● Recruiting

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

Condition: Advanced Or Metastatic Merkel Cell Carcinoma · Sponsor: TuHURA Biosciences, Inc.

PhasePhase 2/Phase 3

Planned participants118

Who can joinAll sexes, 18 Years to no upper limit

Healthy volunteersNo

About this study

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.

This description comes directly from the study's public registry record.

Talk to the study team

Amit Pande, MD · 8138756600 · clinicaltrials@tuhurabio.com

Always discuss trial participation with your own doctor first.

Locations (18)

USC Norris Comprehensive Cancer Center	Los Angeles, California, United States	Recruiting
University of California San Francisco - Helen Diller Family Comprehensive Cancer Center	San Francisco, California, United States	Recruiting
Stanford Health Care - Skin Cancer Program	Stanford, California, United States	Recruiting
University of Colorado Hospital - Anschutz Cancer Pavilion	Aurora, Colorado, United States	Recruiting
Mayo Clinic Comprehensive Cancer Center	Jacksonville, Florida, United States	Recruiting
Sylvester Comprehensive Cancer Center	Miami, Florida, United States	Recruiting
Moffitt Cancer Center	Tampa, Florida, United States	Recruiting
Dana-Farber Cancer Institute	Boston, Massachusetts, United States	Recruiting
Mayo Clinic Comprehensive Cancer Center	Rochester, Minnesota, United States	Recruiting
Hackensack University Medical Center	Hackensack, New Jersey, United States	Recruiting
Atlantic Health System	Morristown, New Jersey, United States	Recruiting
East Carolina University	Greenville, North Carolina, United States	Recruiting

+ 6 more locations — full list on the registry record.

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Source record: clinicaltrials.gov/study/NCT06947928