NCT01649024

Brief Summary

The study is designed to define the immunologic and clinical activity of Tremelimumab in patients with advanced mesothelioma.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
29

participants targeted

Target at below P25 for phase_2

Timeline
Completed

Started May 2009

Typical duration for phase_2

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

May 1, 2009

Completed
3.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2012

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

July 18, 2012

Completed
7 days until next milestone

First Posted

Study publicly available on registry

July 25, 2012

Completed
10 months until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2013

Completed
Last Updated

July 25, 2012

Status Verified

July 1, 2012

Enrollment Period

3.1 years

First QC Date

July 18, 2012

Last Update Submit

July 20, 2012

Conditions

Malignant Mesothelioma

Keywords

TremelimumabMalignant Mesotheliomaanti-CTLA-4 mAb

Outcome Measures

Primary Outcomes (1)

  • Objective tumor response by modified Response Evaluation Criteria in Solid Tumor (RECIST)

    The objective tumor response is defined as a confirmed complete response (CR) or partial response (PR) according to the modified RECIST criteria for pleural mesothelioma

    Weeks 24

Secondary Outcomes (3)

  • Disease control rate

    1 year

  • Progression free survival

    1 year

  • Safety

    2 years

Study Arms (1)

single arm of Tremelimumab

EXPERIMENTAL

Tremelimumab is administered at 15 mg/kg on day 1 every 12 weeks for 4 doses

Drug: Tremelimumab

Interventions

TremelimumabDRUG

Given IV

Also known as: CP-675,206
single arm of Tremelimumab

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Histologically or cytologically confirmed malignant mesothelioma (MM)
  • Have received only one prior systemic chemotherapy platinum-based regimen for advanced MM
  • Disease not amenable to curative surgery
  • No known brain metastasis
  • Age 18 and over
  • Performance status 0-2
  • Life expectancy \> 12 weeks
  • Adequate hematologic, hepatic and renal function
  • Not pregnant or nursing
  • 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

You may not qualify if:

  • Symptomatic chronic inflammatory or autoimmune disease
  • Active hepatitis B or C
  • Clinically relevant cardiovascular disease, i.e., myocardial infarction or other severe coronary artery diseases within the prior 6 months, cardiac arrythmia requiring medication, uncontrolled hypertension, overt cardiac failure or not compensated chronic heart disease in NYHA class II or more
  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Medical Oncology and Immunotherapy Unit, University Hospital of Siena

Siena, 53100, Italy

Location

Related Publications (1)

  • Calabro L, Morra A, Fonsatti E, Cutaia O, Amato G, Giannarelli D, Di Giacomo AM, Danielli R, Altomonte M, Mutti L, Maio M. Tremelimumab for patients with chemotherapy-resistant advanced malignant mesothelioma: an open-label, single-arm, phase 2 trial. Lancet Oncol. 2013 Oct;14(11):1104-1111. doi: 10.1016/S1470-2045(13)70381-4. Epub 2013 Sep 11.

    PMID: 24035405DERIVED

MeSH Terms

Conditions

Mesothelioma, Malignant

Interventions

tremelimumab

Condition Hierarchy (Ancestors)

MesotheliomaAdenomaNeoplasms, Glandular and EpithelialNeoplasms by Histologic TypeNeoplasmsNeoplasms, MesothelialLung NeoplasmsRespiratory Tract NeoplasmsThoracic NeoplasmsNeoplasms by SitePleural NeoplasmsLung DiseasesRespiratory Tract Diseases

Study Officials

  • Michele Maio, MD

    Medical Oncology and Immunotherapy Unit, University Hospital of Siena

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 2
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Head of Medical Oncology and Immunotherapy, University Hospital of Siena

Study Record Dates

First Submitted

July 18, 2012

First Posted

July 25, 2012

Study Start

May 1, 2009

Primary Completion

June 1, 2012

Study Completion

June 1, 2013

Last Updated

July 25, 2012

Record last verified: 2012-07

Locations

IT(1)