Avelumab, Utomilumab, Anti-OX40 Antibody PF-04518600, and Radiation Therapy in Treating Patients With Advanced Malignancies

StatusActive, Not Recruiting
PhasePhase 1/2
Started

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Record History

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  1. Study completion pushed from Apr 30, 2026 to Apr 30, 2028 Show 4 more changesShow less
    • Eligibility criteria shortened, about 15 words
    • Secondary endpoints: details revised at 6 of 6 entries
    • Study description revised
    • Publications: details revised at 2 of 2 entries
  2. Re-verified, no change to tracked fieldsv30
  3. Study completion date: Sep 30, 2025 to Apr 30, 2026v29
  4. Results first posted: Oct 14, 2025v28
  5. Primary endpoint revised
    • Secondary endpoints: details revised at 6 of 6 entries
    v27
Show 25 earlier versionsHide 25 earlier versions
  1. Primary endpoints: 2 to 1
    • Primary completion date changed from estimate of Sep 30, 2025 to Sep 2, 2025
    • Secondary endpoints revised (6)
    v26
  2. Study Identification, Study Status, Oversight, Conditionsv25
  3. Study Identification, Study Status, Oversight, Conditionsv24
  4. Primary and study completion dates: Sep 30, 2024 to Sep 30, 2025v23
  5. 3 versions Re-verified since Jun 13, 2023, no change to tracked fieldsv20-v22
  6. Primary and study completion dates pushed to Sep 30, 2024v19
  7. Re-verified, no change to tracked fieldsv18
  8. Interventions: Anti-OX40 Antibody PF-04518600 (Biological), Avelumab (Drug), Radiation Therapy (Radiation), Utomilumab (Biological) to Avelumab (Drug), Ivuxolimab (Biological), Radiation Therapy (Radiation), Utomilumab (Biological)
    • Eligibility criteria shortened, about 38 words
    • Study description expanded, about 19 words
    v17
  9. Trial status: Recruiting to Active, Not Recruiting
    • Enrollment target: estimated 184 to confirmed 173
    • Site details revised
    v16
  10. 2 versions Re-verified since Mar 19, 2020, no change to tracked fieldsv14-v15
  11. Primary endpoints revised (2)v13 Show 11 more changesShow less
    • Enrollment target: 188 to 184
    • Primary completion date: Aug 2022 to Sep 30, 2022
    • Study completion date: Aug 2023 to Sep 30, 2023
    • Interventions: Avelumab (Drug), Cisplatin (Drug), PF-04518600 (Drug), Radiation (Radiation), Utomilumab (Drug) to Anti-OX40 Antibody PF-04518600 (Biological), Avelumab (Drug), Radiation Therapy (Radiation), Utomilumab (Biological)
    • Eligibility criteria shortened, about 36 words
    • Secondary endpoints: 5 to 6
    • Study description expanded, about 581 words
    • Study site revised
    • Collaborator revised
    • Study title shortened, about 6 words
    • Study arms: 7 to 6
  12. 2 versions Re-verified since Mar 18, 2019, no change to tracked fieldsv11-v12
  13. Study description shortened, about 5,217 words
    • Site contact updated
    v10
  14. Study description revisedv9
  15. Re-verified, no change to tracked fieldsv8
  16. Study description expanded, about 2,219 wordsv7
  17. Study completion date: Aug 2022 to Aug 2023v6
  18. 2 versions Re-verified since Oct 26, 2017, no change to tracked fieldsv4-v5
  19. Trial status: Not Yet Recruiting to Recruiting
    • Primary and study completion dates: Sep 2022 to Aug 2022
    • Start date changed from estimate of Sep 2017 to Aug 2, 2017
    • Site details revised
    v3
  20. Re-verified, no change to tracked fieldsv2
  1. Study First Submitted
  • Notable: the trial’s plan changed such as a big move in its timeline or size, a new primary endpoint, sponsor or phase, or recruiting opened or resumed.
  • Minor: routine progress and housekeeping, such as sites added or enrollment closed.
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.
Trial Details
NCT Number NCT03217747
Lead Sponsor M.D. Anderson Cancer Center
Collaborators: National Cancer Institute (NCI)
Conditions
(from sponsor)		 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 +2 more
Related terms Neoplasm Metastasis, Prostatic Neoplasms
Enrollment 173 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov