Clinical trialPhase 2Withdrawn
A Study of Durvalumab in Patients With BR PDA Following Neoadjuvant Therapy and Successful Surgical Resection
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
- Outcome
- Stopped earlyCancelled by PI (Other)
- Phase
- Phase 2
- Status
- Withdrawn
- Study type
- Interventional
- Start
- 12 June 2017
- Expected end
- 1 April 2019
- Enrollment
- 0 participants
- Sites
- 1
- Primary outcomes
- The number of subjects with disease free survival (DFS)
- Sponsor
- Other
- Results posted
- No
- Last update
- 14 September 2020
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Brief summary public domain (ClinicalTrials.gov)
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 public domain (ClinicalTrials.gov)
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