None listed
Conditions
Interventions
Drug : nivolumab 3mg/kg, IV. Q 2 weeks, until death, progressive disease, toxicity, investigator judgment, etc
Sponsors
Yonsei University Health System, Severance Hospital
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1) Histologically confirmed recurrent/metastatic carcinosarcoma 2) ECOG performance status of 0 to 1 3) = 19 years of age 4) At least 1 prior chemotherapy 5) Patients who have at least 1 measurable disease per the RECIST Guideline Ver. 1.1 as confirmed by imaging within 28 days before first treatment 6) Subjects who meet the following criteria: - Absolute neutrophil count (ANC) = 1500 /µ - Platelet count = 75,000/ µL - Serum creatinine < 1.5 x upper limit of normal (ULN) - AST (SGOT) and ALT (SGPT) < 3 x upper limit of normal (ULN) (If there is Liver Metastasis < 5 x upper limit of normal (ULN)) -Total bilirubin < 1.5 x upper limit of normal (ULN) 7) Women of childbearing potential (including women with chemical menopause or no menstruation for other medical reasons) #1 must agree to use contraception#2 from the time of informed consent until 5 months or more after the last dose of the investigational 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. Men must agree to use contraception#2 from the start of study treatment until 7 months or more after the last dose of the investigational product.
Exclusion criteria
Exclusion criteria: 1) More than 4 prior cytotoxic agents 2) Prior treatment with systemic PD-L1-directed therapy 3) Patient who has had chemotherapy, radiotherapy, or biological therapy within 2 weeks prior to entering the study, or who has not recovered from the adverse events due to previous agents administered more than 2 weeks prior to study day 4) Subjects with symptomatic central nervous system (CNS) metastases who are neurologically unstable or have required increasing doses of steroids within the 2 weeks prior to study entry to manage CNS symptoms 5) Patients with multiple primary cancers (with the exception of completely resected basal cell carcinoma, stage I squamous cell carcinoma, carcinoma in situ, intramucosal carcinoma, or superficial bladder cancer, or any other cancer that has not recurred for at least 3 years) 6) History of active non-infectious pneumonitis requiring treatment with steroids, or history or current signs of chronic interstitial lung disease 7) Known active infection - Active infection including tuberculosis - Active hepatitis B (HBsAg reactive and HBV DNA is detected) - Active hepatitis C (anti-HCV reactive and HCV RNA [qualitative] is detected) - Human immunodeficiency virus infection 8) Patients with concurrent autoimmune disease or history of chronic or recurrent autoimmune disease 9) Patients with a history of uncontrollable or significant cardiovascular disease meeting any of the following criteria: - Myocardial infarction within 180 days before randomization - Uncontrollable angina pectoris within 180 days before randomization - New York Heart Association (NYHA) Class III or IV congestive heart failure - Uncontrollable hypertension despite appropriate treatment (e.g., systolic blood pressure =150 mmHg or diastolic blood pressure = 90 mmHg lasting 24 hours or more) - Arrhythmia requiring treatment 10) Patients receiving or requiring anticoagulant therapy for a disease. Patients receiving antiplatelet therapy including low-dose aspirin may be enrolled. 11) Patients who have received systemic corticosteroids (except for temporary use, e.g., for examination or prophylaxis of allergic reactions) or immunosuppressants within 28 days before screening
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Progression free rate (PFR) at 6 months | — |
Secondary
| Measure | Time frame |
|---|---|
| overall survival | — |
Countries
Korea, Republic of
Contacts
Public ContactRha
Yonsei University Health System, Severance Hospital
Outcome results
None listed