Phase Ib/II non-randomized non-comparative two-cohort study of Niraparib and Dostarlimab plus (Chemo)RadIotherapy in Locally-Advanced head and Neck squamous cell carcinoma (RADIAN)

Conditions

Carcinoma

Brief summary

1-year disease free survival

Detailed description

● Treatment-related adverse events (TRAEs) as per NCI CTCAE v5.0. ● Rate of completion of niraparib during the neoadjuvant phase. ● Rate of disease progression as per clinical examination per treating physician during neoadjuvant phase. ● Rate of radiotherapy completion. ● Rate of completion of the maintenance phase of the study, ● Locoregional control at 12, 18 and 24 months ● Distant control at 12, 18 and 24 months ● Event-free survival ● Overall survival, ● Correlation between levels of circulating tumor DNA (ctDNA) clearance at post-treatment timepoints and 1-year disease-free survival in patients with positive/detectable ctDNA at baseline. ● Correlation of ctDNA dynamics (increase/decrease) across timepoints: Pre first dose dostarlimab (Day -21); Pre first dose niraparib (Day -14); Pre radiotherapy; At cycle 4 of maintenance; EOT and/or PD, and 1-year disease-free survival and secondary outcomes.

Related papers

No related papers found yet.

Interventions

DRUGZejula 100 mg film-coated tablets

DRUGJEMPERLI 500 mg concentrate for solution for infusion

Eligibility

Sex/Gender

All

Age

18 Years to No maximum

Design outcomes

Primary

Measure	Time frame
1-year disease free survival	—

Secondary

Measure	Time frame
● Treatment-related adverse events (TRAEs) as per NCI CTCAE v5.0. ● Rate of completion of niraparib during the neoadjuvant phase. ● Rate of disease progression as per clinical examination per treating physician during neoadjuvant phase. ● Rate of radiotherapy completion. ● Rate of completion of the maintenance phase of the study, ● Locoregional control at 12, 18 and 24 months ● Distant control at 12, 18 and 24 months ● Event-free survival ● Overall survival, ● Correlation between levels of circulating tumor DNA (ctDNA) clearance at post-treatment timepoints and 1-year disease-free survival in patients with positive/detectable ctDNA at baseline. ● Correlation of ctDNA dynamics (increase/decrease) across timepoints: Pre first dose dostarlimab (Day -21); Pre first dose niraparib (Day -14); Pre radiotherapy; At cycle 4 of maintenance; EOT and/or PD, and 1-year disease-free survival and secondary outcomes.	—

Measure

Time frame

● Treatment-related adverse events (TRAEs) as per NCI CTCAE v5.0. ● Rate of completion of niraparib during the neoadjuvant phase. ● Rate of disease progression as per clinical examination per treating physician during neoadjuvant phase. ● Rate of radiotherapy completion. ● Rate of completion of the maintenance phase of the study, ● Locoregional control at 12, 18 and 24 months ● Distant control at 12, 18 and 24 months ● Event-free survival ● Overall survival, ● Correlation between levels of circulating tumor DNA (ctDNA) clearance at post-treatment timepoints and 1-year disease-free survival in patients with positive/detectable ctDNA at baseline. ● Correlation of ctDNA dynamics (increase/decrease) across timepoints: Pre first dose dostarlimab (Day -21); Pre first dose niraparib (Day -14); Pre radiotherapy; At cycle 4 of maintenance; EOT and/or PD, and 1-year disease-free survival and secondary outcomes.

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Countries

Spain

Outcome results

None listed