Malignant Pleural Mesothelioma
Conditions
Interventions
investigational material(s)
Generic name etc : GEN0101, Cisplatin and Pemetrexed
INN of investigational material : -
Therapeutic category code : 429 Other antitumor agents
Dosage and Administration fo
Sponsors
National Hospital Organization Osaka Toneyama Medical Center, Director of a hospital, Meinoshin Okumura
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1) Patients providing a written informed consent by voluntary agreement. 2) Age 20 ==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
Exclusion criteria
Exclusion 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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| efficacy Centrally reviewed, Disease control rate (DCR) based on Modified RECIST criteria: 28 weeks and 32 weeks | — |
Secondary
| Measure | Time frame |
|---|---|
| safety efficacy exploratory Efficacy: 1) Centrally reviewed, DCR based on Modified RECIST criteria: 48 weeks and 52 weeks 2) Centrally reviewed, DCR based on irRECIST: 28 weeks, 32 weeks, 48 weeks and 52 weeks 3) Centrally reviewed, DCR based on PERCIST: 28 weeks, 40 weeks and 52 weeks 4) Local Institution reviewed, DCR based on Modified RECIST criteria: 28 weeks, 32 weeks, 48 weeks and 52 weeks 5) Centrally reviewed, DCR and Best overall response (BOR) based on Modified RECIST criteria and irRECIST: 28 weeks, 32 weeks, 48 weeks and 52 weeks 6) Centrally reviewed, DCR and BOR based on PERCIST: 28 weeks,40 weeks and 52 weeks 7) Local Institution reviewed, DCR and BOR based on Modified RECIST criteria: 28 weeks, 32 weeks, 48 weeks and 52 weeks 8) Centrally reviewed, Progression-free survival (PFS) and Proportion progression-free (PPF) based on PERCIST: 28 weeks 52 weeks 9) Centrally reviewed, PFS and PPF based on Modified RECIST criteria and irRECIST: 32 weeks 52 weeks 10) Local Institution reviewed, Overall survival: 32 weeks and 52 weeks Induction of antitumor immunity 1) NK cell: 8 weeks and 12 weeks Safety 1) DLT 2) Safety | — |
Countries
Japan
Outcome results
None listed