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Mesothelioma, MalignantPhase 2ARTEMISNCT02357147

Study of the Safety and Efficacy of Amatuximab in Combination With Pemetrexed and Cisplatin in Subjects With Unresectable Malignant Pleural Mesothelioma (MPM)

A Phase 2 study testing Amatuximab, Pemetrexed and Cisplatin in people with Mesothelioma, Malignant, run by Morphotek at 49 sites in 6 countries.

Terminated

Stopped early. The study ended before it was planned to and will not resume.

Official record
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Trial summary

This study was originally designed as a multicenter, double-blind, randomized, parallel-group study, using a placebo control or amatuximab 5 milligrams per kilogram (mg/kg), administered weekly, designed to evaluate the safety and efficacy of amatuximab in combination with pemetrexed and cisplatin in participants with… Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Mesothelioma, Malignant
What is being tested?
Amatuximab, Pemetrexed and Cisplatin
Type of treatment
Injection or infusion
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
124 participants
Where
49 sitesin 6 countries
Study dates
3 Nov 2015to 30 Nov 2018
Phase
Phase 2
Are there results?
Yes, posted in the registrySummary in the doctors' view

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

  • Are at least 18 years of age at the time of informed consent
  • Have confirmed diagnosis of MPM with the following characteristics:
  • Unresectable disease (defined as the participant not being a candidate for curative surgery)
  • Epithelial type
  • Have an archived tissue sample to be submitted either as a formalin fixed paraffin-embedded (FFPE) tumor block, or 5 to 15 unstained slides
  • Have measurable disease at Screening by computed tomography (CT) (or magnetic resonance imaging [MRI]) as defined by at least 1 lesion of greater than or equal to 1.5 cm in the longest diameter for a non-lymph node or greater than or equal to 1.5 cm in the short-axis diameter for a lymph node that is serially measurable according to the modified RECIST criteria
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  • Have other significant medical conditions well-controlled and stable in the opinion of the investigator for at least 30 days prior to Day 1
  • Have an Eastern Cooperative Oncology Group (ECOG) Performance Status 0 or 1 at Screening
  • Have a life expectancy of at least 3 months, as estimated by the investigator
  • Have adequate organ reserve as determined by laboratory test results obtained within 2 weeks prior to Study Day 1 as indicated below:
  • Absolute neutrophil count greater than or equal to 1.5 x 10^9/L
  • Platelet count greater than or equal to 100 x 10^9/L
  • Hemoglobin greater than or equal to 9 g/dL
  • Serum bilirubin less than or equal to 1.5 x upper limit of normal (ULN) (Participants with serum bilirubin abnormalities greater than this specified limit are eligible only if they have known Gilberts disease)
  • Aspartate aminotransferase less than or equal to 3 x ULN
  • Alanine aminotransferase less than or equal to 3 x ULN
  • Alkaline phosphatase less than or equal to 3 x ULN
  • Have a calculated serum creatinine clearance greater than or equal to 45 mL/min using the Cockcroft-Gault equation
  • Participants of childbearing potential must be surgically sterile or consent to use a highly effective method of contraception throughout the study period. All females will be considered to be of childbearing potential unless they are postmenopausal (amenorrheic for at least 12 consecutive months, in the appropriate age group, and without other known or suspected cause) or have been sterilized surgically (ie, bilateral tubal ligation, total hysterectomy, or bilateral oophorectomy, all with surgery at least 1 month before dosing). If a participant of childbearing potential is neither surgically sterile nor postmenopausal, highly effective contraceptive measures must start either prior to or at Screening and continue throughout the entire study period and for at least 6 months after the last dose of chemotherapy and at least 30 days after the last dose of Test Article (amatuximab or placebo) is administered (whichever is later). A highly effective method of contraception is defined as one that results in a low failure rate (that is, less than 1% per year) when used consistently and correctly. Periodic abstinence, the rhythm method, the withdrawal method, condoms, and diaphragms are not acceptable methods of contraception. Women of childbearing potential must also refrain from egg cell donation for 6 months after the final dose of investigational product
  • Male participants must have had a successful vasectomy (confirmed azoospermia) or they and their female partners must meet the criteria above (that is, not of childbearing potential or practicing highly effective contraception throughout the study period and for 6 months after discontinuation of chemotherapy and for 5 weeks after Test Article (amatuximab or placebo) discontinuation (whichever is later). No sperm donation is allowed during the study period and for 90 days after Test Article discontinuation
  • Be willing and able to provide written informed consent
  • Be willing and able to comply with all aspects of the protocol
  • Participants who were enrolled in the study and randomized to the amatuximab treatment arm may, at the discretion of the principle investigator (PI), consent to continue to receive amatuximab therapy until disease progression, intolerable toxicity, or withdraw of consent

