Medical Information Only. Always consult your healthcare provider before enrolling in any clinical trial.
NCT07288112 · ClinicalTrials.gov registry record · Phase 1
DOC1021 Dendritic Cell Immunotherapy for Refractory Melanoma
A Phase 1 study of Refractory Melanoma, sponsored by Diakonos Oncology Corporation.
- Recruiting
- Registry status
- Phase 1
- Development phase
- 35
- Enrollment target
- 1
- Study location
NCT07288112 is a Phase 1 study of Refractory Melanoma that is actively recruiting participants, run by Diakonos Oncology Corporation. The registered enrollment target is 35 participants, below the 42-participant average among 3 other Refractory Melanoma trials with a reported enrollment target (17% lower). The trial reports 1 study location across 1 state.
The verdict
NCT07288112, a Phase 1 study of Refractory Melanoma, is actively recruiting participants, sponsored by Diakonos Oncology Corporation.
- RECRUITING
- Registry status
- Phase 1
- Development phase
- 35 participants
- Enrollment target
- 1
- Study location
Study Summary
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
Conditions Studied
Interventions
- PROCEDURE Tumor resection
- BIOLOGICAL DOC1021
- DRUG pIFN (peginterferon alfa-2a)
Study Locations (1)
Alabama
- The University of Alabama - Birmingham
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 35 participants |
| Start Date | 2026-02-23 |
| Est. Completion | 2033-01 |
| Phase | Phase 1 |
Interested in This Trial?
Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT07288112
The ClinicalTrials.gov registry entry for NCT07288112 describes a study currently listed as recruiting, categorized as Phase 1. The registered enrollment target is 35 participants, a figure that helps gauge the scale of data the investigators plan to collect, below the 42-participant average among 3 other Refractory Melanoma trials with a reported enrollment target (17% lower). The listed sponsor is Diakonos Oncology Corporation, which has 3 total studies on file at ClinicalTrials.gov.
The record links to 1 condition, with Refractory Melanoma appearing as the primary indexed condition, and to 3 interventions - of which Tumor resection is the first listed.
NCT07288112 reports 1 study location spanning 1 distinct geographic area - top geographies include Alabama.
Frequently Asked Questions
What is clinical trial NCT07288112 about?
NCT07288112 is a clinical study titled "DOC1021 Dendritic Cell Immunotherapy for Refractory Melanoma". 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 ...
What is the current status of trial NCT07288112?
This trial is currently recruiting. It is a Phase 1 study. The enrollment target is 35 participants. The study started on 2026-02-23. Estimated completion is 2033-01.
What conditions does trial NCT07288112 study?
This clinical trial studies the following conditions: Refractory Melanoma.
What interventions are being tested in trial NCT07288112?
The interventions under investigation include: Tumor resection (PROCEDURE), DOC1021 (BIOLOGICAL), pIFN (peginterferon alfa-2a) (DRUG).
Who is sponsoring clinical trial NCT07288112?
This trial is sponsored by Diakonos Oncology Corporation, which has 3 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT07288112 being conducted?
This trial has 1 study location across Alabama. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
Similar trials for Refractory Melanoma
Matched on the same primary condition, ranked to surface studies in the same phase first, then by recruiting status, no relevance scoring or editorial curation.
-
Phase 1 Dose Escalation and Expansion Study of PRAME T Cell Receptor (TCR) Engineered NK Cells in Participants With Recurrent and/or Refractory Melanoma (PRAMETIME-Mel)
RECRUITING · Phase 1
-
Testing the PD-1 Antibody, MK3475, Given With Ziv-aflibercept in Patients With Advanced Cancer
ACTIVE NOT RECRUITING · Phase 1
-
Bevacizumab and Atezolizumab With or Without Cobimetinib in Treating Patients With Untreated Melanoma Brain Metastases
ACTIVE NOT RECRUITING · Phase 2
Read our methodology - how this data is sourced, computed, and verified.
Related
Every figure on PlainTrial is rendered directly from the ClinicalTrials.gov registry, no number is typed in by an editor. This page mirrors this trial's own ClinicalTrials.gov registry record, live from the dataset. See our editorial standards & corrections policy, the methodology behind these numbers, or report a data error.