Clinical trialNCT04068194Active, not recruitingPhase 1/PHASE2Interventional

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

SponsorNational Cancer Institute (NCI)Enrollment103Locally Advanced Malignant Solid NeoplasmLocally Advanced Unresectable CholangiocarcinomaLocally Advanced Unresectable Gallbladder CarcinomaLocally Advanced Unresectable Malignant Solid NeoplasmMetastatic CholangiocarcinomaMetastatic Gallbladder Carcinoma+4 more conditions

View the registry record on ClinicalTrials.gov

Summary

The lay summary the sponsor registered on ClinicalTrials.gov.

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.

clinicaltrials.gov ↗

Investigators

The overall officials registered on this study. Names that resolve to a FindMyKOL profile link to it; the rest are shown as registered.

Kristen R Spencer
Laura and Isaac Perlmutter Cancer Center at NYU
Principal Investigator
clinicaltrials.gov ↗

A profile link is shown only when the registered name resolves to a person record with a confident, namesake-checked match; ambiguous names stay unlinked.

Sites

46 registered facilities, with the per-site recruitment status where the registry publishes one. ClinicalTrials.gov does not publish per-site enrollment counts.

United States

City of Hope Comprehensive Cancer Center
Duarte, California, United States
Uci Health - Chao Family Comprehensive Cancer Center and Ambulatory Care
Irvine, California, United States
Uc San Diego Moores Cancer Center
La Jolla, California, United States
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
Smilow Cancer Hospital-Derby Care Center
Derby, Connecticut, United States
Smilow Cancer Hospital Care Center-Fairfield
Fairfield, Connecticut, United States
Smilow Cancer Hospital Care Center at Glastonbury
Glastonbury, Connecticut, United States
Smilow Cancer Hospital Care Center at Greenwich
Greenwich, Connecticut, United States
Smilow Cancer Hospital Care Center - Guilford
Guilford, Connecticut, United States
Smilow Cancer Hospital Care Center at Saint Francis
Hartford, Connecticut, United States
Smilow Cancer Center/yale-New Haven Hospital
New Haven, Connecticut, United States
Yale University
New Haven, Connecticut, United States
Yale-New Haven Hospital North Haven Medical Center
North Haven, Connecticut, United States
Smilow Cancer Hospital Care Center at Long Ridge
Stamford, Connecticut, United States
Smilow Cancer Hospital-Torrington Care Center
Torrington, Connecticut, United States
Smilow Cancer Hospital Care Center-Trumbull
Trumbull, Connecticut, United States
Smilow Cancer Hospital-Waterbury Care Center
Waterbury, Connecticut, United States
Smilow Cancer Hospital Care Center - Waterford
Waterford, Connecticut, United States
Medstar Georgetown University Hospital
Washington D.C., District of Columbia, United States
Sibley Memorial Hospital
Washington D.C., District of Columbia, United States
Um Sylvester Comprehensive Cancer Center at Aventura
Aventura, Florida, United States
Um Sylvester Comprehensive Cancer Center at Coral Gables
Coral Gables, Florida, United States
Um Sylvester Comprehensive Cancer Center at Deerfield Beach
Deerfield Beach, Florida, United States
Um Sylvester Comprehensive Cancer Center at Kendall
Miami, Florida, United States
University of Miami Miller School of Medicine-Sylvester Cancer Center
Miami, Florida, United States
Um Sylvester Comprehensive Cancer Center at Plantation
Plantation, Florida, United States
Emory Saint Joseph'S Hospital
Atlanta, Georgia, United States
Emory University Hospital Midtown
Atlanta, Georgia, United States
Emory University Hospital/winship Cancer Institute
Atlanta, Georgia, 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
Bellevue Hospital Center
New York, New York, 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
Upmc Hillman Cancer Center
Pittsburgh, Pennsylvania, United States

6 more sites on the registry record.ClinicalTrials.gov ↗

Site investigator names are published by ClinicalTrials.gov only while a study recruits, so completed studies list sites without them.

Drugs studied

The drug and biological interventions registered on this study, normalized to their RxNorm ingredient where possible.

Avelumab →Nedisertib

Linked drugs open the directory filtered to KOLs working with them.clinicaltrials.gov ↗

Registration & key dates

Registry attributes as recorded on the ClinicalTrials.gov study record.

Start: 7 Apr 2020
Primary completion: 1 Jul 2027
Completion: 1 Jul 2027
Last update posted: 2 Oct 2026
Registered enrollment: 103
Registry id: NCT04068194

clinicaltrials.gov ↗

Source: ClinicalTrials.gov, via the CTTI AACT database, data as of 11 Nov 2026. Registry facts are shown as registered by the study sponsor; FindMyKOL does not interpret them.