Anti-CTLA4-NF mAb (BMS986218), Nivolumab, and Stereotactic Body Radiation Therapy for the Treatment of Metastatic Solid Malignancies
Part of paid clinical trials in Houston, Texas.
- Sponsor
- M.D. Anderson Cancer Center
- Study ID
- NCT04785287
- Phase
- PHASE1/PHASE2
- Status
- Terminated
Conditions
- Advanced Lung Carcinoma
- Advanced Malignant Solid Neoplasm
- Malignant Adrenal Gland Neoplasm
- Metastatic Liver Carcinoma
- Metastatic Lung Carcinoma
- Metastatic Malignant Solid Neoplasm
- Stage III Liver Cancer
- Stage III Lung Cancer AJCC v8
- Stage IIIA Lung Cancer AJCC v8
- Stage IIIB Lung Cancer AJCC v8
- Stage IIIC Lung Cancer AJCC v8
- Stage IV Liver Cancer
- Stage IV Lung Cancer AJCC v8
- Stage IVA Liver Cancer
- Stage IVA Lung Cancer AJCC v8
- Stage IVB Liver Cancer
- Stage IVB Lung Cancer AJCC v8
Eligibility Criteria
- Sex
- ALL
- Age
- 18 Years - N/A
- Healthy Volunteers
- Not accepted
Interventions
- Anti-CTLA4 Monoclonal Antibody BMS-986218 — BIOLOGICALGiven IV
- Nivolumab — BIOLOGICALGiven IV
- Stereotactic Body Radiation Therapy — RADIATIONUndergo SBRT
Study Details
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.
Key Dates
- Start date
- Mar 29, 2021
- Status verified
- Feb 2026
- Primary completion
- Feb 26, 2026
- Completion
- Feb 26, 2026
Study Design
- Enrollment
- 13 participants (actual)
- Allocation
- RANDOMIZED
- Intervention model
- PARALLEL
- Primary purpose
- TREATMENT
Arms
- Experimental: Arm I (BMS-986218, SBRT)Patients receive anti-CTLA4 monoclonal antibody BMS-986218 IV over 30 minutes on day 1. Treatment repeats every 28 days for 4 cycles in the absence of disease progression or unacceptable toxicity. Patients also undergo SBRT on days 36-39 (days 8-11 of cycle 2).
- Experimental: Arm II (BMS-986218, SBRT, nivolumab)Patients receive anti-CTLA4 monoclonal antibody BMS-986218 and SBRT as in Arm 1. Beginning cycle 2, patients also receive nivolumab IV over 30 minutes starting on day 1. Cycles repeat every 28 days for up to 2 years in the absence of disease progression or unacceptable toxicity.
Primary Outcome Measure
Incidence of adverse events [ Time Frame: Up to 12 months ]
Locations (1)
| Facility | City | State | ZIP | Site coordinators |
|---|---|---|---|---|
| M D Anderson Cancer Center | Houston | Texas | 77030 | - |
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