Working…
ClinicalTrials.gov
ClinicalTrials.gov Menu

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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
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

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.

Condition or disease Intervention/treatment Phase
Urothelial Carcinoma Melanoma Renal Cell Carcinoma Non-small Cell Lung Cancer Head and Neck Cancer Drug: Pembrolizumab or Nivolumab Radiation: SBRT Phase 2

Layout table for study information
Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 97 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: CHEckpoint Inhibition in Combination With an Immunoboost of External Body Radiotherapy in Solid Tumors: CHEERS-trial
Actual Study Start Date : March 9, 2018
Estimated Primary Completion Date : February 14, 2022
Estimated Study Completion Date : August 14, 2022


Arm Intervention/treatment
Experimental: Experimental arm

Stereotactic body radiotherapy concurrent with checkpoint inhibitor treatment:

Pembrolizumab or Nivolumab + SBRT

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.

Active Comparator: Control arm

Checkpoint inhibitor treatment only:

Pembrolizumab or Nivolumab

Drug: Pembrolizumab or Nivolumab
per national standard of care




Primary Outcome Measures :
  1. 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.


Secondary Outcome Measures :
  1. 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.

  2. Tumor response as per RECIST [ Time Frame: 12 weeks ]
    Response of non-irradiated lesions will be evaluated as per RECIST v1.1.

  3. Tumor response as per iRECIST [ Time Frame: 12 weeks ]
    Response of non-irradiated lesions will be evaluated as per iRECIST

  4. 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



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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 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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03511391


Contacts
Layout table for location contacts
Contact: Piet Ost, PhD 003293323045 piet.ost@ugent.be

Locations
Layout table for location information
Belgium
AZ Sint-Lucas Recruiting
Brugge, West-Vlaanderen, Belgium, 8000
Contact: Daan De Maeseneer, MD         
GasthuisZusters Antwerpen Recruiting
Antwerp, Belgium, 2000
Contact: Piet Dirix, PhD         
University Hospital Ghent Recruiting
Ghent, Belgium, 9000
Contact: Piet Ost, PhD       piet.ost@ugent.be   
Sponsors and Collaborators
University Hospital, Ghent
GZA Ziekenhuizen Campus Sint-Augustinus
AZ Sint-Lucas
Investigators
Layout table for investigator information
Principal Investigator: Piet Ost, PhD University Ghent

Layout table for additonal information
Responsible Party: University Hospital, Ghent
ClinicalTrials.gov Identifier: NCT03511391     History of Changes
Other Study ID Numbers: EC2017/1678
First Posted: April 27, 2018    Key Record Dates
Last Update Posted: May 8, 2018
Last Verified: May 2018

Layout table for additional information
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by University Hospital, Ghent:
radiotherapy
checkpoint inhibitors
Additional relevant MeSH terms:
Layout table for MeSH terms
Carcinoma
Carcinoma, Renal Cell
Carcinoma, Transitional Cell
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type
Neoplasms
Neoplasms by Site
Adenocarcinoma
Kidney Neoplasms
Urologic Neoplasms
Urogenital Neoplasms
Kidney Diseases
Urologic Diseases
Nivolumab
Pembrolizumab
Antineoplastic Agents, Immunological
Antineoplastic Agents