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CHEckpoint Inhibition in Combination With an Immunoboost of External Beam Radiotherapy in Solid Tumors | Clinical Trials | Clareo Health

COMPLETEDPHASE2

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

CHEckpoint Inhibition in Combination With an Immunoboost of External Beam Radiotherapy in Solid Tumors: CHEERS-trial

NCT03511391•University Hospital, Ghent

View on ClinicalTrials.gov

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.

Eligibility

Age

18 - No limit years

Sex

ALL

Healthy Volunteers

Inclusion Criteria

•Before patient registration, written informed consent must be given according to ICH/GCP and national/local regulations.
•Histologically confirmed diagnosis of a solid tumour.
•At least one extracranial tumour lesion available for radiotherapy administration.
•Patient will receive a checkpoint inhibitor per standard of care in one of the following settings (locally advanced or metastatic): melanoma (1st - 3rd line nivolumab or pembrolizumab); renal cell carcinoma (2nd line nivolumab); non-small cell lung carcinoma (2nd or 3rd line nivolumab, pembrolizumab or atezolizumab); urothelial cell carcinoma ( 1st-3rd line nivolumab, pembrolizumab or atezolizumab); head-\& neck squamous cell carcinoma (1st-2nd line pembrolizumab, 2nd line nivolumab).
•Karnofsky Performance status \> 60.
•Age 18 years or older.

Exclusion Criteria

•Prior radiotherapy preventing treatment with SBRT.
•Prior treatment with an anti-PD-(L)1 antibody.
•Has a known additional malignancy that is progressing or requires active treatment. Exceptions include basal cell carcinoma of the skin or squamous cell carcinoma of the skin that has undergone potentially curative therapy or in situ cervical cancer or prostate cancer that has undergone potentially curative therapy and with normalized PSA.
•Uncontrolled central nervous system (CNS) metastases at baseline (controlled = previously-treated CNS metastases (surgery ± radiotherapy, radiosurgery, or gamma knife) and who meet both of the following criteria: a) are asymptomatic and b) have no requirement for steroids or enzyme-inducing anticonvulsants), and/or carcinomatous meningitis.
•Any condition requiring systemic treatment with corticosteroids (\> 10 mg daily prednisone equivalent) or other immunosuppressive medication within 14 days prior to the first dose of study drug. Inhaled steroids and adrenal replacement steroid doses \> 10 mg daily prednisone equivalent are permitted in the absence of active autoimmune disease.
•Has a diagnosis of immunodeficiency or history of human immunodeficiency virus (HIV), Hepatitis B or Hepatitis C infection.
•Mental condition rendering the patient unable to understand the nature, scope and possible consequences of the study.
•Patient not likely to comply with the protocol; I.e. uncooperative attitude, inability to return for follow-up visits and unlikely to complete the study.
•Contraindication for radiotherapy.
•Female subjects of childbearing potential must be willing to use an adequate method of contraception for the course of the study through 120 days after the last dose of study medication.

Locations (5)

AZ Sint-Lucas

Ghent, Oost-Vlaanderen, Belgium

AZ Sint-Lucas

Bruges, West-Vlaanderen, Belgium

GasthuisZusters Antwerpen

Antwerp, Belgium

Jules Bordet Institute

Brussels, Belgium

University Hospital Ghent

Ghent, Belgium

Key Dates

Start Date

March 9, 2018

Primary Completion Date

February 1, 2022

Completion Date

January 23, 2024

Last Updated

January 23, 2024

Enrollment

ACTUAL participants

Conditions

Urothelial CarcinomaMelanomaRenal Cell CarcinomaNon-small Cell Lung CancerHead and Neck Cancer

Interventions

Nivolumab or Pembrolizumab or Atezolizumab

DRUG

SBRT

RADIATION

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RECRUITINGPHASE1

IACS-6274 With or Without Bevacizumab and Paclitaxel for the Treatment of Advanced Solid Tumors

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Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: January 23, 2024Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

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

Inclusion Criteria

Exclusion Criteria

Association Between Galectin-3 Levels and Outcomes in Patients With Renal Cell Carcinoma, Transitional Cell Carcinoma , Non Small Cell Lung Cancer, and Hepatocellular Carcinoma, Treated With PD-1/PDL-1 Inhibitors

IACS-6274 With or Without Bevacizumab and Paclitaxel for the Treatment of Advanced Solid Tumors

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SUPRAME-ACTengine® IMA203 vs. Investigator's Choice of Treatment in Previously Treated, Unresectable or Metastatic Cutaneous Melanoma