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Malignant MelanomaPhase 2NCT03448666

ECT-Pembrolizumab in Patients With Unresectable Melanoma With Superficial or Superficial and Visceral Metastases

A Phase 2 study testing Pembrolizumab in people with Malignant Melanoma, run by European Institute of Oncology at 1 site in Italy.

Withdrawn

Withdrawn. The study stopped before anyone enrolled.

Official record
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Trial summary

This is a Phase 2 multicenter, open label, non-randomized, interventional study enrolling 53 patients.The objectives and purposes of the clinical study described herein are to determine if concomitant Pembrolizumab (Keytruda) and ECT treatments are safe and able to improve local and systemic response rates.ECT will be… Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Malignant Melanoma
What is being tested?
Pembrolizumab
Could I receive a placebo?
No, everyone receives an active treatment
How many people
0 participants
Where
1 siteItaly
Study dates
1 Mar 2021to 1 Dec 2023
Phase
Phase 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 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Have a histologically confirmed advanced melanoma stages III b/c or IV, with at least the following superficial lesions: 5 lesions if diameter < 1 cm or 3 lesions if diameter > 1 cm.
  • Could have received previous therapy included CT, antiCTLA4 or antiBRAF/antiMEK treatment or be treatment naïve.
  • Be willing and able to provide written informed consent/assent for the trial.
  • Be >= 18 years of age on day of signing informed consent.
  • Have measurable disease based on RECIST 1.1.
  • Be willing to provide tissue from a newly obtained core or excisional biopsy of a tumor lesion. Newly-obtained is defined as a specimen obtained up to 6 weeks (42 days) prior to initiation of treatment on Day 1. Subjects for whom newly-obtained samples cannot be provided (e.g. inaccessible or subject safety concern) may submit an archived specimen only upon agreement from the Sponsor.
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  • Have a performance status ≤ 2 on the ECOG Performance Scale. (Ambulatory and capable of all self-care but unable to carry out any work activities. Up and about more than 50% of waking hours.)
  • Demonstrate adequate organ function as defined in
  • Have a baseline total body CT scan (brain MRI if brain metastasis are suspected)
  • Patients with brain metastasis are allowed to participate if previously treated and brain lesion stability or inactivity is demonstrated. Patients with a history of brain metastasis are required to have a pre-baseline brain MRI at least 60 days (2 months) before the Screening/Baseline visit (Visit 1) for comparison to the Screening (Visit 1) MRI. Patients for whom MRI is contraindicated will undergo head CT. Stable/inactive disease is determined by comparing the pre- baseline and screening/baseline MRI/CT results.
  • Patients presenting with brain metastasis at Screening/Baseline who had no known previous brain involvement and who had no brain MRI/CT tests at least 60 days (2 months) before Screening/Baseline are considered screening failures and will be excluded from study enrollment.
  • Have cutaneous or subcutaneous metastases from melanoma that are accessible for the application of electric pulses using the single use, sterile CLINIPORATOR™ electrodes (5 lesions if diameter <1 cm or 3 lesions if diameter >1 cm). For patients presenting with more than 7 lesions, the lesions with the largest diameters that fall within the <10 to 30 mm size requirements will be considered "target" lesions for RECIST criteria and study purposes. The others will be recorded and monitored but will not considered as Target.
  • Have lesions clearly requiring palliative treatment [e.g., symptomatic (bleeding, draining, painful), disfiguring or causing distress to the patient].
  • A treatment-free period of three (3) weeks before enrolling in the study. NOTE: Patients receiving concomitant treatments for unrelated existing pathologies are eligible for enrollment.
  • Life expectancy > 3 months.
  • Female subject of childbearing potential should have a negative urine or serum pregnancy within 72 hours prior to receiving the first dose of study medication. If the urine test is positive or cannot be confirmed as negative, a serum pregnancy test will be required.
  • Female subjects of childbearing potential (Section 5.7.2) must be willing to use an adequate method of contraception as outlined in Section 5.7.2 - Contraception, for the course of the study through 120 days after the last dose of study medication. Note: Abstinence is acceptable if this is the usual lifestyle and preferred contraception for the subject.
  • Male subjects of childbearing potential (Section 5.7.1) must agree to use an adequate method of contraception as outlined in Section 5.7.1- Contraception, starting with the first dose of study therapy through 120 days after the last dose of study therapy. Note: Abstinence is acceptable if this is the usual lifestyle and preferred contraception for the subject.

