Title
IFx-Hu2.0 as an Adjunctive Therapy to Pembrolizumab in Checkpoint Inhibitor Naïve Subjects With Advanced or Metastatic Merkel Cell Carcinoma

Description
IFx-Hu2.0 As An Adjunctive Therapy To Pembrolizumab In Checkpoint Inhibitor Naïve Subjects With Advanced Or Metastatic Merkel Cell Carcinoma

Objective
Primary:
To evaluate safety and feasibility of visceral administration of IFx-Hu2.0, as an adjunctive therapy, followed by pembrolizumab for the treatment of CPI naïve adult subjects with advanced or metastatic MCC.
Secondary:
To evaluate preliminary efficacy of visceral administration of IFx-Hu2.0, as an adjunctive therapy, followed by pembrolizumab for the treatment of CPI naïve adult subjects with advanced or metastatic MCC.

Treatment This Phase 1, multicenter, open-label trial will assess the safety and feasibility of IFx-Hu2.0 as adjunctive therapy to pembrolizumab in adult patients (≥18 years) with non-cutaneous Merkel Cell Carcinoma. Nine subjects will receive IFx-Hu2.0 as a visceral lesion injection in a single lesion followed by pembrolizumab.

Key Eligibility 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.

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).

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 visceral injectable lesion equal to or greater than 3 mm



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.

Applicable Disease Sites
Melanoma/Skin cancer

Participating Institutions
UW Health Eastpark Medical Center; UW Health University Hospital