NCT06947928 Placebo-Controlled Trial of IFx-Hu2.0 Followed By Pembrolizumab In Checkpoint Inhibitor Naïve Participants With Advanced Or Metastatic Merkel Cell Carcinoma
| NCT ID | NCT06947928 |
| Status | Recruiting |
| Phase | Phase 2, Phase 3 |
| Sponsor | TuHURA Biosciences, Inc. |
| Condition | Advanced Or Metastatic Merkel Cell Carcinoma |
| Study Type | INTERVENTIONAL |
| Enrollment | 118 participants |
| Start Date | 2025-12-11 |
| Primary Completion | 2027-03-31 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
In Phase 2, researchers evaluate early signs of effectiveness. You may be randomized to receive the active treatment or a comparator. Monitoring continues closely.
This trial targets 118 participants in total. It began in 2025-12-11 with a primary completion date of 2027-03-31.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
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 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 Criteria
Inclusion Criteria: 1. At least 18 years of age. 2. Life expectancy equal to or greater than six months. 3. Eastern Cooperative Oncology Group (ECOG) Performance Status \< 2. 4. 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 1. Must have at least one injectable lesion equal to or greater than 3 mm. 2. Must have measurable disease as defined by RECIST v1.1. 5. Participants should be CPI naïve i.e., no prior therapy with CPI including but not limited to Pembrolizumab, avelumab, ipilimumab, nivolumab. 6. 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. 7. Adequate hematological, hepatic, and renal function according to laboratory ranges and medical criteria defined within the study protocol. Exclusion Criteria: 1. 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. 2. 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. 3. Participants with recurrent resectable MCC 4. Participants with prior systemic chemotherapy 5. Pregnant or breastfeeding females and females desiring to become pregnant or breastfeed within the timeframe of this study. 6. 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. 7. 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.
Contact & Investigator
Andrew S Brohl, MD
PRINCIPAL INVESTIGATOR
Collaborator
Frequently Asked Questions
Who can join the NCT06947928 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, studying Advanced Or Metastatic Merkel Cell Carcinoma. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
What phase is the NCT06947928 trial and what does that mean for participants?
Phase 2 trials evaluate whether the treatment shows signs of effectiveness while continuing to monitor safety. More participants are enrolled than in Phase 1 to help refine the treatment protocol.
Is NCT06947928 currently recruiting?
Yes, NCT06947928 is actively recruiting participants. Contact the research team at clinicaltrials@tuhurabio.com for enrollment information.
Where is the NCT06947928 trial being conducted?
This trial is being conducted at Los Angeles, United States, San Francisco, United States, Stanford, United States, Aurora, United States and 11 additional locations.
Who is sponsoring the NCT06947928 clinical trial?
NCT06947928 is sponsored by TuHURA Biosciences, Inc.. The principal investigator is Andrew S Brohl, MD at Collaborator. The trial plans to enroll 118 participants.