Phase I/II, open-label, multicenter study of durvalumab in combination with tremelimumab in pediatric patients with advanced solid tumors - Summary - MDSpire
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Phase I/II, open-label, multicenter study of durvalumab in combination with tremelimumab in pediatric patients with advanced solid tumors
To evaluate the efficacy and safety of durvalumab combined with tremelimumab in pediatric patients with relapsed/refractory solid tumors.
Key Findings:
The RP2D was determined as durvalumab (30 mg/kg) + tremelimumab (1 mg/kg).
In the dose-expansion phase, 21 patients were treated; no objective responses were observed in patients with sarcoma; one patient with chordoma had a confirmed partial response.
76% of patients experienced treatment-related adverse events, with 19% being grade 3 or 4.
Interpretation:
The combination of durvalumab and tremelimumab showed limited antitumor activity in pediatric patients, but the safety profile was manageable and consistent with adult data, indicating a need for further investigation.
Limitations:
Small sample size in the dose-expansion phase may limit the generalizability of the findings.
Limited antitumor activity observed, particularly in sarcoma patients.
Conclusion:
While the combination therapy had limited efficacy, it was well-tolerated, suggesting potential for further investigation in pediatric oncology.
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