NCT06699836

CLOVER - CCR5-targeting Leronlimab With Oral Chemotherapy and VEGF-inhibitor Enriched Regimen

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Registry fields

Overall status
ACTIVE_NOT_RECRUITING
Conditions
Metastatic Colorectal Cancer (mCRC)
Study type
INTERVENTIONAL
Phase
PHASE2
Primary purpose
TREATMENT
Intervention type
DRUG
Interventions
350 mg leronlimab, 700 mg leronlimab, 200 mg pembrolizumab
Lead sponsor
CytoDyn, Inc. (INDUSTRY)

Cached at: 2026-09-10 09:09:06

View on ClinicalTrials.gov

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 MSS, mCRC who have progressed on prior treatment, with optional open label leronlimab plus pembrolizumab cohort for participants who have documented disease progression during the initial treatment period of the study and who continue to meet the initial inclusion and exclusion criteria.

The main questions this study aims to answer are:

1. Can leronlimab, in combination with standard of care therapies trifluridine and tipiracil+ bevacizumab, increase the objective response rate in participants with MSS, mCRC who have progressed on prior treatment before participating in the study.
2. In participants who have documented progressive disease during the initial treatment period of the study, what is the objective response rate when leronlimab is administered in combination with pembrolizumab.
3. Is leronlimab safe and well tolerated when used in combination with trifluridine and tipiracil+ bevacizumab or in combination with pembrolizumab.

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