Window of Opportunity Trial of Nivolumab and Tadalafil in Patients With Squamous Cell Carcinoma of the Head and Neck
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|ClinicalTrials.gov Identifier: NCT03238365|
Recruitment Status : Recruiting
First Posted : August 3, 2017
Last Update Posted : October 11, 2017
|Condition or disease||Intervention/treatment||Phase|
|Lip, Oral Cavity and Pharynx Larynx||Biological: Nivolumab Drug: Tadalafil Procedure: Therapeutic Conventional Surgery||Early Phase 1|
I. To investigate whether adding the PDE5 inhibitor, tadalafil, to nivolumab therapy affects intratumoral and systemic anti-tumor immunity.
I. Characterize the combined effects of nivolumab and tadalafil on safety, exosome composition and function, the composition of intratumoral immune cell populations, wound healing, and tumor radiographic response.
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||50 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||None (Open Label)|
|Official Title:||Window of Opportunity Trial of Nivolumab and Tadalafil in Patients With Squamous Cell Carcinoma of the Head and Neck|
|Actual Study Start Date :||August 10, 2017|
|Estimated Primary Completion Date :||December 16, 2019|
|Estimated Study Completion Date :||December 16, 2020|
Active Comparator: Arm I (nivolumab)
Patients receive nivolumab IV over 60 minutes on days 3 and 17 and undergo surgery on day 31.
Other Name: OpdivoProcedure: Therapeutic Conventional Surgery
Experimental: Arm II (nivolumab, tadalafil)
Patients receive nivolumab IV over 60 minutes on days 3 and 17 and tadalafil PO QD on days 3-31. Patients then undergo surgery on day 31.
Other Name: OpdivoDrug: Tadalafil
Other Name: CialisProcedure: Therapeutic Conventional Surgery
- Change in immune cell polarization (Th1/Th2; M1/M2) in peripheral blood and tumor specimens using multiplex cytokine analysis [ Time Frame: Baseline up to day 31 of treatment ]Analyze the immune cell polarization (Th1/Th2; M1/M2) in peripheral blood and tumor specimen supernatants will look at an entire panel of inflammatory markers, utilizing Luminex technology with the milliplex MAP human cytokine/chemokine magnetic kit I
- Prevalence of intratumoral immune cell populations [ Time Frame: Baseline up to 29 months ]We will use immunohistochemistry (IHC) to determine the prevalence of intratumoral immune cell populations in patients treated with nivolumab and tadalafil as compared to patients treated with nivolumab alone.
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): NCT03238365
|Contact: Adam Luginbuhl, MD||(215) email@example.com|
|United States, Pennsylvania|
|Sidney Kimmel Cancer Center at Thomas Jefferson University||Recruiting|
|Philadelphia, Pennsylvania, United States, 19107|
|Contact: Adam Luginbuhl, MD firstname.lastname@example.org|
|United States, Tennessee|
|Vanderbilt University||Not yet recruiting|
|Nashville, Tennessee, United States, 37232|
|Contact: VICC Clinical Trials Reporting Program 800-811-8480|
|Principal Investigator:||Adam Luginbuhl, MD||Sidney Kimmel Cancer Center at Thomas Jefferson University|