Condition: Refractory Melanoma · Sponsor: Diakonos Oncology Corporation
The goal of this clinical trial is to learn if DOC1021 + pIFN will be safe and will lead to tumor responses in patients with refractory melanoma. DOC1021 is a dendritic cell immunotherapy derived from a patient's own blood cells and loaded with antigens from the patient's tumor in the form of tumor lysate and mRNA. The goal is to stimulate a T cell immune response that eliminates tumor cells. The study consists of two components: an initial phase I safety study to confirm safety/tolerability of the treatment regimen, and, subsequently, a single-arm phase II cohort to assess efficacy of the treatment regimen. All participants will: * Take filgrastim subcutaneously x 5 doses and subsequently undergo a leukapheresis collection * Receive two doses of DOC1021 under image guidance 2 weeks apart * Receive subcutaneous pIFN injections weekly for a total of 4 doses in parallel with the DOC1021 injections * Undergo an optional image-guided perinodal DOC1021 booster injection approximately 6 months after the first DOC1021 dose along with additional subcutaneous pIFN injections at time of the booster and the subsequent week for a total of 2 pIFN doses * Visit the clinic regularly to assess quality of life, symptoms, medication use, imaging, bloodwork, and to receive optional treatment with anti-PD1 agents
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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| The University of Alabama at Birmingham | Birmingham, Alabama, United States | Recruiting |
| Banner MD Anderson Cancer Center | Gilbert, Arizona, United States | Recruiting |
| Arizona State University-Honor Health Research Institute | Scottsdale, Arizona, United States | Recruiting |
| City of Hope | Duarte, California, United States | Recruiting |
| Massachusetts General Hospital Cancer Institute | Boston, Massachusetts, United States | Recruiting |
| University of North Carolina | Chapel Hill, North Carolina, United States | Recruiting |
| UT Southwestern | Dallas, Texas, United States | Recruiting |
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Source record: clinicaltrials.gov/study/NCT07288112