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.

NCT06947928

Placebo-Controlled Trial of IFx-Hu2.0 Followed By Pembrolizumab In Checkpoint Inhibitor Naïve Participants With Advanced Or Metastatic Merkel Cell Carcinoma

Recruiting
PHASE2Ages 18+InterventionalTreatment
TuHURA Biosciences, Inc.
~118 participants
Updated 2026-04-17 on ClinicalTrials.gov
What's tested:IFx-Hu2.0PlaceboPembrolizumab

At a glance

Recruiting sites
18 of 18 listed sites are recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Objective response rate (ORR)
Measured over 12 weeks post-treatment initiation and confirmed on a second response assessment at least 28 days after the initial response assessment
Advanced Or Metastatic Merkel Cell Carcinoma

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.

  • Andrew S Brohl, MD · PRINCIPAL_INVESTIGATOR · Collaborator

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  • 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.