Who cannot join

  • Is currently participating and receiving study therapy or has participated in a study of an investigational agent and received study therapy or used an investigational device within 4 weeks of the first dose of treatment or has any ongoing treatment for melanoma or with any non-study anticancer therapy or immunosuppressive agent.
  • Has a diagnosis of immunodeficiency or is receiving systemic steroid therapy or any other form of immunosuppressive therapy within 7 days prior to the first dose of trial treatment.
  • Has a known history of active TB (Bacillus Tuberculosis)
  • Hypersensitivity to pembrolizumab or any of its excipients or known allergies to Bleomycin.
  • Has received a cumulative lifetime dose of Bleomycin exceeding 250 mg/m2
  • Has had a prior anti-cancer monoclonal antibody (mAb) within 4 weeks prior to study Day 1 or who has not recovered (i.e., ≤ Grade 1 or at baseline) from adverse events due to agents administered more than 4 weeks earlier.
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  • Has had prior chemotherapy, targeted small molecule therapy, or radiation therapy within 2 weeks prior to study Day 1 or who has not recovered (i.e., ≤ Grade 1 or at baseline) from adverse events due to a previously administered agent.
  • Note: Subjects with ≤ Grade 2 neuropathy are an exception to this criterion and may qualify for the study.
  • Note: If subject received major surgery, they must have recovered adequately from the toxicity and/or complications from the intervention prior to starting therapy.
  • Patient has a history of a malignancy (other than the disease under treatment in the study) within 5 years prior to first study drug administration. This should exclude adequately treated Stage 1 or Stage 2 basal/squamous cell carcinoma of the skin, carcinoma in situ of the cervix or breast, or other in situ cancers. Shorter intervals can be considered after discussion with Merck.
  • Has known active central nervous system (CNS) metastases and/or carcinomatous meningitis. Subjects with previously treated brain metastases may participate provided they are stable (without evidence of progression by imaging for at least four weeks prior to the first dose of trial treatment and any neurologic symptoms have returned to baseline), have no evidence of new or enlarging brain metastases, and are not using steroids for at least 14 days prior to trial treatment. This exception does not include carcinomatous meningitis which is excluded regardless of clinical stability.
  • Has epilepsy.
  • Has active autoimmune disease that has required systemic treatment in the past 2 years (i.e. with use of disease modifying agents, corticosteroids or immunosuppressive drugs). Replacement therapy (eg., thyroxine, insulin, or physiologic corticosteroid replacement therapy for adrenal or pituitary insufficiency, etc.) is not considered a form of systemic treatment.
  • Has a history of (no-infectious) pneumonitis that require steroids or current pneumonitis.
  • Has an active infection requiring systemic therapy.
  • Has a history or current evidence of any condition, therapy, or laboratory abnormality that might confound the results of the trial, interfere with the subject's participation for the full duration of the trial, or is not in the best interest of the subject to participate, in the opinion of the treating investigator.
  • Has known psychiatric or substance abuse disorders that would interfere with cooperation with the requirements of the trial.
  • Is pregnant or breastfeeding, or expecting to conceive or father children within the projected duration of the trial, starting with the pre-screening or screening visit through 120 days after the last dose of trial treatment.
  • Has received prior therapy with an anti-PD-1, anti-PD-L1, or anti-PD-L2 agent.
  • Has a known history of Human Immunodeficiency Virus (HIV) (HIV 1/2 antibodies).
  • Has known active Hepatitis B (e.g., HBsAg reactive) or Hepatitis C (e.g., HCV RNA [qualitative] is detected).
  • Has primary ocular melanoma
  • Non-cutaneous/subcutaneous symptomatic or rapidly progressive metastases
  • Cardiac arrhythmias [e.g., significant ventricular arrhythmia such as persistent ventricular tachycardia and/or ventricular fibrillation; severe conduction disorders as atrioventricular block 2 and 3, sinoatrial block]
  • Has received a live vaccine within 30 days of planned start of study therapy. Note: Seasonal influenza vaccines for injection are generally inactivated flu vaccines and are allowed; however intranasal influenza vaccines (e.g., Flu-Mist®) are live attenuated vaccines, and are not allowed.