Who cannot join

  • Have any history of the following:
  • Prior systemic therapy or radiotherapy for MPM; local radiotherapy of noncurative intent (ie, for prevention of instrument-tract recurrence and/or symptom control) is permitted
  • Evidence of other active, invasive malignancy requiring treatment within the past 5 years; noninvasive cancer history (such as carcinoma-in-situ [CIS] that has been resected) is allowed
  • Currently have mesothelioma of the sarcomatous type, mixed histologic disease, or have malignant peritoneal mesothelioma
  • Have confirmed presence of central nervous system metastases
  • Active viral hepatitis or active human immunodeficiency virus infection
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  • Have evidence of any other serious systemic disease, including active bacterial or fungal infection, or any medical condition that, in the opinion of the investigator(s) could affect the participant's safety or interfere with the study assessments
  • Clinically significant heart disease (eg, congestive heart failure of New York Heart Association Class 3 or 4, angina not well controlled by medication, or myocardial infarction within 6 months)
  • Electrocardiogram (ECG) demonstrating clinically significant arrhythmias (Note: participants with chronic atrial arrhythmia, ie, atrial fibrillation or paroxysmal supraventricular tachycardia, are eligible). A clinically significant ECG abnormality, including a marked prolonged QT/QTc interval (eg, a repeated demonstration of a QTc interval of greater than 500 ms)
  • Have known intolerance to the Test Article (ie, documented hypersensitivity AE to prior monoclonal antibody therapy, or to amatuximab or any of its excipients)
  • Pregnant and/or lactating females are excluded; a negative beta-human chorionic gonadotropin [B-hCG]) is required during Screening, and a separate local assessment is required if a negative screening pregnancy test was obtained more than 72 hours before the first dose of Test Article
  • Have any medical or other condition that in the opinion of the investigator(s) would preclude the participant's participation in a clinical study
  • Are scheduled for debulking surgery during the study
  • Are currently enrolled in another clinical study or used any investigational drug or device within 30 days (or 5 x the half-life of the investigational drug/device, whichever is longer) preceding informed consent
  • Participants previously randomized to placebo
  • Participants who have not signed the updated informed consent form associated with this amendment 2
  • Participants who have radiographic or clinical disease progression or intolerable toxicity such that ongoing amatuximab treatment through this study is not appropriate

Trial locations and contacts

49 sites in 6 countries.

49 sites in 6 countries

Italy11 sites

  • Study site

    Alessandria

  • Study site

    Aviano

  • Study site

    Bari

  • Study site

    Bergamo

  • Study site

    Genoa

  • Study site

    Genova

  • Study site

    Monza

  • Study site

    Orbassano

  • Study site

    Parma

  • Study site

    Pisa, Paradisa 2, 56124

  • Study site

    Rozzano, Milano

Other trials in Italy

United Kingdom10 sites

  • Study site

    Dundee

  • Study site

    Hereford

  • Study site

    Leicester

  • Study site

    London

  • Study site

    Maidstone, Kent

  • Study site

    Middlesex

  • Study site

    Preston

  • Study site

    Southampton

  • Study site

    Swindon

  • Study site

    Taunton

Other trials in United Kingdom

Germany9 sites

  • Study site

    Berlin

  • Study site

    Esslingen am Neckar

  • Study site

    Frankfurt am Main

  • Study site

    Gauting

  • Study site

    Hamburg

  • Study site

    Hanover

  • Study site

    Löwenstein

  • Study site

    Ulm

  • Study site

    Wöhrendamm

Other trials in Germany

France8 sites

  • Study site

    Caen

  • Study site

    Créteil

  • Study site

    La Tronche

  • Study site

    Lille

  • Study site

    Lyon

  • Study site

    Marseille

  • Study site

    Rennes

  • Study site

    Toulouse

Other trials in France

United States7 sites

  • Study site

    Bethesda, Maryland

  • Study site

    Dallas, Texas

  • Study site

    La Jolla, California

  • Study site

    Newark, Delaware

  • Study site

    Philadelphia, Pennsylvania

  • Study site

    Rochester, Minnesota

  • Study site

    Spokane, Washington

Other trials in United States

Australia4 sites

  • Study site

    Auchenflower, Queensland

  • Study site

    Camperdown, New South Wales

  • Study site

    Perth, Western Australia

  • Study site

    Richmond, Victoria, 3121

Other trials in Australia

About this study

Official title: A Randomized, Double-blind, Placebo-controlled Study of the Safety and Efficacy of Amatuximab in Combination With Pemetrexed and Cisplatin in Subjects With Unresectable Malignant Pleural Mesothelioma

