Clinical trial NCT06947928: Placebo-Controlled Trial of IFx-Hu2.0 Followed By Pembrolizumab In Checkpoint Inhibitor Naïve Patients With Advanced Or Metastatic Merkel Cell Carcinoma
Official title: A Multicenter, Randomized, Double-Blinded, Placebo-Controlled Trial of IFx-Hu2.0 Followed By Pembrolizumab In Checkpoint Inhibitor Naïve Patients With Advanced Or Metastatic Merkel Cell Carcinoma
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: PHASE2
PHASE3
Conditions: Advanced Or Metastatic Merkel Cell Carcinoma
Keywords: Merkel Cell Carcinoma
Advanced
Metastatic
MCC
pembrolizumab
Innate Immune Agonist
Skin Cancer
Lead sponsor: TuHURA Biosciences, Inc.
Sponsor class: INDUSTRY
First posted: 2025-04-27
Enrollment: 118
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: This Phase 2/3, multicenter, randomized, double-blind, placebo-controlled trial will evaluate Objective Response Rate (ORR) of IFx-Hu2.0 as an adjunctive therapy to pembrolizumab in adult patients (≥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 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. Subject 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. 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 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 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 randomization. Inhaled or topical steroids are permitted in the absence of active autoimmune disease.

Primary outcomes:
measure: Objective response rate (ORR)
timeFrame: 12 weeks post-treatment initiation and confirmed on a second response assessment at least 28 days after the initial response assessment
Secondary outcomes:
measure: Progression free survival (PFS)
timeFrame: up to 5 years
Other outcomes:
Locations:
Study officials:
affiliation: Collaborator
name: Andrew S Brohl, MD
role: PRINCIPAL_INVESTIGATOR
References: