LUMINOS-103: A Basket Trial Evaluating the Safety and Efficacy of PVSRIPO and PVSRIPO in Combination With Anti-PD-1/L1 Checkpoint Inhibitors in Patients With Advanced Solid Tumors
Last updated on July 2021Recruitment
- 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