Source: REVAC-DXd_budget_v3.xlsx (31 October 2026). Low and high figures follow the minimal and maximal sample sizes (BOIN and Simon futility stops). Dato-DXd and rilvegostomig are supplied. AP-HP fees of 9% are applied to every line.
Per-patient costs: phase 1a and 1b 3,300 €; cohort A 12,800 € (including 10,000 € of EV on average); cohort B 12,800 € (including 10,000 € of primary radiotherapy on average); cohort C 3,550 €.
Fixed costs (158,000 € for the whole trial) are split three ways. Shared, incurred once whatever the parts (74,000 €): medical coordination, CTIS submission, eCRF licence, pharmacy circuits, URC set-up, miscellaneous, and half of project management, vigilance and data management. Part-specific: biostatistics, 2,500 € per part, and the extra data management, statistics and vigilance of phase 1b and cohort C, 12,500 € each. Scaled to patients (49,000 €): the other half of project management, vigilance and data management, and the independent safety review, in proportion to the patients of the parts selected.
With all four parts selected and no translational research, the total equals the spreadsheet: 974,515 € to 1,431,006 €.
Translational research, optional: pharmacokinetics of the four molecules, 250 k€, and ctDNA in urine and plasma, 300 k€, both all-in envelopes for the full trial, scaled to the patients of the parts selected. Tissue biomarkers from the spreadsheet: IHC panel and RNA-seq on two tissue samples per patient in phase 1 and cohort A, one in cohorts B and C, central pathology review and shipping, plus bioinformatics and statistics (20–40 k€), with 9% AP-HP fees. TROP2 QCS-NMR is proposed in kind by Daiichi Sankyo / AstraZeneca.
REVAC-DXd
