IFx-Hu2.0 with Pembrolizumab for Advanced Merkel Cell Carcinoma
This study is testing a new combination treatment for advanced or metastatic Merkel Cell Carcinoma (a rare and aggressive skin cancer). It combines IFx-Hu2.0, which is an innate immune agonist (a drug that stimulates your body's natural defenses), with pembrolizumab, an immunotherapy (a drug that helps your immune system fight cancer). Researchers want to see how safe and practical this combination is. You might be able to join if you are at least 18 years old, have a life expectancy of six months or more, and have measurable disease. The study will look at safety and feasibility 28 days after the last dose of IFx-Hu2.0. This study is currently recruiting a small number of participants.
- Study design
- This is a Phase 1, multicenter, open-label study involving 9 participants. It is designed to evaluate the safety and feasibility of the treatment combination.
- What's involved
- Participants will receive IFx-Hu2.0 as an injection into a tumor, followed by pembrolizumab. The specific schedule of visits and tests is not detailed in the record.
- Compensation
- Not stated in the trial record.
- Follow-up
- Safety and feasibility will be measured 28 days from the last dose of IFx-Hu2.0.
AI-generated from the public study record. Only the study team can confirm whether you're eligible — confirm details with them before making decisions.
IFx-Hu2.0 As An Adjunctive Therapy To Pembrolizumab In Advanced Or Metastatic Merkel Cell Carcinoma (MCC)
At a glance
Conditions
NCT06940440
Where you'd take part
This study runs at 2 sites. They're the same protocol — you choose where, and that choice sets who your contact draft is addressed to.
H. Lee Moffitt Cancer Center and Research Institute
Tampa, Floridastudy coordinator listed
Recruiting
University of Wisconsin Carbone Cancer Center
Madison, Wisconsinstudy coordinator listed
Recruiting
Sites open and close at different times, so the status above is per site — it can differ from the study's overall status.
Study leadership
- Andrew S Brohl, MD · PRINCIPAL_INVESTIGATOR · Collaborator
Who to contact
Opens a ready-to-send draft in your own email app — review before sending.
What this trial measures
- Safety28 days from last dose of IFx-Hu2.0
Safety is defined as the absence of any grade 3-5, treatment-related Adverse Events (AEs) per Common Terminology Criteria for Adverse Events (CTCAE) v5.0 from first injection Day 1 to 28-day follow-up after the final dose of IFx-Hu2.0.
- Feasibility28 days from last dose of IFx-Hu2.0
Feasibility is defined as the ability to treat ≥50% of subjects (i.e. 5/9) in the per-protocol analysis.