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UMIN-CTR Clinical Trial |
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Name: | UMIN ID: |
Recruitment status | No longer recruiting |
Unique ID issued by UMIN | UMIN000030892 |
Receipt No. | R000034363 |
Scientific Title | Phase 2 trial of first-line combination therapy of cisplatin, pemetrexed and nivolumab in participants with unresectable malignant pleural mesothelioma |
Date of disclosure of the study information | 2018/01/19 |
Last modified on | 2020/10/21 |
Basic information | ||
Public title | Phase 2 trial of first-line combination therapy of cisplatin, pemetrexed and nivolumab in participants with unresectable malignant pleural mesothelioma | |
Acronym | Phase 2 trial of first-line combination therapy of cisplatin, pemetrexed and nivolumab in participants with unresectable malignant pleural mesothelioma | |
Scientific Title | Phase 2 trial of first-line combination therapy of cisplatin, pemetrexed and nivolumab in participants with unresectable malignant pleural mesothelioma | |
Scientific Title:Acronym | Phase 2 trial of first-line combination therapy of cisplatin, pemetrexed and nivolumab in participants with unresectable malignant pleural mesothelioma | |
Region |
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Condition | ||
Condition | malignant pleural mesothelioma | |
Classification by specialty |
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Classification by malignancy | Malignancy | |
Genomic information | NO |
Objectives | |
Narrative objectives1 | To assess efficacy and safety of the first-line combination therapy of cisplatin, pemetrexed and nivolumab for advanced or metastatic malignant pleural mesothelioma which is untreated and unresectable |
Basic objectives2 | Safety,Efficacy |
Basic objectives -Others | |
Trial characteristics_1 | |
Trial characteristics_2 | |
Developmental phase | Phase II |
Assessment | |
Primary outcomes | Centrally reviewed, overall response rate based on Modified RECIST criteria: to last administration |
Key secondary outcomes | Safety: adverse event, laboratory test, vital sign, body weight, 12-lead electrocardiogram, chest X-ray, ECOG Performance Status
Efficacy: 1) Response rate (assessment by local institution, Modified RECIST criteria) 2) Disease control rate (central review, Modified RECIST criteria) 3) Overall survival 4) Progression-free survival (central review, Modified RECIST criteria) 5) Duration of response (central review, Modified RECIST criteria) 6) Time to response (central review, Modified RECIST criteria) 7) best overall response (central review, Modified RECIST criteria) 8) The rate of change of the sum of the target lesion length (assessment by local institution, Modified RECIST criteria) QOL: EQ-5D, LCSS-Meso |
Base | |
Study type | Interventional |
Study design | |
Basic design | Single arm |
Randomization | Non-randomized |
Randomization unit | |
Blinding | Open -no one is blinded |
Control | Uncontrolled |
Stratification | |
Dynamic allocation | |
Institution consideration | |
Blocking | |
Concealment |
Intervention | ||
No. of arms | 1 | |
Purpose of intervention | Treatment | |
Type of intervention |
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Interventions/Control_1 | Continue to administer the combination therapy of cisplatin, pemetrexed and nivolumab and the maintenance therapy of nivolumab to a patient until the patient correspond to the withdrawal criteria for individual subject. | |
Interventions/Control_2 | ||
Interventions/Control_3 | ||
Interventions/Control_4 | ||
Interventions/Control_5 | ||
Interventions/Control_6 | ||
Interventions/Control_7 | ||
Interventions/Control_8 | ||
Interventions/Control_9 | ||
Interventions/Control_10 |
Eligibility | ||||
Age-lower limit |
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Age-upper limit |
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Gender | Male and Female | |||
Key inclusion criteria | 1) Age: more than 20 years old at the date of informed consent
2) Pathologically confirmed pleural malignant mesothelioma 3) Advanced or metastatic malignant pleural mesothelioma which is untreated and unresectable 4) Patients who have a measurable lesion designated by Modified RECIST criteira 5) Available tumor sample for testing of PD-L1 expression 6) Eastern Cooperative Oncology Group performance status (ECOG PS) is 0 or 1 7) Life expectancy is >= 90 days 8) SpO2 measured by pulse oximeter within 7 days is >= 94% 9) Meet the defined lab value criteria 10) Females of childbearing potential who agree to prevent pregnancy and lactating to at least 5 months after last administration of nivolumab 11) Males who agree to contraception at least 7 months after last administration of nivolumab 12) Patients who understand the study contents and give a written consent at their free will |
