Summary

Eligibility
for people ages 18-130 (full criteria)
Location
at San Francisco, California and other locations
Dates
study started
completion around

Description

Summary

The main purpose of this study is to assess the efficacy and safety of volrustomig compared to observation in participants with unresected locally advanced head and neck squamous cell carcinoma (LA-HNSCC) who have not progressed after receiving definitive concurrent chemoradiotherapy (cCRT).

Official Title

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 (eVOLVE-HNSCC)

Keywords

Locally Advanced Head and Neck Squamous Cell Carcinoma, Carcinoma, Squamous Cell Carcinoma, Squamous Cell Carcinoma of Head and Neck, volrustomig

Eligibility

You can join if…

Open to people ages 18-130

  • 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.

You CAN'T join if...

  • 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.

Locations

  • Research Site not yet accepting patients
    San Francisco California 94143 United States
  • Research Site not yet accepting patients
    Santa Rosa California 95403 United States
  • Research Site accepting new patients
    Tacoma Washington 98415 United States
  • Research Site accepting new patients
    Goyang-si 410-769 Korea, Republic of
  • Research Site accepting new patients
    Gyeonggi-do 13620 Korea, Republic of
  • Research Site accepting new patients
    Incheon 21565 Korea, Republic of
  • Research Site accepting new patients
    Seoul 06351 Korea, Republic of
  • Research Site not yet accepting patients
    Seoul 5505 Korea, Republic of
  • Research Site not yet accepting patients
    Suwon 16247 Korea, Republic of

Details

Status
accepting new patients at some sites,
but this study is not currently recruiting here
Start Date
Completion Date
(estimated)
Sponsor
AstraZeneca
ID
NCT06129864
Phase
Phase 3 research study
Study Type
Interventional
Participants
Expecting 1145 study participants
Last Updated