RecruitingLocally Advanced Pancreatic AdenocarcinomaStage III Pancreatic Cancer AJCC v8

Testing the Addition of a New Anti-cancer Drug, M3814 (Peposertib), to the Usual Radiotherapy in Patients With Locally Advanced Pancreatic Cancer

Eligible age

18+ yrs

Accepts

All genders

Locations

17 states

Healthy volunteers

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About this study

This phase I/II trial studies the safety, side effects and best dose of M3814 and to see how well it works when given together with radiation therapy in treating patients with pancreatic cancer that has spread to nearby tissue or lymph nodes (locally advanced). M3814 may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth. Hypofractionated radiation therapy delivers higher doses of radiation therapy over a shorter period of time and may kill more tumor cells and have fewer side effects. Giving M3814 and hypofractionated radiation therapy together may be safe, tolerable and/or more effective than radiation therapy alone in treating patients with locally advanced pancreatic cancer.

Sponsor: National Cancer Institute (NCI)

You may qualify if…

✓ Patients must have pathologically confirmed pancreatic adenocarcinoma. Patients with alternative or mixed histologies (i.e., squamous, neuroendocrine, acinar, colloid) are not eligible
✓ Received 4-6 months of induction chemotherapy with fluorouracil, irinotecan, leucovorin and oxaliplatin (FOLFIRINOX), fluorouracil, liposomal irinotecan, leucovorin, oxaliplatin (NALIRIFOX), or gemcitabine/Abraxane, as per standard of care
✓ Patients must have locally advanced pancreatic cancer according to National Comprehensive Cancer Network (NCCN) Guidelines (version 1.2020) on pancreas protocol CT scan performed within 21 days of registration. Locally advanced disease is defined as any of the following:
✓ For head or uncinate process tumors:
✓ Solid tumor contact with superior mesenteric artery \> 180 degrees
✓ Solid tumor contact with the celiac axis \> 180 degrees
✓ Solid tumor contact with the common or proper hepatic arteries \> 180 degrees or
✓ For pancreatic body or tail tumors:

You may not qualify if…

✕ Patients who have completed induction chemotherapy less than 2 weeks or more than 8 weeks prior to study enrollment
✕ Patients who have not recovered from adverse events due to prior anti-cancer therapy (i.e., have residual toxicities \> grade 1) with the exception of alopecia and neuropathy grade =\< 2
✕ Patients who are receiving any other investigational agents
✕ History of allergic reactions attributed to compounds of similar chemical or biologic composition to M3814 (peposertib)
✕ Evidence of distant metastatic disease
✕ More than 1 line of chemotherapy for the treatment of localized pancreatic cancer, unless the change in treatment was made only for toxicity
✕ Prior abdominal radiation
✕ Active inflammatory bowel disease or connective tissue disease