RecruitingPhase 1NCT05411094

Testing the Safety of the Anti-Cancer Drugs Durvalumab and Olaparib During Radiation Therapy for Locally Advanced Unresectable Pancreatic Cancer

A Phase 1 Study of Olaparib in Combination With Durvalumab (MEDI4736) and Concurrent Radiation Therapy Following First-Line Chemotherapy in Locally Advanced Unresectable Pancreatic Cancer


Sponsor

National Cancer Institute (NCI)

Enrollment

18 participants

Start Date

May 22, 2023

Study Type

INTERVENTIONAL

Conditions

Summary

This phase I trial tests the safety and tolerability of olaparib in combination with durvalumab and radiation therapy in patients with pancreatic cancer that has spread to nearby tissue or lymph nodes (locally advanced) and cannot be removed by surgery (unresectable). Olaparib is an inhibitor of PARP, an enzyme that helps repair deoxyribonucleic acid (DNA) when it becomes damaged. Blocking PARP may help keep cancer cells from repairing their damaged DNA, causing them to die. PARP inhibitors are a type of targeted therapy. Immunotherapy with monoclonal antibodies, such as durvalumab, may help the body's immune system attack the cancer, and may interfere with the ability of tumor cells to grow and spread. Radiation therapy uses high energy x-rays, particles, or radioactive seeds to kill cancer cells and shrink tumors. The combination of targeted therapy with olaparib, immunotherapy with durvalumab and radiation therapy may stimulate an anti-tumor immune response and promote tumor control in locally advanced unresectable pancreatic cancer.


Eligibility

Min Age: 18 Years

Plain Language Summary

Simplified for easier understanding

This study is testing whether adding two drugs — durvalumab (an immunotherapy) and olaparib (a targeted DNA repair drug) — to radiation therapy is safe and effective for people with locally advanced pancreatic cancer that cannot be surgically removed. **You may be eligible if...** - You have been diagnosed with unresectable locally advanced pancreatic cancer (confirmed by biopsy) - Your cancer could not be removed surgically - You have already completed at least 16 weeks of first-line chemotherapy without your cancer getting significantly worse **You may NOT be eligible if...** - Your pancreatic cancer has spread to distant organs (metastatic) - You have already received radiation to this area - You have certain other serious health conditions that make this treatment unsafe Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

PROCEDUREBiopsy Procedure

Undergo biopsy

PROCEDUREBiospecimen Collection

Undergo collection of blood and buccal samples

PROCEDUREComputed Tomography

Undergo CT scan

BIOLOGICALDurvalumab

Given IV

PROCEDUREMagnetic Resonance Imaging

Undergo MRI

DRUGOlaparib

Given PO


Locations(11)

UCI Health - Chao Family Comprehensive Cancer Center and Ambulatory Care

Irvine, California, United States

Los Angeles General Medical Center

Los Angeles, California, United States

USC / Norris Comprehensive Cancer Center

Los Angeles, California, United States

UC Irvine Health/Chao Family Comprehensive Cancer Center

Orange, California, United States

University of Michigan Rogel Cancer Center

Ann Arbor, Michigan, United States

University of Michigan - Brighton Center for Specialty Care

Brighton, Michigan, United States

UNC Lineberger Comprehensive Cancer Center

Chapel Hill, North Carolina, United States

Ohio State University Comprehensive Cancer Center

Columbus, Ohio, United States

University of Wisconsin Carbone Cancer Center - Eastpark Medical Center

Madison, Wisconsin, United States

University of Wisconsin Carbone Cancer Center - University Hospital

Madison, Wisconsin, United States

University Health Network-Princess Margaret Hospital

Toronto, Ontario, Canada

View Full Details on ClinicalTrials.gov

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NCT05411094


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