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

Part of paid clinical trials in Irvine, California.

Sponsor
National Cancer Institute (NCI)
Study ID
NCT05411094
Phase
PHASE1
Status
Suspended

Conditions

  • Locally Advanced Pancreatic Carcinoma
  • Stage II Pancreatic Cancer AJCC v8
  • Stage III Pancreatic Cancer AJCC v8
  • Unresectable Pancreatic Carcinoma

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • Biopsy Procedure — PROCEDURE
    Undergo biopsy
  • Biospecimen Collection — PROCEDURE
    Undergo collection of blood and buccal samples
  • Computed Tomography — PROCEDURE
    Undergo CT scan
  • Durvalumab — BIOLOGICAL
    Given IV
  • Magnetic Resonance Imaging — PROCEDURE
    Undergo MRI
  • Olaparib — DRUG
    Given PO

Study Details

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.

Key Dates

Start date
May 22, 2023
Status verified
May 2026
Primary completion
Jul 1, 2026
Completion
Jul 1, 2028

Study Design

Enrollment
18 participants (estimated)
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT

Arms

  • Experimental: Treatment (olaparib, durvalumab, radiation therapy)
    Patients receive olaparib PO BID on days 1-28 and durvalumab IV over 55-65 minutes on day 1 of each cycle. Beginning cycle 2, patients also undergo radiation therapy daily on weekdays for 3 weeks. Cycles repeat every 28 days for up to 2 years in the absence of disease progression or unacceptable toxicity. Patients undergo Patients undergo CT scan with or without MRI and collection of blood samples throughout the study. Patients may undergo optional collection of buccal samples and optional biopsy at screening and/or on study.

Primary Outcome Measure

Dose-limiting toxicities (DLTs) for olaparib in combination with durvalumab and radiation [ Time Frame: From start of radiation therapy for up to 6 weeks ]

Locations (10)

FacilityCityStateZIPSite coordinators
UCI Health - Chao Family Comprehensive Cancer Center and Ambulatory CareIrvineCalifornia92612-
Los Angeles General Medical CenterLos AngelesCalifornia90033-
USC / Norris Comprehensive Cancer CenterLos AngelesCalifornia90033-
UC Irvine Health/Chao Family Comprehensive Cancer CenterOrangeCalifornia92868-
University of Michigan Rogel Cancer CenterAnn ArborMichigan48109-
University of Michigan - Brighton Center for Specialty CareBrightonMichigan48116-
UNC Lineberger Comprehensive Cancer CenterChapel HillNorth Carolina27599-
Ohio State University Comprehensive Cancer CenterColumbusOhio43210-
University of Wisconsin Carbone Cancer Center - Eastpark Medical CenterMadisonWisconsin53718-
University of Wisconsin Carbone Cancer Center - University HospitalMadisonWisconsin53792-

Find similar trials in Irvine, CA

By research site
UCI Health - Chao Family Comprehensive Cancer Center and Ambulatory Care· Irvine, CALos Angeles General Medical Center· Los Angeles, CAUSC / Norris Comprehensive Cancer Center· Los Angeles, CAUC Irvine Health/Chao Family Comprehensive Cancer Center· Orange, CAUniversity of Michigan Rogel Cancer Center· Ann Arbor, MIUniversity of Michigan - Brighton Center for Specialty Care· Brighton, MI

Related Studies