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Table 1 Treatment Arms in the WIRE trial. bd: twice daily, IMP: Investigational Medicinal Product, i.v.: intravenous, od: once daily. Dose reductions permissible in case of toxicity

From: The WIRE study a phase II, multi-arm, multi-centre, non-randomised window-of-opportunity clinical trial platform using a Bayesian adaptive design for proof-of-mechanism of novel treatment strategies in operable renal cell cancer – a study protocol

Arm

IMP

Dosing, Stopping and Dose Adjustments

1

Cediranib

20 mg oral od, until 36 h before surgery, single reduction to 15 mg od

2

Cediranib + Olaparib

Cediranib 20 mg oral od and Olaparib 300 mg oral bd, stopping and dose adjustments as in single-agent arms

3

Olaparib

300 mg oral bd, until morning of surgery, two reductions to 250 mg bd and 200 mg bd

4

Durvalumab

1500 mg i.v. (single infusion)

5

Olaparib + Durvalumab

Olaparib 300 mg oral bd and Durvalumab 1500 mg i.v. (single infusion). Stopping and dose adjustment for Olaparib as in single-agent arm above.

  1. bd twice daily, od once daily, i.v. intravenous