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CHEckpoint Inhibition in Combination With an Immunoboost of External Beam Radiotherapy in Solid Tumors

NCT03511391 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 99

Last updated 2024-01-23

No results posted yet for this study

Summary

This randomized controlled phase II trial will investigate whether the addition of stereotactic body radiotherapy to checkpoint inhibitor treatment in patients with non-small-cell lung carcinoma, urothelial carcinoma, renal cell carcinoma, melanoma or head-and-neck carcinoma can improve progression-free survival as compared to checkpoint inhibitor monotherapy. The primary outcome is progression-free survival; secondary outcomes include overall survival, response according to iRecist and Recist v1.1 and toxicity.

Conditions

Interventions

DRUG

Nivolumab or Pembrolizumab or Atezolizumab

per national standard of care

RADIATION

SBRT

Stereotactic body radiotherapy is administered to maximally 3 lesions in 3 fractions of 8Gy prior to the second/third cycle of checkpoint inhibitors.

Sponsors & Collaborators

  • GZA Ziekenhuizen Campus Sint-Augustinus

    collaborator OTHER

  • AZ Sint-Lucas Brugge

    collaborator OTHER

  • Jules Bordet Institute

    collaborator OTHER

  • AZ Sint-Lucas Gent

    collaborator OTHER

  • University Hospital, Ghent

    lead OTHER

Principal Investigators

  • Piet Ost, PhD · University Ghent

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2018-03-09
Primary Completion
2022-02-01
Completion
2024-01-23

Countries

  • Belgium

Study Locations

More Related Trials

Entities

Diseases

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 NCT03511391 on ClinicalTrials.gov