Unresectable malignant pleural mesothelioma
Conditions
Interventions
A triple combination therapy of nivolumab, ipilimumab, and the oral cancer vaccine B440
Sponsors
Tachihara Motoko
Tachihara Motoko
Kijima Takashi
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1) The patient has received sufficient explanation regarding the conduct of this clinical trial and has provided written informed consent to participate. 2) The patient is 18 years of age or older at the time of consent. 3) Histologically confirmed malignant pleural mesothelioma. 4) Confirmed positive WT1 expression. 5) Unresectable and untreated. 6) Patients are candidates for standard therapy (combination therapy with nivolumab and ipilimumab). 7) The patient's performance status (PS) is 0 or 1 on the ECOG Performance Status scale. 8) The patient has at least one measurable lesion (including lymph node lesions) that has not undergone radiation therapy, based on modified RECIST v1.1. 9) The most recent laboratory values obtained within 14 days prior to enrollment (including the same day of the week 14 days prior to the enrollment date) meet all of the following criteria. This is conditional on no blood transfusion having been administered within 14 days prior to testing (including the same day of the week 14 days prior to the test date). 1. Neutrophil count >= 1,500 /mm3 2. Hemoglobin >= 8.0 g/dL 3. Platelet count >= 75,000 /mm3 4. Total bilirubin = 93%
Exclusion criteria
Exclusion criteria: 1) History of systemic anticancer drug therapy for malignant pleural mesothelioma. 2) History of therapy with anti-PD-1, anti-PD-L1, anti-PD-L2, or anti-CTLA-4 antibodies. 3) Administration of other systemic anticancer drugs (including investigational drugs) within 28 days prior to registration (including the same day of the week 28 days before the registration date). 4) Has primary peritoneal, pericardial, or testicular/scrotal mesothelioma. 5) Has active, untreated brain metastases. 6) Has multiple active cancers. 7) Has an infection requiring systemic treatment. 8) Has severe complications (e.g., intestinal paralysis, intestinal obstruction, pulmonary fibrosis, uncontrolled diabetes, heart failure, myocardial infarction, angina pectoris, renal failure, hepatic failure, cerebrovascular disease, ulcers requiring transfusion, etc.). 9) Has a history of or concurrent obvious interstitial pneumonia. 10) Has severe psychiatric disorders. 11) Is pregnant, may be pregnant as determined by a doctor, or is breastfeeding*. (*: Breastfeeding women who discontinue breastfeeding are still ineligible for this trial.) 12) The subject or their partner has no intention of using contraception from the start date of B440, nivolumab, and ipilimumab administration until the specified period** after the final dose of nivolumab and ipilimumab. (**: 217 days after the last dose for males; 161 days after the last dose for females of childbearing potential) 13) Unable to perform a pregnancy test during screening for subjects of childbearing potential. 14) History of severe drug allergy. 15) Testing within 6 months prior to enrollment shows positivity for either HBs antigen or HCV antibody. Also, patients who are HBs antigen negative but HBs antibody positive or HBc antibody positive, and have HBV-DNA quantification above the detection limit. 16) Past testing shows HIV antibody positivity. 17) Receiving ongoing systemic administration (oral or intravenous) of steroids (prednisolone equivalent > 10 mg/day) or other immunosuppressive agents. 18) Received a live vaccine within 30 days prior to registration. 19) History of concomitant autoimmune disease or chronic/recurrent autoimmune disease. 20) History of hypersensitivity to B440, nivolumab, ipilimumab, or bifidobacteria protein. 21) If you have received treatment for a previous malignant tumor, adverse events related to treatment have not recovered to Grade 1 or below according to CTCAE v5.0-JCOG. Or, Grade 2 evemts (e.g., alopecia, peripheral sensory neuropathy, hyperpigmentation of the skin, dysgeusia) have not stabilized. 22) Patients who participated in another clinical trial involving an intervention within 6 months prior to enrollment, or patients who plan to participate in another clinical trial involving an intervention during the period of participation in this trial. 23 Other patients deemed inappropriate for participation in this trial by the principal investigator or sub-investigator.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| (1) Safety evaluation - Applicability to safety evaluation criteria (2) Efficacy evaluation - Objective response rate | — |
Secondary
| Measure | Time frame |
|---|---|
| (1) Safety evaluation 1) Adverse event, Adverse drug reaction 2) Value of IL-6 in blood (2) Efficacy evaluation 1) Progression free survival: PFS 2) Overall survival: OS 3) Disease control rate: DCR 4) Time to response: TTR 5) Duration of response: DOR | — |
Contacts
Public ContactSayaka Kajikawa
Kobe University Hospital
Outcome results
None listed