Recruitment

Recruitment Status
Not yet recruiting
Estimated Enrollment
Same as current

Summary

Conditions
  • Bladder Cancer
  • Solid Tumor
Type
Interventional
Phase
Phase 1Phase 2
Design
Allocation: N/AIntervention Model: Single Group AssignmentMasking: None (Open Label)Primary Purpose: Treatment

Participation Requirements

Age
Between 18 years and 125 years
Gender
Both males and females

Description

For each solid tumor cancer, a Phase 1 evaluation of the safety and tolerability of PVSRIPO monotherapy intratumoral injections will be completed prior to initiation of enrollment in the Phase 2 portion of the study where the anti-tumor efficacy of PVSRIPO in combination with anti PD 1/L1 therapy wi...

For each solid tumor cancer, a Phase 1 evaluation of the safety and tolerability of PVSRIPO monotherapy intratumoral injections will be completed prior to initiation of enrollment in the Phase 2 portion of the study where the anti-tumor efficacy of PVSRIPO in combination with anti PD 1/L1 therapy will be assessed. Bladder Cancer has been selected as the first solid tumor cancer of interest. Two cohorts of patients will be enrolled: Cohort A will include cisplatin-ineligible patients with resectable MIBC being treated in the neoadjuvant setting and Cohort B will include patients with bladder cancer being treated in the 1st/2nd line unresectable/metastatic setting. The Phase 1 portion of the study (PVSRIPO monotherapy) will only enroll patients from Cohort A. Once the Data Safety Monitoring Committee (DSMC) has evaluated the safety of the patients enrolled in the Phase 1 portion of the study and determined it is "safe to proceed", then the Phase 2 portion of the study (PVSRIPO/pembrolizumab combination) will open. Approximately 6 patients will be enrolled in Phase 1 (Cohort A), and 50 patients will be enrolled in Phase 2 (25 patients in Cohort A and 25 patients in Cohort B).

Tracking Information

NCT #
NCT04690699
Collaborators
Not Provided
Investigators
Not Provided