This study was originally designed as a multicenter, double-blind, randomized, parallel-group study, using a placebo control or amatuximab 5 milligrams per kilogram (mg/kg), administered weekly, designed to evaluate the safety and efficacy of amatuximab in combination with pemetrexed and cisplatin in participants with unresectable Malignant Pleural Mesothelioma (MPM) who have not received prior systemic therapy.

Per a business decision made by the Sponsor, participants who were randomized to amatuximab and were still on active treatment at the time of the protocol amendment may have consented to continue to receive weekly treatment with amatuximab until disease progression or intolerable toxicity at the discretion of the principal investigator. Participants randomized to placebo or who were in follow-up at the time of the amendment have been discontinued from the study.

Being tested
Placebo, Amatuximab, Pemetrexed, Cisplatin
Keywords
Amatuximab, Pemetrexed, Cisplatin, Unresectable Malignant Pleural Mesothelioma, ARTEMIS
Medical subject headings
Mesothelioma, Malignant, Severe combined immunodeficiency with sensitivity to ionizing radiation

What participants receive

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

  • PlaceboDrug

    Combination Phase - Placebo will be administered IV (intravenous infusion) once weekly for six 21-day cycles.

    Maintenance Phase - Placebo will be administered IV (intravenous infusion) once weekly until disease progression.

  • AmatuximabDrug

    Combination Phase - Amatuximab 5mg/kg will be administered IV (intravenous infusion) once weekly for six 21-day cycles.

    Maintenance Phase - Amatuximab 5mg/kg will be administered IV (intravenous infusion) once weekly until disease progression.

  • PemetrexedDrug

    Combination Phase - Pemetrexed 500 mg/m^2 will be administered IV on Day 1 of each 21-day cycle for 6 cycles.

  • CisplatinDrug

    Combination Phase - Cisplatin 75 mg/m^2 will be administered IV on Day 1 of each 21-day cycle for 6 cycles.

Study groups in NCT02357147
Study groupRoleWhat they receive
Arm 1ExperimentalCombination Phase - Amatuximab + Pemetrexed and Cisplatin Maintenance Phase - Amatuximab
Receives: Drug: Amatuximab; Drug: Pemetrexed; Drug: Cisplatin
Arm 2ExperimentalCombination Phase - Placebo + Pemetrexed and Cisplatin Maintenance Phase - Placebo
Receives: Drug: Placebo; Drug: Pemetrexed; Drug: Cisplatin

What is being measured

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

  1. Number of Participants With Adverse Events (AEs) and Serious Adverse Events (SAEs)

    AEs included both non-SAEs and SAEs and the same participant can have both SAEs and as well non-SAEs.

    Measured: Baseline up to 3 years

Timeline

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

  1. First posted6 Feb 2015 (estimated)
  2. Study start3 Nov 2015
  3. Primary completion30 Nov 2018
  4. Study completion30 Nov 2018

Why it stopped: Due to business reasons

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
Randomised
Intervention model
Parallel groups
Masking
Quadruple blind
Who is masked
Participant, Care provider, Investigator, Outcomes assessor
Enrolment
124 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT02357147
Sponsor's protocol ID
MORAb-009-201
Other IDs
2014-004489-85, 2014
Acronym
ARTEMIS
Status last verified
Feb 2017
First submitted
14 Jan 2015
Last updated
17 Mar 2020
Data monitoring committee
Yes
FDA-regulated drug
Yes
FDA-regulated device
No

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing Amatuximab, Pemetrexed and Cisplatin in people with Mesothelioma, Malignant, run by Morphotek at 49 sites in 6 countries.

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 23 inclusion and 17 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: stopped early, as of the sponsor's last update on 17 Mar 2020. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 49 sites in Italy, United Kingdom, Germany, France, United States and 1 more country. 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?

Yes. Results are posted in the registry (first posted 17 Mar 2020). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

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?

Number of Participants With Adverse Events (AEs) and Serious Adverse Events (SAEs) (time frame: Baseline up to 3 years). 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 NCT02357147.

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 17 Mar 2020.

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