DOC1021 Immunotherapy for Refractory Melanoma
This study is testing a new treatment called DOC1021, combined with pIFN (peginterferon alfa-2a), for people with melanoma that has not responded to previous treatments, including anti-PD-1 therapies. DOC1021 is a special immunotherapy made from your own blood cells and parts of your tumor, designed to help your immune system fight the cancer. The researchers want to see if this combination is safe and if it can shrink tumors. The study plans to enroll 35 participants. The first part of the study will check for side effects, and the second part will look at how well the treatment works over 5 years. To join, you must be 18 or older and have unresectable or metastatic melanoma that has progressed after at least one prior systemic therapy, including anti-PD-1.
- Study design
- This is an interventional study with two parts: an initial safety study (Phase I) followed by a study to assess how well the treatment works (Phase II). It plans to include 35 participants.
- What's involved
- You would receive DOC1021 and pIFN, and may undergo tumor resection or biopsy. pIFN is given as an injection under the skin once a week for four doses.
- Compensation
- Not stated in the trial record.
- Follow-up
- The study will measure how well the treatment works for up to 5 years.
AI-generated from the public study record. Only the study team can confirm whether you're eligible — confirm details with them before making decisions.
DOC1021 Dendritic Cell Immunotherapy for Refractory Melanoma
At a glance
Conditions
Where it's being run
8 sites across 7 statesWho to contact
Opens a ready-to-send draft in your own email app — review before sending.
What this trial measures
- Phase I: To evaluate the number of dose limiting toxicities reportedFrom time of first DOC1021 dose administration to 6 weeks later
- Phase II: To evaluate the objective response rate (ORR) as the proportion of patients with a confirmed complete response (CR) or partial response (PR) to treatment, as per RECIST 1.1 criteria5 years