Phase II clinical trial of combination therapy with GEN0101 and standard chemotherapy in pleural mesothelioma patients.
- Conditions
- Malignant Pleural Mesothelioma
- Registration Number
- JPRN-jRCT2080224548
- Lead Sponsor
- ational Hospital Organization Osaka Toneyama Medical Center, Director of a hospital, Meinoshin Okumura
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- completed
- Sex
- All
- Target Recruitment
- 50
1) Patients providing a written informed consent by voluntary agreement.
2) Age 20 =< years old at the time of informed consent
3) Have a diagnosis of malignant pleural mesothelioma as confirmed by histology
4) Malignant pleural mesothelioma which is untreated and unresectable
5) PaO2 >=70 mmHg and SpO2>=93%
6) Expected survival period is more than 12 weeks after planned start date of investigational product
7) ECOG Performance Status 0 or 1
8) Patients with lesions which can be detected by diagnostic imaging such as MRI or CT scan prior to treatment
9) Meet the defined lab value criteria
1) Positive result of the prick test of GEN0101
2) Have serious complications such as uncontrolled active infection
3) Received systemic chemotherapy, radiotherapy or immunotherapy
4) Had a history of othr malignancy, except for the relapse-free and metastasis-free for more than 5 years after the last treatment at the registration
5) Have a interstitial pneumonia or fibrosing disease of the lung that need treatment
6) Receiving systemic adrenal cortical hormone or immunosuppressive agents
7) Had a history of the autologous or homogeneous organ or tissue transplantation (Receiving immunosuppressive medication)
8) PT(%) less than 10% of the lower limit of normal or APTT more than 1.5 times of the upper limit of normal of local reference range at the screening visit
9) Inappropriate to be enrolled in this study judged by the investigators
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method efficacy<br>Centrally reviewed, Disease control rate (DCR) based on Modified RECIST criteria: 28 weeks and 32 weeks
- Secondary Outcome Measures
Name Time Method