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.

NCT07288112

DOC1021 Dendritic Cell Immunotherapy for Refractory Melanoma

Recruiting
PHASE1Ages 18+InterventionalTreatment
Diakonos Oncology Corporation
~35 participants
Updated 2026-08-12 on ClinicalTrials.gov
What's tested:DOC1021Tumor resectionpIFN (peginterferon alfa-2a)

At a glance

Recruiting sites
8 of 8 listed sites are recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Phase I: To evaluate the number of dose limiting toxicities reported
Measured over From time of first DOC1021 dose administration to 6 weeks later
+1 more outcome measured
Refractory Melanoma
8 sites across 7 states
Arizona2
Alabama1
California1
Massachusetts1
New Jersey1
North Carolina1
Texas1

Opens a ready-to-send draft in your own email app — review before sending.

  • 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