults and mainly in pediatric cancer are still disappointing. Modulators of angiogenesis, such as VEGF, have a broad range of diverse effects on the immune system and the tumor micro-environment that are mainly immunosuppressive. In patients with early-stage disease, anti-VEGF therapy can lead to antitumor effects by modulating immune mechanisms - provided that therapy is maintained for an adequate length and tumors are sufficiently immunogenic. Nevertheless, blocking angiogenic molecules using a strategy based on a single therapeutic approach is likely insufficient to generate a complete or robust immune response against cancer, especially in patients with advanced-stage disease. Based on the results of previous studies which evaluated the safety profile of spartalizumab, of pazopanib and the combination of antiangiogenic agents with checkpoint inhibitors, a study combining spartalizumab and low-dose pazopanib in refractory or relapsed solid tumors of pediatric and adults is proposed. This study will include 2 separate cohorts: * the pediatric cohort will consist of a phase I study (dose-finding and expansion phases) combining pazopanib at a fixed dose of 225 mg/m2 and spartalizumab with four potential candidate doses (2, 3, 4 and 6 mg/kg). * the adult cohort will consist of a phase II study combining pazopanib at a fixed dose of 400 mg and spartalizumab at the RP2D of 400 mg every 4 weeks.
Trial Details
NCT Number NCT05210413
Lead Sponsor University Hospital, Bordeaux
Collaborators: National Cancer Institute, France, Fondation ARC, Novartis
Conditions Refractory or Recurrent Solid Tumor
Enrollment 80 participants
Start Date 2022-05-17
Primary Completion 2025-08-26 (estimated)
Study Completion 2027-11-17 (estimated)
Updated on ClinicalTrials.gov 2026-01-15