Clinical Trials

A completed Phase 2 clinical trial sponsored by Merck Sharp & Dohme LLC evaluated the safety and efficacy of vicriviroc malate in combination with pembrolizumab for participants with advanced colorectal neoplasms. Overall, this industry-sponsored effort represents the documented clinical development evaluating target inhibition with this agent in advanced gastrointestinal oncology.

NCT Number Recruitment Conditions Sponsor/Collaborators Start Date Phases
NCT03631407 Completed
Colorectal Neoplasms
Merck Sharp & Dohme LLC
 2018-09-24 Phase 2

(data from https://clinicaltrials.gov, updated on 2024-05-22)

Check the Vicriviroc Malate product page for in-depth specifications, including solubility, stock solutions, MOA, and working concentrations.

Compliance for Clinical Use

Mechanism and Biochemical Profile

Vicriviroc malate acts as a potent antagonist of the CCR5 coreceptor, binding the receptor to inhibit GTPγS exchange, downstream intracellular calcium mobilization, and G-protein-coupled signaling. By blocking CCR5-mediated signal transduction and chemotactic cell migration, the compound interrupts chemokine-driven cellular pathways, providing a therapeutic rationale for its clinical evaluation in combination regimens for advanced colorectal neoplasms.

Appendix RUO and cGMP Quality Standards

Quality Dimension RUO (Research Use Only) cGMP (Current Good Manufacturing Practice)
Clinical Applicability Prohibited in human clinical trials or medical diagnostics. Mandatory for human clinical trials (Phase I–III) and therapies.
Regulatory Status Non-regulated grade; exempt from drug manufacturing laws. Legally enforced by health authorities (e.g., FDA, EMA, NMPA).
Facility Environment Unclassified analytical or research laboratories. Validated Cleanrooms (ISO Class 5–8) with continuous monitoring.
Quality Control Basic purity and activity testing. Rigorous safety release testing (Sterility, Endotoxin, Mycoplasma).
Process Validation Basic equipment calibration; no process validation required. Full qualification (IQ/OQ/PQ) and complete batch records.
Quality Assurance Vendor self-declared without required formal QMS. Mandatory QA/QC unit, Change Control, CAPA, and vendor audits.
Regulatory Impact High risk of IND rejection if used as a critical raw material. Required for IND/NDA filings, supported by Drug Master Files (DMF).

Footnotes

Regulatory Note: Governed by FDA (21 CFR Parts 210/211/312), EMA (EudraLex Vol 4), ICH Guidelines (E6/Q7/Q9/Q10), and compendial standards (USP <71>/<85>/<1043>).

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Note: Technical data last updated: Sep 1, 2026.