Efficacy & Safety of rAd-IFN Administered With Celecoxib & Gemcitabine in Patients With Malignant Pleural Mesothelioma

Completed · Phase 3

Conditions studied: Malignant Pleural Mesothelioma

In brief

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

Key facts

Study ID: NCT03710876
Run by: Ferring Ventures Limited
People needed: 53
Starts: 2019-01-21
Expected to finish: 2026-01-16
Last updated by the study team: 2026-04-21

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

Patients who meet all of the following criteria will be eligible to participate in the study:
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;
Adjuvant or neoadjuvant therapy represent 1 line of therapy each;
Patients who have undergone primary surgical resection and/or radiation therapy to the pulmonary site are eligible to participate. For clarity, surgical resection and/or radiation therapy to the pulmonary site are not exclusionary and are not considered a line of therapy;
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 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:
Female patients of childbearing potential must have a negative pregnancy test upon entry into this study and agree to use a highly effective method of contraception from Screening until 1 month after the last dose of gemcitabine;
Highly effective methods of contraception that result in a low failure rate (i.e., <1% per year) when used consistently and correctly include combined (estrogen and progestogen containing) hormonal contraception associated with inhibition of ovulation (oral, intravaginal, or transdermal), progestogen-only hormonal contraception associated with inhibition of ovulation (oral, injectable, or implantable), intrauterine device, intrauterine hormone-releasing system, bilateral tubal occlusion, vasectomized partner, or sexual abstinence;
True abstinence, when in line with the preferred and usual lifestyle of the patient, is considered a highly effective method only if defined as refraining from heterosexual intercourse during the entire period of study participation and for 1 month after the last dose of gemcitabine. The reliability of sexual abstinence needs to be evaluated in relation to the duration of the clinical study and the preferred and usual lifestyle of the patient. Periodic abstinence (e.g., calendar, ovulation, symptothermal, and post-ovulation method) and withdrawal are not acceptable methods of contraception; and
Female patients of non-childbearing potential must be either postmenopausal (no menstrual period for a minimum of 12 months) or surgically sterile upon entry into the study;
Male patients must be either surgically sterile or agree to use a double-barrier contraception method from Screening until 6 months after the last dose of gemcitabine; o Where available and in accordance with local practice, male patients must be advised to seek further advice regarding cryoconservation of sperm prior to gemcitabine treatment due to the possibility of infertility after therapy with gemcitabine; and
Adequate laboratory values at Screening:
Hemoglobin 9 g/dL;
White blood cell count 3500/µL;
Absolute neutrophil count 1500/µL;
• Platelet count 100,000/µL;
International normalized ratio (INR) and activated partial thromboplastin time (aPTT) below the upper limit of normal (ULN). It is expected that patients receiving anticoagulation therapy will not have INR and aPTT results that fall within normal limits. It is not intended to exclude these patients and, therefore, medical discretion is permitted for patients who have clinically acceptable results in regards to their current concomitant anticoagulant therapy;
Aspartate aminotransferase (AST) 3 × ULN;

You may not qualify if…

Patients who meet any of the following criteria will be excluded from participation in the study:
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;
Has stage IV extrathoracic metastatic disease;
Inadequate pulmonary function of clinical significance as per Investigator review;
Clinically significant pericardial effusion (i.e., as judged by the Investigator and/or requiring drainage) detected by computed tomography (CT) scan at Screening. Standard of care CT scans completed within 2 weeks prior to Screening may be used in place of the Screening CT scan on a case by-case basis as agreed with the Medical Monitor;
Prior therapy(ies), if applicable, must be completed according to the criteria below prior to vector administration:
Cytotoxic chemotherapy, at least 21 days from last dose;
Non-cytotoxic chemotherapy (e.g., small molecule inhibitor), at least 14 days from last dose;
Monoclonal antibody, at least 30 days from last dose;
Non-antibody immunotherapy (e.g., tumor vaccine), at least 42 days from last dose;
Radiotherapy, at least 14 days from last local site radiotherapy;
Hematopoietic growth factor, at least 14 days from last dose; or
Study drug, 30 days or 5 half-lives, whichever is longer, from last dose;
Patient previously treated with IFNs (e.g., for chronic active hepatitis);
Suspected/known hypersensitivity to IFN-α2b or rAd-IFN (including any of its excipients);
Known hypersensitivity to celecoxib (including any of its excipients) or sulfonamides;
Known hypersensitivity to gemcitabine (including any of its excipients);
Impaired cardiac function or clinically significant cardiac disease including the following:
New York Heart Association class III or IV congestive heart failure;
Myocardial infarction within the last 12 months; and
Patients known to have impaired left ventricular ejection fraction per institutional standards and of clinical significance as per Investigator review;
Women who are pregnant or breastfeeding;
Uncontrolled intercurrent illness including, but not limited to, ongoing or active infection, symptomatic congestive heart failure, unstable angina pectoris, cardiac arrhythmia, depression, or psychiatric illness/social situations within the last 12 months;

Where it is running

University of California, Los Angeles (UCLA) - Medical Center — Los Angeles, California, United States
University of California, San Francisco (UCSF) — San Francisco, California, United States
H. Lee Moffitt Cancer Center & Research Institute — Tampa, Florida, United States
Marlene & Stewart Greenbaum Comprehensive Cancer Center — Baltimore, Maryland, United States
University of Maryland Medical Center — Baltimore, Maryland, United States
Masonic Cancer Center - University of Minnesota — Minneapolis, Minnesota, United States
University of Pennsylvania Abramson Cancer Center — Philadelphia, Pennsylvania, United States
Chris O'Brien Lifehouse — Camperdown, New South Wales, Australia
Monash Medical Centre — Clayton, Victoria, Australia
Institut Universitaire de Cardiologie et de Pneumologie De Quebec — Québec, Sainte-Foy, Canada
Institut Bergonie — Bordeaux, France
CHRU de Brest - Hopital Augustin Morvan — Brest, France
CHU de Caen - Hopital Cote de Nacre — Caen, France
CHRU de Lille — Lille, France
Institut Curie - Oncologie Medicale — Paris, France
Centre Hospitalier Lyon Sud — Pierre-Bénite, France
CHU de Nantes - Hôpital Nord Laennec — Saint-Herblain, France
Evangelisches Krankenhaus Hamm — Hamm, Germany
Universitatsklinikum Regensburg — Regensburg, Germany
Azienda Ospedaliero Universitaria Senese, Cancer Immunotherapy — Siena, Tuscany, Italy
Med Polonia Sp. z o.o. — Poznan, Poland
Centrum Onkologii Instytut im. Marii Sklodowskiej - Curie, Klinika Nowotworow Tkanek Miekkich, Kosci i Czerniakow — Warsaw, Poland
Petrov National Medical Research Center of Oncology — Saint Petersburg, Russia
Volgograd Regional Clinical Oncology Dispensary — Volgograd, Russia
Derriford Hospital ; Derriford Hospital — Plymouth, Devon, United Kingdom

Full record on ClinicalTrials.gov

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