Arm 1: Lysate Pulsed Dendritic Cells (PV-001-DC) in Patients With Melanoma

July 4, 2023 updated by: PrimeVax Immuno-Oncology Inc.

A Study to Evaluate the Safety and Efficacy of Intratumoral Injection of PV-001-DV in Combination With Infusion of PV-001-DC in Patients With Advanced Melanoma

Autologous monocyte-derived dendritic cells pulsed with tumor lysate (PV-001-DC) will be given to a group of 3 people. If this is found to be safe, it will be given to up to 7 other people, for a total of up to 10 people in this arm. This will be the first study of PV-001-DC.

Eligible patients must be progressing after having completed prior therapy with a PD-1/PD-L1 antagonist alone or in combination with anti-CTLA-4. If the patient is positive for BRAF, the patient must have progressed on at least one BRAF inhibitor in addition to a PD-1/PD-L1 inhibitor alone or in combination with CTLA-4 for metastatic melanoma.

Although other kinds of dendritic cells (DCs) have been approved to treat some forms of cancer, they have not been approved to treat melanoma. PV-001-DC is a special kind of DCs that is combined with tumor lysate. The study procedures will start with the removal of a small amount of tumor tissue processed into protein fragments (lysate). There will also be collection of white blood cells through apheresis (a procedure in which blood is drawn from a patient and separated into its different cell types), the white blood cells will be collected and the remainder returned to the patient. Dendritic cells will be grown from the collected white blood cells and combined with the lysate to form PV-001-DC.

On the first day of study treatment, patients will go to the clinic and have a needle placed in a vein. The PV-001-DC product will be infused into the patient's vein. Approximately every 3 weeks, for a total of 4 treatments, patients will receive additional infusions of PV-001-DC. Patients will be at the clinic for at least 1 hour following the end of the PV-001-DC infusion and if they feel fine, they may go home.

Scans will be performed during the study at different times to see if their tumors have changed in size. Patients will also have their blood and small samples of tumors tested for changes to the immune system. After 365 days, the trial will be completed for that patient.

Investigators will monitor patients carefully for any harmful side effects. The side effects in people cannot be completely known ahead of time

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Not yet recruiting

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Estimated)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
10

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  • Biopsy confirmed patients with un-resectable AJCC Stage III or IV melanoma who have measurable disease. Measurable disease is required, and is defined as tumor can be measured in two dimensions.
  • Patient must have progressed with prior therapy with a PD-1 / PD-L1 antagonist alone or in combination with anti-CTLA-4. If the patient is positive for BRAF, the patient must have progressed on at least one BRAF inhibitor in addition to a PD-1 / PD-L1 inhibitor alone or in combination with CTLA4 for metastatic melanoma.
  • Tumor specimens must be available for tumor lysates and immunological studies.
  • ECOG Performance Status of ≤ 2 (corresponds to a Karnofsky Performance Status (KPS) of ≥ 70).
  • Patients must be 18 years or older and able to give informed consent.
  • Adequate bone marrow function of White Blood Cell (WBC) count to ≥ 1,500/uL; platelet count ≥ 100,000/mm3; absolute neutrophil count (ANC) > 1,200/uL
  • Patients must have adequate renal function by serum creatinine of ≤ 2.0 mg/dL.
  • Adequate hepatic function of bilirubin ≤ 2.5 mg/dL; SGOT/SGPT < 3× upper limit of normal (ULN).

  • Patients must have the required wash out periods from prior therapy:

    • Topical therapy: 2 weeks.
    • Chemotherapy and radiotherapy: 4 weeks.
    • Other investigational therapy: 4 weeks
  • Patients of reproductive potential and their partners must agree to use an effective (>90% reliability) form of contraception during the study and for 4 weeks following the last study drug.
  • Women of reproductive potential must have a negative urine pregnancy test.
  • Patients should have a life expectancy of > 6 months.
  • Patient should be able to comply with the treatment schedule and have the ability to understand and willingness to sign the informed consent document.
  • Patients with manageable central nervous system metastases may be selected to this trial. The CNS metastases are defined as manageable if there is no progression for at least 4 weeks as determined by clinical examination and brain imaging (MRI and/or CT).

Exclusion Criteria:

  • Pre-existing autoimmune or antibody mediated disease including systemic lupus erythematous, rheumatoid arthritis, multiple sclerosis, Sjogren's syndrome, autoimmune thrombocytopenia, but excluding controlled thyroid disease, or the presence of autoantibodies without clinical autoimmune disease.
  • Known history of human immunodeficiency virus (HIV) or any active immunosuppressive systemic infection or a suppressed immune system, including acquired immuno-deficiency syndrome (AIDS) or HIV positivity and known hepatitis infections (HCV or HBC), as assessed by serology.
  • Patients on immunosuppressive therapy. Concurrent steroid use of not more than an equivalent of 10 mg of prednisone is allowed.
  • Previous organ transplantation.
  • Patients with active infection or with a fever >101°F (38.5°C) within 3 days prior to the first scheduled treatment.
  • Concurrent participation in other treatment related clinical studies. Non-treatment studies (e.g. observation or tumor cell analysis studies) are allowed.

  • Prior malignancy (active within 3 years of screening) except basal cell or completely excised non-invasive squamous cell carcinoma of the skin, or in situ squamous cell carcinoma of the cervix.

    o Significant cardiovascular disease (i.e., New York Heart Association (NYHA) class 3 congestive heart failure; myocardial infarction within the past 6 months; unstable angina; coronary angioplasty within the past 6 months; uncontrolled atrial or ventricular cardiac arrhythmias).

  • Female patients who are pregnant or lactating.
  • Patients taken off Checkpoint Blockade agents: Ipilimumab, Nivolumab, Pembrolizumab, for Grade 3 or greater autoimmune toxicity.
  • Patients who are positive for B-RafV600 mutation and are responding to targeted therapy.
  • Any other medical history, including laboratory results, deemed by the investigator to be likely to interfere with his/her participation in the study, or to interfere with the interpretation of the results.
  • Patients with endocrinopathy greater than grade III.
  • Patients who have undergone a splenectomy in their previous medical history will be excluded from this trial. Evidence of a splenectomy will be from history or records.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Experimental: PV-001-DC alone
Autologous Monocyte-derived Lysate Pulsed Dendritic Cells
Biological: PV-001-DC
Patient-specific cellular therapeutic for cancer immunotherapy

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Incidence and severity of Treatment-Emergent Adverse Events
Time Frame: 365 days
Treatment-Emergent Adverse Event Incidence in patients receiving IV infusion of PV-001-DC
365 days

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Overall Response Rate (ORR)
Time Frame: 365 days
Tumor response will be measured per investigator's assessment according to RECIST v1.1 and iRECIST
365 days
Progression-Free Survival (PFS)
Time Frame: 365 days
The length of time during the treatment of a disease, such as cancer, that a patient lives with the disease but it does not get worse, up to the end of the study
365 days
Overall Survival (OS)
Time Frame: 365 days
Overall Survival is measured from the date of enrollment to the date of death for a dead patient. If a patient is still alive or is lost to follow up, the patient will be censored at the last contact date, up to the end of the study
365 days

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
PrimeVax Immuno-Oncology Inc.

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Estimated)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
April 1, 2024

Primary Completion (Estimated)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
August 30, 2024

Study Completion (Estimated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
December 31, 2024

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
December 31, 2018

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
January 10, 2019

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
January 14, 2019

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
July 6, 2023

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
July 4, 2023

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
July 1, 2023

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • PV001-001 (Arm 1)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

Yes

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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