A Study of Durvalumab in Patients With BR PDA Following Neoadjuvant Therapy and Successful Surgical Resection

Part of paid clinical trials in Aurora, Colorado.

Sponsor
University of Colorado, Denver
Study ID
NCT03038477
Phase
PHASE2
Status
Withdrawn

Conditions

Eligibility Criteria

Sex
ALL
Age
18 Years - 101 Years
Healthy Volunteers
Accepted

Interventions

  • Durvalumab — DRUG
    1500mg of Durvalumab will be given every 4 weeks (Q4W) for 12 months in patients enrolled in Arm A.

Study Details

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.

Key Dates

Start date
Jun 12, 2017
Status verified
Sep 2020
Primary completion
Apr 1, 2019
Completion
Apr 1, 2019

Study Design

Enrollment
0 participants (actual)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Experimental: 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.
  • No Intervention: No Durvalumab
    Patients in Arm B will be observed.

Primary Outcome Measure

The number of subjects with disease free survival (DFS) [ Time Frame: 26 Months ]

Locations (1)

FacilityCityStateZIPSite coordinators
University of ColoradoAuroraColorado80045-

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