A Study of Durvalumab in Patients With BR PDA Following Neoadjuvant Therapy and Successful Surgic… (NCT03038477) | Clinical Trial Compass
WithdrawnPhase 2
A Study of Durvalumab in Patients With BR PDA Following Neoadjuvant Therapy and Successful Surgical Resection
Stopped: Cancelled by PI
United States0Started 2017-06-12
Plain-language summary
This is a two-arm, open-label, phase II study of in adult patients who have successfully undergone R0/R1 resection of PDAs following neoadjuvant chemotherapy and completion of adjuvant chemotherapy. Within 1-3 months of treatment completion, patients will be enrolled and randomized at a 1:1 ratio to receive durvalumab versus observation.
Who can participate
Age range18 Years – 101 Years
SexALL
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AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion criteria
✓. Written informed consent and any locally-required authorization (e.g., HIPAA in the USA, EU Data Privacy Directive in the EU) obtained from the subject prior to performing any protocol-related procedures, including screening evaluations
✓. Age \> 18 years at time of study entry, age \> 20 years for Japanese subjects.
✓. Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1
✓. Life expectancy of \> 2 years
✓. Adequate normal organ and marrow function as defined below:
✓. Women must either be of non-reproductive potential (ie, post-menopausal by history: ≥60 years old and no menses for ≥1 year without an alternative medical cause; OR history of hysterectomy, OR history of bilateral tubal ligation, OR history of bilateral oophorectomy) or must have a negative serum pregnancy test upon study entry (minimum sensitivity 25 IU/L or equivalent units of human chorionic gonadotropin \[HCG\]).
✓. Both women of childbearing potential (WOCBP) and men who are sexually active with WOCBP must agree to use two (2) highly effective methods of contraception as outlined in this protocol for the duration of treatment with study drug plus 5 half-lives of study drug plus 90 days (duration of sperm turnover) for a total of 31 weeks post-treatment completion.
✓. Subject 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
✕. Involvement in the planning and/or conduct of the study (applies to both AstraZeneca staff and/or staff at the study site). Previous enrollment in the present study
What they're measuring
1
The number of subjects with disease free survival (DFS)
✕. Participation in another clinical study with an investigational product during the last 4 weeks.
✕. Any previous treatment with a PD1 or PD-L1 inhibitor, including durvalumab.
✕. History of another primary malignancy except for:
✕. Malignancy treated with curative intent and with no known active disease ≥5 years before the first dose of study drug and of low potential risk for recurrence
✕. Adequately treated non-melanoma skin cancer or lentigo maligna without evidence of disease
✕. Adequately treated carcinoma in situ without evidence of disease eg, cervical cancer in situ
✕. Receipt of the last dose of anti-cancer therapy (chemotherapy, immunotherapy, endocrine therapy, targeted therapy, biologic therapy, tumor embolization, monoclonal antibodies, other investigational agent) ≤ 28 days prior to the first dose of study drug (≤ 28 days prior to the first dose of study drug for subjects who have received prior TKIs \[e.g., erlotinib, gefitinib and crizotinib\] and within 6 weeks for nitrosourea or mitomycin C). (If sufficient wash-out time has not occurred due to the schedule or PK properties of an agent, a longer wash-out period may be required.)