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Refractory MelanomaPhase 1/2NCT07288112

DOC1021 Dendritic Cell Immunotherapy for Refractory Melanoma

A Phase 1/2 study testing DOC1021, Tumor resection and pIFN (peginterferon alfa-2a) in people with Refractory Melanoma, run by Diakonos Oncology Corporation at 8 sites in United States.

Recruiting

Looking for participants now. Contact the study team or a site below to ask about taking part.

Sites and contacts
Official record
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Trial 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. Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Refractory Melanoma
What is being tested?
DOC1021, Tumor resection and pIFN (peginterferon alfa-2a)
Could I receive a placebo?
No, everyone receives an active treatment
How many people
35 participants
Where
8 sitesUnited States
Study dates
6 Apr 2026to Jan 2033
Phase
Phase 1/2
Are there results?
Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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 as per SITC guidelines, except that confirmatory scan not required if clinical progression requiring surgery or radiation to relieve symptoms
  • Willing and able to withhold anti-PD-1 treatment from the time of enrollment through at least 6 weeks after the first DOC1021 administration
  • One or more lesions available for biopsy or resection expected to yield at least 50 mg and preferably 100 mg of tumor for generating DOC1021 and at least 1 measurable target tumor lesion evaluable after DOC1021 by RECIST version 1.1.
Show all 16Show fewer
  • Brain metastases allowed if stable after prior treatment
  • Ability to receive leukapheresis (with filgrastim if clinically indicated) and perinodal injections of DOC1021 near regional nodes + weekly pIFN x 4 weeks (i.e., sufficient clinical stability and anticipated life expectancy to complete the treatment period and allow time for an immune response to develop).
  • 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:
  • For males = (140 - age[years]) x (body weight [kg]) / (72 x serum creatinine [mg/dL]) ii. For females = 0.85 x value from male formula e. Total bilirubin ≤ 1.5 times upper limit of normal (ULN) except in patients with Gilbert's disease for which total bilirubin must be ≤ 3 times ULN f. Aspartate transaminase AST (SGOT) and alanine aminotransferase ALT (SGPT) ≤ 3 times the ULN (or ≤ 5.0 × ULN if liver metastases)
  • Eastern Cooperative Oncology Group (ECOG) Performance Score 0 or 1

Who cannot join

  • 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 also remain eligible.
  • 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, systemic autoimmune disorders requiring immunosuppression*, autoimmune hyper/hypothyroidism, untreated viral hepatitis, autoimmune hepatitis (*autoimmune disorders include but are not limited to rheumatoid arthritis, psoriasis and inflammatory bowel disease and immunosuppressive medications include DMARDs like methotrexate, TNF inhibitors, IL-6 receptor blockers, CD80/86 inhibitors, anti-CD20 and JAK inhibitors)
  • 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.

Trial locations and contacts

8 sites in 1 country. Contact the study team or a site near you to ask about taking part.

