Efficacy of Immunotherapy Plus a Drug in Patients With Progressive Advanced Mucosal Cancer of Dif… (NCT04357873) | Clinical Trial Compass
CompletedPhase 2
Efficacy of Immunotherapy Plus a Drug in Patients With Progressive Advanced Mucosal Cancer of Different Locations
France112 participantsStarted 2020-10-28
Plain-language summary
Interventional study evaluating the efficacy of an immunotherapy (pembrolizumab) in combination with a targeted therapy (vorinostat) in patient with recurrent and/or metastatic squamous cell carcinoma (localisations : head and neck, lung, cervix, anus, vulva, and penis)
Who can participate
Age range18 Years
SexALL
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Inclusion criteria
✓. Aged ≥18 years old.
✓. Patients with Eastern Cooperative Oncology Group (ECOG) performance status ≤1.
✓. Patients must have histologically confirmed recurrent and/or metastatic squamous cell carcinoma of the head and neck, cervix, lung, anus, vulva, or penis.
✓. Patients must have radiologically confirmed progressive recurrent and/or metastatic disease.
✓. Patients naive or previously treated for recurrent and/or metastatic disease for which a treatment with an anti-PD1/PD-L1 agents and vorinostat is an acceptable option according to investigator.
✓. Disease amenable to biopsy for study purpose.
✓. Measurable disease according to RECIST v1.1.
✓. Adequate renal function: serum creatinine ≤1.5 x upper limit of normal (ULN) (OR creatinine clearance \[Cockcroft and Gault\] ≥30 mL/min for participant with creatinine levels \>1.5 × ULN) within 14 days prior inclusion.
Exclusion criteria
✕. Prior treatment with anti-PD-1/PD-L1 agents or histone deacetylases (HDAC) inhibitors.
✕. Patients with central nervous system involvement that has not been controlled for \>3 months.
✕. Patients with no other site for biopsy than bone lesions.
. Patients with other concurrent severe and/or uncontrolled medical disease which could compromise participation in the study, including uncontrolled diabetes, cardiac disease, uncontrolled hypertension, congestive cardiac failure, ventricular arrhythmias, active ischemic heart disease, myocardial infection within one year, chronic liver or renal disease, active gastrointestinal tract ulceration, severely impaired lung function.
✕. Known history of human immunodeficiency virus (HIV), Hepatitis B virus (HBV; defined as Hepatitis B surface antigen \[HBsAg\] reactive) or known active Hepatitis C virus (HCV; defined as HCV RNA detected) virus infection.
✕. History of autoimmune disease with the exception of:
✕. History of allogeneic organ or bone marrow transplantation.
✕. History of non-infectious pneumonitis that required steroids or has current pneumonitis.