Clinical Trials

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).Prior radiation therapy and surgery will be allowed if there is active measurable disease burden.
• 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 as documented by a complete physical examination and imaging studies within 4 weeks prior to randomization.
    • Imaging studies must include a diagnostic CT scan of the involved disease sites including full body CT head, neck, torso, abdomen, pelvis, extremities and all known sites of resected disease and brain magnetic resonance (MRI) or CT (brain CT allowable if MRI is contraindicated or if there is no known history of resected brain lesions).
  • Must have measurable disease as defined by RECIST v1.1.
    •  Measurable lesions are lesions that can be accurately measured in at least one dimension with a minimum size of:
      • 10 mm by CT scan (CT scan slice thickness no greater than 5 mm)
      • 10 mm caliper measurement by clinical exam (lesions which cannot be accurately measured with calipers should be recorded as non-measurable).
• 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.
• Subject with histologically confirmed diagnosis of MCC including immunocytochemical (ICC) staining of cytokeratin 20 (CK-20), neuron-specific enolase (NSE) and neurofilament protein (NFP).
• Males and females of childbearing potential must agree to continuously use adequate contraception prior to study entry and for up to 4 months after the last dose of pembrolizumab. A female is of childbearing potential unless she has had a surgical procedure that would accomplish sterility such a bilateral tubal ligation, hysterectomy or has not had menses for the past 12 months.
• Females of childbearing potential must have a negative serum pregnancy test within one week prior to start of treatment.
• The entry laboratory criteria for subject eligibility must be less than or equal to Grade 1 adverse event levels for the parameters tested as defined by CTCAE v5.0
  • Bone Marrow Function:
    • Hemoglobin (Hb) ≥ 9.0 g/dL
    • White Blood Cell Count (WBC) > LLN - 3,000 cells/mcL
    • Platelet count (PLT) > LLN - 75,000 /mcL
  • Blood Coagulation Parameters:
    • PT, INR < 1.5 x institutional ULN unless subject is therapeutically anticoagulated.
    • If on anticoagulation PT/INR need to be within appropriate anticoagulation limits for the clinical indication. Subjects who are receiving anticoagulants may participate in the trial if their anticoagulation can be stopped safely for several days at the time of biopsy.
  • Renal Function:
    • Serum Creatinine (SCr) ≤ 1 - 1.5 x ULN
  • Hepatic Function:
    • Blood bilirubin ≤ 1 - 1.5 x ULN
    • Serum Alanine Aminotransferase (ALT) ≤ 1 - 3 x ULN
    • Serum Aspartate Aminotransferase (AST) ≤ 1 - 3 x ULN
    • Alkaline Phosphatase (ALP) ≤ 1 - 2.5 x ULN
    • Gamma Glutylamyltransferase (GGT) ≤ 1 - 2.5 x ULN

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.
• Subjects with active brain 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.
• Subjects with recurrent resectable MCC
• Subjects with prior systemic chemotherapy
• Subjects who have received oncologic therapy within 2 weeks of planned IFx-Hu2.0 injection.
• Concurrent use of any other investigational product or participation in another trial within 28 days before start of study treatment.
• 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 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.
• Subjects with prior history of non-Merkel cell carcinoma malignancies are excluded except adequately treated basal cell, squamous cell skin cancer, chronic lymphocytic leukemia or other indolent diseases not requiring therapy; adequately treated, with curative intent, cancer from which the subject is currently in complete remission per investigator's judgment; or subjects with history of breast cancer and no evidence of disease on hormonal therapy to prevent recurrence and subjects with prostate cancer on adjuvant hormonal therapy with undetectable PSA are eligible.
• 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.

Note: Other protocol defined Inclusion/Exclusion Criteria may apply.

Eligibility last updated 2/18/2025. Questions regarding updates should be directed to the study team contact.