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Key exclusion criteria | 1) Patients with history of anaphylaxis induced by other drugs
2) Autoimmune disease 3) Double cancer 4) Metastasis to brain or meninges 5) Interstitial lung disease or pulmonary fibrosis 6) Diverticulitis or peptic ulcer 7) Pleural effusion necessary for emission every 2 weeks or more 8) Treating pericardial effusion or ascites 9) Uncontrollable tumor pain 10) Transient ischemic attack, cerebrovascular accident, thrombosis or thromboembolism within 180 days 11) Uncontrollable severe cardiovascular disease 12) Anticoagulant therapy 13) Uncontrollable diabetes 14) Treating systemic infection 15) Transplantation therapy 16) Obviously positive to HIV infection 17) HTLV-1 antibody positive, HBs antigen positive or HCV antibody positive. Either HBs antigen positive or HBc antibody positive and HBV-DNA detection although HBs antigen is negative. 18) History of treatment for T cell regulation 19) Surgery with local or surface anesthesia within 14 days 20) Surgery with general anesthesia within 28 days 21) Pleurodesis within 14 days 22) Pleurodesis using picibanil within 28 days 23) Adhesions surgery of pericardium or peritoneum 24) Radiation therapy for pain relief within 14 days 25) Radiopharmaceutical therapy within 56 days 26) Administration of unapproved drugs within 28 days or unapproved antibody within 90 days 27) Administration of systemic adrenal cortical hormone or immunosuppressive agents 28) Females who are or may be pregnant or lactating 29) Patients who are incapable of giving consent (for example, dementia) 30) Any other inadequacy for this study |
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Target sample size | 18 |
Research contact person | |||||||
Name of lead principal investigator |
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Organization | Okayama Rosai Hospital | ||||||
Division name | Department of Medical Oncology | ||||||
Zip code | 7028055 | ||||||
Address | 1-10-25 Chikkomidorimachi, Minami-ku, Okayama-city, Okayama 702-8055 | ||||||
TEL | 086-262-0131 | ||||||
nobufujimot@gmail.com |
Public contact | |||||||
Name of contact person |
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Organization | Fiverings Co.,Ltd. | ||||||
Division name | Medical team | ||||||
Zip code | 5300044 | ||||||
Address | Urban Ace Higashitenma-BLDG, 1-1-19, Higashitenma, Kita-ku, Osaka 530-0044 Japan | ||||||
TEL | 06-6358-7110 | ||||||
Homepage URL | |||||||
gotou@fiverings.co.jp |
Sponsor | |
Institute | Okayama Rosai Hospital |
Institute | |
Department |
Funding Source | |
Organization | Ono pharmaceutical Co, Ltd. |
Organization | |
Division | |
Category of Funding Organization | Profit organization |
Nationality of Funding Organization |
Other related organizations | |
Co-sponsor | |
Name of secondary funder(s) |
IRB Contact (For public release) | |
Organization | - |
Address | - |
Tel | - |
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Secondary IDs | |
Secondary IDs | NO |
Study ID_1 | |
Org. issuing International ID_1 | |
Study ID_2 | |
Org. issuing International ID_2 | |
IND to MHLW |
Institutions | |
Institutions | 岡山大学病院(岡山県)、独立行政法人労働者健康安全機構岡山労災病院(岡山県)、独立行政法人国立病院機構山口宇部医療センター(山口県)、独立行政法人国立病院機構四国がんセンター(愛媛県) |
Other administrative information | |||||||
Date of disclosure of the study information |
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Related information | |
URL releasing protocol | |
Publication of results | Unpublished |
Result | |
URL related to results and publications | |
Number of participants that the trial has enrolled | 18 |
Results | |
Results date posted | |
Results Delayed | |
Results Delay Reason | |
Date of the first journal publication of results | |
Baseline Characteristics | |
Participant flow | |
Adverse events | |
Outcome measures | |
Plan to share IPD | |
IPD sharing Plan description |
Progress | |||||||
Recruitment status | No longer recruiting | ||||||
Date of protocol fixation |
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Anticipated trial start date |
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Last follow-up date |
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Date analysis concluded |
Other | |
Other related information |
Management information | |||||||
Registered date |
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Last modified on |
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Link to view the page | |
URL(English) | https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000034363 |
Research Plan | |
Registered date | File name |
Research case data specifications | |
Registered date | File name |
Research case data | |
Registered date | File name |