Advanced Malignant Solid Neoplasm Clinical Trial
Official title:
Phase I/II Trial of Anti-CTLA4-NF mAb (BMS-986218) in Combination With Nivolumab and Hypofractionated Stereotactic Radiation Therapy in Patients With Advanced 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, 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 OBJECTIVE: I. To evaluate the safety profile of intravenous anti-CTLA4 monoclonal antibody BMS-986218 (anti-CTLA4-NF mAb [BMS-986218]) alone or with nivolumab administered in combination with stereotactic body radiation therapy (SBRT) targeting 1-4 lesion(s) for patients with metastatic cancers. SECONDARY OBJECTIVES: I. To determine antitumor activity of anti-CTLA4-NF mAb (BMS-986218) therapy with SBRT treatment for 1-4 lesions in non-irradiate tumors (abscopal lesions; out of external beam radiation [XRT] field) as defined by Immune-Related Response Criteria (irRC). II. To determine antitumor activity of anti-CTLA4-NF mAb (BMS-986218) therapy with RadScopal treatment in the low dose treated lesion as defined by irRC. III. To evaluate treatment efficacy in different SBRT treatment sites (liver versus [vs.] adrenal, lung vs. adrenal). IV. To evaluate treatment efficacy by comparing anti-CTLA4-NF mAb (BMS-986218) alone with SBRT treatment vs. anti-CTLA4-NF mAb (BMS-986218) in combination with nivolumab and SBRT treatment. EXPLORATORY OBJECTIVES: I. To evaluate treatment efficacy by comparing anti-CTLA4-NF mAb (BMS-986218) alone or with SBRT treatment vs. ipilimumab alone or with SBRT treatment (previous trial). II. To evaluate the associations of tumor-associated and systemic immune biomarkers for therapy with clinical response outcomes and toxicity prediction. III. To evaluate whether skeletal mass, neutrophil, neutrophil to lymphocyte ratio, and tumor bulk are correlated with clinical outcomes and adverse events. IV. To evaluate whether tumor kinetics in combination with clinical correlates can help determine treatment response. OUTLINE: Patients are randomized to 1 of 2 arms. ARM I: Patients receive anti-CTLA4 monoclonal antibody BMS-986218 intravenously (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). ARM II: 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. After completion of study treatment, patients are followed up at 30 and 60 days and 6 and 12 months after last cycle of anti-CTLA4 monoclonal antibody BMS-986218. ;
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