Intranasal WSK-IM05 Vaccine Plus Tislelizumab as Neoadjuvant Therapy for HPV+ OPSCC
Trial statusRecruiting
Trial phasePhase 1
Trial typeInterventional
Biological sexAll
Age18+
SponsorWest China Hospital
About this trial
This phase I, open-label, single-arm trial uses a "3+3" dose-escalation design to evaluate the safety, tolerability, and preliminary efffcacy of intranasal WSK-IM05 vaccine combined with tislelizumab as neoadjuvant therapy in patients with resectable HPV-positive oropharyngeal squamous cell carcinoma. Participants receive two cycles of WSK-IM05 (intranasal) and tislelizumab (200 mg IV) on day 1 of each 3-week cycle, followed by surgery. After surgery, patients receive standard of care (chemoradiotherapy or radiotherapy as indicated) plus 15 cycles of adjuvant tislelizumab. The main outcomes include dose-limiting toxicities and treatment-related adverse events.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
None
Disqualifiers
None
Trial design
Design model
Sequential
Treatments tested in this trial
WSK-IM05 (4×10^10 vp)
Biological/VaccineIntranasal recombinant adenovirus vaccine WSK-IM05 at a dose of 4×10\^10 vp administered via nasal spray on day 1 of each 3-week cycle for 2 cycles.
WSK-IM05 (8×10^10 vp)
Biological/VaccineIntranasal recombinant adenovirus vaccine WSK-IM05 at a dose of 8×10\^10 vp administered via nasal spray on day 1 of each 3-week cycle for 2 cycles.
WSK-IM05 (1.6x10^11 vp)
Biological/VaccineIntranasal recombinant adenovirus vaccine WSK-IM05 at a dose of 1.6x10\^11 vp administered via nasal spray on day 1 of each 3-week cycle for 2 cycles.
Tislelizumab
DrugTislelizumab at a dose of 200 mg administered intravenously on day 1 of each 3-week cycle for 2 cycles (neoadjuvant phase), followed by 200 mg intravenously every 3 weeks for 15 cycles (adjuvant phase after surgery).
Treatment groups
9 Participants
are divided into 3 treatment groupsGroup A: WSK-IM05 (4×10^10 vp) + TislelizumabExperimental treatment 2 interventions
Group B: Arm 2: WSK-IM05 (8×10^10 vp) + TislelizumabExperimental treatment 2 interventions
Group C: Arm 3: WSK-IM05(1.6×10^11 vp) + TislelizumabExperimental treatment 2 interventions
Trial outcomes
Primary outcomes
1
Incidence of Dose-Limiting Toxicities (DLTs)
Proportion of participants experiencing DLTs within the DLT observation period (first 21 days after the first dose), as defined per protocol.
Time frame
First 21 days after first dose of WSK-IM05 (approximately 21 days in total)2
Incidence and Severity of Treatment-Related Adverse Events (TRAEs)
Type, incidence, severity (grade 1-5 according to CTCAE v5.0), and causality assessment of all treatment-related adverse events.
Time frame
From first dose through 30 days after last dose of WSK-IM05 (approximately 2 months in total)3
Incidence of Serious Adverse Events (SAEs)
Including immune-related adverse events (irAEs), injection/administration site reactions, allergic reactions, etc.
Time frame
From first dose through 30 days after last dose (approximately 2 months in total)Secondary outcomes
1
Major Pathological Response (MPR)
Proportion of participants who undergo surgery with residual viable tumor ≤10% (%RVT ≤10%) in the tumor bed according to irPRC criteria, regardless of lymph node status.
Time frame
At time of surgery (approx. Week 6-10)2
Pathological Complete Response (pCR)
Proportion of participants who undergo surgery with no residual viable tumor cells (%RVT = 0) in the tumor bed and resected lymph nodes according to irPRC criteria.
Time frame
At time of surgery (approx. Week 6-10)3
Objective Response Rate (ORR)
Proportion of participants achieving complete response (CR) or partial response (PR) according to RECIST 1.1 criteria.
Time frame
After 2 cycles of neoadjuvant therapy (prior to surgery, approx. Week 5-9)4
Event-Free Survival (EFS)
Time from first dose to first occurrence of any of the following: disease progression during neoadjuvant therapy leading tolerability to undergo radical surgery; local, regional, or distant tumor recurrence after surgery; or death from any cause.
Time frame
From first dose up to approximately 3 yearsOther outcomes
1
Vaccine-Induced Systemic Immune Responses
Assessment of HPV16 E6/E7 Tetramer+ CD8+ T cells, IFN-γ+ CD8+ T cells in peripheral blood.
Time frame
Baseline and after neoadjuvant therapy (approx. Week 6)2
Biomarkers of Efffcacy
Correlation of tumor PD-L1 expression, tumor mutation burden (TMB), and changes in the tumor immune microenvironment with clinical efffcacy.
Time frame
Baseline (tumor tissue) and at surgery (post-treatment tissue) (approx. Week 6-10)Sponsors and contacts
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Source ClinicalTrials.gov