Spartalizumab and Low-dose PAzopanib in Refractory or Relapsed Solid TumOrs of Pediatric and Young Adults
Status:
Not yet recruiting
Trial end date:
2027-10-01
Target enrollment:
Participant gender:
Summary
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 young 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 young 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.
Phase:
Phase 1/Phase 2
Details
Lead Sponsor:
University Hospital, Bordeaux
Collaborators:
Fondation ARC Institut National du Cancer INCa-ARC_14820 Novartis Pharma S.A.S.