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Malignant MesotheliomaPhase 2NCT01655888

The Anti-CTLA-4 Monoclonal Antibody Tremelimumab in Malignant Mesothelioma

A Phase 2 study testing Tremelimumab in people with Malignant Mesothelioma, run by Azienda Ospedaliera Universitaria Senese at 1 site in Italy.

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 The sponsor has not verified this record for over two years, so it may be out of date.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

RATIONAL: Preliminary results fron the Study MESOT-TREM-2012 indicate a promising activity of tremelimumab in malignant mesothelioma (MM) patients. PURPOSE: The proposed study MESOT-TREM-2012 aims to explore the efficacy of a more intensive schedule of treatment with tremelimumab in 29 MM patients. Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Malignant Mesothelioma
What is being tested?
Tremelimumab
Type of treatment
Injection or infusion
Could I receive a placebo?
No, everyone receives an active treatment
How many people
29 participants
Where
1 siteItaly
Study dates
Jul 2012to Jan 2015
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

  • Histologically or cytologically confirmed MM
  • Have received only one prior systemic chemotherapy platinum-based regimen for advanced MM
  • Measurable disease, defined at least 1 unidimensionally measurable lesion > 20 mm by conventional techniques or > 10 mm by spiral CT scan (modified RECIST criteria)
  • Disease not amenable to curative surgery
  • No known brain metastasis
  • Age 18 and over
Show all 18Show fewer
  • Performance status 0-2
  • Life expectancy > 12 weeks
  • Adequate hematologic, hepatic and renal function
  • Platelet count > 75000/mm3
  • Absolute granulocyte count > 1000/mm3
  • Hemoglobin > 9 g/dL
  • Bilirubin total < 1.5 x ULN (Upper limited normal), except patients with documented Gilbert's syndrome, who must have a total bilirubin < 3.0 mg/dl
  • AST and ALT < 2.5 x ULN ( < 5 x ULN if documented liver metastasis are present)
  • Creatinine level < 2mg/dl or calculated creatinine clearance > 60 mL/min as determined by the Cockcroft Gault equation.
  • Not pregnant or nursing
  • Fertile patients must use effective contraception
  • Patient must be willing and able to provide written informed consent, and the trial have to be approved by the institutional review board at each institution

Who cannot join

  • Symptomatic chronic inflammatory or autoimmune disease
  • Active hepatitis B or C
  • Prior treatment with tremelimumab or other anti-CTLA-4 antibody or anti-PD1, anti-PDL-1 agents
  • Clinically relevant cardiovascular disease
  • History of psychiatric disabilities, potentially interfering with the capability of giving adequate informed consent
  • Uncontrolled active infections
  • Other concurrent chemotherapy, immunotherapy, radiotherapy or investigational agents
  • History of other malignancies except for adequately treated basal cell carcinoma or squamous cell skin cancer or carcinoma of cervix, unless the patient has been disease-free for at least 5 years

Trial locations and contacts

1 site in 1 country.

Michele Maio, MD contact

+39-0577586335

mmaio@cro.it

Luana Calabrò, MD contact

+39-0577586116

l.calabro@ao-siena.toscana.it

Italy1 site, 1 recruiting

  • Medical Oncology and Immunotherapy Unit, University Hospital of Siena

    Siena, 53100

    Michele Maio, MD, +39-0577586335, mmaio@cro.it

    Luana Calabrò, MD, +39-0577586116, l.calabro@ao-siena.toscana.it

    Recruiting

Other trials in Italy

About this study

Official title: A SECOND-LINE, SINGLE ARM, PHASE II CLINICAL STUDY WITH TREMELIMUMAB, A FULLY HUMAN ANTI-CTLA-4 MONOCLONAL ANTIBODY, AS MONOTHERAPY IN PATIENTS WITH UNRESECTABLE MALIGNANT MESOTHELIOMA. The MESOT-TREM-2012

RATIONAL: Preliminary results fron the Study MESOT-TREM-2012 indicate a promising activity of tremelimumab in malignant mesothelioma (MM) patients.

