Status:
RECRUITING
Placebo-Controlled Trial of IFx-Hu2.0 Followed By Pembrolizumab In Checkpoint Inhibitor Naïve Participants With Advanced Or Metastatic Merkel Cell Carcinoma
Lead Sponsor:
TuHURA Biosciences, Inc.
Conditions:
Advanced Or Metastatic Merkel Cell Carcinoma
Eligibility:
All Genders
18+ years
Phase:
PHASE2
PHASE3
Brief 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 particip...
Eligibility Criteria
Inclusion
- At least 18 years of age.
- Life expectancy equal to or greater than six months.
- Eastern Cooperative Oncology Group (ECOG) Performance Status \< 2.
- Must be recurrent and/or unresectable Stage III or Stage IV American Joint Committee on Cancer (AJCC) (8th edition) and have histologically confirmed Merkel cell carcinoma
- Must have at least one injectable lesion equal to or greater than 3 mm.
- Must have measurable disease as defined by RECIST v1.1.
- Participants should be CPI naïve i.e., no prior therapy with CPI including but not limited to Pembrolizumab, avelumab, ipilimumab, nivolumab.
- Tumor tissue from an archival core biopsy or resected site of disease must be provided for biomarker analyses. If archival tissue is not available, then a new biopsy should be performed.
- Adequate hematological, hepatic, and renal function according to laboratory ranges and medical criteria defined within the study protocol.
Exclusion
- Uncontrolled intercurrent illness including, but not limited to, ongoing or active infection, symptomatic congestive heart failure, unstable angina pectoris, cardiac arrhythmia, or psychiatric illness/social situations that would limit compliance with protocol requirements.
- Participants with known active brain metastases with the exception of treated brain metastases that have imaging proving stability at least 4 weeks prior to the start of study treatment, no new metastases, and not requiring steroids.
- Participants with recurrent resectable MCC
- Participants with prior systemic chemotherapy
- Pregnant or breastfeeding females and females desiring to become pregnant or breastfeed within the timeframe of this study.
- Active, known, or suspected autoimmune disease. Potential Participants with type I diabetes mellitus, residual hypothyroidism due to autoimmune thyroiditis only requiring hormone replacement, skin disorders (such as vitiligo, psoriasis, or alopecia) not requiring systemic treatment are permitted to enroll. Low-grade autoimmune toxicity is NOT an exclusion under this criterion.
- A condition requiring systemic treatment with either corticosteroids (\> 10 mg daily prednisone equivalent) or other immunosuppressive medications within 14 days of randomization. Inhaled or topical steroids are permitted in the absence of active autoimmune disease.
Key Trial Info
Start Date :
October 1 2025
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
December 30 2032
Estimated Enrollment :
118 Patients enrolled
Trial Details
Trial ID
NCT06947928
Start Date
October 1 2025
End Date
December 30 2032
Last Update
October 14 2025
Active Locations (8)
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1
USC Norris Comprehensive Cancer Center
Los Angeles, California, United States, 90033
2
Stanford Health Care - Skin Cancer Program
Palo Alto, California, United States, 94304
3
University of California San Francisco - Helen Diller Family Comprehensive Cancer Center
San Francisco, California, United States, 94143
4
Dana-Farber Cancer Institute
Boston, Massachusetts, United States, 02215