durvalumab plus tremelimumab (n=119) vs. BSC (n=61)
randomized controlled trial
durvalumab plus tremelimumab and BSC
75 mg of tremelimumab intravenously every 4 weeks for the initial 4 cycles only, durvalumab 1500 mg of intravenously every 4 weeks and BSC
BSC
No crossover was allowed between treatment groups
mCRC - 2nd line (L2)
Received a prior thymidylate synthase inhibitor (e.g. 5-fluorouracil (5-FU), capecitabine, raltitrexed, UFT) for metastatic disease or as adjuvant therapy.
open label
27 cancer centers across Canada
P2/ two sided (10%) No interim analysis. No specific statistic plan for secondary endpoint, but treshold at 10%
This phase 2 study suggests that combined immune checkpoint inhibition with durvalumab plus tremelimumab may be associated with prolonged OS in patients with advanced refractory CRC