IFx-Hu2.0 and Pembrolizumab for Advanced Merkel Cell Carcinoma
This study is testing a new treatment for advanced or metastatic Merkel cell carcinoma, a type of skin cancer. It combines a drug called IFx-Hu2.0 with an existing immunotherapy drug, pembrolizumab. You would receive either IFx-Hu2.0 or a placebo (an inactive substance) injected directly into a tumor, followed by pembrolizumab given through an IV. The researchers want to see how many people respond to the treatment, specifically if their tumors shrink or disappear, which will be checked at 12 weeks and again at least 28 days later. To join, you must be at least 18 years old, have a life expectancy of at least six months, and have advanced or metastatic Merkel cell carcinoma that has come back or cannot be removed by surgery. The study is currently recruiting 118 participants.
- Study design
- This is a Phase 2/3, randomized, double-blind, placebo-controlled study involving 118 participants. This means participants are randomly assigned to receive either the study drug or a placebo, and neither you nor your doctors will know which you are receiving.
- What's involved
- You would receive injections of IFx-Hu2.0 or placebo into a tumor, followed by intravenous (IV) infusions of pembrolizumab. Your response to treatment will be assessed at 12 weeks and again at least 28 days later.
- Compensation
- Not stated in the trial record.
- Follow-up
- Your response to treatment will be assessed at 12 weeks after starting treatment and confirmed on a second assessment at least 28 days later.
AI-generated from the public study record. Only the study team can confirm whether you're eligible — confirm details with them before making decisions.
Placebo-Controlled Trial of IFx-Hu2.0 Followed By Pembrolizumab In Checkpoint Inhibitor Naïve Participants With Advanced Or Metastatic Merkel Cell Carcinoma
At a glance
Conditions
NCT06947928
Where you'd take part
This study runs at 18 sites. They're the same protocol — you choose where, and that choice sets who your contact draft is addressed to.
Atlantic Health System
Morristown, New Jerseystudy coordinator listed
Recruiting
Dana-Farber Cancer Institute
Boston, Massachusettsstudy coordinator listed
Recruiting
East Carolina University
Greenville, North Carolinastudy coordinator listed
Recruiting
Fred Hutchinson Cancer Research Center
Seattle, Washingtonstudy coordinator listed
Recruiting
Hackensack University Medical Center
Hackensack, New Jerseystudy coordinator listed
Recruiting
Inova Schar Cancer
Fairfax, Virginiastudy coordinator listed
Recruiting
Mayo Clinic Comprehensive Cancer Center
Jacksonville, Floridastudy coordinator listed
Recruiting
Mayo Clinic Comprehensive Cancer Center
Rochester, Minnesotastudy 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
- Objective response rate (ORR)12 weeks post-treatment initiation and confirmed on a second response assessment at least 28 days after the initial response assessment
ORR defined as the proportion of participants who achieve a complete response (CR) or partial response (PR) at 12 weeks and confirmed on a second response assessment at least 28 days after the initial response assessment, in the treatment arm based on BICR assessment according to RECIST v1.1. Confirmed response persisting at the time of response assessment, at approximately 24 weeks will constitute the data utilized for the endpoint analysis.