Advanced stage or metastatic carcinoma cancer
Conditions
Interventions
Treatment may be delivered via either an endoluminal or percutaneous approach
at the discretion of the clinical investigator utilizing two available device
configurations:
- Endoluminal: Galvanize A
Sponsors
Galvanize Therapeutics Inc.
Eligibility
Age
18 Years to 99 Years
Inclusion criteria
Inclusion criteria: • Patient is eligible if diagnosed and currently under physician care for one of the following advanced stage or metastatic conditions: o Stage IV non-small cell lung cancer o Stage IV hepatocellular carcinoma o Stage IV renal cell carcinoma • Patient is currently receiving PD-1/PD-L1 axis immunotherapy as their most recent line of therapy, either alone or in combination with standard of care systemic therapy for their malignancy. • Patient has exhibited at least 6 months of response to PD-1/PD-L1 axis immunotherapy regimen (defined as complete response (CR), partial response (PR), or stable disease (SD) in their index tumors per RECIST 1.1) prior to progression. • Patient has radiologically documented or confirmed progressive disease (per RECIST 1.1) defined as a total of = 15mm in short axis. • In the judgement of the investigator, the patient is able to remain on PD-1/PD-L1 axis immunotherapy for at least 3 months after PEF treatment. • New tumors and areas of growth on existing tumors are amenable to standard of care biopsy in order to confirm disease progression. • Patient must be willing to undergo biopsy of at least one tumor prior to PEF treatment delivery unless there is documented histological confirmation of malignancy within 4 weeks prior to PEF treatment. • Patient refuses surgery and/or stereotactic body radiotherapy (SBRT). • Life expectancy >= 12 weeks. • ECOG performance status 0-1.
Exclusion criteria
Exclusion criteria: • Patient has implanted lung devices or electronic devices. • Patient is receiving bevacizumab concurrently with their PD-1/PD-L1 axis immunotherapy. • Patient has received any prior systemic therapy (systemic chemotherapy, immunotherapy or investigational drug) in another study within 21 days prior to study enrollment. • Patient is scheduled to receive any concurrent chemotherapy, immunotherapy, biologic or hormonal therapy for off-label cancer treatment while on this study. • Patient has unresolved adverse reaction to immunotherapy that requires dose modification. • Patient has received any radiation therapy within 6 weeks prior to study enrollment. • Patient for whom the investigator considers that the PEF treatment is not in the patient's best interest.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| The primary safety endpoint will be the rate of device and/or procedure related serious adverse events (SAEs) from the initial PEF treatment through 30 days. AEs and SAEs will be summarized using a standard medical coding dictionary (MedDRA). AEs and SAEs will be also be summarized based on Common Terminology for Adverse Events (CTCAE) version 5.0, relatedness to the device and/or procedure, and within discrete time periods in relation to the index procedure. The primary clinical utility endpoint will be radiological assessment of response of PEF-treated tumors and lymph nodes (e.g., change in longest diameter of tumor, change in short axis of lymph node) at 90-day follow-up. | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary clinical endpoints include: • Immunologic and biomarker assessments at baseline and follow-up including: o Changes in phenotypes of lymphocytes (e.g. CD3+, CD4+, CD8+, Treg, NK, Neutrophils MDSC, etc.) and serum levels of cytokines (e.g. IL-2, IL-6, IL-10, IL-12, IFN-*) from blood samples Other endpoints will include: • Procedural success of accessing tumors and delivering PEF treatment. • Duration of checkpoint inhibitor treatment beyond PEF treatment • Patient progression free survival (PFS) at 90 days. o PEF-treated tumor progression, new tumor appearance after PEF treatment, transition from indeterminate to cancer of previously existing lesion • Patient overall survival (OS) at 12 months. • Time to focal re-intervention of PEF-treated tumor(s) | — |
Countries
Netherlands
Outcome results
None listed