Clinical trial · Interventional
A Clinical Study With Tremelimumab as Monotherapy in Malignant Mesothelioma
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
NCT01649024CI-TRIAL-00007551unknownPhase 2ClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
The study is designed to define the immunologic and clinical activity of Tremelimumab in patients with advanced mesothelioma.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Malignant Mesothelioma | Malignant Mesothelioma | ONTOLOGY_EXACT | 0.98 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Tremelimumab | Drug | Tremelimumab | ALIAS |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- single arm of Tremelimumab
- description
- Tremelimumab is administered at 15 mg/kg on day 1 every 12 weeks for 4 doses
- interventionNames
- Drug: Tremelimumab
Primary outcomes (1)
- measure
- Objective tumor response by modified Response Evaluation Criteria in Solid Tumor (RECIST)
- timeFrame
- Weeks 24
- description
- 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
Secondary outcomes (3)
- measure
- Disease control rate
- timeFrame
- 1 year
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: * 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 Exclusion Criteria: * 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
References
Publications (1)
- DERIVEDCalabro 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 24035405