Adding checkpoint inhibitors is not a part of the protocol. The protocol was established in Nov 2024. (Citation required).
It appears the tracking of PD-L1 from mTNBC forward to this p.2 study has been initiated by us to further verify our MOA. And as it should be. I hope you’re not overly impatient. I think tracking PD-L1 is a grand place to be in our mss-CRC P.2 trial.
Here’s the study overview. As well as a detailed description. No mention of studying checkpoint inhibitors. Stop throwing shade please. Are you disappointed in this study?? Seriously. WTF. We may get to ICI in mss-CRC in some other FDA approved trial…say a p3, but this is where we are in the current p2 trial. Deal with it.
“Study Overview
Brief Summary
This is an open label, randomized, two arm, multi-center study to explore the effect of leronlimab on the overall response rate/ overall survival and safety and tolerability when used in combination with trifluridine and tipiracil + bevacizumab in patients with CCR5+, MSS, mCRC who have progressed on prior treatment before participating in the study. The main questions this study aims to answer are:
Can leronlimab, in combination with standard of care therapies trifluridine and tipiracil+ bevacizumab, increase the objective response rate in persons with CCR5+, MSS, mCRC who have progressed on prior treatment before participating in the study.
Is leronlimab safe and well tolerated in these subjects when used in combination with standard of care therapies trifluridine and tipiracil+ bevacizumab.”
Detailed Description
This is an open label, randomized, two arm, multi-center study to explore the effect of leronlimab on the overall response rate/ overall survival and the safety and tolerability when used in combination with trifluridine and tipiracil + bevacizumab in patients with CCR5+, MSS, relapsed refractory, mCRC who have been previously treated with fluoropyrimidine, oxaliplatin, and irinotecan-based chemotherapy, an anti-VEGF therapy, and, if RAS wild-type and medically appropriate, an anti-EGFR therapy.
This study will enroll approximately 60 participants, 30 participants in each of two arms evaluating either 350 mg or 700 mg of leronlimab, who are 18 years of age or older, with histologically confirmed metastatic colorectal cancer that is microsatellite stable (MSS) and CCR5+ (confirmed by an immunohistochemistry (IHC) assay). Participants will be randomized 1:1 to each arm, where approximately 30 participants will receive 350 mg of leronlimab + trifluridine and tipiracil + bevacizumab and approximately 30 will receive 700 mg of leronlimab + trifluridine and tipiracil + bevacizumab.
It appears the tracking of PD-L1 from mTNBC forward to this p.2 study has been initiated by us to further verify our MOA. And as it should be. I hope you’re not overly impatient. I think tracking PD-L1 is a grand place to be in our mss-CRC P.2 trial.
Here’s the study overview. As well as a detailed description. No mention of studying checkpoint inhibitors. Stop throwing shade please. Are you disappointed in this study?? Seriously. WTF. We may get to ICI in mss-CRC in some other FDA approved trial…say a p3, but this is where we are in the current p2 trial. Deal with it.
“Study Overview
Brief Summary
This is an open label, randomized, two arm, multi-center study to explore the effect of leronlimab on the overall response rate/ overall survival and safety and tolerability when used in combination with trifluridine and tipiracil + bevacizumab in patients with CCR5+, MSS, mCRC who have progressed on prior treatment before participating in the study. The main questions this study aims to answer are:
Can leronlimab, in combination with standard of care therapies trifluridine and tipiracil+ bevacizumab, increase the objective response rate in persons with CCR5+, MSS, mCRC who have progressed on prior treatment before participating in the study.
Is leronlimab safe and well tolerated in these subjects when used in combination with standard of care therapies trifluridine and tipiracil+ bevacizumab.”
Detailed Description
This is an open label, randomized, two arm, multi-center study to explore the effect of leronlimab on the overall response rate/ overall survival and the safety and tolerability when used in combination with trifluridine and tipiracil + bevacizumab in patients with CCR5+, MSS, relapsed refractory, mCRC who have been previously treated with fluoropyrimidine, oxaliplatin, and irinotecan-based chemotherapy, an anti-VEGF therapy, and, if RAS wild-type and medically appropriate, an anti-EGFR therapy.
This study will enroll approximately 60 participants, 30 participants in each of two arms evaluating either 350 mg or 700 mg of leronlimab, who are 18 years of age or older, with histologically confirmed metastatic colorectal cancer that is microsatellite stable (MSS) and CCR5+ (confirmed by an immunohistochemistry (IHC) assay). Participants will be randomized 1:1 to each arm, where approximately 30 participants will receive 350 mg of leronlimab + trifluridine and tipiracil + bevacizumab and approximately 30 will receive 700 mg of leronlimab + trifluridine and tipiracil + bevacizumab.
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