Tadalafil and Pembrolizumab in Recurrent or Metastatic Head and Neck Cancer

  • STATUS
    Recruiting
  • End date
    Dec 24, 2022
  • participants needed
    30
  • sponsor
    University of California, San Diego
Updated on 24 January 2021
cancer
measurable disease
carcinoma
squamous cell carcinoma
pembrolizumab
primary cancer
head and neck cancer
tadalafil
neck cancer
advanced head and neck carcinoma
metastatic head and neck cancer
metastatic squamous cell carcinoma
advanced head and neck cancer

Summary

This study will examine the combination of pembrolizumab and tadalafil for safety and efficacy in advanced head and neck cancer.

Description

Immune competent animal models of HNSCC demonstrate that combination PDE-5 inhibitor (tadalafil) and PD-1 inhibitor therapy is more effective than either therapy alone based on the concept of targeting multiple immune repressive abnormalities simultaneously (PD-1 checkpoint and myeloid suppressive pathways).

This trial will test the hypothesis that combination PD-1 inhibition and PDE-5 inhibition can be safely co-administered, and secondarily test the hypothesis that the combination of both therapies will be more effective than PD-1 inhibition alone in recurrent/metastatic HNSCC.

Details
Condition Oral Neoplasm, Cancer, Esophageal Diseases, Esophageal Cancer, head and neck cancer, Cancer/Tumors, Esophageal Carcinoma, Squamous Cell Carcinoma of the Head and Neck, Head and Neck Squamous Cell Carcinoma, Ewing's Family Tumors, Squamous Cell Carcinoma of Head and Neck, Head and Neck Carcinoma, Head and Neck Cancer Metastatic, Carcinoma of the Head and Neck, Cancer (Pediatric), Esophageal Disorders, Oral Cavity Cancer, Neoplasms, Oral Cancer, Metastatic Head and Neck Cancer, Cancer Metastatic, Head and Neck Cancer Stage III, Head and Neck Cancer Stage IV, neck cancer, primary cancer, primary malignant neoplasm, malignancy, cancers, malignancies, malignant tumor, malignant tumors, esophagus cancer, oesophageal cancer, cancer of the head and neck, oral cancers, cancers metastatic, cancer of the esophagus, oesophageal carcinoma
Treatment Pembrolizumab, Tadalafil
Clinical Study IdentifierNCT03993353
SponsorUniversity of California, San Diego
Last Modified on24 January 2021

Eligibility

Yes No Not Sure

Inclusion Criteria

Is your age greater than or equal to 18 yrs?
Gender: Male or Female
Do you have any of these conditions: Cancer (Pediatric) or Oral Cancer or Head and Neck Cancer Metastatic or Head and Neck Cancer Stage IV or Cancer Metastatic or Cancer/Tumors or Oral Ne...?
Do you have any of these conditions: malignancy or Head and Neck Squamous Cell Carcinoma or Metastatic Head and Neck Cancer or Ewing's Family Tumors or malignant tumors or Esophageal Dise...?
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

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)
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