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New treatment option for Refractory Melanoma
Official title DOC1021 Dendritic Cell Immunotherapy for Refractory Melanoma
ClinicalTrials.gov ID: NCT07288112
What this study is testing
What is DOC1021?
DOC1021 is an investigational medicine, given as an once-weekly injection under the skin, being studied as a potential treatment for refractory melanoma.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- 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.
- Phase 2: a mid-size study of how well it works
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 and older
You may be able to join if
- Provision of signed and dated informed consent form
- Stated willingness to comply with all study procedures and avail-ability for the duration of the study
- Age 18 years or older
- Patients diagnosed with unresectable or metastatic melanoma and progressed following ≥1 prior systemic therapy including anti-PD-1 (i.e., refractory...
- Willing and able to withhold anti-PD-1 treatment from the time of enrollment through \~6 weeks after the first DOC1021 administration
You likely can't join if
- Patients who are pregnant or breastfeeding.
- Known active HIV or hepatitis infection. Patients with HIV that is well-controlled and have undetectable viral titers remain eligible. Patients with...
- Any severe or uncontrolled medical condition or other condition that could affect participation in this study as determined by the investigator...
- Residual immune-related toxicities from prior immunotherapy \> Grade 1 severity. However, patients who experienced prior endocrine toxicity are...
- Treatment with another investigational drug or other experimental intervention within the last 30 days.
See the full eligibility criteria
- Provision of signed and dated informed consent form
- Stated willingness to comply with all study procedures and avail-ability for the duration of the study
- Age 18 years or older
- Patients diagnosed with unresectable or metastatic melanoma and progressed following ≥1 prior systemic therapy including anti-PD-1 (i.e., refractory to anti-PD-1). Refractory defined as primary or secondary resistance...
- Willing and able to withhold anti-PD-1 treatment from the time of enrollment through \~6 weeks after the first DOC1021 administration
- One or more lesions available for biopsy or resection to yield at least 50 mg (e.g., 5 core biopsies) and preferably 100 mg of tumor for generating DOC1021 and at least 1 measurable target tumor lesion evaluable after...
- Brain metastases allowed if stable after prior treatment
- Ability to receive filgrastim (e.g. Neupogen), leukapheresis and perinodal injections of DOC1021 near regional nodes + weekly pIFN x 4 weeks.
- Females of reproductive potential must have a negative serum pregnancy test and agree to use effective contraception (as deter-mined appropriate for the patient by the investigator) during study treatment.
- Adequate kidney, liver, bone marrow function, and immune function, as follows:
- Hemoglobin ≥ 8.0 gm/dL (use of transfusion or other intervention to achieve is acceptable)
- Absolute neutrophil count (ANC) ≥ 1,500 cells/mm3
- Platelet count ≥ 75,000/mm3
- Calculated creatinine clearance (CrCl) \> 30 mL/min using Cockcroft and Gault formula: i. For males = (140 - age[years]) x (body weight [kg]) / (72 x serum creatinine [mg/dL]) ii. For females = 0.85 x value from male...
- Eastern Cooperative Group (ECOG) Performance Score 0 or 1
- Patients who are pregnant or breastfeeding.
- Known active HIV or hepatitis infection. Patients with HIV that is well-controlled and have undetectable viral titers remain eligible. Patients with history of HCV adequately treated such that RNA viral load is negative...
- Any severe or uncontrolled medical condition or other condition that could affect participation in this study as determined by the investigator, including but not limited to uncontrolled or severe cardiac dis-ease...
- Residual immune-related toxicities from prior immunotherapy \> Grade 1 severity. However, patients who experienced prior endocrine toxicity are eligible if well-controlled on replacement therapy.
- Treatment with another investigational drug or other experimental intervention within the last 30 days.
The study team makes the final eligibility decision.
Where it's taking place
- Birmingham, Alabama, United States
- Gilbert, Arizona, United States
- Scottsdale, Arizona, United States
- Duarte, California, United States
- Boston, Massachusetts, United States
- Chapel Hill, North Carolina, United States
- Dallas, Texas, United States
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years and older. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Birmingham, Alabama, United States; Gilbert, Arizona, United States; Scottsdale, Arizona, United States; Duarte, California, United States; Boston, Massachusetts, United States; Chapel Hill, North Carolina, United States and 1 more location(s). Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.