Testing a New Anti-Cancer Drug Combination with Radiation for Advanced Solid Tumors and Liver Cancers
Sponsor: National Cancer Institute (NCI)
ClinicalTrials ID:NCT04068194
This clinical trial is exploring a new treatment combining the drug peposertib with avelumab and radiation therapy to see if it can better treat advanced solid tumors and liver-related cancers that have spread.
Patient Parameters
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Program Overview
The study aims to find the best dose and understand the side effects of peposertib when used with avelumab and a special type of radiation therapy. This combination is being tested to see if it can stop cancer cells from growing and spreading more effectively than current treatments. Peposertib may block enzymes that help cancer cells grow, while avelumab helps the immune system attack cancer. The radiation therapy used delivers higher doses over a shorter time, potentially killing more cancer cells with fewer side effects.
Description
The study is divided into two phases. In Phase I, researchers will determine the safest dose of peposertib when combined with avelumab and radiation therapy for patients with advanced solid tumors. In Phase II, the effectiveness of this combination will be compared to avelumab and radiation alone in patients with advanced liver-related cancers.
Primary Objectives:
- Phase I: Find the safest dose of peposertib with radiation and avelumab.
- Phase II: Compare the effectiveness of the combination treatment to avelumab and radiation alone in liver cancers.
Secondary Objectives:
- Observe anti-tumor activity and safety.
- Study how the drugs are processed in the body.
- Measure how long patients live without the disease getting worse.
Exploratory Objectives:
- Analyze genetic and immune changes in tumors to see if they affect treatment response.
Study Outline:
- Phase I: Patients with advanced solid tumors receive radiation, peposertib, and avelumab.
- Phase II: Patients with advanced liver cancers are divided into two groups:
- Group A: Receives radiation and avelumab.
- Group B: Receives radiation, peposertib, and avelumab.
After treatment, patients are monitored regularly to assess their health and treatment response.
Eligibility Criteria
Inclusion Criteria
- Must have advanced solid tumors or liver cancers that cannot be removed by surgery and have not responded to standard treatments.
- Must be 18 years or older.
- Must be in good overall health with a performance status that allows for daily activities.
- Must have at least one tumor that can be treated with radiation.
- Must be willing to undergo biopsies and provide blood samples.
- Must have adequate blood counts and organ function.
- Women of childbearing potential must have a negative pregnancy test and agree to use contraception during the study.
Exclusion Criteria
- Cannot have received certain immune therapies before.
- Cannot have had recent chemotherapy or radiation.
- Cannot have untreated brain cancer.
- Cannot have active autoimmune diseases requiring high-dose steroids.
- Cannot have serious infections or uncontrolled illnesses.
- Cannot be pregnant or breastfeeding.
- Cannot have received live vaccines recently.
Locations
| FACILITY | ZIP | CITY | STATE |
|---|---|---|---|
| UCI Health - Chao Family Comprehensive Cancer Center and Ambulatory Care | 92612 | Irvine | California |
| UC Irvine Health/Chao Family Comprehensive Cancer Center | 92868 | Orange | California |
| University of California Davis Comprehensive Cancer Center | 95817 | Sacramento | California |
| UCHealth University of Colorado Hospital | 80045 | Aurora | Colorado |
| Smilow Cancer Hospital-Derby Care Center | 06418 | Derby | Connecticut |
| Smilow Cancer Hospital Care Center-Fairfield | 06824 | Fairfield | Connecticut |
| Smilow Cancer Hospital Care Center at Glastonbury | 06033 | Glastonbury | Connecticut |
| Smilow Cancer Hospital Care Center at Greenwich | 06830 | Greenwich | Connecticut |
| Smilow Cancer Hospital Care Center - Guilford | 06437 | Guilford | Connecticut |
| Smilow Cancer Hospital Care Center at Saint Francis | 06105 | Hartford | Connecticut |
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