Phase 1b investigator initiated trial of combination therapy of Metformin and Nivolumab in participants with advanced or recurrent solid cancer.

UMIN ID: UMIN000028405

Registered date:27/07/2017

Basic Information

• Recruitment status: Complete: follow-up continuing
• Health condition(s) or Problem(s) studied: <Stage 1> Advanced or recurrent solid cancer <Stage 2> Advanced or recurrent non-small cell lung cancer, advanced or recurrent thymic epithelial tumor and advanced or recurrent pancreatic cancer
• Date of first enrollment: 2017/08/25
• Target sample size: 39
• Countries of recruitment: Japan
• Study type: Interventional
• Intervention(s): Continue to administer Nivolumab and Metformin to a patient until the patient correspond to the withdrawal criteria for individual subjects

Outcome(s)

• Primary Outcome: 1) Safety - Maximum tolerant dose (MTD):from first administration to last administration (stage 1 only) - Dose limiting toxicity (DLT): for 4 weeks from first administration (stage 1 only) - Adverse event:from first administration to 30 days after last administration 2) Pharmacokinetics property of metformin: from cycle 1 day8 to a day before cycle 2 day 1
• Secondary Outcome: 1) Efficacy - Response rate - Progression-free survival - Overall survival 2) Estimation of effective blood concentration of metformin

Key inclusion & exclusion criteria

• Age minimum: 20years-old
• Age maximum: Not applicable
• Gender: Male and Female
• Exclude criteria: 1)Patients with obviously HIV antibody positive 2)Patients with HCV antibody positive 3)Patients with HBs antigen positive, HBc antibody or HBs antibody positive 4)Autoimmune disease 5)Interstitial lung disease, pulmonary fibrosis, or radiation pneumonitis 6)Have a history or complication of TB 7)Lactic acidosis 8)Undergoing artificial dialysis 9)Serious liver dysfunction 10)Dysfunction in cardiovascular or respiratory system, likely to be a hypoxemia 11)Alcohol addict 12)Patients with history of anaphylaxis induced by component of the study drug or biguanide-based medicine 13)Patients with history of serious (Grade 3) anaphylaxis induced by antibody preparation 14)Uncontrollable hypertension 15)Uncontrollable endocrine disease 16)Patients who have active inflammatory bowel disease or other serious GI chronic conditions associated with diarrhea 17)Diabetes 18)Patients who have unstable angina or myocardial infarction 19)Patients with double cancer 20)Patients who had administration of biguanide-based medicine within last a year 21)Patients who have or plan to have administration of other anti-cancer agents, other study drugs, sustained systemic adrenal corical steroids or immunosuppressive agents within last 3 weeks 22)Patients with history of cancer immunotherapy 23)Radiation therapy within last 4 weeks 24)Patient who have or plan to have live vaccination within last 28 days 25)Pregnant or lactating females, female and male patients who cannot agree to practice the adequate birth control after the consent during the study 26)Serious infection or inflammatory disease 27)Patients with psychosis or dementia to interfere to obtain informed consent appropriately 28)Patients who received a transplantation therapy 29)Patients who have obviously metastasis to central nervous system or pia mater 30)Patients who have tumor originated from central nervous system 31)Any other inadequacy for this study

Related Information

• Primary Sponsor: Okayama University Hospital Center for Innovative Clinical Medicine
• Source(s) of Monetary Support: Ono Pharmaceutical Co.Ltd.