Condition: Advanced or Metastatic Merkel Cell Carcinoma · Advanced or Metastatic Cutaneous Squamous Cell Carcinoma · Advanced or Metastatic Melanoma · Sponsor: Exicure, Inc.
This is a phase 1b/2, open-label, two-part, multicenter trial designed to evaluate the safety, tolerability, pharmacokinetics, pharmacodynamics and preliminary efficacy of intratumoral cavrotolimod injections alone and in combination with intravenous pembrolizumab or cemiplimab in patients with Merkel Cell Carcinoma, cutaneous squamous cell carcinoma, and advanced solid tumors. Phase 1b of this trial is a 3+3 dose escalation study evaluating escalating or intermediate dose levels of cavrotolimod given with a fixed dose of pembrolizumab. The Phase 2 dose expansion part of the study will consist of two primary cohorts of patients: Merkel cell carcinoma and cutaneous squamous cell carcinoma. Patients in the Merkel Cell Carcinoma cohort will receive IT cavrotolimod combined with a fixed, standard dose of pembrolizumab while the Cutaneous Squamous Cell Carcinoma cohort will receive IT cavrotolimod combined with a fixed, standard dose of cemiplimab. The Phase 2 dose expansion is designed to provide a preliminary estimate of efficacy in patients that have progressed on an anti-PD-(L)1 CPI.
This description comes directly from the study's public registry record.
Contact details are listed per location below or on the registry record.
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| University of Arizona Cancer Center | Tucson, Arizona, United States | — |
| University of California Irvine | Orange, California, United States | — |
| UCSF Helen Diller Family Comprehensive Cancer Center | San Francisco, California, United States | — |
| John Wayne Cancer Institute / Providence St. John's Health Center | Santa Monica, California, United States | — |
| University of Colorado Cancer Center | Aurora, Colorado, United States | — |
| Western States Cancer Center | Englewood, Colorado, United States | — |
| Sylvester Comprehensive Cancer Center | Miami, Florida, United States | — |
| Northwestern University Feinberg School of Medicine | Chicago, Illinois, United States | — |
| Holden Comprehensive Cancer Center | Iowa City, Iowa, United States | — |
| Norton Cancer Center | Louisville, Kentucky, United States | — |
| Dana Farber Cancer Institute | Boston, Massachusetts, United States | — |
| Washington University St. Louis | St Louis, Missouri, United States | — |
+ 14 more locations — full list on the registry record.
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Source record: clinicaltrials.gov/study/NCT03684785