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
๐ฉบ 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
๐งช Interventions in This Study
๐ "Do I Qualify?" โ 1-Minute Self Screener
Instant ChecklistFull eligibility criteria are available on the official NIH protocol. View the criteria โ
๐ 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
๐ฐ 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.
More studies in Solid Tumor
- A Safety And Efficacy Study Of HLA-G- Targeted CAR-T Cells IVS-3001 In Subjects With Previously Treated Advanced HLA-G-Positive Solid Tumors โ Houston, Texas
- A Study of AZD1390 and Stereotactic Body Radiotherapy (SBRT) for People With Metastatic Solid Tumor Cancer โ Middletown, New Jersey
- A Study of RP-3500 in Combination With Standard Radiation Therapy in People With Solid Tumor Cancer โ Basking Ridge, New Jersey
- Study of PD1 Blockade by Pembrolizumab With Stereotactic Body Radiotherapy in Advanced Solid Tumors โ Chicago, Illinois
- A Study Evaluating DS-1055a in Participants With Relapsed or Refractory Locally Advanced or Metastatic Solid Tumors โ New York, New York
- Concurrent Azeliragon With Craniospinal Irradiation โ New York, New York
Explore by condition: All Solid Tumor clinical trials
๐ก How to Participate
- Check the checklist above to see if you may qualify.
- Review the official NIH record below to find the coordinating site.
- Ask about the visit schedule, what is covered at no cost, and any travel support.
- Confirm with your own doctor before making a decision.