Testing the Combination of New Anti-cancer Drug Peposertib With Avelumab and Radiation Therapy for Advanced/Metastatic Solid Tumors and Hepatobiliary Malignancies
Public ClinicalTrials.gov record NCT04068194. Field values are reproduced from the official study page; the official ClinicalTrials.gov record remains the source of truth for eligibility, enrollment, and contact information.
Data is sourced from official ClinicalTrials.gov public API records. Always review the official ClinicalTrials.gov record for the latest information.
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
Brief summary
Reproduced verbatim from the official ClinicalTrials.gov record. Not medical advice.
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.
Study identification
- NCT ID
- NCT04068194
- Recruitment status
- Active, not recruiting
- Study type
- Interventional
- Phase
- Phase 1, Phase 2
- Enrollment
- 103 participants
Conditions and interventions
Conditions
- Locally Advanced Malignant Solid Neoplasm
- Locally Advanced Unresectable Cholangiocarcinoma
- Locally Advanced Unresectable Gallbladder Carcinoma
- Locally Advanced Unresectable Malignant Solid Neoplasm
- Metastatic Cholangiocarcinoma
- Metastatic Gallbladder Carcinoma
- Metastatic Malignant Solid Neoplasm
- Stage III Gallbladder Cancer AJCC v8
- Stage IV Gallbladder Cancer AJCC v8
- Unresectable Malignant Solid Neoplasm
Interventions
- Avelumab Drug
- Biopsy Procedure Procedure
- Biospecimen Collection Procedure
- Computed Tomography Procedure
- Hypofractionated Radiation Therapy Radiation
- Peposertib Drug
Drug · Procedure · Radiation
Eligibility (public fields only)
- Age range
- 18 Years and older
- Sex
- All
- Healthy volunteers
- Healthy volunteers not accepted
This page does not interpret eligibility. Detailed inclusion and exclusion criteria are on the official ClinicalTrials.gov record.
Study timeline
- Start date
- Apr 7, 2020 (Actual)
- Primary completion
- Jul 1, 2027 (Estimated)
- Completion
- Jul 1, 2027 (Estimated)
- Last update posted
- Oct 2, 2026
2020 – 2027
United States locations
- U.S. sites
- 46
- U.S. states
- 16
- U.S. cities
- 37
| Facility | City | State | ZIP | Site status |
|---|---|---|---|---|
| City of Hope Comprehensive Cancer Center | Duarte | California | 91010 | — |
| UCI Health - Chao Family Comprehensive Cancer Center and Ambulatory Care | Irvine | California | 92612 | — |
| UC San Diego Moores Cancer Center | La Jolla | California | 92093 | — |
| UC Irvine Health/Chao Family Comprehensive Cancer Center | Orange | California | 92868 | — |
| University of California Davis Comprehensive Cancer Center | Sacramento | California | 95817 | — |
| UCHealth University of Colorado Hospital | Aurora | Colorado | 80045 | — |
| Smilow Cancer Hospital-Derby Care Center | Derby | Connecticut | 06418 | — |
| Smilow Cancer Hospital Care Center-Fairfield | Fairfield | Connecticut | 06824 | — |
| Smilow Cancer Hospital Care Center at Glastonbury | Glastonbury | Connecticut | 06033 | — |
| Smilow Cancer Hospital Care Center at Greenwich | Greenwich | Connecticut | 06830 | — |
| Smilow Cancer Hospital Care Center - Guilford | Guilford | Connecticut | 06437 | — |
| Smilow Cancer Hospital Care Center at Saint Francis | Hartford | Connecticut | 06105 | — |
| Smilow Cancer Center/Yale-New Haven Hospital | New Haven | Connecticut | 06510 | — |
| Yale University | New Haven | Connecticut | 06520 | — |
| Yale-New Haven Hospital North Haven Medical Center | North Haven | Connecticut | 06473 | — |
| Smilow Cancer Hospital Care Center at Long Ridge | Stamford | Connecticut | 06902 | — |
