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NCT04785287 · ClinicalTrials.gov registry record · Phase 1
Anti-CTLA4-NF mAb (BMS986218), Nivolumab, and Stereotactic Body Radiation Therapy for the Treatment of Metastatic Solid Malignancies
A Phase 1 study, sponsored by M.D. Anderson Cancer Center.
- Terminated
- Registry status
- Phase 1
- Development phase
- 13
- Enrollment target
NCT04785287: Clinical Trial Phase 1 study, sponsored by M.D. Anderson Cancer Center.
NCT04785287 is a Phase 1 study that was terminated before completion, run by M.D. Anderson Cancer Center. The registered enrollment target is 13 participants, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (78% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT04785287, a Phase 1 study, was terminated before completion, sponsored by M.D. Anderson Cancer Center.
- TERMINATED
- Registry status
- Phase 1
- Development phase
- 13 participants
- Enrollment target
Study Summary
This phase I/II trial studies the side effects of anti-CTLA4-NF monoclonal antibody (mAb) (BMS986218), nivolumab, and stereotactic body radiation therapy in treating patients with solid malignancies that has spread to other places in the body (metastatic). Immunotherapy with monoclonal antibodies, such as anti-CTLA4-NF mAb (BMS-986218) and nivolumab, may help the body's immune system attack the cancer, and may interfere with the ability of tumor cells to grow and spread. Stereotactic body radiation therapy uses special equipment to position a patient and deliver radiation to tumors with high precision. This method may kill tumor cells with fewer doses over a shorter period and cause less damage to normal tissue. Giving -CTLA4-NF mAb (BMS986218), nivolumab, and stereotactic body radiation therapy may kill more tumor cells.
Primary Outcome
The incidence of clinical and laboratory adverse events will be reported and graded according to the National Cancer Institute Common Terminology Criteria for Adverse Events version 5.0. Adverse events will be reported in frequency tables overall, by intensity, and by relationship. Laboratory values will be reported in shift tables and with summary statistics. Chi-squared or Fisher exact tests will be used to compare safety between two arms. Logistic regression may be used to evaluate the predic
Interventions
- RADIATION Stereotactic Body Radiation Therapy
- BIOLOGICAL Nivolumab
- BIOLOGICAL Anti-CTLA4 Monoclonal Antibody BMS-986218
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 13 participants |
| Start Date | 2021-03-29 |
| Est. Completion | 2026-02-26 |
| Phase | Phase 1 |
Why NCT04785287 stopped before completion
NCT04785287 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 13 participants, a relatively small participant target, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (78% lower).
The record links to 0 conditions, and to 3 interventions - of which Stereotactic Body Radiation Therapy is the first listed.
NCT04785287 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT04785287 about?
NCT04785287 is a clinical study titled "Anti-CTLA4-NF mAb (BMS986218), Nivolumab, and Stereotactic Body Radiation Therapy for the Treatment of Metastatic Solid Malignancies". This phase I/II trial studies the side effects of anti-CTLA4-NF monoclonal antibody (mAb) (BMS986218), nivolumab, and stereotactic body radiation therapy in treating patients with solid malignancies that has spread to other places in the body (metastatic). Immunotherapy with monoclonal antibodies, s...
What is the current status of trial NCT04785287?
This trial is currently terminated. It is a Phase 1 study. The enrollment target is 13 participants. The study started on 2021-03-29. Estimated completion is 2026-02-26.
What interventions are being tested in trial NCT04785287?
The interventions under investigation include: Stereotactic Body Radiation Therapy (RADIATION), Nivolumab (BIOLOGICAL), Anti-CTLA4 Monoclonal Antibody BMS-986218 (BIOLOGICAL).
Who is sponsoring clinical trial NCT04785287?
This trial is sponsored by M.D. Anderson Cancer Center, which has 2,692 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT04785287's enrollment target sits among peer trials
13 1847th of 2000 higher than 149 of 2,000 other Phase 1 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 1 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.
Source ClinicalTrials.gov registry export · 2026-08-08
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