Placebo-Controlled Trial of IFx-Hu2.0 Followed By Pembrolizumab In Checkpoint Inhibitor Naïve Participants With Advanced Or Metastatic Merkel Cell Carcinoma (NCT06947928)
A Multicenter, Randomized, Double-Blind, Placebo-Controlled Trial of IFx-Hu2.0 as an Adjunctive Therapy to Pembrolizumab in Checkpoint-Inhibitor Naïve Participants With Advanced or Metastatic Merkel Cell Carcinoma
🩺 Plain-English Summary (8th-Grade Level)
This Phase 2/3, multicenter, randomized, double-blind, placebo-controlled trial will evaluate the Objective Response Rate (ORR) of IFx-Hu2.0 as an adjunctive therapy to pembrolizumab in adult participants (≥18 years) with advanced or metastatic Merkel Cell Carcinoma. A total of 118 participants will be randomized to receive either IFx-Hu2.0 or placebo via intralesional injection in a single lesion, followed by pembrolizumab.
Who can join: Review the eligibility criteria below.
Location: USC Norris Comprehensive Cancer Center — Los Angeles, California
Age range: 18 Years
🧪 Interventions in This Study
📋 "Do I Qualify?" — 1-Minute Self Screener
Instant ChecklistFull eligibility criteria are available on the official NIH protocol. View the criteria ↗
📍 All Participating Trial Locations (18 Sites)
- USC Norris Comprehensive Cancer Center — Los Angeles, California
- University of California San Francisco - Helen Diller Family Comprehensive Cancer Center — San Francisco, California
- Stanford Health Care - Skin Cancer Program — Stanford, California
- University of Colorado Hospital - Anschutz Cancer Pavilion — Aurora, Colorado
- Mayo Clinic Comprehensive Cancer Center — Jacksonville, Florida
- Sylvester Comprehensive Cancer Center — Miami, Florida
- Moffitt Cancer Center — Tampa, Florida
- Dana-Farber Cancer Institute — Boston, Massachusetts
- Mayo Clinic Comprehensive Cancer Center — Rochester, Minnesota
- Hackensack University Medical Center — Hackensack, New Jersey
- Atlantic Health System — Morristown, New Jersey
- East Carolina University — Greenville, North Carolina
- UPMC Hillman Cancer Center — Pittsburgh, Pennsylvania
- The University of Texas MD Anderson Cancer Center — Houston, Texas
- Inova Schar Cancer — Fairfax, Virginia
- Virginia Commonwealth University — Richmond, Virginia
- Fred Hutchinson Cancer Research Center — Seattle, Washington
- West Virginia University — Morgantown, West Virginia
📞 Contact the Study Coordinator
Phone: (813) 875-6600
Email: clinicaltrials@tuhurabio.com
Coordinator details come directly from the registered NIH protocol. Confirm the study is still recruiting before traveling.
💰 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 § 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.
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💡 How to Participate
- Check the checklist above to see if you may qualify.
- Contact the study coordinator using the phone/email above.
- Ask about the visit schedule, what is covered at no cost, and any travel support.
- Confirm with your own doctor before making a decision.