Radiotherapy With Double Checkpoint Blockade of Locally Advanced HNSCC

Sponsor
University of Erlangen-Nürnberg Medical School
Study ID
NCT03426657
Phase
PHASE2
Status
Completed

Conditions

  • Locally Advanced Head and Neck Squamous Cell Carcinoma

Eligibility Criteria

Sex
ALL
Age
18 Years - 100 Years
Healthy Volunteers
Not accepted

Interventions

  • Durvalumab + Tremelimumab + RT — COMBINATION_PRODUCT
    Patients with an increased CD8+ tumor infiltrating immune cell density and at least clinically stable disease will receive radioimmunotherapy with the PD-L1 Inhibitor Durvalumab and the CTLA4-Inhibitor Tremelimumab (altogether 4 doses q4w including the induction dose) followed by maintenance therapy with Durvalumab (8 additional doses q4w).

Study Details

First-line treatment of locally advanced HNSCC with double checkpoint blockade and radiotherapy dependent on intratumoral CD8+ T cell Infiltration.

Key Dates

Start date
Sep 20, 2018
Status verified
Aug 2023
Primary completion
Sep 16, 2021
Completion
Feb 29, 2024

Study Design

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

Arms

  • Experimental: Durvalumab + Tremelimumab + RT
    Durvalumab (1500 mg,q4W) + Tremelimumab (75 mg, q4W / since Amendment 3: 300 mg absolute dose d5) for up to a maximum of 4 doses/cycles combined with radiotherapy (35 x 2.0/1.8/1.6 Gy) followed by durvalumab monotherapy 1500mg via IV infusion q4W, starting 4 weeks after the last infusion of the combination, for up to a maximum of 8 additional durvalumab doses.

Primary Outcome Measure

Assessment of the number of participants receiving the protocol treatment until cycle 6 of antibody treatment [ Time Frame: At the end of cycle 6 of antibody treatment (each cycle is 4 weeks) ]

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