drugset / Trial / NCT03217747
Avelumab, Utomilumab, Anti-OX40 Antibody PF-04518600, and Radiation Therapy in Treating Patients With Advanced Malignancies
Phase 1/2
Active not recruiting
173 enrolled
M.D. Anderson Cancer Center
National Cancer Institute (NCI) · collab
Non-randomizedParallel-groupOpen-labelTreatment
Summary
This phase I/II trial studies the side effects of avelumab when given in different combinations with utomilumab, anti-OX40 antibody PF-04518600, and radiation therapy in treating patients with malignancies that have spread to other places in the body (advanced). Immunotherapy with monoclonal antibodies, such as avelumab, utomilumab, and anti-OX40 antibody PF-04518600, may help the body's immune system attack the cancer, and may interfere with the ability of tumor cells to grow and spread. Radiation therapy uses high-energy rays to kill tumor cells and shrink tumors. It is not yet known how well avelumab works in combination with these other anti-cancer therapies in patients with advanced malignancies.
Timeline
- Start
- 2017-08-02
- Primary completion
- 2025-09-02
- Completion
- 2026-04-30
Publications
- Lermi NO, Gouda MA, Ahmed J, Jiang X, Lee Y, Mohanty V, Derbala M, Stephen B, Jhingran A, Mohammad MM, Joo D, Francisco-Cruz A, Chen H, Calderon LA, Laberiano C, Arrechedera C, Pandurengan R, Gurses S, Yang Y, Solis Soto LM, Ahnert JR, Chen K, Meric-Bernstam F, Koay EJ, Javle M, Haymaker C, Naing A. Tumor microenvironment changes after treatment with avelumab and immune-stimulating agent combinations in patients with advanced solid tumors. Res Sq [Preprint]. 2026 Jan 19:rs.3.rs-7775526. doi: 10.21203/rs.3.rs-7775526/v1.
- Ahmed J, Knisely A, Torrado C, Stephen B, Yang Y, Song J, Alshawa A, Zarifa A, Jhingran A, Koay EJ, Morris VK, Javle M, Wolff RA, Meric-Bernstam F, Pant S, Rodon J, Naing A. A phase I/II trial of avelumab combinations with ivuxolimab, utomilumab, and radiation therapy in patients with advanced gastrointestinal malignancies. Oncologist. 2025 Mar 10;30(3):oyaf032. doi: 10.1093/oncolo/oyaf032.
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Avelumab | Monoclonal antibody | — | Intravenous |
| Subject | Ivuxolimab | Monoclonal antibody | — | Intravenous |
| Subject | Utomilumab | Monoclonal antibody | — | Intravenous |