Unresectable advanced germ cell tumors refractory to second-line or further chemotherapy
Conditions
Interventions
ONO-4538 240mg will be administered intravenously at 2-weeks intervals. Six weeks will counts as 1cycle of treatment.
Sponsors
University of Tsukuba
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1.Patients diagnosed as gonadal or extragonadal germ cell tumor by histological examination or tumor marker profile 2.Patients received platinum based chemotherapy 3.Patients received chemotherapy using 2 or more regimens 4.Patients with no indication of curative surgery 5.Patients having chemo-refractory disease to the last chemotherapy defined by at least one of the following criteria a)>20% increase of total diameter of target lesions by RECIST guideline v1.1 b)Development of new lesion c)At least 2 consecutive tumor marker elevation with 1 or more weeks interval 6.Patietns with a life expectancy of at least 12 weeks 7.Patients having measurable target lesion (RECIST guideline v1.1) defined by radiological imaging study within 4 weeks prior to entry 8.ECOG performance status score 0 or 1 9.Patients whose latest laboratory data meet the below criteria within 7 days before registration. a)Neutrophils >1,000/uL b)Platelets >100x103uL c)Hemoglobin>8.0g/dL d)AST and ALT <3.0-fold the upper limit of normal(ULN) e)Total bilirubin <2.0-fold the ULN f)Creatinine <1.5-fold the ULN or creatinine clearance >30mL/min 10.Men must agree to use contraception from the start of study treatment until 7months or more after the last dose of the investigational product. 11.Women of childbearing potential must agree to use contraception from the time of informed consent until 5 months or more after the last dose of the investigationa1 product. Also, women must agree not to breastfeed from the time of informed consent until 5 months or more after the last dose of the investigational product.
Exclusion criteria
Exclusion criteria: 1.Patients with multiple primary cancers 2.Patients with residual adverse effects of prior therapy or effects of surgery that would affect the safety evaluation of the investigational product 3.Patients with current or past history of severe hypersensitivity to any other antibody products 4.Patients with concurrent autoimmune disease or history of chronic or recurrent autoimmune disease 5.Patients with a current or past history of interstitial lung disease or pulmonary fibrosis 6.Patients with concurrent diverticulitis or symptomatic gastrointestinal ulcerative disease 7. Patients with any metastasis in the brain or meninx that is symptomatic or requires treatment. 8.Patients with intracranial germ cell tumor 9.Patients with pericardial fluid, pleural effusion, or ascites requiring treatment 10.Patients with uncontrollable, tumor-related pain 11.Ptients who have experienced a transient ischemic attack, cerebrovascular accident thrombosis, or thromboembolismwithin 180 days before registration 12. Patients with a history of uncontrollable or significant cardiovascular disease 13. Patients with uncontrollable diabetes mellitus 14.Patients with systemic infections requiring treatment 15.Patients who have received systemic corticosteroids or immunosuppressants 16.Patients who have received antineoplastic drugs 17.Patients who have undergone surgical adhesion of the pleura or pericardium 18.Patients who have undergone surgery under general anesthesia 19.Patiebts who have undergone surgery involving local or topical anesthesia 20.Patients who have received radiotherapy 21.Patients who have received any radiopharmaceuticals 22. Patients who have previously shown AIDS symptoms or with positive test results for any of the following: HIV, HTLV-1 antibody, HBs antigen, or HCV antibody
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Objective response rate, central review | — |
Secondary
| Measure | Time frame |
|---|---|
| 1.Objective response rate, assessment by the attending investigator's 2.Disease control rate, DCR 3.Immune-related Disease Control Rate, irDCR 4.Overall Survival, OS 5.Progression Free Survival, PFS 6.Immune-related Progression Free Survival, irPFS 7.Time to Progression,TTP 8.Duration of response 9.Time to response 10.Best overall response, BOR 11.Immune-related best overall response 12.Percent change from baseline in the diameters 13.Evaluation of response according to Japanese Classification of testicular tumor 14.Rate of metastasectomy | — |
Countries
Japan
Contacts
Public ContactKoichi Hashimoto
University of Tsukuba, Tsukuba Clinical Research & Development Organization Clinical Research Service Center
Outcome results
None listed