PURPOSE: The proposed study MESOT-TREM-2012 aims to explore the efficacy of a more intensive schedule of treatment with tremelimumab in 29 MM patients. Subjects will receive investigational product every 4 weeks (wks) for 6 doses, followed by doses every 12 wks until confirmed disease progression.

Read the detailed description

Primary endpoint:

  1. To assess the rate of objective clinical complete response (CR) or partial response (PR)

Secondary endpoints:

  1. To define toxicity profile according to NCI CT-CAE V. 3
  2. To assess the overall survival (OS)
  3. To estimate disease control rate (DCR) (proportion of patients with best response of CR+PR+SD) according to the modified Recist criteria
  4. To assess the progression-free survival in treated patients according to modified Recist criteria
  5. To evaluate qualitative and quantitative changes in cellular and humoral immune responses
Being tested
Tremelimumab
Keywords
Tremelimumab, anti-CTLA-4 monoclonal antibody, malignant mesothelioma
Medical subject headings
Mesothelioma, Malignant

What participants receive

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

  • TremelimumabDrug

    Also called CP-675,206

    Tremelimumab is administered as endovenous infusion

Study groups in NCT01655888
Study groupRoleWhat they receive
single arm with TremelimumabExperimentalTremelimumab: 10mg/Kg ev day 1 every 4 weeks for 6 doses in induction phase, then every 12 weeks in maintenance phase until disease progression of severe toxicity
Receives: Drug: Tremelimumab

What is being measured

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

  1. To determine the objective response

    The objective response is defined as a confirmed complete response (CR), or partial response (PR) according to the modified RECIST Criteria for pleural mesothelioma and the immune-related (ir) Response Criteria

    Measured: Weeks 24

Secondary outcomes (3)

  1. Disease control rate (DCR)

    DCR is the proportion of treated subjects that achieved confirmed CR or PR or stable disease (SD) The DCR is assessed using the modified RECIST Criteria for pleural mesothelioma umor assessment and the the immune-related response criteria

    Measured: 1 year

  2. Safety

    The assessment of safety includes serious and non-serious adverse events according to NCI-CTC criteria version 3.0. In addition, laboratory evaluation, abnormal vital signs and physycal examination findings are also included.

    Measured: 3 years

  3. Progression free survival

    Progression free survival is computed from the first day of study treatment to the day of documented progression according to the modified RECIST Criteria for pleural mesothelioma or death, whichever occurs first

    Measured: 1 years

Timeline

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

  1. First posted2 Aug 2012 (estimated)
  2. Study startJul 2012
  3. Primary completionJan 2014 (estimated)
  4. Study completionJan 2015 (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 2
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrolment
29 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT01655888
Sponsor's protocol ID
MESOT-TREM-2012
Other IDs
2012-002762-12
Status last verified
Jul 2012
First submitted
31 Jul 2012
Last updated
2 Aug 2012
Results posted
No
Data monitoring committee
Yes

Publications

  • Calabro L, Morra A, Fonsatti E, Cutaia O, Fazio C, Annesi D, Lenoci M, Amato G, Danielli R, Altomonte M, Giannarelli D, Di Giacomo AM, Maio M. Efficacy and safety of an intensified schedule of tremelimumab for chemotherapy-resistant malignant mesothelioma: an open-label, single-arm, phase 2 study. Lancet Respir Med. 2015 Apr;3(4):301-9. doi: 10.1016/S2213-2600(15)00092-2. Epub 2015 Mar 26.

    PubMed 25819643

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing Tremelimumab in people with Malignant Mesothelioma, run by Azienda Ospedaliera Universitaria Senese 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 8 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 2 Aug 2012. 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?

Results are not available in the source record.

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

Contact Michele Maio, MD (+39-0577586335, mmaio@cro.it), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

To determine the objective response (time frame: Weeks 24). 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 NCT01655888, which also lists 1 linked publication.

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 2 Aug 2012.

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