Brief Title
CHEckpoint Inhibition in Combination With an Immunoboost of External Beam Radiotherapy in Solid Tumors
Official Title
CHEckpoint Inhibition in Combination With an Immunoboost of External Beam Radiotherapy in Solid Tumors: CHEERS-trial
Brief 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.
Study Phase
Phase 2
Study Type
Interventional
Primary Outcome
Progression-free survival
Secondary Outcome
Overall survival
Condition
Urothelial Carcinoma
Intervention
Nivolumab or Pembrolizumab or Atezolizumab
Study Arms / Comparison Groups
Experimental arm
Description: Stereotactic body radiotherapy concurrent with checkpoint inhibitor treatment: Nivolumab or Pembrolizumab or Atezolizumab + SBRT
Publications
* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.
Recruitment Information
Recruitment Status
Drug
Estimated Enrollment
99
Start Date
March 9, 2018
Completion Date
August 14, 2022
Primary Completion Date
February 14, 2022
Eligibility Criteria
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.
Gender
All
Ages
18 Years - N/A
Accepts Healthy Volunteers
No
Contacts
Piet Ost, PhD, ,
Location Countries
Belgium
Location Countries
Belgium
Administrative Informations
NCT ID
NCT03511391
Organization ID
EC2017/1678
Responsible Party
Sponsor
Study Sponsor
University Hospital, Ghent
Collaborators
GZA Ziekenhuizen Campus Sint-Augustinus
Study Sponsor
Piet Ost, PhD, Principal Investigator, University Ghent
Verification Date
October 2020