Focused Ultrasound Ablation and PD-1 Antibody Blockade in Advanced Solid Tumors (NCT04116320) | Clinical Trial Compass
TerminatedPhase 1
Focused Ultrasound Ablation and PD-1 Antibody Blockade in Advanced Solid Tumors
Stopped: Unable to enroll enough patients to complete targeted enrollment in a reasonable time.
United States5 participantsStarted 2019-11-21
Plain-language summary
This study evaluates whether it is safe to Focused Ultrasound Ablation (FUSA) treatments with and without PD-1 blockade and with and without intratumoral poly-ICLC. A device called the Echopulse will be used for the FUSA therapy. Patients will be assigned to 1 of 2 cohorts depending on their disease and treatment status. In Cohort 1, patients will receive FUSA therapy while receiving PD-1 blockade therapy as part of standard clinical care treatment. In Cohort 2, patients who discontinue or are ineligible for PD-1 blockade therapy will undergo FUSA without concurrent systemic therapy, with the goal of utilizing the FUSA to boost the innate immune response. The optional secondary regimen will combine FUSA (+/- PD-1 blockade) with intratumoral poly-ICLC.
Who can participate
Age range18 Years
SexALL
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Inclusion criteria
✓. Age ≥18 years.
✓. Advanced solid tumor with measurable disease.
✓. Subject must have failed or have contraindication to standard therapies.
✓. For Cohort 1, primary regimen (Regimen 1a): Patients with advanced solid malignancy for which PD1 or PDL1 antibody monotherapy administered on a 3-week schedule is FDA-approved for treatment, who have one or more tumor deposits that are accessible to focused ultrasound treatment, and who are eligible to receive (or to continue to receive) PD1 or PDL1 blockade therapy. Uveal melanoma patients are not eligible for Regimen 1a.
✓. For Cohort 1, secondary regimen (Regimen 2a): For those patients treated with primary regimen 1a, select participants may be enrolled in a secondary regimen. This would include participants in the following scenarios:
✓. For Cohort 2, primary regimen (Regimen 1b): The following patient subsets would be eligible for the Cohort 2 primary regimen, as long as they have failed (progressed or not tolerated) or are not eligible for all effective available approved therapies known to confer clinical benefit:
✓. For Cohort 2, secondary regimen (Regimen 2b): For those patients treated with primary regimen 1a or 1b, select participants may be enrolled in a secondary regimen. This would include participants in the following scenarios:
What they're measuring
1
To assess the safety and toxicity of FUSA administered alone or in combination with PD-1 antibody blockade.
Timeframe: 30 days after the last study intervention
2
To estimate the proportion of patients with increased CD8+ T cell infiltration of spot FUSA-treated metastasis.