Open-label Phase II Trial for the Combination of GX-188E HPV DNA Vaccine With GX-I7 or Pembrolizumab OR the Triple Combination of GX-188E HPV DNA Vaccine, GX-I7, and Pembrolizumab in Patients With Advanced, Resectable HPV Type 16 or 18 Positive Head and Neck Cancer (Expanded Cohort)
The study is open label, phase II clinical trial for the Combination of GX-188E HPV DNA Vaccine with GX-I7 or Pembrolizumab OR the Triple Combination of GX-188E HPV DNA Vaccine, GX-I7, and Pembrolizumab in Patients With Advanced, Resectable HPV Type 16 or 18 Positive Head and Neck Cancer.
⁃ 7\. Patients with suitable organ function as defined in Table 1 below should be patients. Samples must be collected within 28 days prior to the initiation of clinical trial drugs.
⁃ \< Requirements for long-term function for conformity evaluation \> Laboratory examination of the body organs \[Hematology\] Absolute neutrophil count (ANC) ≥1,500/μL Platelet count ≥100,000/μLHemoglobin ≥9.0 g/dL \[Kidney\] Measurement or calculation of creatinine or creatinine cleaning rate 2 (GFR may be used instead of creatinine or CrCl) ≤1.5 × ULN or, creatinine \>1.5x (If you're a test subject of ULN) ≥60 mL/min \[Liver\]Serum total bilirubin ≤1.5 × ULN or, total bilirubin \>1.5 x (If you're a test subject of ULN) direct bilirubin ≤ULN (This will not apply to patients with confirmed Gilbert's syndrome, total bilirubin \<3x ULN and ALT\<3xULN) AST (SGOT)/ALT (SGPT) ≤2.5 x institutional upper limit of normal unless liver metastases are present, in which case it must be ≤5x ULN \[Blood coagulation\] INR or prothrombin Time(PT), Activation TromboplastinTime(aPTT)
⁃ ≤1.5 × Unless ULN, PT or aPTT is within the scope of treatment for the intended anticoagulant use, the patient is not receiving anticoagulant therapy --------------------------------------------------------------------------------- ALT (SGPT)= alanine aminotransferase, serum glutamic pyruvic transaminase; AST (SGOT)= aspartate aminotransferase serum glutamic oxaloacetic transaminase; GFR(glomerular filtration rate); ULN=normal range , upper limit of normal ---------------------------------------------------------------------------------
• It must meet the criteria without dependence on red blood cells within the past 4 weeks and without receiving concentrated red blood cell (pRBC) blood transfusions.
• Measured creatinine clearance (CrCl) by the Cockcroft-Gault formula (Cockcroft and Gault 1976) --------------------------------------------------------------------------------- 8. Patient with RECIST measurable diseases defined as below: Tumor lesions with a long axis diameter (LD) ≥1 cm in axial CT or MRI images (restoration interval ≤5 mm) or lymph node ≥1.5 cm in short axis CT (restoration interval 5 mm) 9. For fertile woman (WOCBP), patient with negative results of serum or urine pregnancy tests conducted within 72 hours prior to the first administration of clinical trial drugs. If the urine test result is positive or cannot be confirmed negative, a serum pregnancy test should be performed.
⁃ 10\. Fertile woman must agree to use appropriate double contraception by 120 days after the entire course of this trial and the last administration of clinical trial drugs. Woman who are menopause (over 45 years of age and have no menstruation for more than a year) and women who are surgically infertile are exempt from this requirement.
⁃ Note: abstinence is permitted if it is the daily lifestyle of the test subject and the contraceptive method preferred by the test subject.