Lung Cancer Cryo-Activation as a Novel Approach to Augment Immunotherapy Efficacy (CRYOVATE)

Official Title

Lung Cancer Cryo-Activation as a Novel Approach to Improve Cancer Immunogenicity and Augment Immunotherapy Efficacy

Summary:

Cryo-activation involves the insertion of a cryoprobe in the tumour bed with subsequent cell necrosis and tumour antigens release. Such technique has the potential to induce immune-specific reactions influencing cancer cells outside of the ablated region. The addition of cryo-activation to immune-checkpoint blockers (ICB) in the advanced NSCLC setting could represent a synergistic therapeutic avenue in order to potentiate treatment responses

Trial Description

Primary Outcome:

  • Best overall response rate (BORR; change from baseline)
Secondary Outcome:
  • Incidence of treatment-related adverse events (Safety and tolerability)
  • Progression-free survival (PFS)
  • Overall survival (OS)
Innovative ablation techniques have gained momentum in the last decade in order to offer alternative approaches to patients not amenable to conventional surgery. Cryoablation, a procedure by which tumour cell death is induced through cycles of freezing and thawing, represents such a pioneering technique. The procedure involves the insertion of a cryoprobe in the tumour bed with subsequent application of very low temperatures leading to cell necrosis and tumour antigens release. In the absence of significant heat-related denaturation seen in other ablative therapy techniques (microwave, radio frequency, steam, HIFU, etc.) and as intracellular content remains in circulation following cryo-activation, it is hypothesized that such technique has the potential to induce immune-specific reactions influencing cancer cells outside of the ablated region. This phenomenon would be reminiscent of the abscopal effect, a reaction mediated by locoregional radiation therapy exposure with the potential to trigger a systemic immune response prompting metastatic disease regression. While such immune activation would in itself be insufficient to eradicate tumour cells at distant sites, the addition of immunotherapy through checkpoint inhibition in the advanced setting could represent a synergistic therapeutic avenue in order to potentiate treatment responses in patients with NSCLC. A phase I/II clinical trial will be conducted in order to evaluate the safety and efficacy of cryo-activation therapy in patients with previously untreated advanced NSCLC amenable to anti-PD-1 monotherapy (i.e. PD-L1 ≥50%).

View this trial on ClinicalTrials.gov

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Resources

Canadian Cancer Society

These resources are provided in partnership with the Canadian Cancer Society