Malignant MesotheliomaPhase 2NCT01649024
A Clinical Study With Tremelimumab as Monotherapy 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.
Trial summary
The study is designed to define the immunologic and clinical activity of Tremelimumab in patients with advanced mesothelioma. 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
- May 2009to Jun 2013
- 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 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
Show all 10Show fewer
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
Italy1 site
Medical Oncology and Immunotherapy Unit, University Hospital of Siena
Siena, 53100
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 study is designed to define the immunologic and clinical activity of Tremelimumab in patients with advanced mesothelioma.
Read the detailed description
No effective standard treatment can improve significantly the prognosis of malignant mesothelioma (MM) patients. However, there is evidence that MM patients may benefit from immunotherapeutic agents.
Clinical studies examining CTLA-4 blockade are providing convincing evidences on the immunobiological effects and on the clinical activity of this new class of immunomodulating therapeutic agents, likely due to their ability to stimulate patients'immune system to more effectively attack tumor cells by blocking a negative regulatory signal.
Tremelimumab is a fully human anti-CTLA-4 monoclonal antibody (mAb), developed as an IgG2 isotype to minimize complement activation and reduce the risk of cytokine storm. As a single agent, Tremelimumab can induce durable tumor regression in 7-10% of patients with advanced melanoma. Tremelimumab has been tested in several clinical trials as single-agent or in combination with other agents in different solid tumors.
The evidences above unveil a strong immunologic potential of treatment with Tremelimumab also in MM patients.
- Conditions
- Malignant Mesothelioma
- Being tested
- Tremelimumab
- Keywords
- Tremelimumab, Malignant Mesothelioma, anti-CTLA-4 mAb
- 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
Given IV
| Study group | Role | What they receive |
|---|---|---|
| single arm of Tremelimumab | Experimental | Tremelimumab is administered at 15 mg/kg on day 1 every 12 weeks for 4 doses Receives: Drug: Tremelimumab |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: Weeks 24
Secondary outcomes (3)
Disease control rate
Disease control rate (DCR) is the proportion of treated subjects that achieved confirmed complete response, or partial response, or stable disease.
The DCR is assessed using the modified RECIST criteria for pleural mesothelioma
Measured: 1 year
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 year
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 physical examination findings are also included.
Measured: 2 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Jul 2012 (estimated)
- Study startMay 2009
- Primary completionJun 2012
- Study completionJun 2013 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Malignant MesotheliomaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
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 (actual)
Sponsor and investigators
- Lead sponsor
- Azienda Ospedaliera Universitaria Senese
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Michele Maio, Azienda Ospedaliera Universitaria Senese
- Investigators
- Michele Maio, MD, Principal investigator, Medical Oncology and Immunotherapy Unit, University Hospital of Siena
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01649024
- Sponsor's protocol ID
- MESOT-TREM-2008
- Other IDs
- 2008-005171-95, 2008
- Status last verified
- Jul 2012
- First submitted
- 18 Jul 2012
- Last updated
- 25 Jul 2012
- Results posted
- No
- Data monitoring committee
- Yes
Publications
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.
PubMed 24035405
Study at a glance
From the registry record, last updated by the sponsor on 25 Jul 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT01649024
- Acronym / sponsor ID
- MESOT-TREM-2008
- Conditions
- Malignant Mesothelioma
- Keywords
- Tremelimumab, Malignant Mesothelioma, anti-CTLA-4 mAb
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 29 participants (actual)
- Lead sponsor
- Azienda Ospedaliera Universitaria SeneseUniversity, hospital or other
- Study start
- May 2009
- Primary completion
- Jun 2012 (actual)
- Study completion
- Jun 2013 (estimated)
- First posted
- 25 Jul 2012 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The study is designed to define the immunologic and clinical activity of Tremelimumab in patients with advanced mesothelioma.
Detailed description
No effective standard treatment can improve significantly the prognosis of malignant mesothelioma (MM) patients. However, there is evidence that MM patients may benefit from immunotherapeutic agents.
Clinical studies examining CTLA-4 blockade are providing convincing evidences on the immunobiological effects and on the clinical activity of this new class of immunomodulating therapeutic agents, likely due to their ability to stimulate patients'immune system to more effectively attack tumor cells by blocking a negative regulatory signal.
Tremelimumab is a fully human anti-CTLA-4 monoclonal antibody (mAb), developed as an IgG2 isotype to minimize complement activation and reduce the risk of cytokine storm. As a single agent, Tremelimumab can induce durable tumor regression in 7-10% of patients with advanced melanoma. Tremelimumab has been tested in several clinical trials as single-agent or in combination with other agents in different solid tumors.
The evidences above unveil a strong immunologic potential of treatment with Tremelimumab also in MM patients.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| single arm of Tremelimumab | Experimental | Drug: TremelimumabTremelimumab is administered at 15 mg/kg on day 1 every 12 weeks for 4 doses |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (10 listed)
- 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
Key exclusion criteria (7 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| TremelimumabAlso: CP-675,206Given IV | Drug | single arm of Tremelimumab |
Primary outcome
Objective tumor response by modified Response Evaluation Criteria in Solid Tumor (RECIST)
Time frame: Weeks 24
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
3 secondary outcomes
Disease control rate
Time frame: 1 year
Progression free survival
Time frame: 1 year
Safety
Time frame: 2 years
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 Jul 2012.
- Derived from this study: PubMed 24035405Calabro 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Michele Maio, MD principal investigator
Medical Oncology and Immunotherapy Unit, University Hospital of Siena
1 site in 1 country: see every site and its status.
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 10 inclusion and 7 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 25 Jul 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?
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?
Objective tumor response by modified Response Evaluation Criteria in Solid Tumor (RECIST) (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 NCT01649024, 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 25 Jul 2012.