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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.
Enrollment
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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
Subject 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.
Adequate hematological, hepatic, and renal function according to laboratory ranges and medical criteria defined within the study protocol.
Exclusion criteria
Primary purpose
Allocation
Interventional model
Masking
118 participants in 2 patient groups, including a placebo group
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Central trial contact
James Bianco, MD
Data sourced from clinicaltrials.gov
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