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
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|ClinicalTrials.gov Identifier: NCT04690699|
Recruitment Status : Not yet recruiting
First Posted : December 31, 2020
Last Update Posted : June 14, 2021
|Condition or disease||Intervention/treatment||Phase|
|Solid Tumor Bladder Cancer||Biological: PVSRIPO Biological: Anti-PD-1 / L1||Phase 1 Phase 2|
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).
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||155 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||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|
|Estimated Study Start Date :||June 30, 2021|
|Estimated Primary Completion Date :||May 2025|
|Estimated Study Completion Date :||May 2025|
Experimental: Arm 1: PVSRIPO and Anti-PD-1/L1 Therapy
Subjects will be treated with a combination of PVSRIPO and an FDA-approved anti-PD-1/L1 therapy, the choice of which will be determined based on the solid tumor cancer of interest and specified in the associated tumor specific appendix.
PVSRIPO administered via intertumoral injection.
Biological: Anti-PD-1 / L1
Anti-PD-1 / L1 Therapy administered per package insert instructions.
- Safety and Tolerability: Number of participants with treatment-related adverse events as assessed by CTCAE [ Time Frame: 24 months ]To evaluate the safety and tolerability of PVSRIPO administered as monotherapy and in combination with an anti-PD-1/L1 therapy.
- Tumor Response measured by RECIST 1.1 [ Time Frame: 24 months ]To evaluate the tumor response to PVSRIPO administered in combination with an anti-PD-1/L1 therapy.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04690699
|Contact: Kristin Orrfirstname.lastname@example.org|
|Contact: Lisa Franklinemail@example.com|