IFx-Hu2.0 As An Adjunctive Therapy To Pembrolizumab In Advanced Or Metastatic Merkel Cell Carcinoma (MCC)

Launched by TUHURA BIOSCIENCES, INC. · Apr 18, 2025

Keywords

ClinConnect Summary

This clinical trial is investigating a new treatment called IFx-Hu2.0 to see how safe and effective it is when combined with another medication called pembrolizumab for adults with advanced or metastatic Merkel Cell Carcinoma (MCC), a rare and aggressive form of skin cancer. The trial will involve nine participants who will receive an injection of IFx-Hu2.0 directly into a tumor, followed by treatment with pembrolizumab. The main goal is to assess how well this combination works and whether it can be safely given to patients.

To be eligible for this trial, participants must be at least 18 years old, have a life expectancy of six months or more, and have measurable cancer that has not responded to previous treatments. They should not have had any prior immunotherapy, and they must provide a biopsy sample for testing. Participants will be monitored closely throughout the trial, and while it is not yet recruiting, those interested should be aware that certain health conditions may prevent them from joining. This trial offers a potential new option for patients with this challenging disease, and those who qualify will receive careful medical oversight during the study.

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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. Active disease measurable by CT or MRI, measurable lesions are lesions that can be accurately measured in at least one dimension (longest diameter in the plane of measurement is to be recorded).
• • 5. 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
• • a. Must have at least one visceral injectable lesion equal to or greater than 3 mm
• • 6. Subject should be CPI naïve i.e., no prior therapy with CPI including but not limited to Pembrolizumab, avelumab, ipilimumab, nivolumab.
• • 7. 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.
• • 8. 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. Subjects with active brain metastases, with the exception of treated brain metastases that have imaging proving stability at least 4 weeks after treatment, no new metastases, and not requiring steroids.
• • 3. Subjects with recurrent resectable MCC
• • 4. Subjects who have received 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 subjects 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 IFx-Hu2.0 administration. Inhaled or topical steroids are permitted in the absence of active autoimmune disease.