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Testing the Combination of New Anti-cancer Drug Peposertib With Avelumab and Radiation Therapy for Advanced/Metastatic Solid Tumors and Hepatobiliary Malignancies
NCT04068194 · View on ClinicalTrials.gov ↗
Study Summary
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.
Conditions Studied
Interventions
- PROCEDURE Biospecimen Collection
- PROCEDURE Computed Tomography
- PROCEDURE Biopsy Procedure
- RADIATION Hypofractionated Radiation Therapy
- DRUG Avelumab
Study Locations (20)
Connecticut
- Smilow Cancer Hospital-Derby Care Center — Derby
- Smilow Cancer Hospital Care Center-Fairfield — Fairfield
- Smilow Cancer Hospital Care Center at Glastonbury — Glastonbury
- Smilow Cancer Hospital Care Center at Greenwich — Greenwich
- Smilow Cancer Hospital Care Center - Guilford — Guilford
- Smilow Cancer Hospital Care Center at Saint Francis — Hartford
- Smilow Cancer Center/Yale-New Haven Hospital — New Haven
- Yale University — New Haven
- Yale-New Haven Hospital North Haven Medical Center — North Haven
- Smilow Cancer Hospital Care Center at Long Ridge — Stamford
- Smilow Cancer Hospital-Torrington Care Center — Torrington
- Smilow Cancer Hospital Care Center-Trumbull — Trumbull
- Smilow Cancer Hospital-Waterbury Care Center — Waterbury
- Smilow Cancer Hospital Care Center - Waterford — Waterford
California
- City of Hope Comprehensive Cancer Center — Duarte
- UCI Health - Chao Family Comprehensive Cancer Center and Ambulatory Care — Irvine
- UC San Diego Moores Cancer Center — La Jolla
- UC Irvine Health/Chao Family Comprehensive Cancer Center — Orange
- University of California Davis Comprehensive Cancer Center — Sacramento
Colorado
- UCHealth University of Colorado Hospital — Aurora
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 103 participants |
| Start Date | 2020-04-07 |
| Est. Completion | 2027-07-01 |
| Phase | Phase 1 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT04068194
The ClinicalTrials.gov registry entry for NCT04068194 describes a study currently listed as active not recruiting. It is categorized as Phase 1, which is the standard way researchers label where a study sits along the investigational pathway from early safety work through later efficacy and post-marketing evaluation. The registered enrollment target is 103 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is National Cancer Institute (NCI), which has 2,390 total studies on file at ClinicalTrials.gov, and sponsors are the parties responsible for study design, oversight, and regulatory filings.
The record links to 10 conditions, with Metastatic Malignant Solid Neoplasm appearing as the primary indexed condition, and to 5 interventions — of which Biospecimen Collection is the first listed. Interventions can include drugs, devices, procedures, behavioral programs, or observational arms, and each is tracked as a separate registry field so that downstream queries can filter accurately. When a trial lists multiple interventions, it usually reflects a multi-arm design or a comparison protocol rather than a single treatment being tested in isolation. The brief summary published in the registry is the clearest source of protocol intent and should be read before drawing conclusions from any sidebar tags.
Geographic footprint matters for practical reasons: NCT04068194 reports 20 study locations spanning 3 distinct geographic areas — top geographies include Connecticut, California, Colorado. A larger site network tends to correlate with broader recruitment capacity, but it does not imply anything about study quality, and site-level enrollment status can diverge from the overall registry status shown above. Every data point on this page comes from the public ClinicalTrials.gov dataset and is reproduced here for reference only; it is not a medical recommendation, an endorsement of the sponsor, or an invitation to enroll. Verify current status, eligibility criteria, and contact details directly at ClinicalTrials.gov, and discuss any participation decision with your own healthcare provider.
Frequently Asked Questions
What is clinical trial NCT04068194 about?
NCT04068194 is a clinical study titled "Testing the Combination of New Anti-cancer Drug Peposertib With Avelumab and Radiation Therapy for Advanced/Metastatic Solid Tumors and Hepatobiliary Malignancies". 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). Pepos...
What is the current status of trial NCT04068194?
This trial is currently active not recruiting. It is a Phase 1 study. The enrollment target is 103 participants. The study started on 2020-04-07. Estimated completion is 2027-07-01.
What conditions does trial NCT04068194 study?
This clinical trial studies the following conditions: Metastatic Malignant Solid Neoplasm, Unresectable Malignant Solid Neoplasm, Locally Advanced Malignant Solid Neoplasm, Metastatic Cholangiocarcinoma, Stage III Gallbladder Cancer AJCC v8. These conditions were identified from the trial registry and reflect the primary focus areas of the research.
What interventions are being tested in trial NCT04068194?
The interventions under investigation include: Biospecimen Collection (PROCEDURE), Computed Tomography (PROCEDURE), Biopsy Procedure (PROCEDURE), Hypofractionated Radiation Therapy (RADIATION), Avelumab (DRUG). Each intervention is being evaluated for safety and efficacy as part of this clinical study.
Who is sponsoring clinical trial NCT04068194?
This trial is sponsored by National Cancer Institute (NCI), which has 2,390 total clinical trials registered on ClinicalTrials.gov. The sponsor is responsible for the study's design, funding, and regulatory compliance.
Where is trial NCT04068194 being conducted?
This trial has 20 study locations across California, Colorado, Connecticut. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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