None listed
Conditions
Interventions
Drug : 1. Neoadjuvant treatment:
Standard chemotherapy + Durvalumab + Tremelimumab
Durvalumab : 1500mg q3 weeks (total 3 dosing)
Tremelimumab : 75mg q 3 weeks (total 3 dosing)
Chemotherapy regimen: Pa
1120mg q3 weeks (total 12 dosing)
Chemotherapy regimen: Paclitaxel 175mg/m2, carboplatin AUC 5-6 q 3weeks (total3 dosing)
Sponsors
Yonsei University Health System, Severance Hospital
Eligibility
Sex/Gender
Female
Inclusion criteria
Inclusion criteria: 1. Histologically confirmed adenocarcinoma of ovary, fallopian tube, primary peritoneum 2. Clinical stage IIIC/IV 3. Capable of giving signed informed consent which includes compliance with the requirements and restrictions listed in the informed consent form (ICF) and in this protocol. Written informed consent and any locally required authorization (eg, Health Insurance Portability and Accountability Act in the US, European Union [EU] Data Privacy Directive in the EU) obtained from the patient/legal representative prior to performing any protocol-related procedures, including screening evaluations. 4. Female aged 20 years older at the time of acquisition of informed consent 5. Eastern Cooperative Oncology Group (ECOG) performance status of 0 ~ 1 6. Must have life expectancy of at least 16 weeks 7. Body weight >30kg 8. Adequate normal organ and marrow function as defined below: ? Haemoglobin =9.0 g/dL ? Absolute neutrophil count (ANC =1.5 x 109/L ? Platelet count =100 x 109/L ? Serum bilirubin =1.5 x institutional upper limit of normal (ULN). > ? AST (SGOT)/ALT (SGPT) =2.5 x institutional upper limit of normal unless liver metastases are present, in which case it must be =5x ULN ? Measured creatinine clearance (CL) >40 mL/min or Calculated creatinine clearance CL>40 mL/min by the Cockcroft-Gault formula (Cockcroft and Gault 1976) or by 24-hour urine collection for determination of creatinine clearance: Males: Creatinine CL (mL/min) = Weight (kg) x (140 – Age) 72 x serum creatinine (mg/dL) Females: Creatinine CL (mL/min) = Weight (kg) x (140 – Age) x 0.85 72 x serum creatinine (mg/dL) 9. Evidence of post-menopausal status or negative urinary or serum pregnancy test for female pre-menopausal patients. Women will be considered post-menopausal if they have been amenorrheic for 12 months without an alternative medical cause. The following age-specific requirements apply: ? Women 1 year ago, had chemotherapy-induced menopause with last menses >1 year ago, or underwent surgical sterilization (bilateral oophorectomy, bilateral salpingectomy or hysterectomy). 10. Patient is willing and able to comply with the protocol for the duration of the study including undergoing treatment and scheduled visits and examinations including follow up.
Exclusion criteria
Exclusion criteria: 1. Involvement in the planning and/or conduct of the study (applies to both AstraZeneca staff and/or staff at the study site) 2. Participation in another clinical study with an investigational product during the last 60 days 3. Concurrent enrolment in another clinical study, unless it is an observational (non-interventional) clinical study or during the follow-up period of an interventional study 4. Any previous treatment with anti-PD-1, PD-L1, CTLA-4 (including durvalumab and tremelimumab) 5. Any unresolved toxicity NCI CTCAE Grade =2 from previous anticancer therapy with the exception of alopecia, vitiligo, and the laboratory values defined in the inclusion criteria ? Patients with Grade =2 neuropathy will be evaluated on a case-by-case basis after consultation with the Study Physician. ? Patients with irreversible toxicity not reasonably expected to be exacerbated by treatment with durvalumab or tremelimumab may be included only after consultation with the Study Physician. 6. Any concurrent chemotherapy, IP, biologic, or hormonal therapy for cancer treatment. Concurrent use of hormonal therapy for non–cancer-related conditions (e.g., hormone replacement therapy) is acceptable. > 7. Major surgical procedure (except diagnostic laparoscopy) within 28 days prior to the first dose of IP. Note: Local surgery of isolated lesions for palliative intent is acceptable. 8. History of allogenic organ transplantation. 9. Active or prior documented autoimmune or inflammatory disorders (including inflammatory bowel disease [e.g., colitis or Crohn's disease], diverticulitis [with the exception of diverticulosis], systemic lupus erythematosus, Sarcoidosis syndrome, or Wegener syndrome [granulomatosis with polyangiitis, Graves' disease, rheumatoid arthritis, hypophysitis, uveitis, etc]). The following are exceptions to this criterion: ? Patients with vitiligo or alopecia ? Patients with hypothyroidism (e.g., following Hashimoto syndrome) stable on hormone replacement ? Any chronic skin condition that does not require systemic therapy ? Patients without active disease in the last 5 years may be included but only after consultation with the study physician ? Patients with celiac disease controlled by diet alone 10. Uncontrolled intercurrent illness, including but not limited to, ongoing or active infection, symptomatic congestive heart failure, uncontrolled hypertension, unstable angina pectoris, cardiac arrhythmia, interstitial lung disease, serious chronic gastrointestinal conditions associated with diarrhea, or psychiatric illness/social situations that would limit compliance with study requirement, substantially increase risk of incurring AEs or compromise the ability of the patient to give written informed consent 11. Other malignancy within the last 5 years except: adequately treated non-melanoma skin cancer, curatively treated in situ cancer of the cervix, ductal carcinoma in situ (DCIS), Stage 1, grade 1/2 endometrial carcinoma, or other solid tumours including lymphomas (without bone marrow involvement) curatively treated with no evidence of disease for =5 years. Patients with a history of localised breast cancer may be eligible, provided they completed their adjuvant chemotherapy more than two years prior to registration, and that the patient remains free of recurrent or metastatic disease 12. History of leptomeningeal carcinomatosis 13. Brain metastases or
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Progression free survival | — |
Secondary
| Measure | Time frame |
|---|---|
| response rate by RECIST(Response Evaluation Criteria in Solid Tumors) version 1.1;immune-related response;response rate by PERCIST(Positron Emission Tomography Response Criteria in Solid Tumors);R0 rate of IDS;the rate of chemotherapy response score 3;overall survival;safety | — |
Countries
Korea, Republic of
Contacts
Public ContactJung-Yun Lee
Yonsei University Health System, Severance Hospital
Outcome results
None listed