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Prostate CancerPhase 1/2NCT02844699

A Multicenter Randomized Double-blind Placebo-controlled Pilot Study of Safety, Pharmacodynamics and Efficacy of Different Treatments of Immunotherapeutic Drug Mobilan (M-VM3) in Patients With Diagnosed Prostate Cancer

A Phase 1/2 study testing Mobilan (M-VM3) in people with Prostate Cancer, run by Panacela Labs LLC at 4 sites in Russia.

Unknown status

Status not confirmed. The sponsor has not verified this record for over two years, so it may be out of date.

Official record
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Trial summary

A Phase Ib2, multicenter, randomized, double-blind, placebo-controlled safety and efficacy study evaluating different regimens of the immunotherapeutic drug, Mobilan (M-VM3), in patients with prostate cancer. Read more about this study

Who is it for?
Ages 45 to 75 years, men only
Conditions the study is for
Prostate Cancer
What is being tested?
Mobilan (M-VM3)
Type of treatment
Injection or infusion
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
24 participants
Where
4 sitesRussia
Study dates
Jul 2016to Jan 2018
Phase
Phase 1/2
Are there results?
None posted in the registry

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 45 to 75 years
  • Men only
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Subscribed Informed consent for participation in the trial
  • Men aged 45 to 75 years
  • Patients with histologically verified prostate cancer, stage Т1-Т3, N0, M0
  • Patient's ECOG status 0-2
  • Negative tests for serologic markers of HIV-infection, viral hepatitis В and С, syphilis
  • Patient and his partner should agree to use barrier contraception throughout the study period

Who cannot join

  • Failure to obtain Informed consent
  • Clinical or radiological signs of metastases
  • Indication to hormone therapy of prostate cancer
  • Clinically significant cardiovascular diseases:
  • Myocardial infarction within 6 months prior the screening
  • Unstable stenocardia within 3 months prior the screening
Show all 33Show fewer
  • Severe circulation failure (FC III)
  • Clinically significant arrhythmias
  • Hypotension (systolic blood pressure < 86 mm Hg) or bradycardia with HR < 50 beats per min.
  • Uncontrolled arterial hypertension (systolic blood pressure > 170 mm Hg or diastolic blood pressure > 105 mm Hg.)
  • Clinically significant CNS diseases at the screening
  • Current infection or another severe or systemic disease which increases risk of treatment sequel
  • Pituitary gland or adrenal disorders in medical history
  • Other malignant tumors within the last 5 years
  • Other concomitant diseases in medical history which according to Investigator may aggravate during the study, including uncontrolled diabetes mellitus, rectal diseases, rectal fissures, hemorrhoid, rectal polyps, rectostenosis, inflammatory urinary diseases: chronic prostatitis, cystitis, urethral catheter, chronic urine retention.
  • Complicated allergic history, systemic allergic reaction, any dietary allergy, intolerability, limitations or specific diets which according to the Investigator may be a contraindication for subject participation in the present study.
  • Administration of drug products which have a marked effect on immune system within 3 previous months prior the screening, long-term intake of disaggregants (warfarin, low molecular heparin except for ThromboASS).
  • Participation in other clinical studies or administration of investigational drug products within 30 days prior the screening, or persisting adverse reactions of any investigational drug product.
  • Any clinically significant patient's health disorders and/or laboratory abnormalities not enlisted in the Protocol which are identified at the screening, and/or any reason which according to the Investigator may prevent the patient's participation in the study.
  • Drug or alcohol abuse at the screening or in the past which according to the Investigator makes the patient ineligible for participation in the study.
  • Vaccination made 14 days prior the study
  • Unability to understand or follow study instructions
  • Lack of availability during 6 months after administration of the investigational drug product, fails to follow visit schedule
  • 19. Individual intolerability of the investigational drug product components
  • Study withdrawal criteria:
  • Any patient may refuse from the study participation on his own wish in any moment on any study stage.
  • Principal Investigator may withdraw any patient from the study in the following cases:
  • Investigator makes the decision that a patient should be withdrawn in his own best interests
  • Patient develops any serious adverse reactions/events in the screening period
  • Patient has been enrolled to the study with violations, or does not follow the protocol requirements
  • Patient needs additional treatment in the screening period
  • Sponsor has right to terminate the study in any moment.
  • Regulatory authorities have right to terminate the study in any moment.

