Avelumab, Utomilumab, Anti-OX40 Antibody PF-04518600, and Radiation Therapy in Treating Patients With Advanced Malignancies
NCT03217747 · Status: ACTIVE_NOT_RECRUITING · Phase: PHASE1/PHASE2 · Type: INTERVENTIONAL · Enrollment: 173
Last updated 2026-05-05
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.
Conditions
- Advanced Malignant Solid Neoplasm
- Castration-Resistant Prostate Carcinoma
- Malignant Solid Neoplasm
- Metastatic Malignant Solid Neoplasm
- Metastatic Prostate Carcinoma
- Prostate Carcinoma Metastatic in the Bone
- Refractory Malignant Solid Neoplasm
- Stage IV Prostate Cancer AJCC v8
- Stage IVA Prostate Cancer AJCC v8
- Stage IVB Prostate Cancer AJCC v8
Interventions
- DRUG
-
Avelumab
Given IV
- BIOLOGICAL
-
Ivuxolimab
Given IV
- RADIATION
-
Radiation Therapy
Undergo radiation therapy
- BIOLOGICAL
-
Utomilumab
Given IV
Sponsors & Collaborators
-
National Cancer Institute (NCI)
collaborator NIH -
M.D. Anderson Cancer Center
lead OTHER
Principal Investigators
-
Aung Naing · M.D. Anderson Cancer Center
Study Design
- Allocation
- NON_RANDOMIZED
- Purpose
- TREATMENT
- Masking
- NONE
- Model
- PARALLEL
Eligibility
- Min Age
- 18 Years
- Sex
- ALL
- Healthy Volunteers
- No
Timeline & Regulatory
- Start
- 2017-08-02
- Primary Completion
- 2025-09-02
- Completion
- 2026-04-30
- FDA Drug
- Yes
Countries
- United States
Study Locations
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