Cervical Cancer FIGO stage Ib2-IVa Cervical Cancer
Conditions
Interventions
Type of intervention: pharmaceuticals
Name of intervention: nivolumab
Drug formulation/generic name of the medical device: Injection (including dissolvable for use and trans-central intravenous feedin
Nivolumab
Sponsors
Kosei Hasegawa
Eligibility
Sex/Gender
Female
Inclusion criteria
Inclusion criteria: 1) Patients with pathological certification that primary site is initial and non-treatment cervix cancer(squamous cell carcinoma, adenosquamous carcinoma, adenocarcinoma) 2) FIGO stage Ib2, IIa, IIb, IIIa, IIIb, IVa 3) Patients will receive CCRT therapy 4) Patients are 20-75 years old at the time of informed consent 5) ECOG performance status score 0 or 1 6) Patients in whom function of the major organ systems is maintained and with laboratory data which meet the following criteria (To be confirmed by the most recent laboratory data within 28 days prior to enrollment); 1.Neutrophils >= 1,500 /mm3 2.Hemoglobin >= 9.0 g/dL 3.Platelets >= 100,000 /mm3 4.AST(GOT), ALT(GPT) < ULN X 3.0 5.Total bilirubin < ULN X 2.0 6.Creatinine < 1.2 mg/dL 7.Electrocardiogram: normal range, or abnormality which has no symptom and not need treatment 7) Women of childbearing potential must agree to use contraception from the time of informed consent until 20 weeks or more after the last dose of the investigational product. Also, women must agree not to breastfeed from the time of informed consent until 20 weeks or more after the last dose of the investigational product.
Exclusion criteria
Exclusion criteria: 1) Patients with history of treatment using anti-PD-1 Ab, anti-PD-L1 Ab, anti-PD-L2 Ab, anti-CD137 Ab, anti-CTLA-4 Ab, or other Ab or drugs intended for T-cell regulation 2) Patients with current or past history of severe hypersensitivity to any other antibody products 3) Patients with concurrent autoimmune disease or history of chronic or recurrent autoimmune disease 4) Patients with history of serious allergic disease 5) Patients with history of transplantation therapy or need to receive transplantation therapy 6) Patients with other active multiple primary malignancy 7) Patients with uncontrollable, tumor-related pain 8) Patients with pericardial fluid, pleural effusion, or ascites requiring persistently treatment 9) Patients with a history of uncontrollable or significant cardiovascular disease 10) Patients with a current or past history of interstitial lung disease or pulmonary fibrosis 11) Patients with concurrent diverticulitis or symptomatic gastrointestinal ulcerative disease 12) Patients with intestinal obstruction 13) Patients with systemic infections requiring treatment 14) Patients with positive test results for any of the following; HIV-1 antibody, HIV-2 antibody, HTLV-1 antibody, HBs antigen, or HCV antibody. In spite of negative test results for HBs antigen, patients with positive test results for HBs antibody or HBc antibody and detected HBV-DNA more than sensitivity of detection. 15) Patients who have experienced a transient ischemic attack, cerebrovascular accident thrombosis, or thromboembolism within 180 days prior to registration 16) Patients who receive anticoagulant therapy or have any diseases which need anticoagulant therapy 17) Patients with a serious disease such as uncontrollable diabetes or bleeding tendency 18) Patients who have received any radiopharmaceuticals within 56 days prior to registration 19) Patients with a history of radiotherapy to whole pelvic area 20) Patients who have received radiotherapy within 28 days prior to registration 21) Patients who have received other unapproved drugs within 28 days (90 days in case of antibody products) prior to registration 22) Patients who have received antineoplastic drugs within 28 days prior to registration 23) Patients who have received systemic corticosteroids or immunesuppressants within 28 days prior to registration 24) Patients who have undergone surgical adhesion of the pleura or pericardium within 28 days prior to registration 25) Patients who have undergone surgery under general anesthesia within 28 days prior to registration 26) Patients who have undergone surgery involving local or topical anesthesia within 14 days prior to registration 27) Patients who are seemed to be unable to participate in this trial, such as lack of consent ability because of mental disease or dementia 28) Patients who are pregnant now or possibly, or breast feeding 29) Patients with unsuitable condition judged by their own investigators
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Rates of adverse events higher than grade 3 at acute phase for cohort A and cohort B | — |
Secondary
| Measure | Time frame |
|---|---|
| 1.Rate of recurrence at one year after treatment ends 2.Adverse events 2-1.Rates of adverse events at acute phase for cohort A and cohort B 2-2.Number of DLT for cohort A, cohort B and cohort C 2-3.Rates of adverse events for all patients 2-4.Rates of Immune-related adverse events for all patients 3.Objective response rate of pretreatment with ONO-4538 before CCRT for cohort B 4.Rates of postponement of planned start date of CCRT caused by adverse events related with pretreatment with ONO-4538 | — |
Countries
Japan
Contacts
Public ContactEri Hasegawa
Gynecologic Oncology Trial and Investigation Consortium(GOTIC)
Outcome results
None listed