A Phase 2, Multi-Center, Open Label Study to Evaluate Adenoviral p53 (Ad-p53) in Combination With Immune Checkpoint Inhibitor Therapy in Patients With Recurrent or Metastatic Head and Neck Squamous Cell Carcinoma and Other Tumors Approved for Anti-PD-1 or Anti-PD-L1 Therapy
Trial Snapshot
- Phase
- Phase 2
- Sponsor
- MultiVir, Inc.
- Enrollment
- 40
- Locations
- 3
- Primary Endpoint
- The primary efficacy endpoint is objective response rate (ORR)
Study Overview
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.
Study Design
- Study Type
- Interventional
- Allocation
- Na
- Intervention Model
- Single Group
- Primary Purpose
- Treatment
- Masking
- None
Eligibility Criteria
- Ages
- 18 Years to — (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- Not provided
Exclusion Criteria
- Not provided
Arms & Interventions
Ad-p53 with anti-PD-1/anti-PD-L1 100% of patients
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
Intervention: Ad-p53 (Drug)
Outcomes
Primary Outcomes
The primary efficacy endpoint is objective response rate (ORR)
Time Frame: 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
Time Frame: Signed Informed Consent through 30 Days following the final treatment
Safety evaluations will tabulate adverse events per CTCAE
Secondary Outcomes
- Preliminary assessment of Duration of Response (DoR) by RECIST 1.1(Day 1 through end of study, approximately 2 years)
- Preliminary assessment of progression free survival (PFS) by RECIST 1.1(Day 1 through end of study, approximately 2 years)