| Smilow Cancer Hospital-Torrington Care Center | Torrington | Connecticut | 06790 | — |
| Smilow Cancer Hospital Care Center-Trumbull | Trumbull | Connecticut | 06611 | — |
| Smilow Cancer Hospital-Waterbury Care Center | Waterbury | Connecticut | 06708 | — |
| Smilow Cancer Hospital Care Center - Waterford | Waterford | Connecticut | 06385 | — |
| MedStar Georgetown University Hospital | Washington D.C. | District of Columbia | 20007 | — |
| Sibley Memorial Hospital | Washington D.C. | District of Columbia | 20016 | — |
| UM Sylvester Comprehensive Cancer Center at Aventura | Aventura | Florida | 33180 | — |
| UM Sylvester Comprehensive Cancer Center at Coral Gables | Coral Gables | Florida | 33146 | — |
| UM Sylvester Comprehensive Cancer Center at Deerfield Beach | Deerfield Beach | Florida | 33442 | — |
| University of Miami Miller School of Medicine-Sylvester Cancer Center | Miami | Florida | 33136 | — |
| UM Sylvester Comprehensive Cancer Center at Kendall | Miami | Florida | 33176 | — |
| UM Sylvester Comprehensive Cancer Center at Plantation | Plantation | Florida | 33324 | — |
| Emory University Hospital Midtown | Atlanta | Georgia | 30308 | — |
| Emory University Hospital/Winship Cancer Institute | Atlanta | Georgia | 30322 | — |
| Emory Saint Joseph's Hospital | Atlanta | Georgia | 30342 | — |
| Northwestern University | Chicago | Illinois | 60611 | — |
| Wayne State University/Karmanos Cancer Institute | Detroit | Michigan | 48201 | — |
| Weisberg Cancer Treatment Center | Farmington Hills | Michigan | 48334 | — |
| Rutgers Cancer Institute of New Jersey | New Brunswick | New Jersey | 08903 | — |
| Bellevue Hospital Center | New York | New York | 10016 | — |
| Laura and Isaac Perlmutter Cancer Center at NYU Langone | New York | New York | 10016 | — |
| NYP/Columbia University Medical Center/Herbert Irving Comprehensive Cancer Center | New York | New York | 10032 | — |
| NYP/Weill Cornell Medical Center | New York | New York | 10065 | — |
| UPMC Hillman Cancer Center | Pittsburgh | Pennsylvania | 15232 | — |
| Smilow Cancer Hospital Care Center - Westerly | Westerly | Rhode Island | 02891 | — |
| Vanderbilt University/Ingram Cancer Center | Nashville | Tennessee | 37232 | — |
| Huntsman Cancer Institute/University of Utah | Salt Lake City | Utah | 84112 | — |
| VCU Massey Comprehensive Cancer Center | Richmond | Virginia | 23298 | — |
| University of Wisconsin Carbone Cancer Center - Eastpark Medical Center | Madison | Wisconsin | 53718 | — |
| University of Wisconsin Carbone Cancer Center - University Hospital | Madison | Wisconsin | 53792 | — |
Site contact phone numbers, emails, and investigator names are intentionally not displayed here. Open the official ClinicalTrials.gov record for site contact information.
About this trial record page
- What this page shows
- Public field values for ClinicalTrials.gov record NCT04068194, including study identification, conditions, interventions, eligibility (age, sex, healthy volunteer), timeline, and U.S. site list.
- What this page does not do
- No medical advice, eligibility judgments, treatment recommendations, study quality scoring, or AI-generated medical summaries. No site contact phone numbers, emails, or investigator names.
- Where the data comes from
- Sourced from the official ClinicalTrials.gov public API. The official record is the source of truth.
- Last refresh
- Last update posted Oct 2, 2026 · Synced Oct 16, 2026
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Open the official record
The complete public registry record, listed eligibility criteria, and available contact information for NCT04068194 live on ClinicalTrials.gov.