A Phase III, Randomized, Open-Label, Multi-Center, Global Study of Volrustomig (MEDI5752) as Sequential Therapy Versus Observation in Participants with Unresected Locally Advanced Head and Neck Squamous Cell Carcinoma, Who Have Not Progressed Following Definitive Concurrent Chemoradiotherapy.
Primary:
- To demonstrate the superiority of volrustomig administered after cCRT relative to observation by assessment of PFS in participants with unresected LA-HNSCC with tumors PD-L1.
Secondary:
- To compare the efficacy of volrustomig administered after cCRT relative to the observation assessment of PFS2.
- To assess the PK of volrustomig.
- To investigate the immunogenicity of volrustomig.
- To assess participant-reported physical functioning in participants treated with volrustomig relative to observation.
- Rutgers Cancer Institute of New Jersey
- Principal Investigator
- Missak Haigentz MD
- Principal Investigator
Inclusion Criteria
- Histologically or cytologically documented locally advanced squamous cell carcinoma
of the oropharynx, hypopharynx, oral cavity, or larynx with no evidence of
metastatic disease (i.e. M0).
- Confirmed unresected Stage III, Stage IVA or IVB according to the eighth edition of
the American Joint Committee on Cancer (AJCC) staging manual (tumor, node,
metastasis (TNM) staging system).
- Participants will have completed definitive concurrent chemoradiotherapy (cCRT) with
curative intent within 12 weeks prior to randomization.
Exclusion Criteria
- Histologically/cytologically confirmed head and neck cancer of any other primary
anatomic location in the head and neck not specified in the inclusion criteria
including participants with squamous cell carcinoma of unknown primary or
non-squamous histologies (eg, nasopharynx or salivary gland). Participants with >1
primary tumors are not eligible for the study.
- Participants with any of the following:
1. Residual disease that needs further treatment with curative intent after
definitive cCRT administration;
2. LA-HNSCC that was resected before definitive cCRT
3. LA-HNSCC that was treated and is recurrent at the time of screening
- Participants who have received radiotherapy (RT) alone as definitive local therapy
for LA-HNSCC.
- Receipt of the last dose of anticancer therapy (chemotherapy and/or RT) > 12 weeks
(84 days) prior to randomization.
Please note that we have obtained the inclusion and exclusion criteria information from the National Institutes of Health’s clinical trials web site ClinicalTrials.gov. The listed criteria may not necessarily reflect recent amendments to the protocol and the current criteria.
For further information about clinical trials, please contact us at 732-235-7356.