IFx-Hu2.0 with pembrolizumab for advanced or metastatic Merkel cell carcinoma

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This is a Phase 2/3, multicenter, randomized, double-blind, placebo-controlled trial enrolling 118 adult participants with unresectable or metastatic Merkel cell carcinoma. Participants will be randomized to receive intralesional IFx-Hu2.0 or placebo in a single lesion, followed by systemic pembrolizumab, with response measured by RECIST v1.1. All participants must be checkpoint-inhibitor–naïve, have measurable disease and provide tumor tissue for biomarker analysis. The primary efficacy endpoint is objective response rate, and safety and biomarker correlates will also be collected.

Why it matters

Who can join: the full rules

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. Participants 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. 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.
3. Participants with recurrent resectable MCC
4. Participants 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 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.
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.

Where it's running

• USC Norris Comprehensive Cancer Center
  Los Angeles, California, United States Recruiting
• University of California San Francisco - Helen Diller Family Comprehensive Cancer Center
  San Francisco, California, United States Recruiting
• Stanford Health Care - Skin Cancer Program
  Stanford, California, United States Recruiting
• University of Colorado Hospital - Anschutz Cancer Pavilion
  Aurora, Colorado, United States Recruiting
• Mayo Clinic Comprehensive Cancer Center
  Jacksonville, Florida, United States Recruiting
• Sylvester Comprehensive Cancer Center
  Miami, Florida, United States Recruiting

Study contacts

• Principal investigator: Andrew S Brohl, MD — Collaborator
• Study coordinator: Amit Pande, MD
• Email: clinicaltrials@tuhurabio.com
• Phone: 8138756600

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.