Finding studies
Finding studies
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Lead
M.D. Anderson Cancer Center
With
PRIMARY OBJECTIVE: I. To determine the effect of cryoablation on adaptive resistance to immunotherapy in metastatic cancer patients. SECONDARY OBJECTIVES: I. To assess additional efficacy response to treatment. II. To assess the safety and tolerability of cryoablation in this population. III. To compare the radiologic response of ablated and non-ablated lesions using Immune-Modified Response Evaluation Criteria in Solid Tumors (iRECIST) and RECIST 1.1. IV. To assess the immune effect of cryoablation on the non-ablated lesion using pre- and post-treatment biopsies. EXPLORATORY OBJECTIVE: I. To evaluate the immune microenvironment and systemic changes as a result of cryoablation with the goal of biomarker discovery. OUTLINE: Beginning 1 week prior to the next scheduled standard of care immunotherapy infusion, patients undergo core biopsy of the lesion to be ablated and a non-ablated lesion and also undergo cryoablation. Patients undergo a mandatory second core biopsy of the non-ablated lesion at 4 weeks after cryoablation. After completion of study, patients are followed up for 12 months after cryoablation and then periodically thereafter.
Age
18–any
Sex
ALL
Healthy volunteers
Not accepted
