Safety and Efficacy of Ad-p53 in Head and Neck Cancer
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|ClinicalTrials.gov Identifier: NCT03544723|
Recruitment Status : Recruiting
First Posted : June 4, 2018
Last Update Posted : March 7, 2019
|Condition or disease||Intervention/treatment||Phase|
|Recurrent Head and Neck Cancer||Drug: Ad-P53||Phase 2|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||20 participants|
|Intervention Model:||Single Group Assignment|
|Intervention Model Description:||intratumoral Ad-p53 combined with monthly IV Opdivo (nivolumab) infusions|
|Masking:||None (Open Label)|
|Official Title:||A Phase 2, Multi-Center, Open Label, Randomized Study to Evaluate Efficacy and Safety of Adenoviral p53 (Ad-p53) in Combination With Nivolumab in Patients With Advanced, Recurrent Head and Neck Squamous Cell Carcinoma (HNSCC)|
|Actual Study Start Date :||October 1, 2018|
|Estimated Primary Completion Date :||January 1, 2020|
|Estimated Study Completion Date :||September 1, 2020|
Experimental: Ad-p53 with Nivolumab 100% of patients
Up to 20 patients, all patients treated with intra-tumoral Ad-P53 3 times week 1 of each cycle, dose determined by tumor size, in combination with IV nivolumab (Opdivo) 480 mg, every 4 weeks, on Day 5 of each Cycle.
Antineoplastic, Monoclonal Antibody; PD-1/PD-L1 Inhibitors
- Progression-Free Survival (PFS) of patients using RECIST 1.1 [ Time Frame: Day 1 to progression through end of study, approximately 18 months. ]PFS determined by review of scans every 8 weeks for disease progression in accordance with RECIST 1.1. Scans are read locally but kept for possible central review. Scans are done every 8 weeks. Sites will review questionable findings on scans with Immune Related Response Criteria (irRC) [Wolchok 2009].
- Safety assessed by CTCAE [ Time Frame: Screening to 30-days following Final Treatment (approximately 20 weeks) ]Incidence of treatment-emergent and treatment-related adverse events (all AEs, laboratory AEs, SAEs and Fatal AEs, in accordance with the CTCAE
- Efficacy as determined by biomarker testing and immunohistochemistry testing [ Time Frame: Day 1 of Treatment to End of Study (approximately 18 months) ]Efficacy endpoints will be correlated with central biomarker testing for PDL-1, PD-2, as well as central biomarker testing for immune cell infiltrates and tumor mutational burden biomarkers in exploratory analyses, through Cancer Genetics, Inc.
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): NCT03544723
|Contact: Beatha H Sellman, MAemail@example.com|
|Contact: Kerstin B Menander, MD PhDfirstname.lastname@example.org|
|United States, Ohio|
|University of Toledo Dana Cancer Center||Recruiting|
|Toledo, Ohio, United States, 43614|