Trial locations and contacts

4 sites in 1 country.

Russia4 sites

  • Moscow State Budgetary Healthcare Institution "City Clinical Hospital № 57" of Moscow Healthcare Department

    Moscow

  • Moscow State University of Medicine and Dentistry

    Moscow

  • Federal State Budgetary Institution "Saint Petersburg Clinical Scientific and Practical Center for Special types of medical care (Oncological)"

    Saint Petersburg

  • Federal State Budgetary Institution "Scientific Research Oncology Institute named after N.N. Petrov" of the Ministry of Health of the Russian Federation

    Saint Petersburg

Other trials in Russia

About this study

A Phase Ib2, multicenter, randomized, double-blind, placebo-controlled safety and efficacy study evaluating different regimens of the immunotherapeutic drug, Mobilan (M-VM3), in patients with prostate cancer.

Read the detailed description

Mobilan is a nanoparticle-formulated, recombinant non-replicating adenovirus immunotherapeutic drug that directs expression of both toll-like receptor 5 (TLR5) and a specific agonistic ligand, entolimod (which is a recombinant form of the natural TLR5 ligand, flagellin).

The viral construct infects cells expressing the Coxsackie virus and adenovirus receptor (CAR), which has been shown in preclinical studies to be highly expressed in human prostatic tissue, including prostate cancer tissue. Upon infection, co-expression of both receptor and ligand in the same transfected cell triggers persistent autocrine stimulation of the nuclear factor-kappa B (NF-κB) signaling cascade. In a syngeneic mouse prostate cancer model, prostatic injection of Mobilan leads to activation of an innate immune response with infiltration of neutrophils and natural killer cells (NK) cells and induction of an adaptive immune response, comprising cytotoxic (cluster of differentiation [CD]8+) T cells. Necrotic changes in tumor cells were observed in Mobilan-treated animals with concomitant reductions in prostatic volume. Mobilan also show anti-metastatic activity in a surgical adjuvant mouse model of prostate cancer.

This clinical trial is a Phase Ib double-blinded, randomized, placebo-controlled trial evaluating the efficacy, safety, and pharmacology of either 1 or 2 injections of Mobilan or placebo when administered as neoadjuvant therapy directly into the prostates of patients with newly diagnosed prostate cancer.

All study subjects will receive 2 study drug injections administered 2 weeks apart and will be randomly allocated in a 1:1:1 ratio to 1 of the following 3 drug administration schedules:

  • Arm A: Mobilan on both Day 1 and on Day 15.
  • Arm B: Placebo on Day 1 and Mobilan on Day 15.
  • Arm C: Placebo on both Day 1 and Day 15 Subjects will subsequently undergo planned prostatectomy, ideally within 2 weeks following the final study drug injection and will remain under observation thereafter.
Conditions
Prostate Cancer
Being tested
Mobilan (M-VM3), Placebo
Keywords
prostate cancer, adenovirus, TLR5, immunotherapy, Ad5
Medical subject headings
Prostatic Neoplasms, Adenoviridae Infections, Alzheimer Disease 5

What participants receive

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

  • Mobilan (M-VM3)Drug

    Mobilan (M-VM3), innovative experimental drug based on non-replicate adenoviral delivery system consisting genomic vector coding TLR5-receptor and its ligand 502s.

  • PlaceboDrug

    Also called Dextrose 5%, Glucose 5%

    5% infusion solution of dextrose (glucose)

