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NCT03217747 · ClinicalTrials.gov registry record · Phase 1
Avelumab, Utomilumab, Anti-OX40 Antibody PF-04518600, and Radiation Therapy in Treating Patients With Advanced Malignancies
A Phase 1 study of Malignant Solid Neoplasm and Advanced Malignant Solid Neoplasm, sponsored by M.D. Anderson Cancer Center.
- Active
- Registry status
- Phase 1
- Development phase
- 173
- Enrollment target
- 1
- Study location
NCT03217747: Active Phase 1 study of Malignant Solid Neoplasm and Advanced Malignant Solid Neoplasm, sponsored by M.D. Anderson Cancer Center.
NCT03217747 is a Phase 1 study of Malignant Solid Neoplasm and Advanced Malignant Solid Neoplasm that is active but no longer recruiting, run by M.D. Anderson Cancer Center. The registered enrollment target is 173 participants, below the 1,140-participant average among 176 other Malignant Solid Neoplasm trials with a reported enrollment target (85% lower). The trial reports 1 study location across 1 state. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT03217747, a Phase 1 study of Malignant Solid Neoplasm and Advanced Malignant Solid Neoplasm, is active but no longer recruiting, sponsored by M.D. Anderson Cancer Center.
- ACTIVE NOT RECRUITING
- Registry status
- Phase 1
- Development phase
- 173 participants
- Enrollment target
- 1
- Study location
Study 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.
Primary Outcome
DLTs were adverse events (AEs) related to study drug in the first 2 cycles and fulfilled one of the following * Discontinuation due to drug and/or XRT-related toxicity before DLT period ends * Delay \>28 days in receiving the next cycle due to drug and/or XRT-related toxicity * Hematologic * Gr4 neutropenia ≥7 days * Febrile neutropenia * Gr ≥3 thrombocytopenia associated with bleeding, or Gr 4 thrombocytopenia * Gr 4 anemia * Non-hematologic * Gr ≥3 nausea/vomiting or diarrhea ≥72
Conditions Studied
Interventions
- RADIATION Radiation Therapy
- DRUG Avelumab
- BIOLOGICAL Utomilumab
- BIOLOGICAL Ivuxolimab
Study Locations (1)
Texas
- M D Anderson Cancer Center - Houston
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 173 participants |
| Start Date | 2017-08-02 |
| Est. Completion | 2026-04-30 |
| Phase | Phase 1 |
What the registry record for NCT03217747 still lists
NCT03217747 is an interventional study that assigns participants to a tested intervention. The registered 173 participants enrollment target is mid-sized for trials with a published cap, below the 1,140-participant average among 176 other Malignant Solid Neoplasm trials with a reported enrollment target (85% lower).
The record links to 10 conditions, with Malignant Solid Neoplasm appearing as the primary indexed condition, and to 4 interventions - of which Radiation Therapy is the first listed.
NCT03217747 reports a single indexed study location in Texas.
Frequently Asked Questions
What is clinical trial NCT03217747 about?
NCT03217747 is a clinical study titled "Avelumab, Utomilumab, Anti-OX40 Antibody PF-04518600, and Radiation Therapy in Treating Patients With Advanced Malignancies". 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 antibod...
What is the current status of trial NCT03217747?
This trial is currently active not recruiting. It is a Phase 1 study. The enrollment target is 173 participants. The study started on 2017-08-02. Estimated completion is 2026-04-30.
What conditions does trial NCT03217747 study?
This clinical trial studies the following conditions: Malignant Solid Neoplasm, Advanced Malignant Solid Neoplasm, Metastatic Malignant Solid Neoplasm, Refractory Malignant Solid Neoplasm, Stage IVB Prostate Cancer AJCC v8.
What interventions are being tested in trial NCT03217747?
The interventions under investigation include: Radiation Therapy (RADIATION), Avelumab (DRUG), Utomilumab (BIOLOGICAL), Ivuxolimab (BIOLOGICAL).
Who is sponsoring clinical trial NCT03217747?
This trial is sponsored by M.D. Anderson Cancer Center, which has 2,692 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT03217747 being conducted?
This trial has 1 study location across Texas. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
Similar trials for Malignant Solid Neoplasm
Matched on the same primary condition, ranked to surface studies in the same phase first, then by recruiting status, no relevance scoring or editorial curation.
Where NCT03217747's enrollment target sits among peer trials
173 72nd of 176 higher than 105 of 176 other Malignant Solid Neoplasm trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Malignant Solid Neoplasm trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
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