Efficacy & Safety of rAd-IFN Administered With Celecoxib & Gemcitabine in Patients With Malignant… (NCT03710876) | Clinical Trial Compass
CompletedPhase 3
Efficacy & Safety of rAd-IFN Administered With Celecoxib & Gemcitabine in Patients With Malignant Pleural Mesothelioma
United States53 participantsStarted 2019-01-21
Plain-language summary
This study will evaluate intrapleural administration of Adenovirus-Delivered Interferon Alpha-2b (rAd-IFN) in combination with Celecoxib and Gemcitabine in patients with histologically confirmed Malignant Pleural Mesothelioma (MPM) who have failed a minimum of 1 treatment regimen and a maximum of 2 treatment regimens, 1 of which must have been an anti-folate and platinum combination regimen.
Eligible patients will be randomized 1:1 to either:
1. Treatment group: rAd-IFN + Celecoxib followed by Gemcitabine
2. Control group: Celecoxib followed by Gemcitabine
Patients randomized to the treatment group will receive rAd-IFN administered into the pleural space via an Intrapleural catheter (IPC) or similar intrapleural device on study Day 1.
The primary objective of this study is to compare the overall survival (OS) associated with rAd IFN, when administered with celecoxib and gemcitabine, versus that associated with celecoxib and gemcitabine alone for the treatment of patients with MPM
Who can participate
Age range18 Years
SexALL
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AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion criteria
✓. Aged 18 years or older at the time of consent;
✓. Able to give informed consent;
✓. Has a confirmed histological diagnosis of MPM with histological type epithelioid or biphasic (if biphasic, histology must be predominantly \[50%\] epithelioid). Histological diagnosis of MPM will be confirmed centrally using specimens or slides from tumor specimens obtained at the time of initial presentation or a subsequent procedure. Central confirmation of diagnosis with immunohistochemistry will be performed, and independent central confirmation will be required for study entry;
✓. Measurable disease, per modified Response Evaluation Criteria in Solid Tumors \[RECIST\] 1.1 (see Section 7) for pleural mesothelioma;
✓. Has received a minimum of 1 treatment regimen and a maximum of 2 treatment regimens, which may have been chemotherapeutic and/or immunotherapeutic treatment regimens for MPM which included at least 1 anti-folate and platinum combination regimen;
Exclusion criteria
✕. Has a pleural space accessible for IPC or similar device insertion. Patients with a previously inserted IPC or similar device may be enrolled, and the pre-existing IPC or similar device can be used for vector administration as long as it is functional and has no evidence of local infection;
✕. Life expectancy 12 weeks in the judgement of the Investigator;
✕. Eastern Cooperative Oncology Group (ECOG) status of 1 or 0;
✕. Female and male patients:
✕0. Adequate laboratory values at Screening:
✕. Is "treatment-naïve" (i.e., has not received at least 1 anti-folate and platinum combination regimen);
✕. Has previously received 3 or more lines of systemic chemotherapeutic or immunotherapeutic treatment. Treatment that is split between pre-surgical resection and post-surgical resection and is the same regimen will be counted as 1 regimen. Patients meeting this condition should be discussed with the Medical Monitor prior to including the patient in the study;
✕. Has previously received treatment with gemcitabine;