HPV 16-positive and/or HPV 18-positive Recurrent and/or For Patients With Metastatic Head and Nec… (NCT05280457) | Clinical Trial Compass
RecruitingPhase 2
HPV 16-positive and/or HPV 18-positive Recurrent and/or For Patients With Metastatic Head and Neck Cancer to Evaluate GX-188E DNA Vaccination, GX-I7 and Nivolumab Combination Therapy
South Korea21 participantsStarted 2022-04-15
Plain-language summary
This study is to explore the efficacy and safety of GX-188E DNA vaccination, GX-I7, and nivolumab combination therapy in HPV 16-positive and/or HPV-18 positive R/M HNSCC patients. The objective of this study is as follows.
* Primary objective: Objective response rate (ORR) according to RECIST v1.1
* Secondary objectives: disease control rate (DCR) according to RECIST v1.1, progression-free survival (PFS) at 6 months, median progression-free survival (PFS), median overall survival (OS), biomarker correlation, safety and tolerability.
Who can participate
Age range19 Years
SexALL
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Inclusion criteria
✓. 19 years of age or older
✓. Histologically confirmed, advanced or metastatic, HPV-positive (positive on p16 immunohistochemistry and positive on HPV-16 or HPV-18 nucleic acid test) R/M HNSCC patients
✓. Patients with disease progression after platinum-based chemotherapy are eligible for participation.
✓. Patients with recurrence within 6 months after conventional platinum-based chemotherapy are considered platinum-based treatment failure.
✓. Patients who have received first-line or second-line chemotherapy are eligible to participate. That is, patients whose treatment in this trials is the second or third lince chemotherapy can be enrolled.
✓. PD-L1 (DAKO 28-8 TPS) ≥1%
✓. Eastern Cooperative Oncology Group (ECOG) Activity Status 0-1
✓. Patients with a life expectancy of at least 6 months
Exclusion criteria
✕. When the disease is suitable for topical therapy for the purpose of cure
What they're measuring
1
Objective Response Rate(ORR)
Timeframe: documented progression or date of death from any cause, whichever came first, assessed up to 24 months
✕. If it is confirmed that there is another malignant disease that is currently ongoing or required active treatment within the past 3 years.
✕. Patients expected to require another antineoplastic treatment during the trial; This treatment includes systemic chemotherapy, radiotherapy (except palliative care), biological therapy, or immunotherapy not specified in the protocol.
✕. Patients with a history of active central nervous system (CNS) metastasis and/or carcinoma meningitis. Patients with asymptomatic or controlled CNS metastases may be eligible.
✕. Past treatment with anti-PD-1, anti-PD-L1, or anti-PD-L2 drugs or drugs that act directly on other stimulatory or co-inhibitory T-cell receptors (e.g., CTLA-4, OX40, CD137)
✕. Patients with active autoimmune disease requiring systemic immunosuppressive therapy (eg, use of disease modulators, corticosteroids, or immunosuppressants) within the past 2 years. Replacement therapy (e.g., replacement of thyroxine, insulin, or physiological corticosteroids due to adrenal or pituitary insufficiency) is allowed because it is not considered a form of systemic treatment.
✕. Patients who underwent allogeneic solid organ transplant or allogeneic bone marrow transplant
✕. Non-PD-1/PD-L1/PD-L2, anticancer monoclonal antibody (mAb) (eg, bevacizumab, cetuximab, etc.) has been administered within 4 weeks prior to the first administration of the investigational drug, or for more than 4 weeks Patients who have not yet recovered (eg, Grade 1 or lower or to baseline levels) from adverse events due to medications administered prior to a time point.