Trial locations and contacts

1 site in 1 country.

Italy1 site

  • IEO Istituto Europeo di Oncologia

    Milan, 20141

Other trials in Italy

About this study

Official title: A Phase II, Multicentric, Open Label, Non-randomized, Interventional Study of Pembrolizumab in Combination With Electrochemotherapy in Patients With Unresectable Melanoma With Superficial or Superficial and Visceral Metastases

This is a Phase 2 multicenter, open label, non-randomized, interventional study enrolling 53 patients.The objectives and purposes of the clinical study described herein are to determine if concomitant Pembrolizumab (Keytruda) and ECT treatments are safe and able to improve local and systemic response rates.ECT will be performed with the CLINIPORATOR and a single IV dose of Bleomycin

Read the detailed description

ECT induces immunogenic cell death of cancer cells with a more efficient antigen presentation of tumor-derived antigens by APCs to T-cells, particularly CD8+ antigen-specific T cells. Anti-PD-1 mAb reverts T-cell exhaustion induced by PD-1/PD-L1 and PD-L2 engagement on CD8+ T cells. Moreover, it may also be beneficial in the priming phase of the antitumor immune responses, inducing long-lived tumor antigen-specific CD8+ T-cell effectors.

The main hypothesis is to establish if concomitant treatment of Pembrolizumab and ECT is able to lead to a 20% increase of the ORR using as a reference the proportion of success available in the literature for Pembrolizumab.

The investigators will perform a proteomic analysis of sera of treated patients, collected before and after treatments, with particular emphasis on cytokines and chemokines, to evaluate possible markers associated with a better clinical outcome.

Being tested
Pembrolizumab
Keywords
ECT, pembrolizumab, advanced melanoma
Medical subject headings
Melanoma

What participants receive

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

  • PembrolizumabCombination product

    Also called Electrochemotherapy

    Electrochemotherapy will be performed with the CLINIPORATOR™ after the first treatment of Pembrolizumab

Study groups in NCT03448666
Study groupRoleWhat they receive
pembrolizumab and elettrochemiotherapyExperimentaldrug: Pembrolizumab 200 mg flat dose every three weeks procedure: elettrochemiotherapy once after first pembrolizumab dose
Receives: Combination Product: Pembrolizumab

What is being measured

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

  1. Overall Response rate, as Determined by RECIST v1.1

    CT scan

    Measured: Baseline up to disease progression or death due to any cause, whichever occurs first (up to approximately 60 months)

Timeline

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

  1. First posted28 Feb 2018
  2. Study start1 Mar 2021
  3. Primary completion1 Dec 2023 (estimated)
  4. Study completion1 Dec 2023 (estimated)

Why it stopped: no financial support

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 2
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Model description
This is a single arm trial with a single group assignment
Masking
None (open label)
Enrolment
0 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT03448666
Sponsor's protocol ID
IEO 523
Status last verified
Jun 2023
First submitted
24 Nov 2017
Last updated
23 Sep 2024
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing Pembrolizumab in people with Malignant Melanoma, run by European Institute of Oncology at 1 site in Italy.

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 18 inclusion and 25 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: withdrawn, as of the sponsor's last update on 23 Sep 2024. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Italy. 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 phase mean?

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?

The study was withdrawn before enrolling participants, so there are no results.

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?

Overall Response rate, as Determined by RECIST v1.1 (time frame: Baseline up to disease progression or death due to any cause, whichever occurs first (up to approximately 60 months)). 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 NCT03448666.

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 23 Sep 2024.

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