MENIVO Study

JRCT ID: jRCT2031190074

Registered date:20/08/2019

Basic Information

• Recruitment status: Complete
• Health condition(s) or Problem(s) studied: Meningioma
• Date of first enrollment: 10/09/2019
• Target sample size: 29
• Study type: Interventional

Intervention(s)

480mg of ONO-4538 is administrated intravenously on the first day of each course within about 30 minutes. Every course is set of 28 days. (4 weeks) The second and subsequent drug administration should be done after 26 days or more have passed since the precious administration.
The drug administrations are done for 365 days (1 year) since the first administration. However, if the tumor is no confirmed as progressive disease at the point of 365 days after the first administration, investigational drug may administrate for additional half a year or until the end of the study period (August 2023) after a discussion between investigators and study coordinating physician.

Outcome(s)

• Primary Outcome: Response rate according to iRANO (meningioma) (independent review facility)

Secondary Outcome

1)Efficacy
Response rate according to RANO (meningioma) (independent review facility)
Response rate according to iRANO (meningioma) (investigator-assessed)
Response rate according to Macdonald criteria (independent review facility)
Tumor volume reduction rate (by SPD, iRANO (meningioma) ) (independent review facility)
Progression-free survival rate for 6 months (investigator-assessed)
Progression-free survival (investigator-assessed)
Best overall response according to iRANO (meningioma) (independent review facility)
Best overall response according to iRANO (meningioma) (investigator-assessed)
Best overall response according to RANO (meningioma) (independent review facility)
Best overall response according to Macdonald criteria (independent review facility)
Overall survival (investigator-assessed)

2)Safty
Type, frequency and severity of adverse events (CTCAE ver. 4.0) (investigator-assessed)

Key inclusion & exclusion criteria

• Age minimum: >= 20age old
• Age maximum: <= 79age old
• Gender: Both

Include criteria

1) Older than or equal to 20 years old, younger than 80 years old
2) Diagnosis of meningioma (WHO Grade I - III)
3) History of tumor resection and radiation therapy for meningioma
4) Evidence of recurrence or progression of meningioma after the last treatment for meningioma, and patients who meet either of the following conditions
(1) Neither tumor resection nor radiation therapy is deemed effective for the recurrent/progressive meningioma
(2) Patient who does not wish to have further treatment by tumor resection or radiation therapy
5) Patient who have passed a certain period of time since the last treatment.: 4 weeks after tumor resection. 1 week after biopsy. 12 weeks after radiation therapy/chemotherapy/medication therapy/immunotherapy. It is not necessary to pass 12 weeks, in the case of recurrence or progression out of the radiation field.
6) Patient with a lesion difined as measurable lesion in RANO(meningioma) with diagnostic imaging taken within 14 days before registration.
7) Patient who is possible to submit tumor tissue sample which was daignosed with menigioma.
8) Karnofsky Performance Status more than or equal to 70%.
9) Patients expected to survive 12 weeks or more at the time when the consent is obtained.
10) Patient with adequate laboratory data.

Exclude criteria

1) Cooccurence of cancer other than meningioma. However, completely resected basal cell carcinoma, Stage I squamous cell carcinoma, carcinoma in situ, superficial bladder carcinoma, or any other cancer without recurrence for more than 3 years are allowed.
2) Comorbid autoimmune diseases or history of chronic or recurrent autoimmune diseases.
3) Patient with intracranial hemorrhage with diagnositc imaging taken within 14 days before registration.
4) Patient with uncontrollable hypertension despite appropriate treatment.
5) Central nervous system diseases other than meningioma (eg, epilepsy, etc.) that are not well controlled or may lead to discontinuation of the investigational drug.
6) Patient has or previously had a history of pulmonary hemorrhage/hypoemia.
7) Patient has or previously had a history of hereditary hemorrhagic predisposition or serious coagulation disorders at risk of hemorrhage.
8) Patient undergoing anticoagulation therapy excluding for preventive medication.
9) Patient with active gastrointestinal ulcer or gastrointestinal bleeding.
10) Patient with a history of cerebral infarction or arteriovenous thromboembolism within 180 days before registration.
11) Patient with uncontrollable or serious cardiovascular disease.
12) Patient with uncontrollable diabetes mellitus.
13) Patient with infections requiring systemic treatment.
14) Patient with pulmonary fibrosis or interstitial pneumonia.
15) Patient being treated with immunosuppressants.
16) Patient being treated with corticosteroids. Use of 2.0 mg / day or less of dexamethasone or 10 mg / day or less of prednisolone is acceptable. Short-term use of corticosteroids for the prevention of anaphylaxis, topical (skin, airway etc) corticosteroids use is acceptable.
17) Patient who can not or do not wish to have MRI imaging or contrast-enhanced MRI imaging due to pacemaker, implantable defibrillator use or contrast agent allergy.
18) Patient with a history of anti-PD-1 antibody, anti-PD-L1 antibody, anti-PD-L2 antibody, anti-CD137 antibody, anti-CTLA-4 antibody or other antibody or drug therapy aimed at T cell control.
19) Patient judged to lack consent ability. (e.g. dementia)

Related Information

• Primary Sponsor: Sasaki Hikaru
• Secondary Sponsor: ONO PHARMACEUTICALCO.