Actively Recruiting
Placebo-Controlled Trial of IFx-Hu2.0 Followed By Pembrolizumab In Checkpoint Inhibitor Naïve Participants With Advanced Or Metastatic Merkel Cell Carcinoma
Led by TuHURA Biosciences, Inc. · Updated on 2026-04-17
118
Participants Needed
18
Research Sites
368 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
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.
CONDITIONS
Official Title
Placebo-Controlled Trial of IFx-Hu2.0 Followed By Pembrolizumab In Checkpoint Inhibitor Naïve Participants With Advanced Or Metastatic Merkel Cell Carcinoma
Who Can Participate
Eligibility Criteria
You may qualify if you...
- At least 18 years of age
- Life expectancy of six months or longer
- Eastern Cooperative Oncology Group (ECOG) Performance Status less than 2
- Recurrent and/or unresectable Stage III or Stage IV Merkel cell carcinoma confirmed by biopsy
- At least one injectable lesion 3 mm or larger
- Measurable disease as defined by RECIST v1.1
- No prior treatment with checkpoint inhibitors including pembrolizumab, avelumab, ipilimumab, or nivolumab
- Availability of tumor tissue from biopsy or new biopsy for biomarker analysis
- Adequate blood, liver, and kidney function based on study medical criteria
You will not qualify if you...
- Uncontrolled illnesses such as active infections, symptomatic heart failure, unstable angina, cardiac arrhythmia, or psychiatric/social issues limiting study compliance
- Active brain metastases unless treated and stable for at least 4 weeks without new metastases and not needing steroids
- Recurrent resectable Merkel cell carcinoma
- Prior systemic chemotherapy treatment
- Pregnant or breastfeeding women or those planning pregnancy during the study
- Active or suspected autoimmune disease except for certain allowed conditions like type I diabetes, treated hypothyroidism, or mild skin disorders not needing systemic treatment
- Need for systemic corticosteroids over 10 mg prednisone equivalent or other immunosuppressive drugs within 14 days before randomization, except inhaled or topical steroids without active autoimmune disease
AI-Screening
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Trial Site Locations
Total: 18 locations
1
USC Norris Comprehensive Cancer Center
Los Angeles, California, United States, 90033
Actively Recruiting
2
University of California San Francisco - Helen Diller Family Comprehensive Cancer Center
San Francisco, California, United States, 94143
Actively Recruiting
3
Stanford Health Care - Skin Cancer Program
Stanford, California, United States, 94304
Actively Recruiting
4
University of Colorado Hospital - Anschutz Cancer Pavilion
Aurora, Colorado, United States, 80045
Actively Recruiting
5
Mayo Clinic Comprehensive Cancer Center
Jacksonville, Florida, United States, 32224
Actively Recruiting
6
Sylvester Comprehensive Cancer Center
Miami, Florida, United States, 33136
Actively Recruiting
7
Moffitt Cancer Center
Tampa, Florida, United States, 33612
Actively Recruiting
8
Dana-Farber Cancer Institute
Boston, Massachusetts, United States, 02215
Actively Recruiting
9
Mayo Clinic Comprehensive Cancer Center
Rochester, Minnesota, United States, 55905
Actively Recruiting
10
Hackensack University Medical Center
Hackensack, New Jersey, United States, 07601
Actively Recruiting
11
Atlantic Health System
Morristown, New Jersey, United States, 07960
Actively Recruiting
12
East Carolina University
Greenville, North Carolina, United States, 27834
Actively Recruiting
13
UPMC Hillman Cancer Center
Pittsburgh, Pennsylvania, United States, 15232
Actively Recruiting
14
The University of Texas MD Anderson Cancer Center
Houston, Texas, United States, 77384
Actively Recruiting
15
Inova Schar Cancer
Fairfax, Virginia, United States, 22031
Actively Recruiting
16
Virginia Commonwealth University
Richmond, Virginia, United States, 23298
Actively Recruiting
17
Fred Hutchinson Cancer Research Center
Seattle, Washington, United States, 98109
Actively Recruiting
18
West Virginia University
Morgantown, West Virginia, United States, 26506
Actively Recruiting
Research Team
A
Amit Pande, MD
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
QUADRUPLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
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