RecruitingPhase 2Phase 3NCT06947928

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

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

Sponsor

TuHURA Biosciences, Inc.

Enrollment

118 participants

Start Date

Dec 11, 2025

Study Type

INTERVENTIONAL

Conditions

Advanced Or Metastatic Merkel Cell Carcinoma

Summary

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.

Eligibility

Min Age: 18 Years

Plain Language Summary

Simplified for easier understanding

This study is testing whether a new drug called IFx-Hu2.0, injected directly into tumors, can prime the immune system to respond better to pembrolizumab (an immunotherapy checkpoint inhibitor) in people with advanced Merkel cell carcinoma — a rare and aggressive form of skin cancer — who have never received checkpoint immunotherapy before. **You may be eligible if...** - You are at least 18 years old - You have confirmed Stage III or Stage IV Merkel cell carcinoma that has come back or cannot be surgically removed - You have not previously received checkpoint immunotherapy (such as pembrolizumab, nivolumab, or avelumab) - You have at least one tumor that can be injected that is 3 mm or larger - You have measurable disease on scans - You are in good physical condition (ECOG score below 2) with a life expectancy of at least 6 months **You may NOT be eligible if...** - You have previously received checkpoint immunotherapy - Your tumors are not injectable - You have significant autoimmune conditions or are on immunosuppressants - Your organ function is insufficient for treatment Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

DRUGIFx-Hu2.0

Therapeutic Classification: • Innate immune agonist Route of Administration: • Intralesional

DRUGPlacebo

Route of Administration: • Intralesional

DRUGPembrolizumab

Therapeutic Classification: • Immunotherapy (Immune checkpoint inhibitor) Route of administration: • Intravenous (IV) infusion

Locations(18)

USC Norris Comprehensive Cancer Center

Los Angeles, California, United States

University of California San Francisco - Helen Diller Family Comprehensive Cancer Center

San Francisco, California, United States

Stanford Health Care - Skin Cancer Program

Stanford, California, United States

University of Colorado Hospital - Anschutz Cancer Pavilion

Aurora, Colorado, United States

Mayo Clinic Comprehensive Cancer Center

Jacksonville, Florida, United States

Sylvester Comprehensive Cancer Center

Miami, Florida, United States

Moffitt Cancer Center

Tampa, Florida, United States

Dana-Farber Cancer Institute

Boston, Massachusetts, United States

Mayo Clinic Comprehensive Cancer Center

Rochester, Minnesota, United States

Hackensack University Medical Center

Hackensack, New Jersey, United States

Atlantic Health System

Morristown, New Jersey, United States

East Carolina University

Greenville, North Carolina, United States

UPMC Hillman Cancer Center

Pittsburgh, Pennsylvania, United States

The University of Texas MD Anderson Cancer Center

Houston, Texas, United States

Inova Schar Cancer

Fairfax, Virginia, United States

Virginia Commonwealth University

Richmond, Virginia, United States

Fred Hutchinson Cancer Research Center

Seattle, Washington, United States

West Virginia University

Morgantown, West Virginia, United States

View Full Details on ClinicalTrials.gov

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NCT06947928

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