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

NCT01655888 | Unknown Phase 2 DMC

• 2 other identifiers: MESOT-TREM-20122012-002762-12
• Study Type: interventional
• Target: 29
• Locations: 1 country
• Sites: 1

Brief 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. Subjects will receive investigational product every 4 weeks (wks) for 6 doses, followed by doses every 12 wks until confirmed disease progression.

Conditions

Malignant Mesothelioma

Keywords

Tremelimumab; anti-CTLA-4 monoclonal antibody; malignant mesothelioma

Outcome Measures

Primary Outcomes (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

  Weeks 24

Secondary Outcomes (3)

• Disease control rate (DCR)

  1 year

• Safety

  3 years

• Progression free survival

  1 years

Study Arms (1)

single arm with Tremelimumab

EXPERIMENTAL

Tremelimumab: 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

Drug: Tremelimumab

Interventions

Tremelimumab DRUG

Tremelimumab is administered as endovenous infusion

Also known as: CP-675,206

single arm with Tremelimumab

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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
• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• Azienda Ospedaliera Universitaria Senese: lead
• MedImmune LLC: collaborator

Study Sites (1)

Medical Oncology and Immunotherapy Unit, University Hospital of Siena

Siena, 53100, Italy

RECRUITING

Related Publications (1)

• 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.

  PMID: 25819643 DERIVED

MeSH Terms

Conditions

Mesothelioma, Malignant

Interventions

tremelimumab

Condition Hierarchy (Ancestors)

Mesothelioma; Adenoma; Neoplasms, Glandular and Epithelial; Neoplasms by Histologic Type; Neoplasms; Neoplasms, Mesothelial; Lung Neoplasms; Respiratory Tract Neoplasms; Thoracic Neoplasms; Neoplasms by Site; Pleural Neoplasms; Lung Diseases; Respiratory Tract Diseases

Study Officials

• Michele Maio, MD

  Medical Oncology and Immunotherapy Unit, University Hospital of Siena, Italy

  PRINCIPAL INVESTIGATOR

• Luana Calabrò, MD

  Medical Oncology and Immunotherapy, University Hospital of Siena, Italy

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Michele Maio, MD

CONTACT

+39-0577586335; mmaio@cro.it

Luana Calabrò, MD

CONTACT

+39-0577586116; l.calabro@ao-siena.toscana.it

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 Unit

Study Record Dates

• First Submitted: July 31, 2012
• First Posted: August 2, 2012
• Study Start: July 1, 2012
• Primary Completion: January 1, 2014
• Study Completion: January 1, 2015
• Last Updated: August 2, 2012

Record last verified: 2012-07

Locations

IT (1)