KCT0003742
Recruiting
N/A
A phase II study of Neoadjuvant chemotherapy plus Durvalumab (MEDI4736) and Tremelimumab in Advanced-stage ovarian cancer (TRU-D)
ConditionsNeoplasms
Overview
- Phase
- N/A
- Intervention
- Not specified
- Conditions
- Neoplasms
- Sponsor
- Yonsei University Health System, Severance Hospital
- Enrollment
- 24
- Status
- Recruiting
- Last Updated
- 4 years ago
Overview
Brief Summary
No summary available.
Investigators
Eligibility 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
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.
Outcomes
Primary Outcomes
Not specified
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