Placebo-Controlled Trial of IFx-Hu2.0 Followed By Pembrolizumab In Checkpoint Inhibitor Naïve Par… (NCT06947928) | Clinical Trial Compass
RecruitingPhase 2/3
Placebo-Controlled Trial of IFx-Hu2.0 Followed By Pembrolizumab In Checkpoint Inhibitor Naïve Participants With Advanced Or Metastatic Merkel Cell Carcinoma
United States118 participantsStarted 2025-12-11
Plain-language 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.
Who can participate
Age range18 Years
SexALL
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Inclusion criteria
✓. 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.
Exclusion criteria
✕. 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.
What they're measuring
1
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
✕. 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.