Trial · NCT06699836
CLOVER - CCR5-targeting Leronlimab With Oral Chemotherapy and VEGF-inhibitor Enriched Regimen
NCT06699836, Phase 2, Active not recruiting, CytoDyn, Inc.
3 sourcestrials-2026-11-12-0.4.0
Cite this record
ConductScience Library. CLOVER - CCR5-targeting Leronlimab With Oral Chemotherapy and VEGF-inhibitor Enriched Regimen. Trials, record NCT06699836. Release trials-2026-11-12-0.4.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT06699836
On this page
Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- CLOVER - CCR5-targeting Leronlimab With Oral Chemotherapy and VEGF-inhibitor Enriched Regimen
- NCT number
- NCT06699836
- Status
- Active not recruiting
- Phases
- Phase 2
- Enrollment
- 66 participants, actual
- Lead sponsor
- CytoDyn, Inc.
- Conditions
- Metastatic Colorectal Cancer (mCRC)
- Interventions
- 350 mg leronlimab, 700 mg leronlimab, 200 mg pembrolizumab
- First posted
- 2024-11-21
- Last updated
- 2026-09-09
Source ClinicalTrials.gov
Registered outcomes15
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | The efficacy of leronlimab in combination with trifluridine and tipiracil + bevacizumab in participants with relapsed, refractory, MSS, mCRC. | From enrolment through end of treatment at 12 months | Efficacy will be measured as the effect on objective response rate (ORR) of leronlimab when used in combination with trifluridine and tipiracil + bevacizumab in patients with relapsed, refractory, MSS, mCRC. ORR is defined as the proportion of subjects with the best overall response (BOR) or confirmed CR or confirmed PR according to RECIST v1.1. |
| Secondary | The efficacy of leronlimab in combination with pembrolizumab in participants with MSS, mCRC who have documented progressive disease (PD) during the initial treatment period of the study. | From initiation of treatment in the leronlimab plus pembrolizumab cohort through end of treatment, up to 48 weeks. | Efficacy will be measured as the effect on objective response rate (ORR) of leronlimab when used in combination with pembrolizumab in participants with MSS, mCRC who entered the leronlimab plus pembrolizumab cohort. ORR is defined as the proportion of subjects with the best overall response (BOR) or confirmed CR or confirmed PR according to RECIST v1.1. |
| Secondary | Assessment of safety and tolerability of leronlimab when used in combination with trifluridine and tipiracil + bevacizumab or in combination with pembrolizumab in patients with relapsed, refractory, MSS, mCRC. | From enrollment through end of treatment, up to approximately 24 months. | Treatment Emergent AE's (TEAE) are defined as events with an onset on or after the first treatment. TEAEs will be summarized by treatment group, System Organ Class, and preferred term. The following TEAE summaries will be provided: * All TEAEs * TEAEs related to study drug. * All TEAEs by severity * Serious TEAEs * Serious TEAEs related to study drug. * TEAE reported in 5% or more participants in any treatment group. * TEAEs leading to discontinuation of study treatment. * TEAEs leading to interruption of study treatment. * TEAEs leading to death. |
| Secondary | Assessment of the duration of response (DOR) of leronlimab in combination with trifluridine and tipiracil + bevacizumab and leronlimab in combination with pembrolizumab in participants with relapsed, refractory, MSS, mCRC. | From enrolment through end of treatment, up to 48 weeks. | 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. |
| Secondary | Assessment of PK parameters of leronlimab during the 12-month treatment period. | From enrolment through end of treatment at 12 months. | PK parameters will be calculated following multiple dosing during the Treatment Period (12 months) and will include the following: * Cmax, Tmax, AUC0-168, AUC0-last, and AUC0-τ, trough concentrations * AUC0-inf, t1/2, CL/F, and Vz/F. |
| Secondary | Evaluation of immunogenicity of leronlimab during treatment period and follow-up. | From enrolment through 12 months and approximately 30 days post treatment follow-up. | Incidence of Anti-Drug-Antibodies from pre-dose baseline through 52 weeks of treatment and approximately 30 days post treatment during follow-up. Incidence of Neutralizing Antibodies from pre-dose baseline through 52 weeks of treatment and approximately 30 days post treatment during follow-up. |
| Secondary | Assessment of the DCR (disease control rate) per RECIST criteria (v1.1) for leronlimab in combination with trifluridine and tipiracil + bevacizumab and with pembrolizumab of patients with relapsed, refractory, mCRC. | From enrolment through end of treatment at 24 months. | The proportion of participants with complete response (CR), partial response (PR), or stable disease (SD) lasting at least 6 weeks as their best overall response during treatment, as determined according to RECIST v1.1. |
| Secondary | Assessment of individual progression free survival (PFS). | From first treatment through end of study (up to 160 weeks) | Time from the date of first treatment to the first documented objective radiographic tumor progression per RECIST v1.1 or death from any cause, whichever occurs first. |
| Secondary | Assessment of individual overall survival (OS). | From first treatment through end of study (up to 160 weeks). | Time from date of first treatment until death from any cause. |
| Other | Exploratory biomarkers correlating with clinical response. | From baseline through week 52 and approximately 30 days post-treatment follow-up. | Measurement of serum CCL2, CCL3, CCL4, and CCL5 levels and evaluation of change from baseline, and assessment of their association with clinical response to study treatment. |
1 to 10 of 15Source ClinicalTrials.gov
See all 15 registered outcomesOutcomes0
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
None in this release.
Results by group0
Each measurement the trial posted, group by group, in the words and numbers it posted.
None in this release.
Participant flow0
How many started, completed or left each group, period by period.
None in this release.
Adverse events0
Each adverse event the trial posted, group by group: the participants affected out of those at risk.
None in this release.
Adverse event totals0
The totals the trial posted for each group.
None in this release.
Papers0
The papers the trial lists on ClinicalTrials.gov.
None in this release.
Grants0
The grants NIH RePORTER links to the trial, newest funded first: NIH's, and some of AHRQ's, CDC's, FDA's and VA's. Each shows its title, principal investigators, organization and funder in its newest year.
None in this release.
Trial comparisons0
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
None in this release.
Tests0
The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.
None in this release.
Source
- Release
- trials-2026-11-12-0.4.0
- Release manifest SHA-256
- 0f4a8d8c48aee2a7573ae0fa94ecbeab70c1adbe449bbc95c424bc7d3e97b9d4
- Registry capture
- 2026-11-12
- Results copy, AACT
- 2026-03-23
- NIH clinical studies file
- 2026-11-13
Source ClinicalTrials.gov
Sources 3
- ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
- ClinicalTrials.govNone stated
- NIH RePORTER's clinical studies and project filesPublic domain
Each source's terms
- ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299
- ClinicalTrials.govnone stated
- NIH RePORTER's clinical studies and project filesPublic domain (NIH RePORTER)
ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.
For software
Read this trial from software.
The record and each of its lists are JSON, twenty rows a page. No key.
GET https://conductscience.org/api/trials/v1/NCT06699836
GET https://conductscience.org/api/trials/v1/NCT06699836/registered