CPI-006 vs Oleclumab

NCT03454451 · Phase 1 · completed

Although the registry labels the allocation as randomized, none of the six groups received a placebo or an inactive comparator, and there was no blinding, so this functions as an open-label dose-escalation and combination study rather than a controlled comparison. The main goals were safety, tolerated dose, and drug levels. Registry results were not posted at the time of grading; the key result shown was recovered from the cited external source.

NCT03822351 · Phase 2 · completed

Participants were randomized among three treatment groups, including durvalumab monotherapy as the comparator, but the study was open-label rather than blinded; 60 participants received durvalumab plus oleclumab and 67 received durvalumab alone. The clinical primary endpoint, RECIST 1.1 objective response rate, was numerically higher with oleclumab, but statistical significance of the comparison was not reported, so the result remains unclear.