๐Ÿ›๏ธ Verified NIH Record โ€ข Updated 2026-05-19

Phase 0 Master Protocol for CIVO Intratumoral Microdosing of Anti-Cancer Therapies (NCT04541108)

A Phase 0 Master Protocol Using the CIVOยฎ Platform to Evaluate Intratumoral Microdoses of Anti-Cancer Therapies in Patients With Solid Tumors

๐Ÿ”ต Active, Not Recruiting Early Phase1 ๐Ÿ’Š Investigational Drug / Biologic Sponsor: Presage Biosciences

๐Ÿฉบ Plain-English Summary (8th-Grade Level)

This is a multi-center, open-label Phase 0 Master Protocol designed to study the localized pharmacodynamics (PD) of anti-cancer therapies within the tumor microenvironment (TME) when administered intratumorally in microdose quantities via the CIVO device in patients with surface accessible solid tumors for which there is a scheduled surgical intervention. CIVO stands for Comparative In Vivo Oncology. Multiple substudies will include specified investigational agents and combinations to be evaluated.

Who can join: Review the eligibility criteria below.

Location: LSU Health Sciences Center - Shreveport โ€” Shreveport, Louisiana

Age range: 18 Years

๐Ÿ“‹ "Do I Qualify?" โ€” 1-Minute Self Screener

Instant Checklist

Full eligibility criteria are available on the official NIH protocol. View the criteria โ†—

๐Ÿ“ All Participating Trial Locations (9 Sites)

  • LSU Health Sciences Center - Shreveport โ€” Shreveport, Louisiana
  • Montefiore Medical Center โ€” The Bronx, New York
  • University of North Carolina โ€” Chapel Hill, North Carolina
  • UC Health โ€” Cincinnati, Ohio
  • Oregon Health & Science University (OHSU) โ€” Portland, Oregon
  • University of Pennsylvania โ€” Philadelphia, Pennsylvania
  • Sarah Cannon Research Institute โ€” Charleston, South Carolina
  • MUSC Hollings Cancer Center โ€” Charleston, South Carolina
  • University of Washington โ€” Seattle, Washington

๐Ÿ’ฐ Cost, Insurance & Patient Rights

  • 100% Free Items: The investigational treatment and protocol-required procedures are supplied at zero cost by the sponsor.
  • Routine Patient Care: Under federal law (ACA ยง 2709) and many state statutes, routine care costs are covered during participation.
  • Voluntary Participation: You may withdraw at any time without affecting your standard medical care.

Explore by condition: All Solid Tumor clinical trials

๐Ÿ’ก How to Participate

  1. Check the checklist above to see if you may qualify.
  2. Review the official NIH record below to find the coordinating site.
  3. Ask about the visit schedule, what is covered at no cost, and any travel support.
  4. Confirm with your own doctor before making a decision.
๐Ÿ›๏ธ View Official NIH Record โ†—