๐Ÿ›๏ธ Verified NIH Record โ€ข Updated 2026-08-20

Testing the Combination of New Anti-cancer Drug Peposertib With Avelumab and Radiation Therapy for Advanced/Metastatic Solid Tumors and Hepatobiliary Malignancies (NCT04068194)

A Phase I/II Study of M3814 and Avelumab in Combination With Hypofractionated Radiation in Patients With Advanced/Metastatic Solid Tumors and Hepatobiliary Malignancies

๐Ÿ”ต Active, Not Recruiting Phase1 / Phase2 ๐Ÿ’Š Investigational Drug / Biologic Sponsor: National Cancer Institute (NCI)

๐Ÿฉบ Plain-English Summary (8th-Grade Level)

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.

Who can join: Review the eligibility criteria below.

Location: City of Hope Comprehensive Cancer Center โ€” Duarte, California

Age range: 18 Years

๐Ÿงช Interventions in This Study

๐Ÿ“‹ "Do I Qualify?" โ€” 1-Minute Self Screener

Instant Checklist

Full eligibility criteria are available on the official NIH protocol. View the criteria โ†—

๐Ÿ“ All Participating Trial Locations (46 Sites)

Showing the first 25 of 46 sites.

  • City of Hope Comprehensive Cancer Center โ€” Duarte, California
  • UCI Health - Chao Family Comprehensive Cancer Center and Ambulatory Care โ€” Irvine, California
  • UC San Diego Moores Cancer Center โ€” La Jolla, California
  • UC Irvine Health/Chao Family Comprehensive Cancer Center โ€” Orange, California
  • University of California Davis Comprehensive Cancer Center โ€” Sacramento, California
  • UCHealth University of Colorado Hospital โ€” Aurora, Colorado
  • Smilow Cancer Hospital-Derby Care Center โ€” Derby, Connecticut
  • Smilow Cancer Hospital Care Center-Fairfield โ€” Fairfield, Connecticut
  • Smilow Cancer Hospital Care Center at Glastonbury โ€” Glastonbury, Connecticut
  • Smilow Cancer Hospital Care Center at Greenwich โ€” Greenwich, Connecticut
  • Smilow Cancer Hospital Care Center - Guilford โ€” Guilford, Connecticut
  • Smilow Cancer Hospital Care Center at Saint Francis โ€” Hartford, Connecticut
  • Smilow Cancer Center/Yale-New Haven Hospital โ€” New Haven, Connecticut
  • Yale University โ€” New Haven, Connecticut
  • Yale-New Haven Hospital North Haven Medical Center โ€” North Haven, Connecticut
  • Smilow Cancer Hospital Care Center at Long Ridge โ€” Stamford, Connecticut
  • Smilow Cancer Hospital-Torrington Care Center โ€” Torrington, Connecticut
  • Smilow Cancer Hospital Care Center-Trumbull โ€” Trumbull, Connecticut
  • Smilow Cancer Hospital-Waterbury Care Center โ€” Waterbury, Connecticut
  • Smilow Cancer Hospital Care Center - Waterford โ€” Waterford, Connecticut
  • MedStar Georgetown University Hospital โ€” Washington D.C., District of Columbia
  • Sibley Memorial Hospital โ€” Washington D.C., District of Columbia
  • UM Sylvester Comprehensive Cancer Center at Aventura โ€” Aventura, Florida
  • UM Sylvester Comprehensive Cancer Center at Coral Gables โ€” Coral Gables, Florida
  • UM Sylvester Comprehensive Cancer Center at Deerfield Beach โ€” Deerfield Beach, Florida

๐Ÿ“ž Contact the Study Coordinator

Phone: (800) 826-4673

Coordinator details come directly from the registered NIH protocol. Confirm the study is still recruiting before traveling.

๐Ÿ’ฐ Cost, Insurance & Patient Rights

  • 100% Free Items: The investigational treatment and protocol-required procedures are supplied at zero cost by the sponsor.
  • Routine Patient Care: Under federal law (ACA ยง 2709) and many state statutes, routine care costs are covered during participation.
  • Voluntary Participation: You may withdraw at any time without affecting your standard medical care.

๐Ÿ’ก How to Participate

  1. Check the checklist above to see if you may qualify.
  2. Contact the study coordinator using the phone/email above.
  3. Ask about the visit schedule, what is covered at no cost, and any travel support.
  4. Confirm with your own doctor before making a decision.
๐Ÿ›๏ธ View Official NIH Record โ†—