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Spots Global Cancer Trial Database for Testing the Combination of New Anti-cancer Drug Peposertib With Avelumab and Radiation Therapy for Advanced/Metastatic Solid Tumors and Hepatobiliary Malignancies

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Trial Identification

Brief Title: Testing the Combination of New Anti-cancer Drug Peposertib With Avelumab and Radiation Therapy for Advanced/Metastatic Solid Tumors and Hepatobiliary Malignancies

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

Study ID: NCT04068194

Study Description

Brief Summary: 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.

Detailed Description: PRIMARY OBJECTIVES: I. To determine the safety and tolerability and recommended phase 2 dose (RP2D) of peposertib (M3814) in combination with hypofractionated radiation and avelumab in patients with advanced/metastatic solid tumors. (Phase I) II. To determine the efficacy of the combination of hypofractionated radiation, M3814, and avelumab as compared to the combination of hypofractionated radiation and avelumab in patients with advanced/metastatic hepatobiliary tumors by objective response rate (ORR) in non-irradiated lesions. (Phase II) SECONDARY OBJECTIVES: I. To observe and record anti-tumor activity. (Phase I) II. To characterize the pharmacokinetic (PK) profile of M3814 in combination with avelumab. (Phase I) III. To determine the efficacy and safety of the combination of hypofractionated radiation, M3814, and avelumab as compared to hypofractionated radiation and avelumab by measurement of disease control rate (DCR), duration of response (DOR), progression free survival (PFS), PFS outside the irradiated field, and overall survival (OS) in patients with advanced/metastatic hepatobiliary tumors. (Phase II) IV. To determine if baseline deoxyribonucleic acid (DNA) repair defects inherent to some cholangiocarcinomas correlate with a more dramatic response to radiation compared to those without as measured by gamma H2AX phosphorylated (p)NBS1 multiplex immunofluorescence (IFA) assay. (Phase II) V. To characterize the pharmacokinetic (PK) profiles of M3814 and avelumab. (Phase II) EXPLORATORY OBJECTIVES: I. To perform molecular profiling assays on malignant and normal tissues, including, but not limited to, whole exome sequencing (WES), ribonucleic acid (RNA) sequencing (RNAseq), mass cytometry (CyTOF), multiplexed ion beam imaging (MIBI), and T cell receptor sequencing in order to: Ia. To determine if baseline tumor mutation burden and pattern, and neoantigen burden correlate with response. Ib. To determine if combination therapy results in changes in the immune landscape in both the tumor and the host that correlate with response. Ic. To determine if baseline defects in deoxyribonucleic acid (DNA) damage repair in some cholangiocarcinomas correlate with an increased response. OUTLINE: This is a phase I, dose-escalation study of peposertib followed by a phase II study. PHASE I: Patients with advanced/metastatic malignant solid tumors undergo 8 fractions of hypofractionated radiation therapy (RT) every day (QD) on days -17 to -7. Patients also receive peposertib orally (PO) twice daily (BID) on days 1-28, and avelumab intravenously (IV) over 60 minutes on days 1 and 15. Cycles repeat every 28 days in the absence of disease progression or unacceptable toxicity. PHASE II: Patients advanced/metastatic cholangiocarcinoma/gallbladder cancer are randomized to 1 of 2 arms. ARM A: Patients undergo 8 fractions of hypofractionated RT QD on days -17 to -7. Patients also receive avelumab IV over 60 minutes on days 1 and 15. Cycles repeat every 28 days in the absence of disease progression or unacceptable toxicity. Patients also undergo biopsy, computed tomography (CT), and collection of blood on the trial. ARM B: Patients undergo 8 fractions of hypofractionated RT QD on days -17 to -7. Patients also receive peposertib PO BID on days 1-28, and avelumab IV over 60 minutes on days 1 and 15. Cycles repeat every 28 days in the absence of disease progression or unacceptable toxicity. Patients also undergo biopsy, CT, and collection of blood on the trial. After completion of study treatment, patients are followed up at 30 days, every 6 months for 2 years, then annually thereafter.

Keywords

Eligibility

Minimum Age: 18 Years

Eligible Ages: ADULT, OLDER_ADULT

Sex: ALL

Healthy Volunteers: No

Locations

UC Irvine Health/Chao Family Comprehensive Cancer Center, Orange, California, United States

University of California Davis Comprehensive Cancer Center, Sacramento, California, United States

UCHealth University of Colorado Hospital, Aurora, Colorado, United States

MedStar Georgetown University Hospital, Washington, District of Columbia, United States

Northwestern University, Chicago, Illinois, United States

Wayne State University/Karmanos Cancer Institute, Detroit, Michigan, United States

Weisberg Cancer Treatment Center, Farmington Hills, Michigan, United States

Rutgers Cancer Institute of New Jersey, New Brunswick, New Jersey, United States

Laura and Isaac Perlmutter Cancer Center at NYU Langone, New York, New York, United States

NYP/Columbia University Medical Center/Herbert Irving Comprehensive Cancer Center, New York, New York, United States

NYP/Weill Cornell Medical Center, New York, New York, United States

University of Pittsburgh Cancer Institute (UPCI), Pittsburgh, Pennsylvania, United States

Virginia Commonwealth University/Massey Cancer Center, Richmond, Virginia, United States

University of Wisconsin Carbone Cancer Center - University Hospital, Madison, Wisconsin, United States

Contact Details

Name: Kristen R Spencer

Affiliation: Laura and Isaac Perlmutter Cancer Center at NYU

Role: PRINCIPAL_INVESTIGATOR

Useful links and downloads for this trial

Clinicaltrials.gov

Google Search Results

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