Researchers Open Phase I Clinical Trial of Cryoablation with Keytruda
October 14, 2021
Memorial Sloan Kettering Cancer Center in New York City has opened a novel clinical trial that combines the immunotherapy drug Keytruda with cryoablation for patients with unresectable malignant mesothelioma.
The phase I trial opened in September and will be available at seven Memorial Sloan Kettering locations in the New York City/New Jersey area.
Cryoablation, which is also known as cryotherapy or cryosurgery, is a treatment that freezes localized tumors with argon gas or liquid nitrogen. It has been used effectively with liver, kidney and prostate cancers, but its use with mesothelioma has been limited because of the cancer’s diffuse tumor makeup.
Although cryoablation can kill tumor cells with extreme cold, the aim of this latest study is to evaluate its safety and synergy with Keytruda in activating a patient’s own immune system to fight the cancer.
Keytruda, known generically as pembrolizumab, was approved by the U.S. Food and Drug Administration in 2020 for treatment of certain adult and pediatric cancers, but only for those with high mutational burden and no alternative treatment options.
Trial Targets Patients with Unresectable Mesothelioma
The single-arm, single-institution study is currently recruiting and is expected to be completed by the end of 2023. It is open to pleural mesothelioma and peritoneal mesothelioma patients whose tumors cannot be removed with surgery.
Treatment involves one cycle of Keytruda given intravenously, followed by the cyroablation targeting a designated lesion. Keytruda cycles will be continued for up to 24 months. To participate, patients must have had at least one prior line of systemic therapy.
Keytruda has been especially effective with a small percentage of mesothelioma patients who have tried it under special access programs or in other clinical trials. The rate of success has been varied when combined with other treatments.
Dr. Michael Offin, an oncologist at Memorial Sloan Kettering and the trial’s principal investigator, declined to provide additional insight on the study to The Mesothelioma Center at Asbestos.com.
Cryoablation Has Had Success Slowing Recurrence
Although most cancer hospitals have opted against using cryoablation with mesothelioma, the UCLA Jonsson Comprehensive Cancer Center, which is aligned with the innovative Pacific Mesothelioma Center, found it to be a valuable tool as a follow-up procedure to slow the inevitable recurrence of this aggressive cancer with no definitive cure.
UCLA interventional radiologist Dr. Fereidoun Abtin detailed his cryoablation results after using the procedure 110 times with mesothelioma patients.
In his study, Abtin emphasized the procedure was intended only to delay local recurrence after standard treatment, which involved surgery, chemotherapy and radiation.
“The results have been impressive, a lot better than what else is out there,” he told Asbestos.com in 2016. “It’s something we want people to know about.”
All patients experienced at least 30 days without recurrence after treatment. More than 90% of them went at least six months without recurrence.
Memorial Sloan Kettering Taking the Lead
Memorial Sloan Kettering has several clinical trials involving mesothelioma that are drawing considerable attention beyond the latest with cryoablation. Among those are:
- A phase I clinical trial using a patient’s genetically engineered T cells to kill the tumor by counteracting the protein mesothelin that often stops a patient’s own immune system from working properly.
- A phase I clinical trial to study the safety and efficacy of the cancer vaccine galinpepimut-S when used in combination with the immunotherapy drug nivolumab (Opdivo) for patients with relapsed disease.
- A phase I clinical trial studying the effectiveness of using nivolumab in combination with standard chemotherapy prior to aggressive surgery for patients with pleural mesothelioma.
UCLA Medical Center announced a pilot study in 2020 in line with this latest clinical trial in New York. It intended to measure immune system stimulation when cryoablation was used prior to surgery.
The study, however, was postponed indefinitely, leaving Memorial Sloan Kettering to reopen its mesothelioma cryoablation trial.