| ClinicalTrials.gov Identifier |
| NCT04068194 |
| Institution Name |
| NYU Perlmutter Cancer Center |
| Institution Address (Street) |
| 160 E 34th St |
| Institution City |
| New York |
| Institution State |
| New York |
| Institution ZIP Code |
| 10276 |
| Institution Country |
| United States |
| Institution Website |
| https://clinicaltrials.med.nyu.edu/clinicaltrial/1346/phase-iii-study-m3814/ |
| Additional Institutions |
- Entire NCTN, currently:
UC Irvine Health/Chao Family Comprehensive Cancer Center
Contact:
877-827-8839 ucstudy@uci.edu
Principal Investigator:
Farshid Dayyani
- Northwestern University
Contact:
312-695-1301 cancer@northwestern.edu
Principal Investigator:
Aparna Kalyan
- Rutgers Cancer Institute of New Jersey
Contact:
732-235-7356
Principal Investigator:
Salma K. Jabbour
- NYP/Columbia University Medical Center/Herbert Irving Comprehensive Cancer Center
Contact:
212-305-6361 nr2616@cumc.columbia.edu
Principal Investigator:
Susan E. Bates
- NYP/Weill Cornell Medical Center
Contact:
212-746-1848
Principal Investigator:
Elizabeta C. Popa
- 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 |
