NCT04150939

Cryoablation for the Treatment of Metastatic Cancer

Cryoablation Challenge Evaluated in Adaptive-Immune Resistance (CEDAR)

• Status: Active Not Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 15 (actual)
• Sponsor: M.D. Anderson Cancer Center · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

This interventional trial studies the effectiveness of adding cryoablation treatment in patients who are receiving standard of care immunotherapy to treat cancer that is has spread to other parts of the body (metastatic). Cryoablation uses a probe that freezes the tissue around the tumor to try to kill the cancer cells. Using cryoablation to treat cancerous lesions may help to kill the cancer cells.

Detailed description

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.

Conditions

• Metastatic Malignant Neoplasm

Interventions

Type	Name	Description
PROCEDURE	Core Biopsy	Undergo core biospy
PROCEDURE	Cryosurgery	Undergo cryoablation
DRUG	Immunotherapeutic Agent	Receive standard of care immunotherapy

Timeline

• Start date: 2019-12-23
• Primary completion: 2026-08-31
• Completion: 2026-08-31
• First posted: 2019-11-05
• Last updated: 2026-02-17

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated device study