Testing the Safety of the Anti-Cancer Drugs Durvalumab and Olaparib During Radiation Therapy for … (NCT05411094) | Clinical Trial Compass
RecruitingPhase 1
Testing the Safety of the Anti-Cancer Drugs Durvalumab and Olaparib During Radiation Therapy for Locally Advanced Unresectable Pancreatic Cancer
United States18 participantsStarted 2023-05-22
Plain-language 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.
Who can participate
Age range18 Years
SexALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion Criteria:
* Patients must have histologically confirmed pancreatic cancer (excluding islets) (not otherwise specified \[NOS\]) (Medical Dictionary for Regulatory Activities \[MEDDRA\] code: 10033612).
* Patients must have unresectable locally advanced pancreatic cancer as determined by a multidisciplinary tumor board applying National Comprehensive Cancer Network (NCCN) version (v)2.2021 criteria or as surgically determined during failed resection attempt.
* Patients must have had prior first-line chemotherapy for this cancer for at least 16 weeks without clinical, biochemical, or radiologic progression. There should be a washout of at least 2 weeks from first-line chemotherapy and start of therapy on clinical trial.
* Age \>= 18 years. Because no dosing or adverse event data are currently available on the use of durvalumab and olaparib in combination with radiation in patients \< 18 years of age, children are excluded from this study.
* Body weight \> 30 kg.
* Eastern Cooperative Oncology Group (ECOG) performance status =\< 1 (Karnofsky \>= 70%).
* Hemoglobin \>= 9.0 g/dL without blood transfusion in last 4 weeks (within 2 weeks of enrollment).
* Absolute neutrophil count \>= 1,500/mcL (within 2 weeks of enrollment).
* Platelets \>= 100,000/mcL (within 2 weeks of enrollment).
* Total bilirubin =\< 1.5 x institutional upper limit of normal (ULN) (within 2 weeks of enrollment).
* Aspartate aminotransferase (AST) (serum glutamic oxaloacetic transaminase \[SGOT\])/ala…
What they're measuring
1
Dose-limiting toxicities (DLTs) for olaparib in combination with durvalumab and radiation
Timeframe: From start of radiation therapy for up to 6 weeks