NCT04043975

Brief Summary

The purpose of the observational study is to evaluate the safety and effectiveness of combination therapy with nivolumab and ipilimumab in Japanese participants with advanced or metastatic renal cell carcinoma (aRCC) in the real-world setting in Japan.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
286

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Sep 2019

Longer than P75 for all trials

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

July 31, 2019

Completed
2 days until next milestone

First Posted

Study publicly available on registry

August 2, 2019

Completed
2 months until next milestone

Study Start

First participant enrolled

September 19, 2019

Completed
4.9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 23, 2024

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

August 23, 2024

Completed
Last Updated

February 14, 2025

Status Verified

February 1, 2025

Enrollment Period

4.9 years

First QC Date

July 31, 2019

Last Update Submit

February 13, 2025

Conditions

Advanced or Metastatic Renal Cell Carcinoma

Keywords

JapaneseObservational Study

Outcome Measures

Primary Outcomes (1)

  • Objective Response Rate (ORR)

    Up to 5 years

Secondary Outcomes (7)

  • Overall Survival (OS)

    From date of starting nivolumab plus ipilimumab to the date of death from any cause. (Up to 5 years)

  • Progression-free Survival (PFS) per Response Evaluation Criteria in Solid Tumors (RECIST) 1.1 by Investigator

    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 5 years)

  • Change in tumor response over time

    Up to 5 years

  • Duration of Response (DOR)

    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 5 years)

  • 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

    Up to 6 months

  • +2 more secondary outcomes

Study Arms (1)

Cohort 1

Participants with advanced or metastatic renal cell carcinoma (aRCC) receiving the combination of nivolumab plus ipilimumab as the first line of systemic therapy

Eligibility Criteria

Age20 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodProbability Sample
Study Population

The study population consists of Japanese participants who will be treated with the combination of nivolumab+ipilimumab as first line of systematic therapy in the real world setting.

You may qualify if:

  • Histological confirmation of Renal Cell Carcinoma (RCC)
  • No prior systemic therapy for RCC
  • Participants who are planned to start treatment with nivolumab and ipilimumab regimen in the timeframe between after IRB approval to enrollment-end date
  • International Metastatic Renal Cell Carcinoma Database Consortium (IMDC) risk category Intermediate/Poor

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Local Institution - 0001

Tokyo, 1070052, Japan

Location

Related Publications (2)

  • Sazuka T, Tatsugami K, Shirotake S, Hamamoto S, Nozawa M, Numakura K, Mizokami A, Kondo T, Naito S, Abe T, Ohba K, Kimura G, Onodera S, Yamaguchi K, Uemura H. Outcomes of Nivolumab-Plus-Ipilimumab in Metastatic Renal Cell Carcinoma: Second Interim Analysis of the J-ENCORE Study. Int J Urol. 2026 Jan;33(1):e70281. doi: 10.1111/iju.70281. Epub 2025 Nov 25.

    PMID: 41292059DERIVED

  • Nishimoto K, Kimura G, Sazuka T, Hamamoto S, Nozawa M, Numakura K, Mizokami A, Kondo T, Naito S, Abe T, Ohba K, Nagata M, Onodera S, Ito H, Uemura H. The Effectiveness and Safety Profile of Nivolumab-Plus-Ipilimumab in Previously Untreated Japanese Patients With Advanced or Metastatic Renal Cell Carcinoma (J-ENCORE Study). Int J Urol. 2025 Aug;32(8):961-972. doi: 10.1111/iju.70076. Epub 2025 Apr 24.

    PMID: 40271863DERIVED

Related Links

MeSH Terms

Conditions

Carcinoma, Renal Cell

Condition Hierarchy (Ancestors)

AdenocarcinomaCarcinomaNeoplasms, Glandular and EpithelialNeoplasms by Histologic TypeNeoplasmsKidney NeoplasmsUrologic NeoplasmsUrogenital NeoplasmsNeoplasms by SiteFemale Urogenital DiseasesFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital DiseasesKidney DiseasesUrologic DiseasesMale Urogenital Diseases

Study Officials

  • Bristol-Myers Squibb

    Bristol-Myers Squibb

    STUDY DIRECTOR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

July 31, 2019

First Posted

August 2, 2019

Study Start

September 19, 2019

Primary Completion

August 23, 2024

Study Completion

August 23, 2024

Last Updated

February 14, 2025

Record last verified: 2025-02

Locations

JP(1)