8 sites in 1 country

United States8 sites, 8 recruiting

  • The University of Alabama at Birmingham

    Birmingham, Alabama, 35233

    Luke Hanna, 205-644-2594, lukehanna@uabmc.edu

    John Dubay, MD

    Recruiting

  • Massachusetts General Hospital Cancer Institute

    Boston, Massachusetts, 02114

    Kathryn Cioffi, 866-493-1612, kcioffi@mgh.harvard.edu

    Alexandra Haugh, MD, MPH

    Recruiting

  • University of North Carolina

    Chapel Hill, North Carolina, 27599

    Claire Kowalczyk, 919-962-7337, claire_kowalczyk@med.unc.edu

    Stergios Moschos, MD

    Recruiting

  • UT Southwestern

    Dallas, Texas, 75235

    Desiree Pierre, 214-645-9830, Desiree.Pierre@utsouthwestern.edu

    Sanjay Chandrasekaran, MD

    Recruiting

  • City of Hope

    Duarte, California, 91010

    Doni Woo, 626-218-1970, dwoo@coh.org

    Yan Xing, MD, PhD

    Recruiting

  • Banner MD Anderson Cancer Center

    Gilbert, Arizona, 85234

    Mayra Madrid, 480-256-6444, Mayra.Madrid2@bannerhealth.com

    Fade Mahmoud, MD

    Recruiting

  • Atlantic Health

    Morristown, New Jersey, 07960

    Maureen Nowakowski, 9739715569, maureen.nowakowski@atlantichealth.org

    Eric Whitman, MD

    Recruiting

  • Arizona State University-Honor Health Research Institute

    Scottsdale, Arizona, 85258

    Ashley Allison, 4803231350, aallison@honorhealth.com

    Justin Moser, MD

    Recruiting

Other trials in United States

About this study

Official title: Clinical Study of 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 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.

Read more

All participants will:

  • Undergo a leukapheresis collection (take filgrastim subcutaneously x 5 doses, if clinically necessary, leading up to 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
Being tested
DOC1021, Tumor resection, pIFN (peginterferon alfa-2a)
Keywords
Dendritic Cell Vaccine, Immunotherapy, Tumor Vaccine
Medical subject headings
Melanoma

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • DOC1021Biological

    Double-loaded dendritic cell vaccine, loaded with tumor lysate and mRNA using proprietary method

  • Tumor resectionProcedure or surgery

    Tumor resection or biopsy

  • pIFN (peginterferon alfa-2a)Drug

    pIFN 180 mcg subcutaneously every week for 4 total doses

Study groups in NCT07288112
Study groupRoleWhat they receive
Experimental: DOC1021 + pIFNExperimentalDOC1021 administered by injection near active tumor lesion lymph nodes + pIFN
Receives: Biological: DOC1021; Procedure: Tumor resection; Drug: pIFN (peginterferon alfa-2a)

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Phase I: To evaluate the number of dose limiting toxicities reported

    Measured: From time of first DOC1021 dose administration to 6 weeks later

  2. 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 criteria

    Measured: 5 years

Secondary outcomes (6)

  1. Overall survival (time in months from the date of study enrollment until death for from any cause)

    Measured: 5 years

  2. Time in months from the first documentation of complete or partial response to disease progression by RECIST 1.1 criteria or death, whichever occurs first.

    Duration of Response (DOR)

    Measured: 5 years

  3. Time in months from date of study enrollment to disease progression by RECIST 1.1 criteria or death from any cause

    Progression-free survival (PFS)

    Measured: 5 years

  4. The proportion of participants with complete response, partial response, or stable disease out of the total eligible and evaluable participants.

    Disease control rate (DCR)

    Measured: 5 years

  5. Number of participants with adverse events as assessed by CTCAE v5.0

    Measured: 3 years

  6. 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 immune-related response criteria (iRECIST)

    Measured: 5 years

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted17 Dec 2025
  2. Study start6 Apr 2026
  3. Primary completionJan 2031 (estimated)
  4. Study completionJan 2033 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 1/2
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrolment
35 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT07288112
Sponsor's protocol ID
DOC-RM
Status last verified
Sep 2026
First submitted
3 Dec 2025
Last updated
9 Sep 2026
Results posted
No
Data monitoring committee
No
FDA-regulated drug
Yes
FDA-regulated device
No
Individual data sharing
No

Questions about this trial

What is this clinical trial studying?

A Phase 1/2 study testing DOC1021, Tumor resection and pIFN (peginterferon alfa-2a) in people with Refractory Melanoma, run by Diakonos Oncology Corporation at 8 sites in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 16 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: looking for participants now, as of the sponsor's last update on 9 Sep 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 8 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this combined phase mean?

Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

Each site lists its own contact: choose the nearest one under Trial locations. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Phase I: To evaluate the number of dose limiting toxicities reported (time frame: From time of first DOC1021 dose administration to 6 weeks later). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT07288112.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 9 Sep 2026.

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