Safety and Efficacy of p53 Gene Therapy Combined With Immune Checkpoint Inhibitors in Solid Tumors.
- Registration Number
- NCT03544723
- Lead Sponsor
- MultiVir, Inc.
- Brief Summary
This is a single arm Phase 2 study of the combination of adenoviral p53 (Ad-p53) gene therapy administered intra-tumorally with approved immune checkpoint inhibitors in patients with recurrent or metastatic cancers. Comparison will be made to historical data. General safety and efficacy using RECIST 1.1 and Immune-Related Response Criteria as well as ECOG performance will be utilized.
- Detailed Description
This is a Phase 2 study of the combination of Ad-p53 administered intra-tumorally in combination with physician's choice of FDA approved immune checkpoint inhibitor therapy in patients with recurrent or metastatic cancers. This is a safety and efficacy study with a single cohort, consisting of the combination of Ad-p53 and infusions of immune checkpoint inhibitors. Immune checkpoint inhibitor treatments will be administered in accordance with FDA package inserts. Comparison will be made to historical data. General safety and preliminary efficacy will be determined using RECIST 1.1, ECOG status and Immune-Related Response Criteria. Biomarker testing of archival or fresh tissue is performed during the study. Enrollment will be up to 40 patients.
Recruitment & Eligibility
- Status
- UNKNOWN
- Sex
- All
- Target Recruitment
- 40
Not provided
Not provided
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- Arm && Interventions
Group Intervention Description Ad-p53 with anti-PD-1/anti-PD-L1 100% of patients Ad-p53 Up to 40 patients, all patients treated with intra-tumoral Ad-p53 (dose determined by tumor size) in combination with IV physician's choice of approved immune checkpoint inhibitor
- Primary Outcome Measures
Name Time Method The primary efficacy endpoint is objective response rate (ORR) Change in tumor size at the end of Cycle 2 (each cycle is 28 days) Objective response rate will be evaluated by RECIST 1.1
Safety assessments of adverse events per CTCAE Signed Informed Consent through 30 Days following the final treatment Safety evaluations will tabulate adverse events per CTCAE
- Secondary Outcome Measures
Name Time Method Preliminary assessment of Duration of Response (DoR) by RECIST 1.1 Day 1 through end of study, approximately 2 years RECIST 1.1 will be used to determine Duration of Response (DoR)
Preliminary assessment of progression free survival (PFS) by RECIST 1.1 Day 1 through end of study, approximately 2 years RECIST 1.1 will be used to determine progression free survival
Trial Locations
- Locations (3)
Robert H. Lurie Comprehensive Cancer Center | Northwestern University
🇺🇸Chicago, Illinois, United States
Morristown Medical Center
🇺🇸Morristown, New Jersey, United States
Rush University Cancer Center
🇺🇸Chicago, Illinois, United States