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A Prospective Observational Study of Renal Cell Cancer Patients Treated With Nivolumab Plus Ipilimumab in the Real World Setting in Japan

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: NCT04043975
Recruitment Status : Recruiting
First Posted : August 2, 2019
Last Update Posted : October 1, 2019
Sponsor:
Collaborator:
Ono Pharmaceutical Co. Ltd
Information provided by (Responsible Party):
Bristol-Myers Squibb

Brief Summary:
This is a prospective, observational, descriptive study of renal cell cancer patients who are treated with the combination of nivolumab plus ipilimumab as first line of systematic therapy in the real world setting in Japan.

Condition or disease
Advanced or Metastatic Renal Cell Carcinoma

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Study Type : Observational
Estimated Enrollment : 250 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: Japanese Prospective Real World Registry of Nivolumab Plus Ipilimumab in Subjects With Previously Untreated, Advanced or Metastatic Renal Cell Carcinoma (ARCC) Categorized Into IMDC Intermediate/Poor Risks (J-ENCORE)
Actual Study Start Date : July 3, 2019
Estimated Primary Completion Date : August 1, 2022
Estimated Study Completion Date : August 1, 2022


Group/Cohort
Patients with metastatic RCC
Patients with previously untreated advanced or metastatic renal cell carcinoma (RCC) with intermediate or poor International Metastatic Renal Cell Carcinoma Database Consortium (IMDC) risk classification, who will be treated with Nivolumab + Ipilimumab for the first time



Primary Outcome Measures :
  1. Objective Response Rate (ORR) [ Time Frame: Up to 3 years ]

Secondary Outcome Measures :
  1. Overall Survival (OS) [ Time Frame: From date of starting nivolumab plus ipilimumab to the date of death from any cause. (Up to 3 years) ]
  2. Progression-free Survival (PFS) [ Time Frame: From date of starting nivolumab plus ipilimumab to the first date of documented progression, as determined by the investigators (as per RECIST 1.1 criteria), or death due to any cause, whichever occurs first. (Up to 3 years) ]
  3. Change in tumor response over time [ Time Frame: Up to 3 years ]
  4. Duration of Response (DOR) [ Time Frame: From first documentation of tumor response after the date of starting nivolumab plus ipilimumab to disease progression or death due to any cause, whichever occurs first. (Up to 3 years) ]
  5. The quality of life by National Comprehensive Cancer Network/ Functional Assessment of Cancer Therapy (FACT)-Kidney Symptom Index 19 (NCCN-FACT FKSI-19) v2.0 [ Time Frame: Up to 6 months ]
  6. Number of participants with Adverse Events (AEs) [ Time Frame: During the observation period or until 100 days after discontinuation of dosing with nivolumab and ipilimumab (Up to 3 years) ]
  7. ORR on subsequent therapy [ Time Frame: From initiation of a second line of therapy after discontinuation of first line nivolumab+ipilimumab treatment (Up to 3 years) ]


Information from the National Library of Medicine

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Ages Eligible for Study:   20 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Probability Sample
Study Population
The study population includes adult (≧ 20 years) Japanese patients with histological confirmation of advanced or metastatic renal cell carcinoma (aRCC) and International Metastatic Renal Cell Carcinoma Database Consortium (IMDC) risk category Intermediate/Poor who will be treated with the combination of nivolumab+ipilimumab as first line of systematic therapy in the real world setting.
Criteria

Inclusion Criteria:

  • Histological confirmation of Renal Cell Carcinoma (RCC)
  • No prior systemic therapy for RCC
  • RCC patients who are anticipated to start treatment with nivolumab and ipilimumab regimen in the timeframe between after IRB approval to enrollment-end date
  • IMDC risk category Intermediate/Poor
  • ≧ 20 years old patients for whom informed consent was obtained from the patient at the time of this study participation

Exclusion Criteria:

  • Patients who are enrolled in a post marketing safety study on nivolumab plus ipilimumab combination therapy in Japan
  • Pregnant and/or lactating women
  • Patients who are judged to be inappropriate by investigator

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): NCT04043975


Contacts
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Contact: Recruiting sites have contact information. Please contact the sites directly. If there is no contact information, please email: Clinical.Trials@bms.com
Contact: First line of the email MUST contain NCT # and Site #.

Locations
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Japan
Local Institution Recruiting
Tokyo, Japan, 1070052
Contact: Site 0001         
Sponsors and Collaborators
Bristol-Myers Squibb
Ono Pharmaceutical Co. Ltd
Investigators
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Study Director: Bristol-Myers Squibb Bristol-Myers Squibb

Additional Information:
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Responsible Party: Bristol-Myers Squibb
ClinicalTrials.gov Identifier: NCT04043975    
Other Study ID Numbers: CA209-7CR
First Posted: August 2, 2019    Key Record Dates
Last Update Posted: October 1, 2019
Last Verified: September 2019

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Carcinoma
Carcinoma, Renal Cell
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type
Neoplasms
Adenocarcinoma
Kidney Neoplasms
Urologic Neoplasms
Urogenital Neoplasms
Neoplasms by Site
Kidney Diseases
Urologic Diseases
Nivolumab
Ipilimumab
Antineoplastic Agents, Immunological
Antineoplastic Agents