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IFx-Hu2.0 with pembrolizumab for 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

Phase2; Phase3 Interventional TuHURA Biosciences, Inc. · NCT06947928

This will test whether injecting IFx-Hu2.0 into a tumor before giving pembrolizumab helps adults with advanced or metastatic Merkel cell carcinoma respond better than pembrolizumab alone.

Quick facts

PhasePhase2; Phase3
Study typeInterventional
Enrollment118 (estimated)
Ages18 Years and up
SexAll
SponsorTuHURA Biosciences, Inc. Industry-sponsored
Drugs / interventionsPembrolizumab, avelumab, ipilimumab, nivolumab, chemotherapy, prednisone
Locations18 sites (Los Angeles, California and 17 other locations)
Trial IDNCT06947928 on ClinicalTrials.gov

What this trial studies

This is a Phase 2/3, multicenter, randomized, double-blind, placebo-controlled trial enrolling 118 adult participants with unresectable or metastatic Merkel cell carcinoma. Participants will be randomized to receive intralesional IFx-Hu2.0 or placebo in a single lesion, followed by systemic pembrolizumab, with response measured by RECIST v1.1. All participants must be checkpoint-inhibitor–naïve, have measurable disease and provide tumor tissue for biomarker analysis. The primary efficacy endpoint is objective response rate, and safety and biomarker correlates will also be collected.

Who should consider this trial

Good fit: Adults (≥18) with recurrent or unresectable Stage III/IV Merkel cell carcinoma who are checkpoint-inhibitor–naïve, have at least one injectable lesion ≥3 mm and measurable disease, and meet ECOG and organ-function requirements.

Not a fit: Patients who have previously received checkpoint inhibitors, lack an injectable lesion, have poor performance status, or have a life expectancy under six months are unlikely to benefit from this trial.

Why it matters

Potential benefit: If successful, adding IFx-Hu2.0 could increase response rates and durability of response to pembrolizumab for people with advanced Merkel cell carcinoma.

How similar studies have performed: PD-1/PD-L1 inhibitors have established activity in Merkel cell carcinoma, but intralesional IFx-Hu2.0 is a novel adjunctive approach with limited published data in this disease.

Eligibility criteria

Show full inclusion / exclusion 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.

Where this trial is running

Los Angeles, California and 17 other locations

Study contacts

How to participate

  1. Review the eligibility criteria above with your treating physician.
  2. Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
  3. Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.
View on ClinicalTrials.gov → Find more trials like this →
Conditions Advanced Or Metastatic Merkel Cell CarcinomaMerkel Cell CarcinomaAdvancedMetastaticMCCpembrolizumabInnate Immune AgonistSkin Cancer
Last reviewed 2026-06-13 by the Find a Trial editorial team. Information on this page is for educational purposes and is not medical advice. Always consult qualified healthcare professionals about clinical trial participation.