A Study of Durvalumab (MEDI4736), as an Adjuvant Therapy, Compared to Observation Alone, in Patients With Borderline Resectable Pancreatic Ductal Adenocarcinoma (BR PDA) Following Neoadjuvant Therapy and Successful Surgical Resection

University of Colorado, Denver1 site in 1 countryJune 12, 2017

ConditionsPancreatic Cancer

InterventionsDurvalumab

DrugsDurvalumab

Overview

Phase: Phase 2
Intervention: Durvalumab
Conditions: Pancreatic Cancer
Sponsor: University of Colorado, Denver
Locations: 1
Primary Endpoint: The number of subjects with disease free survival (DFS)
Status: Withdrawn
Last Updated: 5 years ago

Overview Investigators Eligibility Criteria Arms & Interventions Outcomes Sites Similar Trials

Overview

Brief 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.

Detailed Description

Borderline resectable pancreatic cancer (BRPC) patients who have successfully underwent R0/R1 resection of PDAs following neoadjuvant chemotherapy, between 1-3 months after the completion of planned adjuvant chemotherapy will be enrolled and randomized at a 1:1 ratio into two arms (56 per arm). Patients in Arm A will be given anti-PD-L1 antibody, durvalumab, every 2 weeks for a maximum of 26 doses if there is no radiographic evidence of disease recurrence. Patients in Arm B will be observed. Blood draws for immune monitoring and serum banking will be collected at the following time points: Arm A - before Cycles 1, 2, 4, 7 and End of Treatment (EOT) visit; Arm B - before Cycles 1, 4, 7, and End of Treatment (EOT) visit

Registry

clinicaltrials.gov

Start Date

June 12, 2017

End Date

April 1, 2019

Last Updated

5 years ago

Study Type

Interventional

Study Design

Parallel

Sex

All

Investigators

Sponsor

University of Colorado, Denver

Responsible Party

Sponsor

Eligibility Criteria

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:
•Haemoglobin ≥ 9.0 g/dL
•Absolute neutrophil count (ANC) ≥ 1.5 x 109/L (\> 1500 per mm3)
•Absolute lymphocyte count ≥ 500/mm3
•Platelet count ≥ 100 x 109/L (\>100,000 per mm3)
•Serum bilirubin ≤ 1.5 x institutional upper limit of normal (ULN). \<\<This will not apply to subjects with confirmed Gilbert's syndrome (persistent or recurrent hyperbilirubinemia that is predominantly unconjugated in the absence of hemolysis or hepatic pathology), who will be allowed only in consultation with their physician.\>\>

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
•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.)
•Mean QT interval corrected for heart rate (QTc) ≥470 ms calculated from 3 electrocardiograms (ECGs) using Frediricia's Correction
•Current or prior use of immunosuppressive medication within 28 days before the first dose of durvalumab, with the exceptions of intranasal and inhaled corticosteroids or systemic corticosteroids at physiological doses, which are not to exceed 10 mg/day of prednisone, or an equivalent corticosteroid

Arms & Interventions

Durvalumab

Patients in Arm A will be given anti-PD-L1 antibody, durvalumab, every 2 weeks for a maximum of 26 doses if there is no radiographic evidence of disease recurrence. For Arm A, one cycle constitutes two durvalumab treatments on Day 1 and Day 15, respectively, repeated every 28 days.

Intervention: Durvalumab