🏛️ Verified NIH Record • 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

🔵 Active, Not Recruiting Phase1 / Phase2 💊 Investigational Drug / Biologic Sponsor: National Cancer Institute (NCI)

🩺 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: To join this study, participants generally need to meet the listed inclusion criteria (22 items) and avoid the listed exclusions (36 items).

Location: City of Hope Comprehensive Cancer Center — Duarte, California

Age range: 18 Years

🧪 Interventions in This Study

📋 "Do I Qualify?" — 1-Minute Self Screener

Instant Checklist

Check every box below. If you can check all of them, you may meet the study's basic screening requirements (final eligibility is confirmed by the site team).

Usually NOT eligible if any of the following apply:

  • Exclusion Criteria:
  • PHASE I: Patients who have received prior anti-CTLA-4, anti-PD-1, anti-PD-L1 or other immune checkpoint inhibitor therapeutic antibodies or pathway-targeting agents
  • PHASE II: Patients who have received prior anti-CTLA-4, anti-PD-1, anti-PD-L1 or other immune checkpoint inhibitor therapeutic antibodies or pathway-targeting agents with the following exceptions:
  • Patients who have only received previous durvalumab (anti-PD-L1) in combination with gemcitabine +/- cisplatin as part of first line therapy (TOPAZ-1 regimen) are eligible
  • Patients who have only received previous pembrolizumab (anti-PD-1) in combination with gemcitabine +/- cisplatin as part of first line therapy (KEYNOTE-966 regimen) are eligible
  • Patients who have had chemotherapy, definitive radiation, biological cancer therapy, or investigational agent/device within 21 days of first planned dose of study therapy (within 14 days for palliative radiation). Previously irradiated lesions may be re-irradiated provided there is disease progression in the irradiated lesion and the prescribed radiation dosage can safely be re- administered
  • Patients who have not recovered from adverse events due to prior anti-cancer therapy (i.e., have residual toxicities \> Common Terminology Criteria for Adverse Events \[CTCAE\] grade 1) with the exception of alopecia
  • Patients with untreated/uncontrolled central nervous system (CNS)/leptomeningeal disease. Patients with asymptomatic, treated CNS disease are eligible if the treating physician determines that immediate CNS specific treatment is not required and is unlikely to be required during the first cycle of therapy and the following criteria are met:
  • Radiographic demonstration of clinical stability upon the completion of CNS-directed therapy and no evidence of interim progression between the completion of CNS-directed therapy and the screening radiographic study done \>= 4 weeks from completion of radiotherapy and \>= 2 weeks from discontinuation of corticosteroids
  • No stereotactic radiation or whole-brain radiation within 28 days prior to randomization
  • Patients with active autoimmune disease requiring systemic corticosteroids greater than the equivalent of prednisone 10 mg daily including but not limited to: systemic lupus erythematosus, rheumatoid arthritis, inflammatory bowel disease, colitis, vascular thrombosis associated with antiphospholipid syndrome, Wegener's granulomatosis, Sjogren's syndrome, Bell's palsy, Guillain-Barre syndrome, multiple sclerosis, autoimmune thyroid disease, vasculitis, or glomerulonephritis, with the following exceptions:
  • Patients with a history of autoimmune hypothyroidism on a stable dose of thyroid replacement hormone are eligible

🔍 Extracted verbatim from the official NIH eligibility criteria. Always confirm with the study coordinator.

📍 All Participating Trial Locations (46 Sites)

Showing the first 25 of 46 sites.

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

📞 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.

💰 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 § 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.

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💡 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.
🏛️ View Official NIH Record ↗