Trial Evaluating the Tolerance and Safety of Durvalumab - RT Combination for Treatment in SCCHN

Sponsor
Groupe Oncologie Radiotherapie Tete et Cou
Study ID
NCT03726775
Phase
PHASE2
Status
Active Not Recruiting

Conditions

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • Durvalumab — DRUG
    Infusion of durvalumab during RT and after RT during 6 months

Study Details

This study evaluate the regional (neck) nodal control of durvalumab in combination with RT restricted to the primary tumor and the immediately adjacent nodal level (i.e. without prophylactic neck irradiation) in N0 patients with SCCHN.

Key Dates

Start date
Jul 17, 2019
Status verified
May 2025
Primary completion
Jul 31, 2026
Completion
Aug 31, 2026

Study Design

Enrollment
61 participants (actual)
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT

Arms

  • Experimental: RT-durvalumab
    durvalumab at fixed dose of 1120 mg on Day1 of RT and every 3 weeks during the RT. Durvalumab with be continued at a fixed dose of 1500 mg every 4 weeks during 6 months following RT.

Primary Outcome Measure

Regional (neck) nodal control rate [ Time Frame: 1 year ]

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