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Radiation Therapy in Combination With Durvalumab for People With Pancreatic Cancer

NCT03245541 · Status: ACTIVE_NOT_RECRUITING · Phase: PHASE1/PHASE2 · Type: INTERVENTIONAL · Enrollment: 18

Last updated 2025-10-07

No results posted yet for this study

Summary

The purpose of this study is to find out if combining durvalumab with standard stereotactic ablative radiotherapy (SABR) is an effective treatment for people with locally advanced or borderline resectable pancreatic cancer. The researchers will also look at the safety of the combination treatment and any side effects it causes.

Conditions

  • Pancreatic Adenocarcinoma

Interventions

DRUG

Durvalumab

Durvalumab will be given 750 mg, intravenously (IV) over 60 minutes (+/- 5 minutes), Q14 days beginning D1. Four doses of durvalumab will be administered on the Q14 day schedule. Subsequently Durvalumab will continue as maintenance 1500mg, intravenously (IV) over 60 minutes (+/- 5 minutes), Q28 days up to 1 year or until progression (11 doses), unacceptable toxicity or other reason. If a patient undergoes resection, they will resume durvalumab once appropriately healed from surgery (approximately 4-8 weeks) at discretion of treating medical oncologist.

RADIATION

Stereotactic Ablative Body Radiotherapy (SABR)

SABR delivered as 6.6 Gy/fraction x 5 fractions given within two weeks will be administered weekdays and will begin D8.

Sponsors & Collaborators

Principal Investigators

  • Eileen O'Reilly, MD · Memorial Sloan Kettering Cancer Center

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2020-08-14
Primary Completion
2026-09-30
Completion
2026-09-30
FDA Drug
Yes

Countries

  • United States

Study Locations

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Entities

Drugs
Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03245541 on ClinicalTrials.gov