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NCI/CTEP 10276: A Phase 1/2 Study of M3814 and Avelumab in Combination with Hypofractionated Radiation in Patients with Advanced/Metastatic Solid Tumors and Hepatobiliary Malignancies

ClinicalTrials.gov Identifier
NCT04068194
Institution Name
NYU Perlmutter Cancer Center
Full Institution Address
160 E 34th St

New York
New York
10276
United States
Institution Website
https://clinicaltrials.med.nyu.edu/clinicaltrial/1346/phase-iii-study-m3814/
Additional Institutions

  1. Entire NCTN, currently:
    UC Irvine Health/Chao Family Comprehensive Cancer Center
    Contact:
    877-827-8839 ucstudy@uci.edu
    Principal Investigator:
    Farshid Dayyani

  2. Northwestern University
    Contact:
    312-695-1301 cancer@northwestern.edu
    Principal Investigator:
    Aparna Kalyan

  3. Rutgers Cancer Institute of New Jersey
    Contact:
    732-235-7356
    Principal Investigator:
    Salma K. Jabbour

  4. NYP/Columbia University Medical Center/Herbert Irving Comprehensive Cancer Center
    Contact:
    212-305-6361 nr2616@cumc.columbia.edu
    Principal Investigator:
    Susan E. Bates

  5. NYP/Weill Cornell Medical Center
    Contact:
    212-746-1848
    Principal Investigator:
    Elizabeta C. Popa

  6. Virginia Commonwealth University/Massey Cancer Center
    Contact:
    CTOclinops@vcu.edu
    Principal Investigator:
    Jennifer L. Myers
Principal Investigator
Kristen Spencer, DO, MPH
Principal Investigator Phone
(212) 731-6667
Principal Investigator Email
kristen.spencer@nyulangone.org
Study Coordinator
Monica Dureja
Study Coordinator Phone
(212) 263-4415
Study Coordinator Email
Monica.Dureja@nyulangone.org
Study Overview
The phase II portion of this trial studies how well peposertib (a drug that may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth) works with avelumab and hypofractionated radiation therapy in treating patients with hepatobiliary malignancies that have spread to other places in the body (advanced/metastatic).
Enrollment Information
62
Study Start Date
20200407
Study End Date
20241203
Study Purpose

  • 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 response rate.

  • To observe and record anti-tumor activity by measurement of disease control rate (DCR), duration of response (DOR), progression free survival (PFS), and overall survival (OS).

  • To determine if baseline deoxyribonucleic acid (DNA) repair defects inherent to some cholangiocarcinomas correlate with a more dramatic response to radiation.
Inclusion Criteria

  • have a histologically confirmed metastatic or locally advanced unresectable cholangiocarcinoma/gallbladder carcinoma

  • have progressed on at least 1 prior standard of care therapy

  • have an (ECOG) performance status =< 2

  • have 1 tumor to irradiate and at least 1 RECIST measurable lesion that will not be irradiated

  • be willing to undergo fresh biopsies at baseline

  • have the ability to swallow and retain oral medication and not have any clinically significant gastrointestinal abnormalities that might alter absorption
Exclusion Criteria

  • have received prior anti-CTLA-4, anti-PD-1, anti-PD-L1 or other immune checkpoint inhibitor therapeutic antibodies or pathway-targeting agents other than as part of a gemcitabine-based regimen

  • have an active autoimmune disease requiring systemic corticosteroids greater than the equivalent of prednisone 10 mg daily
Required Tests Prior to Study

  • Potentially repeat tumor imaging (e.g. CT scan, PET scan)

  • Potentially a fresh tumor biopsy

  • Blood work

  • EKG
Potential Side Effects

  • Lowered blood counts, electrolyte abnormalities, nausea/vomiting, rash, lung inflammation, colon inflammation
Financial Assistance Available
No