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Bioimmunoradiotherapy (Cetuximab/RT/Avelumab)

NCT02938273 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 10

Last updated 2019-12-11

No results posted yet for this study

Summary

This is an open-label phase IB trial with Bioimmunoradiotherapy, i.e. concurrent radiotherapy with intravenous administration of cetuximab and avelumab followed by avelumab maintenance therapy in patients with locally advanced head and neck cancer, unfit for cisplatin.

Conditions

  • Carcinoma, Squamous Cell of Head and Neck

Interventions

DRUG

avelumab

Avelumab10 mg/kg i.v. at day -7, 7, 21,35 + maintenance therapy i.e avelumab10 mg/kg i.v. every 2 weeks for 6 months

RADIATION

radiotherapy

5 times a week, 7 weeks, total dose 70 Gy

DRUG

cetuximab

loading dose 400 mg/m2 i.v. day -7, 250 mg/m2 i.v weekly wk 1-7

Sponsors & Collaborators

  • Merck KGaA, Darmstadt, Germany

    collaborator INDUSTRY

  • The Netherlands Cancer Institute

    lead OTHER

Principal Investigators

  • Jan Paul de Boer, MD, PhD · The Netherlands Cancer Institute

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2017-02-01
Primary Completion
2019-06-26
Completion
2019-09-30

Countries

  • Netherlands

Study Locations

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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 NCT02938273 on ClinicalTrials.gov