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HOOKIPA / H-200-004

Trial Overview

Official Title

A Randomized, Double-blinded, Phase 2/3 Study of HB-202/HB-201 Alternating 2-Vector Therapy in Combination with Pembrolizumab versus Pembrolizumab Alone as First Line Treatment of HPV 16 Positive and High PD-L1 Combined Positive Score Recurrent and/or Metastatic Oropharyngeal Squamous Cell Carcinoma

Study Purpose

To assess antitumor activity and safety of the study drugs, and any impact they may have on survival and quality of life.

Diagnosis

HPV 16 Positive and High PD-L1 Combined Positive Score Recurrent and/or Metastatic Oropharyngeal Squamous Cell Carcinoma

Eligibility

No prior treatment in the recurrent/metastatic setting, PD-L1 score ≥ 20, HPV 16+ oropharyngeal squamous cell carcinoma, tumor tissue sample required, measurable disease.

Intervention

HB-202/HB-201 alternating 2-vector therapy + Pembrolizumab vs. Placebo + Pembrolizumab

For more information, click the link below:

 

https://clinicaltrials.gov/study/NCT06513884?term=H-200-004&rank=1

 

Key Participation Requirements
Trial Location(s)
Methodist Estabrook Cancer Center
Gender
Male/Female
Age
19 years or older
Enrollment Status
Pending
Phase
Phase II
Methodist Health System Trial Code
H-200-004