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Maintenance Immune Check-point Inhibitor Following Post-operative Chemo-radiation in Subjects With HPV-negative HNSCC

NCT03673735 · Status: WITHDRAWN · Phase: PHASE3 · Type: INTERVENTIONAL

Last updated 2021-05-10

No results posted yet for this study

Summary

This is a phase III randomized blind placebo-controlled study, designed to show the superiority of the experimental arm to the control arm.

After surgery and checking eligibility criteria, patients will be randomized between the control and the experimental arms with a 1:1 ratio (randomization will take place at a maximum 4 weeks after surgery):

* Experimental Arm: Durvalumab (one dose) before chemoradiotherapy (CRT) and for 6 months every 4 weeks (Q4W) after CRT
* Control Arm: placebo (one dose) before CRT and for 6 months Q4W after CRT Radiotherapy planning will take place after randomization. The primary endpoint of this trial is disease free survival (DFS), measured from the date of randomization to the date of first occurrence of any loco-regional recurrence, metastatic progression, or death due to any cause.

Conditions

  • Squamous Cell Head and Neck Carcinoma

Interventions

DRUG

Durvalumab

Durvalumab (one dose) before CRT and for 6 months Q4W after CRT

RADIATION

radiotherapy

radiotherapy is administered in 33 fractions over 6.5 weeks fro a total of 66 Gy

DRUG

Placebo

placebo (one dose) before CRT and for 6 months Q4W after CRT

DRUG

Cisplatin

Cisplatin (100mg/m2) is administered at day 1, 22, 43 of radiotherapy

Sponsors & Collaborators

  • European Organisation for Research and Treatment of Cancer - EORTC

    lead NETWORK

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
TRIPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2021-06-30
Primary Completion
2026-07-31
Completion
2027-12-31

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Entities

Drugs

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03673735 on ClinicalTrials.gov