Study groups in NCT02844699
Study groupRoleWhat they receive
Mobilan (M-VM3) on both Day 1 and on Day 15ExperimentalPatients with histologically verified non-metastatic prostate cancer (stage 1 or 3) treated with Investigational Drug Product (Mobilan (M-VM3)) administered 2 weeks apart. All subjects will subsequently undergo planned prostatectomy, ideally within 2 weeks following the final study drug injection and will remain under observation thereafter.
Receives: Drug: Mobilan (M-VM3)
Placebo on Day 1 and Mobilan (M-VM3) on Day 15ExperimentalPatients with histologically verified non-metastatic prostate cancer (stage 1 or 3) treated with Placebo (Glucose 5%) first on Day 1 and Investigational Drug Product (Mobilan (M-VM3)) in two weeks on Day 15. All subjects will subsequently undergo planned prostatectomy, ideally within 2 weeks following the final study drug injection and will remain under observation thereafter.
Receives: Drug: Mobilan (M-VM3); Drug: Placebo
Placebo on both Day 1 and Day 15Placebo comparatorPatients with histologically verified non-metastatic prostate cancer (stage 1 or 3) treated with Placebo (Glucose 5%) administered 2 weeks apart. All subjects will subsequently undergo planned prostatectomy, ideally within 2 weeks following the final study drug injection and will remain under observation thereafter.
Receives: Drug: Placebo

What is being measured

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

  1. Frequency and intensity of adverse events (according to CTCAE v 4.03 classification)

    Measured: Baseline to up to 45 days after the first drug administration

  2. Counting of CD4+ and CD8+ cells in prostate biopsy and surgery samples

    Using immunological assays

    Measured: Baseline to up to 45 days after the first drug administration

Secondary outcomes (7)

  1. Change in total Prostate-specific antigen (PSA) level

    Measured: Baseline to up to 45 days after the first drug administration

  2. Value of the Irani score of post-operative prostate tissue (if material is available for analysis)

    Irani J (1997) scale include histological assessment of slide mounts obtained after operation as follow:

    Degree of immune cell infiltration:

    0 - No inflammatory cells, 1 - Scattered inflammatory cell infiltrate within the stroma without lymphoid nodules, 2 - Nonconfluent lymphoid nodules, 3 - Large inflammatory areas with confluence of infiltrate

    Measured: On Day 30 after the first drug administration

  3. Value of the Gleason score of post-operative prostate tissue (if material is available for analysis)

    The Gleason grading system is used to evaluate the stage of prostate cancer using samples from biopsy or post- surgical samples as follow:

    1 - The cancerous prostate closely resembles normal prostate tissue. 2 - The tissue still has well-formed glands, but they are larger and have more tissue between them. 3 - The tissue still has recognizable glands, but the cells are darker. 4 - The tissue has few recognizable glands. 5 - The tissue does not have any or only a few recognizable glands.

    Measured: On Day 30 after the first drug administration

  4. Plasma concentration of inflammatory cytokines

    Measured: Baseline to up to 45 days after the first drug administration

  5. Presence of protein 502s in blood plasma

    Using ELISA assay

    Measured: Baseline to up to 45 days after the first drug administration

  6. Presence of protein 502s in prostate biopsy and surgery samples

    Using ELISA assay

    Measured: Baseline to up to 45 days after the first drug administration

  7. Presence of protein TLR5 in prostate biopsy and surgery samples

    Using ELISA assay

    Measured: Baseline to up to 45 days after the first drug administration

Timeline

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

  1. First posted26 Jul 2016 (estimated)
  2. Study startJul 2016
  3. Primary completionJan 2018 (estimated)
  4. Study completionJan 2018 (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
Randomised
Intervention model
Parallel groups
Masking
Triple blind
Who is masked
Participant, Investigator, Outcomes assessor
Enrolment
24 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT02844699
Sponsor's protocol ID
PNC-M-VM3-02
Status last verified
Sep 2017
First submitted
14 Jul 2016
Last updated
20 Sep 2017
Results posted
No
Data monitoring committee
No

Questions about this trial

What is this clinical trial studying?

A Phase 1/2 study testing Mobilan (M-VM3) in people with Prostate Cancer, run by Panacela Labs LLC at 4 sites in Russia.

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 6 inclusion and 33 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: status not confirmed, as of the sponsor's last update on 20 Sep 2017. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 4 sites in Russia. 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. Some participants in this study may receive a placebo. 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?

Results are not available in the source record.

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

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Frequency and intensity of adverse events (according to CTCAE v 4.03 classification) (time frame: Baseline to up to 45 days after the first drug administration). 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 NCT02844699.

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 20 Sep 2017.

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Clinical Trial NCT02844699 | AzTrials