Ph I/II M3814&Avelumab in Combo w/Hypofractionated Rad in Pts w/ Adv/Met Solid Tumor & Hepato Malig

UCI Specialty Area: Cancer

Principal Investigator: Farshid Dayyani

Official Title: A Phase I/II Study of M3814 and Avelumab in Combination with Hypofractionated Radiation in Patients with Advanced/Metastatic Solid Tumors and Hepatobiliary Malignancies

A Study On:

Liver

Study Description

This phase I/II trial studies the best dose and side effects of peposertib and to see how well it works with avelumab and hypofractionated radiation therapy in treating patients with solid tumors and hepatobiliary malignancies that have spread to other places in the body (advanced/metastatic). Peposertib may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth. Immunotherapy with monoclonal antibodies, such as avelumab, may help the body's immune system attack the cancer, and may interfere with the ability of tumor cells to grow and spread. 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 peposertib in combination with avelumab and hypofractionated radiation therapy may work better than other standard chemotherapy, hormonal, targeted, or immunotherapy medicines available in treating patients with solid tumors and hepatobiliary malignancies.

Eligibility

Patient who is at least 18 years of age
Patients with histologically confirmed metastatic or locally advanced unresectable colangiocarcinoma/gallbladder carcinoma that has progressed on at least 1 prior standard of care therapy or for which no acceptable standard of care therapy exists or in which patient declines standard of care therapy.

-Patient with ability to swallow and retain oral medication

Patients who have had chemotherapy, definitive radiation, biological cancer therapy or investigational agent/device within 21 days of first planned dose of study therapy (within 14 days for palliative radiation)
Patients who have undergone prior solid organ or bone marrow transplant
Patients who are pregnant or lactating

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University of California, Irvine - Study Information Sheet

UCI Center for Clinical Research Potential Participant Database

Lead Researcher
Maheswari Senthil, MD
UCI Center for Clinical Research

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