Health TrialsbyHealthPanel

DOC1021 Dendritic Cell Immunotherapy for Refractory Melanoma

ConditionRefractory Melanoma
Trial statusRecruiting
Trial phasePhase 1, Phase 2
Trial typeInterventional
Biological sexAll
Age18+
SponsorDiakonos Oncology Corporation

About this trial

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:

* 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

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

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

Disqualifiers

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.

Trial design

Design model

Single group

Treatments tested in this trial

  • DOC1021

    Biological/Vaccine

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

  • Tumor resection

    Procedure/Surgery

    Tumor resection or biopsy

  • pIFN (peginterferon alfa-2a)

    Drug

    pIFN 180 mcg subcutaneously every week for 4 total doses

Treatment groups

35 Participants
are divided into 1 treatment group
Group A: Experimental: DOC1021 + pIFNExperimental treatment 3 interventions

Trial outcomes

Primary outcomes

1

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

Time frame
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

Time frame
5 years

Secondary outcomes

1

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

Time frame
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)

Time frame
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)

Time frame
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)

Time frame
5 years

Other outcomes

1

Health-related quality of life in all participants as assessed by EORTC Quality of Life Questionnaire Cancer QLC-C30 (Cancer 30-items).

All items are scored 1 (worse outcome) to 4 (better outcome) or 1 (worse outcome) to 7 (better outcome). All of the scales and single-item measures range in score from 0 to 100. A high scale score represents a higher response level.

Time frame
2 years
2

Change in circulating tumor DNA (ctDNA) levels after DOC1021 administration.

Time frame
5 years

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Diakonos Oncology Corporation

Lead sponsor

Source ClinicalTrials.gov
Apply now