Cancer Clinical Trial
Official title:
A Phase II Study of Tadalafil and Pembrolizumab in Recurrent or Metastatic Head and Neck Squamous Cell Carcinoma
NCT number | NCT03993353 |
Other study ID # | 190098 |
Secondary ID | |
Status | Recruiting |
Phase | Phase 2 |
First received | |
Last updated | |
Start date | April 7, 2020 |
Est. completion date | March 1, 2029 |
This study will examine the combination of pembrolizumab and tadalafil for safety and efficacy in advanced head and neck cancer.
Status | Recruiting |
Enrollment | 6 |
Est. completion date | March 1, 2029 |
Est. primary completion date | March 1, 2026 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years and older |
Eligibility | Selected Inclusion Criteria: - Patients (at least 18 years of age) must have recurrent or metastatic squamous cell carcinoma of the head and neck. - Presence of measurable disease. - Life expectancy of greater than 12 weeks - Patients must have normal organ and marrow function Selected Exclusion Criteria: - Prior therapy with an PD-1 or PD-L1 inhibitor in the recurrent or metastatic setting - Uncontrolled central nervous system metastases (stable metastases permitted) - Active autoimmune disease - Chemotherapy =28 days prior to first administration of study treatment and/or monoclonal antibody =8 weeks prior to first administration of study treatment. - Prior daily use of tadalafil or other long-acting PDE5 inhibitors for one month or greater within 3 months of trial enrollment - Current use of all other long-acting PDE5 inhibitors. - Known severe hypersensitivity to tadalafil or any of the excipients of this product - Current treatment with nitrates - Current systemic treatment with a potent cytochrome P450 3A4 (CYP3A4) inhibitor such as ketoconazole or ritonavir. - Current treatment with guanylate cyclase (GC) stimulators such as riociguat. - History of hypotension and/or blindness and/or sensorineural hearing loss during prior treatment with tadalafil or other PDE-5 inhibitors - History of known hereditary degenerative retinal disorders, including retinitis pigmentosa - Prior history of non-arteritic anterior ischemic optic neuropathy - Pregnant or breastfeeding; a negative pregnancy test is required within 14 days of randomization for all women of childbearing potential. - History of stroke within prior 6 months. - History of acute myocardial infarction within prior 3 months, uncontrolled angina, uncontrolled arrhythmia, or uncontrolled congestive heart failure - Left ventricular outflow obstructions, such as aortic stenosis and idiopathic hypertrophic subaortic stenosis - Angina requiring treatment with long-acting nitrates - Angina requiring treatment with short-acting nitrates within 90 days of planned tadalafil administration - Unstable angina within 90 days of visit 1 (Braunwald 1989) - Positive cardiac stress test without documented evidence of subsequent, effective cardiac intervention - History of any of the following coronary conditions within 90 days of planned tadalafil administration: - Myocardial Infarction - Coronary artery bypass graft surgery - Percutaneous coronary intervention (for example, angioplasty or stent placement) - Any evidence of heart disease (NYHA = Class II as defined in Protocol Attachment LVHG.3) within 6 months of planned tadalafil administration - Concurrent systemic immunosuppressant therapy (e.g., cyclosporine A, tacrolimus, etc., or chronic administration of >10 mg/day of prednisone or equivalent) - Prior organ transplantation - Known history of human immunodeficiency virus (HIV) or active infection with hepatitis C virus (HCV) or hepatitis B virus (HBV). |
Country | Name | City | State |
---|---|---|---|
United States | UCSD Moores Cancer Center | La Jolla | California |
Lead Sponsor | Collaborator |
---|---|
University of California, San Diego |
United States,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Rate of Dose Limiting Toxicity (DLT) | Rate of dose limiting toxicity at least possibly attributable to study treatment | 2 years | |
Primary | Overall Survival (OS) | Overall survival at 12 months post-enrollment | 12 months | |
Secondary | Response measured by RECIST 1.1 | 12 months | ||
Secondary | Progression free survival | 2 years | ||
Secondary | Adverse event rates | 2 years |
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