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CHEckpoint Inhibition in Combination With an Immunoboost of External Body Radiotherapy in Solid Tumors (CHEERS)

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ClinicalTrials.gov Identifier: NCT03511391
Recruitment Status : Recruiting
First Posted : April 27, 2018
Last Update Posted : May 8, 2018
Sponsor:
Collaborators:
GZA Ziekenhuizen Campus Sint-Augustinus
AZ Sint-Lucas
Information provided by (Responsible Party):
University Hospital, Ghent

Tracking Information
First Submitted Date  ICMJE April 17, 2018
First Posted Date  ICMJE April 27, 2018
Last Update Posted Date May 8, 2018
Actual Study Start Date  ICMJE March 9, 2018
Estimated Primary Completion Date February 14, 2022   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: April 17, 2018)
Progression-free survival [ Time Frame: 15 months ]
Progression-free survival will be defined as the time from randomization to disease progression (as per iRECIST) or death from any cause.
Original Primary Outcome Measures  ICMJE Same as current
Change History Complete list of historical versions of study NCT03511391 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE
 (submitted: May 2, 2018)
  • Overall survival [ Time Frame: 2 years after start trial treatment ]
    Overall survival will be defined as the time from randomization to death from any cause.
  • Tumor response as per RECIST [ Time Frame: 12 weeks ]
    Response of non-irradiated lesions will be evaluated as per RECIST v1.1.
  • Tumor response as per iRECIST [ Time Frame: 12 weeks ]
    Response of non-irradiated lesions will be evaluated as per iRECIST
  • Incidence of Treatment-Related Adverse Events [safety and tolerability] [ Time Frame: 12 weeks ]
    Adverse events will be monitored as per Common Terminology Criteria for Adverse Events (CTCAE) v5.0
Original Secondary Outcome Measures  ICMJE
 (submitted: April 17, 2018)
  • Overall survival [ Time Frame: 2 years after start trial treatment ]
    Overall survival will be defined as the time from randomization to death from any cause.
  • Tumor response as per RECIST [ Time Frame: 12 weeks ]
    Response of non-irradiated lesions will be evaluated as per RECIST v1.1.
  • Tumor response as per iRECIST [ Time Frame: 12 weeks ]
    Response of non-irradiated lesions will be evaluated as per iRECIST
  • Toxicity [ Time Frame: 12 weeks ]
    Adverse events will be monitored as per Common Terminology Criteria for Adverse Events (CTCAE) v5.0
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE CHEckpoint Inhibition in Combination With an Immunoboost of External Body Radiotherapy in Solid Tumors
Official Title  ICMJE CHEckpoint Inhibition in Combination With an Immunoboost of External Body 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.
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 2
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE
  • Urothelial Carcinoma
  • Melanoma
  • Renal Cell Carcinoma
  • Non-small Cell Lung Cancer
  • Head and Neck Cancer
Intervention  ICMJE
  • Drug: Pembrolizumab or Nivolumab
    per national standard of care
  • Radiation: SBRT
    Stereotactic body radiotherapy is administered to maximally 3 lesions in 3 fractions of 8Gy prior to the third cycle of checkpoint inhibitors.
Study Arms  ICMJE
  • Experimental: Experimental arm

    Stereotactic body radiotherapy concurrent with checkpoint inhibitor treatment:

    Pembrolizumab or Nivolumab + SBRT

    Interventions:
    • Drug: Pembrolizumab or Nivolumab
    • Radiation: SBRT
  • Active Comparator: Control arm

    Checkpoint inhibitor treatment only:

    Pembrolizumab or Nivolumab

    Intervention: Drug: Pembrolizumab or Nivolumab
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Recruiting
Estimated Enrollment  ICMJE
 (submitted: April 17, 2018)
97
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE August 14, 2022
Estimated Primary Completion Date February 14, 2022   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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 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 or pembrolizumab); urothelial cell carcinoma ( 1st or 2nd line nivolumab or pembrolizumab); head-& neck squamous cell carcinoma (2nd line nivolumab).
  • Karnofsky Performance status > 60
  • Age 18 years or older.

Exclusion Criteria:

  • Prior radiotherapy preventing treatment with SBRT.
  • 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.
  • Has a diagnosis of immunodeficiency or is receiving systemic steroid therapy or any other form of immunosuppressive therapy within 7 days prior to the first dose of trial treatment. 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.
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE
Contact: Piet Ost, PhD 003293323045 piet.ost@ugent.be
Listed Location Countries  ICMJE Belgium
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT03511391
Other Study ID Numbers  ICMJE EC2017/1678
Has Data Monitoring Committee Not Provided
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE Not Provided
Responsible Party University Hospital, Ghent
Study Sponsor  ICMJE University Hospital, Ghent
Collaborators  ICMJE
  • GZA Ziekenhuizen Campus Sint-Augustinus
  • AZ Sint-Lucas
Investigators  ICMJE
Principal Investigator: Piet Ost, PhD University Ghent
PRS Account University Hospital, Ghent
Verification Date May 2018

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP