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Personally I am very worry what will happen to these patients with elevated PD-L1 , if protocol will not be amended..

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The primary outcome measure in the trial is overall response rate. The secondary outcomes that are of interest -

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To assess the duration of response of leronlimab in combination with trifluridine and tipiracil + bevacizumab in participants with CCR5+, MSS, mCRC

The time from the first documentation of response, either partial or complete, to the documentation of the objective tumor progression or until death due to any cause.

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Once a patient has progression all outcomes will have been answered to the satisfaction of the FDA. The Data Safety Management Board can recommend that all patients who show progression be moved over to a leronlimab + PD-L1 inhibitor treatment. The turn-arounds from using the combo will firmly establish the importance of adding a PD-L1 inhibitor to the mix.